Baxter Healthcare recalls
123 official recalls and safety alerts involving Baxter Healthcare since 2021-11, from FDA · Device, FDA · Drug. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Baxter Healthcare or the relevant agency.
- 2026-09-30
USBaxter Healthcare Corporation recalls PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to…
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect…
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the country of Canada.Official notice →- US
Baxter Healthcare Corporation recalls Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description:…
Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of Colorado and Florida.Official notice → - 2026-09-16
- US
Baxter Healthcare Corporation recalls Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC…
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
- 2026-09-09
- US
Baxter Healthcare Corporation recalls Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice → - US
Baxter Healthcare Corporation recalls 0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation,…
Presence of particulate matter: Particulates identified as fiberglass
- US
- 2026-08-19
- US
Baxter Healthcare Corporation recalls Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets
Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.
- US
- 2026-07-08
- US
Baxter Healthcare Corporation recalls Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper Back…
The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating…
FDA · DeviceBaxter Healthcare CorporationWorldwide - US Nationwide distribution in the states of Minnesota, Maryland,…Official notice → - US
Baxter Healthcare Corporation recalls Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion…
There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization,…
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the country of Canada.Official notice → - 2026-06-10
- US
Baxter Healthcare Corporation recalls Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing sets with…
Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system…
FDA · DeviceBaxter Healthcare CorporationWorldwide - US Nationwide distribution including in the states of Alabama,…Official notice → - 2026-04-08
- US
Baxter Healthcare Corporation recalls Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy…
Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or…
- 2026-03-25
- US
Baxter Healthcare Corporation recalls Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Software Version:…
Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
FDA · DeviceBaxter Healthcare CorporationWorldwide - US Nationwide distribution in the states of AZ, CO, IL, IN, KS,…Official notice → - 2026-02-25
- US
Baxter Healthcare Corporation recalls Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description:…
Pumps were released without full testing being performed, including occlusion alarm testing.
- 2026-02-04
- US
Baxter Healthcare Corporation recalls Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC:…
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
- 2026-01-28
- US
Baxter Healthcare Corporation recalls SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication…
- 2025-12-10
- US
Baxter Healthcare Corporation recalls Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece…
Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of California, Colorado, Ohio, and…Official notice → - 2025-10-29
- US
Baxter Healthcare Corporation recalls Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400)…
Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing…
FDA · DeviceBaxter Healthcare CorporationDistribution US nationwide, Canada and Colombia.Official notice → - 2025-10-22
- US
Baxter Healthcare Corporation recalls CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
IV sets may leak.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice → - 2025-10-01
- US
Baxter Healthcare Corporation recalls Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m),…
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.
- 2025-09-10
- US
Baxter Healthcare Corporation recalls Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP…
FDA · DeviceBaxter Healthcare CorporationUS distribution including Puerto Rico and OUS (International) CanadaOfficial notice → - 2025-09-03
- US
Baxter Healthcare Corporation recalls Spectrum IQ Infusion Pump, Product Code 3570009
Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having…
- US
- 2025-08-20
- US
Baxter Healthcare Corporation recalls Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double.…
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the country of Canada.Official notice → - 2025-07-23
- US
Baxter Healthcare Corporation recalls Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
Certain Spectrum infusion pumps may have an incorrect version of software.
FDA · DeviceBaxter Healthcare CorporationUS States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.Official notice → - 2025-07-16
- US
Baxter Healthcare Corporation recalls Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoScale 200…
The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched…
- 2025-06-18
- US
Baxter Healthcare Corporation recalls Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove…
- US
Baxter Healthcare Corporation recalls 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can lead to exposure to excessive heat and user burns.
- 2025-06-04
- US
Baxter Healthcare Corporation recalls Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436,…
There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of the bed.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of BAHRAIN, Canada,…Official notice → - 2025-05-28
- US
Baxter Healthcare Corporation recalls Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.
- 2025-05-21
- US
Baxter Healthcare Corporation recalls Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.
A cybersecurity vulnerability was discovered through internal testing.
- 2025-04-23
- US
Baxter Healthcare Corporation recalls Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Product Code/Part…
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- US
Baxter Healthcare Corporation recalls Welch Allyn Connex Vital Signs Monitor (CVSM):
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.
- 2025-04-02
- US
Baxter Healthcare Corporation recalls Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility,…
The air bladders inside the mattress may move out of position when the head of the bed is elevated, causing a dip in the mattress.
- US
Baxter Healthcare Corporation recalls Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to…
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of AR, CA, FL, IA, IN, LA, MO, MT,…Official notice → - US
Baxter Healthcare Corporation recalls Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
- 2025-03-12
- US
Baxter Healthcare Corporation recalls Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX
There is the potential for missing motor mounting screws, which may have occurred during the servicing process.
