Smiths Medical ASD recalls
39 official recalls and safety alerts involving Smiths Medical ASD since 2021-10, from FDA · Device. 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 Smiths Medical ASD or the relevant agency.
- 2025-05-14
USSmiths Medical ASD, Inc. recalls CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number:…
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
- US
Smiths Medical ASD, Inc. recalls CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL…
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
- US
Smiths Medical ASD, Inc. recalls CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to customers using the wireless system. Affected…
Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
- 2025-03-26
- US
Smiths Medical ASD, Inc. recalls CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway…
FDA · DeviceSmiths Medical ASD, Inc.US Nationwide distribution. International distribution pending.Official notice → - US
Smiths Medical ASD, Inc. recalls smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- 2025-03-19
- US
Smiths Medical ASD, Inc. recalls Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035…
Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.
- 2024-12-04
- US
Smiths Medical ASD, Inc. recalls smiths medical PORTEX Tracheal Tube Exchange Guide, 15Ch x 70cm, REF 14-504-68 and REF 14-504-68JP
Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the…
- 2024-11-27
- US
Smiths Medical ASD, Inc. recalls smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF 21-0270-25, for use with the CADD-Solis…
The adapter input plug can become damaged or broken. If the input plug is damaged, the metal contacts to the body of the AC adapter may be exposed or one or more of the AC mains prongs may separate from the input plug.
- 2024-11-06
- US
Smiths Medical ASD Inc. recalls CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory…
Damage to the battery pack may have caused a short to a capacitor within the battery pack. While the battery encasement is designed to be flame retardant, a short to the capacitor could lead to melting of the battery…
- 2024-10-30
- US
Smiths Medical ASD, Inc. recalls medex Arterial Kit 1/EA, Product Code REF MX7827
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable…
- US
Smiths Medical ASD Inc. recalls smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Uncertainty in the seal integrity of the sterile packaging.
- US
Smiths Medical ASD Inc. recalls CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
- 2024-10-02
- US
Smiths Medical ASD Inc. recalls paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.
- 2024-09-18
- US
Smiths Medical ASD Inc. recalls smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number…
There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a manufacturing defect.
- US
Smiths Medical ASD Inc. recalls Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.
- 2024-09-04
- US
Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List…
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
- 2024-08-14
- US
Smiths Medical ASD Inc. recalls CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 ( 21-2120 , 21-2125 , and 21-2127 ) Indicated for the following uses:…
The CADD Solis VIP Ambulatory Infusion Pump is indicated for the following uses: " For intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.
- US
Smiths Medical ASD Inc. recalls CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial,…
CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. Upstream Occlusion, 2. Stop and Power Keys Unresponsive, 3. Manual Mode Air Detector, 4. Single Bubble Air…
- 2024-04-24
- US
Smiths Medical ASD Inc. recalls Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e)…
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead…
- 2024-03-27
- US
Smiths Medical ASD Inc. recalls smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This…
FDA · DeviceSmiths Medical ASD Inc.Worldwide distribution: US (nationwide) and OUS countries of: Algeria,…Official notice → - 2024-02-07
- US
Smiths Medical ASD Inc. recalls smiths medical Medfusion Model 4000 syringe pump
Medfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor Not Running High Priority Alarm (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 2.…
FDA · DeviceSmiths Medical ASD Inc.US nationwide, Canada, Great Britain, Bermuda, Australia, Germany, Singapore,…Official notice → - US
Smiths Medical ASD Inc. recalls smiths medical Medfusion Model 3500 Syringe pump
Medfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with Incorrect Parameters, 3. Screen Lock, 4.…
- 2024-01-24
- US
Smiths Medical Asd Inc recalls 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during…
FDA · DeviceSmiths Medical Asd IncWorldwide distribution - US Nationwide and the countries of Canada, UAE.Official notice → - 2023-11-08
- US
Smiths Medical ASD Inc. recalls Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).
