Browse Device Recalls

1,646 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,646 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 1,646 FDA device recalls in MN.

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DateProductReasonClassFirm
Jul 18, 2024 smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) RE... Uncertainty in the seal integrity of the sterile packaging. Class II Smiths Medical ASD Inc.
Jul 18, 2024 smiths medical portex, Y' PIECE 15MM, REF 100/276/000 Uncertainty in the seal integrity of the sterile packaging. Class II Smiths Medical ASD Inc.
Jul 18, 2024 smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY ... Uncertainty in the seal integrity of the sterile packaging. Class II Smiths Medical ASD Inc.
Jul 18, 2024 vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Mate... There is the potential for holes in the clear sterile barrier of the device pouch which may impac... Class II Boston Scientific Corporation
Jul 18, 2024 smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100... Uncertainty in the seal integrity of the sterile packaging. Class II Smiths Medical ASD Inc.
Jul 18, 2024 Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M00... There is the potential for holes in the clear sterile barrier of the device pouch which may impac... Class II Boston Scientific Corporation
Jul 18, 2024 VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M0012453... There is the potential for holes in the clear sterile barrier of the device pouch which may impac... Class II Boston Scientific Corporation
Jul 16, 2024 CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also ... Damage to the battery pack may have caused a short to a capacitor within the battery pack. While... Class I Smiths Medical ASD Inc.
Jul 12, 2024 DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagn... Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially ... Class II Beckman Coulter, Inc.
Jul 11, 2024 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Produ... Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential ... Class II Medtronic Inc.
Jul 10, 2024 Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RS... Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized Pneumatic... Class II Beckman Coulter, Inc.
Jul 9, 2024 Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312 During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrect... Class II Medtronic Perfusion Systems
Jun 26, 2024 CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model... The adapter input plug can become damaged or broken. If the input plug is damaged, the metal con... Class II Smiths Medical ASD, Inc.
Jun 26, 2024 ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code... Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 17, 2024 Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programm... A subset of the handsets within the kit may not be able to complete the pairing process with the ... Class II Medtronic Neuromodulation
Jun 14, 2024 Discrete photometric chemistry analyzer for clinical use. Beckman Coulter, Inc. has identified a rise in reagent carousel motion errors in Access 2 Immunoa... Class II Beckman Coulter, Inc.
Jun 7, 2024 smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with B... There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation l... Class I Smiths Medical ASD Inc.
Jun 7, 2024 smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BL... There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation l... Class I Smiths Medical ASD Inc.
Jun 7, 2024 smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) ... There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation l... Class I Smiths Medical ASD Inc.
Jun 4, 2024 Dxl 9000 Access Immunoassay Analyzer, Catalog #C11137. The analyzers were built with nonconforming USB cables made with brass contacts instead of specif... Class II Beckman Coulter, Inc.
Jun 3, 2024 Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a ... During sterile barrier testing performed on the decanter product line, the samples were identifie... Class II Microtek Medical Inc.
Jun 3, 2024 C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine wit... During sterile barrier testing performed on the decanter product line, the samples were identifie... Class II Microtek Medical Inc.
Jun 3, 2024 Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a ... During sterile barrier testing performed on the decanter product line, the samples were identifie... Class II Microtek Medical Inc.
Jun 3, 2024 Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a po... During sterile barrier testing performed on the decanter product line, the samples were identifie... Class II Microtek Medical Inc.
Jun 3, 2024 Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a ... During sterile barrier testing performed on the decanter product line, the samples were identifie... Class II Microtek Medical Inc.
May 31, 2024 Pneupac paraPAC plus 300 ventilator kit, REF P300NXX There is a potential for inadvertent tidal volume knob movement from the original setting when se... Class I Smiths Medical ASD Inc.
May 31, 2024 paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N Smiths Medical became aware of an issue related to a potential for the patient outlet connector t... Class I Smiths Medical ASD Inc.
May 31, 2024 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 t... Class I Smiths Medical ASD Inc.
May 31, 2024 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 se... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONA... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHE... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRA... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOM... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIA... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY ... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOM... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY ... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEO... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOS... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NE... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.
May 29, 2024 PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY T... Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/... Class I Smiths Medical ASD Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.