Recalls in 2023
By month
Drugs & medical recalls in the United States in 2023
- 2023-12-27
USStryker Spine recalls LITe Decompression Snake Arm, REF 48080230
Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft.
- US
Siemens Healthcare Diagnostics Inc recalls RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to…
RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of…
FDA · DeviceSiemens Healthcare Diagnostics IncNationwide with Worldwide Distribution to: Albania Algeria Angola Argentina…Official notice → - US
Maquet Medical Systems USA recalls Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable. Fracture of the venous probe cable may influence the management of extracorporeal support. Patient may be…
FDA · DeviceMaquet Medical Systems USADomestic distribution Nationwide. Foreign distribution to Argentina,…Official notice → - US
Abbott Laboratories recalls Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01.…
The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
FDA · DeviceAbbott LaboratoriesDistribution was made to AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA,…Official notice → - US
Zeus Scientific, Inc. recalls ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved by FDA prior to its implementation.
- US
Siemens Healthcare Diagnostics Inc recalls epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX),…
Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the results are run on the epoc NXS…
- US
Maquet Medical Systems USA recalls CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the…
CARDIOHELP-i System was not properly tested to measure leakage current
FDA · DeviceMaquet Medical Systems USANationwide-WW Distribution to Argentina, Australia, Austria, Azerbaijan,…Official notice → - US
Maquet Cardiovascular, LLC recalls Acrobat-i Vacuum Positioner System, Model Number XP-5000Z
The Positioner Arm may not tighten or lock during normal use.
- US
Exactech, Inc. recalls AcuMatch Hip System, Catalog Number 142-32-27
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
FDA · DeviceExactech, Inc.US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and…Official notice → - US
Philips North America Llc recalls The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional…
Three software issues affecting incorrect image display, error interpreting patient images due to image reporting, and patient exposure to incorrect image/function during clinical use.
FDA · DevicePhilips North America LlcDomestic: AL, AR, AZ, CA, FL, GA, HI, IL, IN, KY, LA, MD, ME, MI, MS, NC, NJ,…Official notice → - US
Karl Storz Endoscopy recalls Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
FDA · DeviceKarl Storz EndoscopyUS: MI, NH, SC, PA, FL, NY, NC, MS, MO, CA, NJ, IL, NV, OK, CO, OH, WA, WI,…Official notice → - US
Biomet, Inc. recalls Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02
One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck…
FDA · DeviceBiomet, Inc.US States: AL, CA, MD, MI, NC, OH, OK, TN, TX. Netherlands.Official notice → - US
Olympus Corporation of the Americas recalls ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop…
Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
FDA · DeviceOlympus Corporation of the AmericasUS: AL, FL, GA, KS, LA, MD, MI, NC, NJ, NY, TX, WI & WV and Canada.Official notice → - US
Physio-Control, Inc. recalls AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA.
FDA · DevicePhysio-Control, Inc.US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO,…Official notice → - US
CardioQuip, LLC recalls CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
FDA · DeviceCardioQuip, LLCUS: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: NoneOfficial notice → - US
Vero Biotech, LLC recalls VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric oxide (NO) for…
Cassette did not meet an 1n-process flow criterion.
- US
Inpeco S.A. recalls Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate…
Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing.
FDA · DeviceInpeco S.A.Worldwide - US Nationwide distribution in the state of MA and the countries of…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7…
Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide and the countries of Albania, Algeria, Argentina,…Official notice → - US
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of…
FDA · DeviceFresenius Kabi USA, LLCUS distribution to states of: CA, CO, NJ, UT, and WI.Official notice → - US
ResMed Ltd. recalls AirTouch F20 Full Face Mask and User Guide
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing…
FDA · DeviceResMed Ltd.US nationwide distribution including Puerto Rico, Guam, and Virgin Islands.…Official notice → - US
Nurse Assist, LLC recalls 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH…
Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which…
FDA · DeviceNurse Assist, LLCUS Nationwide Distribution: SC AZ, CA, FL, GA, HI, IA, IN, KS, KY, MA, ME, MN,…Official notice → - US
Blistex Inc recalls Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aerosol cans (UPC 0 41388 0041 2, NDC 10157-4645-1) and b) 5.3…
Chemical contamination: Presence of benzene
- US
Noah's Wholesale LLC recalls THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blister card, Distributed by Steele Productions: Hallandale, FL…
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved…
- US
Fagron, Inc recalls NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot…
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
FDA · DrugFagron, IncProduct was distributed to 1 distributor and may have further distributed the…Official notice → - US
The Harvard Drug Group LLC dba Major Pharmaceuticals and… recalls Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC…
Failed Content Uniformity Specifications
FDA · DrugThe Harvard Drug Group LLC dba Major Pharmaceuticals and…Nationwide in the USAOfficial notice → - US
Private Label Partners, Inc. recalls Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-Coastal Pharma Int. LLC, Shrewsbury, NJ 07702, NDC…
CGMP Deviations: Stability data does not support expiry date.
- US
Insight Pharmaceuticals Corporation recalls TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET WT 4.5 oz (128 g) cans, Distributed by: Insight…
Chemical Contamination; presence of benzene.
- 2023-12-20
- US
Olympus Corporation of the Americas recalls TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.
FDA · DeviceOlympus Corporation of the AmericasWorldwide - US Nationwide distribution in the states of AK, AL, AZ, CA, GA,…Official notice → - US
- US
Maquet Medical Systems USA recalls CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the…
Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the…
FDA · DeviceMaquet Medical Systems USAWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - US
C.R. Bard Inc recalls Sensica Urine Output System, Catalog Number SCCS1002
BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed during a patient monitoring session which resulted in 1)…
- US
GE Hangwei Medical Systems, Co. LTD recalls The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator,…
GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products which may result in a potential fall of elements of the…
- US
CHANGE HEALTHCARE CANADA COMPANY recalls Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.
FDA · DeviceCHANGE HEALTHCARE CANADA COMPANYUS Nationwide distribution. There was no military/government distribution.Official notice → - 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 → - US
Integra LifeSciences Corp. recalls CereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model…
Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective action includes a design change to the extension cable to…
FDA · DeviceIntegra LifeSciences Corp.US distribution nationwide to the following states: AL AR AZ CA CO CT DC DE FL…Official notice → - US
Ortho-Clinical Diagnostics, Inc. recalls VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen…
- US
- US
Encore Medical, LP recalls RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver
FDA · DeviceEncore Medical, LPU.S.: AZ, CA, FL, IN, KS, KY, ME, MN, MS, NJ, OH, Puerto Rico, RI, SC, TN, TX,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls STERILE PVP SOLUTION, REF DYNDA1907
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.Official notice → - US
Limacorporate S.p.A recalls PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Due to incorrect product labeling