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

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

Clear
DateProductReasonClassFirm
Nov 28, 2023 Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056 AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provide... Class II AtriCure, Inc.
Nov 28, 2023 Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053 AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provide... Class II AtriCure, Inc.
May 29, 2019 EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Produ... The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has ... Class II AtriCure, Inc.
Jan 22, 2019 COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002 There is a potential for patients undergoing ablation to experience an elevated risk for TE; duri... Class II AtriCure, Inc.
Jan 22, 2019 COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001 There is a potential for patients undergoing ablation to experience an elevated risk for TE; duri... Class II AtriCure, Inc.
Jan 22, 2019 COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S There is a potential for patients undergoing ablation to experience an elevated risk for TE; duri... Class II AtriCure, Inc.
Jan 22, 2019 COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI There is a potential for patients undergoing ablation to experience an elevated risk for TE; duri... Class II AtriCure, Inc.
Nov 30, 2016 AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A sin... A complaint of the PRO2 jaw breaking prior to surgery being performed. Class II AtriCure, Inc.
Sep 22, 2016 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product ... There is a potential for a component failure of the device which could necessitate medical interv... Class II AtriCure, Inc.
Sep 22, 2016 COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA ... Due to product design and process control, part of the device can separate and remain behind when... Class II AtriCure, Inc.
Jan 23, 2014 Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive,... The firm was notified by a customer of a cracked spring in the handle of the RCD1 device. Class II Atricure Inc

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.