Browse Device Recalls

395 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 395 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 395 FDA device recalls.

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DateProductReasonClassFirm
Mar 4, 2025 Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 2... The impacted lots have a higher occurrence of invalid rates when compared to the product Instruct... Class II Abbott Diagnostics Scarborough, Inc.
Mar 4, 2025 Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number:... the impacted lots have a higher occurrence of invalid rates when compared to the product Instruct... Class II Abbott Diagnostics Scarborough, Inc.
Mar 4, 2025 Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 2... the impacted lots have a higher occurrence of invalid rates when compared to the product Instruct... Class II Abbott Diagnostics Scarborough, Inc.
Feb 15, 2025 Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code... Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal tem... Class II Abbott Medical
Nov 21, 2024 The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model ... Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a speci... Class II Abbott Medical
Nov 6, 2024 20/30 Priority Pack Kit/.115 RHV, REF: 1000186-115, used for cardiovascular p... Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rot... Class II Abbott Vascular Inc
Nov 6, 2024 20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in c... Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rot... Class II Abbott Vascular Inc
Nov 6, 2024 20/30 Priority Pack Accessory Kit/.096 RHV, REF: 1000186, or use during vascu... Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rot... Class II Abbott Vascular Inc
Nov 6, 2024 20/30 Priority Pack Accessory Kit w/Copilot, REF: 1003327, used for cardiovas... Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rot... Class II Abbott Vascular Inc
Oct 17, 2024 Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NV... A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was ... Class II Abbott Medical
Oct 17, 2024 Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, N... A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was ... Class II Abbott Medical
Oct 17, 2024 Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 3... A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was ... Class II Abbott Medical
Oct 17, 2024 Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was ... Class II Abbott Medical
Oct 17, 2024 Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was ... Class II Abbott Medical
Oct 1, 2024 Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merl... Due to heart transmitter not being able to upgrade to the current software version in the field a... Class III Abbott Medical
Oct 1, 2024 Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is i... Due to heart transmitter not being able to upgrade to the current software version in the field a... Class III Abbott Medical
Sep 12, 2024 Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: ... Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control ... Class II Abbott Molecular, Inc.
Sep 12, 2024 Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: ... Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control ... Class II Abbott Molecular, Inc.
Jul 24, 2024 FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 ... Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously ... Class I Abbott Diabetes Care, Inc.
Jun 17, 2024 Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived. Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distr... Class II Abbott Diagnostics Technologies AS
Jun 14, 2024 Alinity hq Analyzer, REF: 09P68-01 1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then ... Class II Abbott Laboratories
May 22, 2024 Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only Their is a potential that the implantable pulse generator replacement indicator and end of servic... Class II Abbott Medical
May 22, 2024 Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only Their is a potential that the implantable pulse generator replacement indicator and end of servic... Class II Abbott Medical
May 22, 2024 Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only Their is a potential that the implantable pulse generator replacement indicator and end of servic... Class II Abbott Medical
May 22, 2024 Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only Their is a potential that the implantable pulse generator replacement indicator and end of servic... Class II Abbott Medical
May 16, 2024 Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx ... The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY Deep brain stimulation system will first turn off after approximately 50 days after the system is... Class II Abbott Medical
May 16, 2024 Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx ... The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx ... The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
May 16, 2024 Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only The duration between the implantable pulse generator reaching the elective replacement indicator... Class II Abbott Medical
Mar 20, 2024 Alinity m System, Part Number: 08N53-002 The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and t... Class II Abbott Molecular, Inc.
Mar 4, 2024 Alinity i Anti-HCV Reagent Kit, List Number 08P0521 Customer complaints were received regarding falsely elevated results for some patient samples. In... Class II Abbott GmbH
Mar 4, 2024 ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35 Customer complaints were received regarding falsely elevated results for some patient samples. In... Class II Abbott GmbH
Mar 1, 2024 Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170 There is a potential that the Cholestech LDX battery (an external battery pack available as an op... Class II Alere San Diego, Inc.
Feb 21, 2024 ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. The reason for the recall is the failure of calibration and quality controls due to a manufacturi... Class II Abbott Laboratories
Feb 5, 2024 Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO Their is a potential that electromagnetic interference may cause leadless pacemaker may result in... Class II Abbott Medical
Feb 1, 2024 In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange... Products that were intended for export only which were not approved or registered in accordance w... Class III Abbott Molecular, Inc.
Feb 1, 2024 In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, R... Products that were intended for export only which were not approved or registered in accordance w... Class III Abbott Molecular, Inc.
Feb 1, 2024 Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This... Products that were intended for export only which were not approved or registered in accordance w... Class III Abbott Molecular, Inc.
Jan 9, 2024 Abbott Point of Care Control Control i-STAT¿ Level 3 1.7 mL Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical... Class II Mckesson Medical-Surgical Inc. Corporate Office
Jan 9, 2024 Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson... Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical... Class II Mckesson Medical-Surgical Inc. Corporate Office
Jan 9, 2024 Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical... Class II Mckesson Medical-Surgical Inc. Corporate Office

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.