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

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

Clear
DateProductReasonClassFirm
Dec 18, 2025 Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE... Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly... Class II Vascutek, Ltd.
Jul 8, 2021 The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular... The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S.... Class II Vascutek, Ltd.
Jul 8, 2021 The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-... The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S.... Class II Vascutek, Ltd.
May 15, 2015 Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an... Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft. Class II Vascutek, Ltd.
May 15, 2015 Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an... Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft. Class II Vascutek, Ltd.
Jul 15, 2014 Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO c... The cautery that is provided with the Gelweave graft in the box has a shorter shelf life indicate... Class II Vascutek, Ltd.

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.