Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

12 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 12 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 12 FDA device recalls.

Clear
DateProductReasonClassFirm
Feb 5, 2019 Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol a... Patient results may be falsely elevated. This patient impact only applies to patients currently ... Class II Abbott Ireland Diagnostics Division
Feb 5, 2019 Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradi... Patient results may be falsely elevated. This patient impact only applies to patients currently ... Class II Abbott Ireland Diagnostics Division
Nov 21, 2018 Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferriti... Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in so... Class II Abbott Ireland Diagnostics Division
Nov 21, 2018 Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532 Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in so... Class II Abbott Ireland Diagnostics Division
Nov 21, 2018 Alinity i TSH Reagent Kit, List Number 07P4830 Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in so... Class II Abbott Ireland Diagnostics Division
Nov 21, 2018 Alinity i Free T4 Reagent Kit, List Number 07P7030 Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in so... Class II Abbott Ireland Diagnostics Division
Nov 21, 2018 Alinity i Estradiol Reagent Kit, List Number 07P5020 Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in so... Class II Abbott Ireland Diagnostics Division
Nov 21, 2018 Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121 Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in so... Class II Abbott Ireland Diagnostics Division
Nov 21, 2018 Alinity i Progesterone Reagent Kit, List Number 08P3620 Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in so... Class II Abbott Ireland Diagnostics Division
Oct 12, 2018 ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR pla... Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results du... Class II Abbott Ireland Diagnostics Division
Oct 12, 2018 ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR plat... Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results du... Class II Abbott Ireland Diagnostics Division
Sep 11, 2014 ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.... 17% of ARCHITECT Total T3 Reagent Kit, LN 7K64-20/-25 reagent lots 38901UI00 and 38901UI01 may ex... Class II Abbott Ireland Diagnostics Division

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.