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Browse Device Recalls

64 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 64 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 64 FDA device recalls.

Clear
DateProductReasonClassFirm
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-18... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-1... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
May 25, 2022 Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C... The products may contain excess coating material on the outside and/or interior of the needle com... Class II Cook Incorporated
May 5, 2022 Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MW... The loading cartridges included with these devices may contain a small, unintended, stainless-ste... Class II Cook Incorporated
May 5, 2022 Tornado Embolization Microcoil, RPN ... The loading cartridges included with these devices may contain a small, unintended, stainless-ste... Class II Cook Incorporated
May 5, 2022 Nester Embolization Microcoil RPN GPN ... The loading cartridges included with these devices may contain a small, unintended, stainless-ste... Class II Cook Incorporated

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.