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

61 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 61 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 61 FDA device recalls.

Clear
DateProductReasonClassFirm
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel P... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Kee... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Kee... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Sep 24, 2013 SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD sc... Baxter Healthcare Corporation is recalling the LCD display screen on the SIGMA SPECTRUM Infusion ... Class II Baxter Healthcare Corp.
Jun 10, 2013 SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used... Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion ... Class II Baxter Healthcare Corp.
Feb 5, 2013 Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma ... Potential for the IM rod to break, leaving fragments in the patient. Surgical Techniques guidance... Class II DePuy Orthopaedics, Inc.
Apr 23, 2012 SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. P... Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIG... Class III Sigma
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

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.