- 2025-01-29
- US
Baxter Healthcare Corporation recalls Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of MN, MO, VA, TX, CA, MA, FL, SC.Official notice → - 2025-01-22
- US
Baxter Healthcare Corporation recalls Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
- 2025-01-08
- US
Baxter Healthcare Corporation recalls Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2
Devices were identified as released after repair without full testing being performed, which includes flow testing.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of AL, IN.Official notice → - 2024-12-04
- US
Baxter Healthcare Corporation recalls Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.
- 2024-11-27
- US
Baxter Healthcare Corporation recalls Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using…
FDA · DeviceBaxter Healthcare CorporationWorldwide Distribution (US Nationwide distribution)Official notice → - 2024-11-20
- US
Baxter Healthcare Corporation recalls Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
The door on the Spectrum IQ Infusion pump may not be able to fully close.
- US
Baxter Healthcare Corporation recalls Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive.
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using…
- 2024-11-13
- US
Baxter Healthcare Corporation recalls Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to…
- US
- 2024-11-06
- US
Baxter Healthcare Corporation recalls a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7900B100208,…
The beds have a potential for an interface issue with the Rauland Responder 5 Nurse Call System where the bed exit system will alert at the bed, but may fail to send a remote alert through the nurse call system.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide. There was government and military…Official notice → - 2024-10-30
- US
Baxter Healthcare Corporation recalls Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke.
- US
Baxter Healthcare Corporation recalls Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3)…
The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not supplied to the ventilator before initiating therapy.
- 2024-09-25
- US
Baxter Healthcare Corporation recalls Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the…
- 2024-09-11
- US
Baxter Healthcare Corporation recalls Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose…
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
- 2024-08-28
- US
Baxter Healthcare Corporation recalls Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 infusion…
The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only impacts customers where the Spectrum V8 or Spectrum IQ…
- 2024-08-14
- US
Baxter Healthcare Corporation recalls Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
Improperly performed testing prior to release
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the state of Florida.Official notice → - US
Baxter Healthcare Corporation recalls Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the PST 500 U Precision Surgical Table due to a potential issue with loose spring pins in the spindle drives. This can cause the tabletop…
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the country of Canada.Official notice → - 2024-07-24
- US
Baxter Healthcare Corporation recalls Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent…
Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
FDA · DeviceBaxter Healthcare CorporationNationwide distribution. International distribution to Canada, France, and…Official notice → - 2024-07-17
- US
Baxter Healthcare Corporation recalls Braun Thermoscan¿ PRO 6000 Ear Thermometer
The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU).
FDA · DeviceBaxter Healthcare CorporationDistributed to United States, Canada, Australia, Malaysia, New Zealand,…Official notice → - US
Baxter Healthcare Corporation recalls Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of the tools…
During manufacturing, the step to install an Electromagnetic Interference (EMI) Absorber was omitted. The purpose of the EMI absorber is to prevent EMI leakage that might potentially affect other devices in the…
- US
Baxter Healthcare Corporation recalls Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical light system products listed below. Specific VidiaPort and…
- US
Baxter Healthcare Corporation recalls Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL…
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
- 2024-07-03
- US
Baxter Healthcare Corporation recalls Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002,…
Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. Damage of the battery charger dongle prevents the…
- 2024-06-26
- US
Baxter Healthcare Corporation recalls Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent…
There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning agents containing bleach.
FDA · DeviceBaxter Healthcare CorporationDistribution was made nationwide. There was also government/military…Official notice → - 2024-05-22
- US
Baxter Healthcare Corporation recalls Spectrum IQ Infusion pump, Product Code 357009
There is a potential for cracks on the mount of the front panel of the device.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of Ohio, Wisconsin.Official notice → - 2024-05-15
- US
Baxter Healthcare Corporation recalls Baxter Spectrum IQ Infusion Pump, Product Code 3570009
One device was improperly performed testing prior to release from a Service Center.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the state of Massachusetts.Official notice → - 2024-05-01
- US
Baxter Healthcare Corporation recalls Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery
Product was distributed in the United States without proper regulatory approval.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of LA, GA, IN, VA FL, NY, CA.Official notice → - 2024-04-24
- US
Baxter Healthcare Corporation recalls Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021,…
The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate…
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of Canada, Ireland,…Official notice → - 2024-04-17
- US
Baxter Healthcare Corporation recalls Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 3400, SUREBP,…
Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and international electrical standards.