FDA · DeviceSmiths Medical ASD Inc.Distribution was made to AZ, CA, FL, HI, IL, IN, MA, MN, MO, MS, NC, NJ, OH,…Official notice → - 2023-11-01
- US
Smiths Medical ASD Inc. recalls Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1
The complaint involved the absence of a component called "ASM Filter-Pro ABG SYR CAP" from the packaging of Pro-Vent Arterial Blood Sampling (ABG) Kits. Specifically, this issue affected a total of 31,900 kits under…
- 2023-10-18
- US
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6
A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large…
FDA · DeviceSmiths Medical ASD Inc.Worldwide distribution - US Nationwide and the country of Canada.Official notice → - 2023-09-06
- US
Smiths Medical ASD Inc. recalls PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
Smiths Medical identified a labeling error in which the barcode (UDI) was not correctly reflecting the expiration date of the product
- 2023-05-24
- US
Smiths Medical ASD Inc. recalls DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Swivel Elbow with Suction Port for use with…
DuraLife devices instructions for cleaning and sterilization have been determined to be inadequate. Specifically, for the DuraLife product, the IFU does not provide the cleaning method, duration of autoclave cycle or…
FDA · DeviceSmiths Medical ASD Inc.Worldwide distribution - US Nationwide and the countries of Canada, New…Official notice → - 2023-02-08
- US
Smiths Medical ASD Inc. recalls CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6)…
There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms
FDA · DeviceSmiths Medical ASD Inc.Worldwide Distribution: US (nationwide) and OUS countries of: CH, CA, ES, FR,…Official notice → - 2022-11-30
- US
Smiths Medical ASD Inc. recalls Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming…
Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation
FDA · DeviceSmiths Medical ASD Inc.US distribution to states of: Indiana, Texas and VirginiaOfficial notice → - 2022-06-29
- US
Smiths Medical ASD Inc. recalls Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306,…
Multiple issues with the potential for interruption of therapy or over-infusion: 1. Primary Audible Alarm (PAA), 2. Unanticipated Depleted Battery Alarms, 3. Time Base Alarm, 4. Intermittent Volume Over Time (IVOT) -…
FDA · DeviceSmiths Medical ASD Inc.Worldwide distribution. US nationwide including US Virgin Islands, Countries…Official notice → - 2022-02-23
- US
Smiths Medical ASD Inc. recalls Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time…
There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. These alarms occur at start up when the pump goes through the…
FDA · DeviceSmiths Medical ASD Inc.Distribution US nationwide, including PR, VI, GU, and MP. There was…Official notice → - 2021-11-03
- US
Smiths Medical ASD Inc. recalls Bivona Aire-Cuf Endotracheal Tube
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
FDA · DeviceSmiths Medical ASD Inc.Worldwide distribution - US Nationwide distribution in the states of AL, AZ,…Official notice → - US
Smiths Medical ASD Inc. recalls Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Two devices were labeled with the same serial number
- 2021-10-27
- US
Smiths Medical ASD Inc. recalls medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-102RE…
Product has a lack of sterility assurance
FDA · DeviceSmiths Medical ASD Inc.International Distribution to countries of: Armenia, Austria, Germany, Great…Official notice → - US
Smiths Medical ASD Inc. recalls smiths medical portex Loss of Resistance Device, REF 100/398/000
The labeling was missing information on sterilization and prohibition of reuse.
FDA · DeviceSmiths Medical ASD Inc.Canada. Belgium, Great Britain, Ireland, Czech Republic, Spain, France,…Official notice → - US
Smiths Medical ASD Inc. recalls CADD Administration Sets, Model #21-7346-24
Product may have been manufactured with an air filter assembled in an incorrect orientation.
- US
Smiths Medical ASD Inc. recalls CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L…
Specific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. If an AILD does not sufficiently discern fluid from air in line, an air in line event may not be recognized by the pump…
FDA · DeviceSmiths Medical ASD Inc.Distribution to European countries: BE, BH, CH, DE, DK, ES, FI, FR, GB, IT,…Official notice → - 2021-10-20
- US
Smiths Medical ASD Inc. recalls smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
FDA · DeviceSmiths Medical ASD Inc.Austria, France, Germany, Great Britain, and Saudi ArabiaOfficial notice →