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 Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations 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 Brand History Cross-category recall lookup by company
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

460 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 460 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 460 FDA device recalls.

Clear
DateProductReasonClassFirm
Jul 13, 2012 AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutritio... After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUT... Class I Baxter Healthcare Corp.
Jul 13, 2012 AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; aut... After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUT... Class I Baxter Healthcare Corp.
Jul 13, 2012 AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition com... After fluid ingress into the keypad of the AUTOMIX Compounder's (AUTOMIX) control module, the AUT... Class I Baxter Healthcare Corp.
Jul 6, 2012 Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic ... Baxter discovered that a Baxter technical service representative was providing incorrect instruct... Class II Baxter Healthcare Renal Div
Jul 6, 2011 Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library,... Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow condition... Class I Baxter Healthcare Corporation
Mar 4, 2011 Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syr... Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (... Class III Baxter Healthcare Corp.
Mar 4, 2011 Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated s... Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (... Class III Baxter Healthcare Corp.
Jul 31, 2009 Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposabl... There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of th... Class II Baxter Healthcare Corp.
Jul 31, 2009 Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposabl... There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of th... Class II Baxter Healthcare Corp.
Jul 31, 2009 Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposabl... There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of th... Class II Baxter Healthcare Corp.

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.