- 2024-04-10
- US
Baxter Healthcare Corporation recalls Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or…
Inconsistencies were identified with service records associated with corrections performed for a previous Medical Device Correction issued by Baxter (ref number: FA-2022-026). Your devices have been identified as…
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the state of Colorado.Official notice → - 2024-04-03
- US
Baxter Healthcare Corporation recalls Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO
A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal…
FDA · DeviceBaxter Healthcare CorporationUS Distribution to states of: CT, VA, TX, PA and IL; and OUS (foreign)…Official notice → - 2024-03-27
- US
Baxter Healthcare Corporation recalls HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's foot for…
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction System, Traction Boot II, due to the boots being assembled incorrectly. The locking ridge on the front face of the boot…
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the state of Florida.Official notice → - 2024-03-20
- US
Baxter Healthcare Corporation recalls CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DEHP solution set listed below due to potential leaks originating from the drip chamber.
- US
Baxter Healthcare Corporation recalls STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to detach from the traction system. If an impacted device…
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the state of Alabama.Official notice → - 2024-02-28
- US
Baxter Healthcare Corporation recalls Baxter Exactamix Pro 1200, REF EXM12DY
An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the…
FDA · DeviceBaxter Healthcare CorporationUS: AL, AZ, CA, FL, GA, IA, KY, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OR,…Official notice → - US
Baxter Healthcare Corporation recalls Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only,…
Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg /…
- 2024-01-17
- US
Baxter Healthcare Corporation recalls XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz,…
Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.
FDA · DeviceBaxter Healthcare CorporationUnited States (including Puerto Rico), Canada, Australia, Bangladesh, Brunei,…Official notice → - US
Baxter Healthcare Corporation recalls Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.25 GLOBAL; c)…
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or…
- 2023-12-20
- US
Baxter Healthcare Corporation recalls Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the country of Canada.Official notice → - 2023-12-13
- US
- 2023-11-15
- US
Baxter Healthcare Corporation recalls Novum IQ Syringe infusion system, Product Code 40800BAXUS
Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump may display an Infusion Complete alarm even though…
FDA · DeviceBaxter Healthcare CorporationUS Nationwide Distribution to states of: AR, AZ, CA, FL, GA, HI, IA, IN, KS,…Official notice → - 2023-11-08
- US
Baxter Healthcare Corporation recalls HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052,…
Progressa+ beds have the potential for static buildup from the casters and/or power drive. This static electricity could be passed to the operator through the transport handle during transport, resulting in a mild…
FDA · DeviceBaxter Healthcare CorporationUS Nationwide Distribution in the states of: CA, FL, IN, MA, NY, OH, TX, VAOfficial notice → - 2023-10-25
- US
Baxter Healthcare Corporation recalls Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter…
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
- 2023-10-04
- US
Baxter Healthcare Corporation recalls Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x.
Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System software listed below due to a report of the caliper tool becoming…
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide distribution including in the states of…Official notice → - 2023-09-20
- US
Baxter Healthcare Corporation recalls Welch Allyn Connex Spot Monitor
Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the state of CA.Official notice → - 2023-09-06
- US
Baxter Healthcare Corporation recalls Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter…
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
- 2023-08-30
- US
Baxter Healthcare Corporation recalls Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare…
Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.
- 2023-07-26
- US
Baxter Healthcare Corporation recalls GEM FLOW COUPLER Monitor, PN 5156-00000-011
An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the last active…
- 2023-07-19
- US
Baxter Healthcare Corporation recalls Allen Advance Chest Support with Pad
Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of Canada, Australia,…Official notice → - US
Baxter Healthcare Corporation recalls The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009
A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream…
- 2023-07-05
- US
Baxter Healthcare Corporation recalls NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be alerted remotely when assigned…
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL.Official notice → - 2023-05-10
- US
Baxter Healthcare Corporation recalls Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g)…
There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress).
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of Canada, Qatar.Official notice → - 2023-05-03
- US
Baxter Healthcare Corporation recalls GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral…
The product is brittle and potentially crumbling upon handling or when being removed from its package.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of China, Germany,…Official notice → - US
Baxter Healthcare Corporation recalls Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare…
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
- 2023-04-26
- US
Baxter Healthcare Corporation recalls ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe
ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter.
- 2023-04-05
- US
Baxter Healthcare Corporation recalls Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
The electrical safety testing was not properly performed on the impacted devices and additional testing is required
FDA · DeviceBaxter Healthcare CorporationUS distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA.Official notice → - 2023-03-15
- US
Baxter Healthcare Corporation recalls Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal…
MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals. This could lead to exposure to air, resulting in…
- 2023-03-08
- US
Baxter Healthcare Corporation recalls Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals
There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.
- 2023-02-01
- US
Baxter Healthcare Corporation recalls Baxter Electrocardiograph, ELI 380 -DCS21
One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.
- 2022-12-28
- US
Baxter Healthcare Corporation recalls Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of Canada, China,…Official notice → - US
Baxter Healthcare Corporation recalls Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by…
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution. US Nationwide including Guam and St. Thomas USVI;…Official notice → - 2022-11-23
- US
Baxter Healthcare Corporation recalls Hill-Rom Progressa Bed System
The compression links on impacted Progressa beds, listed in Appendix A, may bend when raising the head section. The labeling for these beds list a maximum patient weight of 500 lbs., however the bending may still occur…
FDA · DeviceBaxter Healthcare CorporationWorldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, HI,…Official notice → - 2022-11-09
- US
Baxter Healthcare Corporation recalls Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distract the…
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.
FDA · DeviceBaxter Healthcare CorporationMI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South AfricaOfficial notice → - US
Baxter Healthcare Corporation recalls Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P00697903.
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scanner, fetal monitor/doppler, infusion pumps, and insulin…
- 2022-10-19
- US
Baxter Healthcare Corporation recalls Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.
Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight…
- 2022-10-05
- US
Baxter Healthcare Corporation recalls Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts…
Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide Distribution and government/military distribution.Official notice → - 2022-09-21
- US
Baxter Healthcare Corporation recalls Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
Firm noted an increase in customer reports of leaks.
- 2022-08-31
- US
Baxter Healthcare Corporation recalls Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673100
There is a potential of the packaging not maintaining a sterile barrier for the tip caps.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution: US (nationwide) distribution and OUS (foreign) :…Official notice → - US
Baxter Healthcare Corporation recalls The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the…
There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution: US Nationwide, Canada, Uruguay, Argentina, Brazil,…Official notice → - 2022-08-24
- US
Baxter Healthcare Corporation recalls Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only,…
Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
- 2022-08-03
- US
Baxter Healthcare Corporation recalls ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Abacus V3.1…
There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
FDA · DeviceBaxter Healthcare CorporationUnited States (including Puerto Rico), Argentina, Bermuda, Chile, Colombia,…Official notice → - 2022-07-27
- US
Baxter Healthcare Corporation recalls Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress.
The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of…
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice → - 2022-07-06
- US
Baxter Healthcare Corporation recalls NaviCare Nurse Call/Voalte Nurse Call
An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalte Nurse Call, software versions 3.9.100 through 3.9.300. Calls…
- US
Baxter Healthcare Corporation recalls #1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED
Packaging error.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of Japan, Canada,…Official notice → - 2022-06-08
- US
Baxter Healthcare Corporation recalls 3,65 m Extension Set with Luer-lock Connector
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of CA, MO, MA, AZ, TX, FL, NY, MD, OH.Official notice → - US
Baxter Healthcare Corporation recalls In-Line ventilator adaptor
There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of TX, FL, VA, KY, CA, AZ, WI, IL,…Official notice → - 2022-05-25
- US
Baxter Healthcare Corporation recalls Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and…
Firm discovered a firmware memory leak with a supplier-manufactured component.
- 2022-05-11
- US
Baxter Healthcare Corporation recalls Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to…
There is a potential for foreign matter.
FDA · DeviceBaxter Healthcare CorporationDistribution in the United States including AL, CA, KY, NY, OR, PA, and TX OUS…Official notice → - 2022-05-04
- US
Baxter Healthcare Corporation recalls PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701
This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the Return Pressure Drop Limit…
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of Mexico, Brazil,…Official notice → - 2022-04-27
- US
Baxter Healthcare Corporation recalls Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.
Product is mislabeled as self-righting Luer slip tip caps, yellow.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide distribution in the states of FL, GA,…Official notice → - 2022-04-06
- US
Baxter Healthcare Corporation recalls MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484
Devices distributed lacked regulatory clearance.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of California, Colorado, District of…Official notice → - US
Baxter Healthcare Corporation recalls Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and P3156087.
An incorrect center bolt was used in the assembly of the product which could result in a patient fall during use.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide distribution in the states of AK, AZ,…Official notice → - 2022-03-30
- US
Baxter Healthcare Corporation recalls Compella Therapy Air Supply Unit
Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2022-02-16
- US
Baxter Healthcare Corporation recalls Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as…
- 2022-02-09
- US
Baxter Healthcare Corporation recalls Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of…
FDA · DeviceBaxter Healthcare CorporationWorldwide Distribution. US nationwide Puerto Rico and St. Thomas. There was…Official notice → - 2021-11-17
- US
Baxter Healthcare Corporation recalls Hemodialysis Delivery System, Software Version 2.x.
If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original…
FDA · DeviceBaxter Healthcare CorporationDistributed nationwide to AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KY,…Official notice →