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Browse Device Recalls

19 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 19 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 19 FDA device recalls.

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DateProductReasonClassFirm
Nov 24, 2025 Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer. A certain component of affected devices was not delivered within specification and contained impu... Class I Draeger, Inc.
Nov 24, 2025 Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer. A certain component of affected devices was not delivered within specification and contained impu... Class I Draeger, Inc.
Nov 10, 2025 ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for c... Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. Class I Draeger, Inc.
Nov 10, 2025 ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for condu... Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. Class I Draeger, Inc.
Nov 10, 2025 ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for co... Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. Class I Draeger, Inc.
Nov 10, 2025 ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for c... Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. Class I Draeger, Inc.
Sep 9, 2025 Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 ... The device either indicated a failure of the piston ventilator before use or suffered a failure o... Class I Draeger, Inc.
Sep 9, 2025 Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 S... The device either indicated a failure of the piston ventilator before use or suffered a failure o... Class I Draeger, Inc.
Jun 16, 2025 HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter. Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filt... Class I Draeger, Inc.
Jun 16, 2025 SafeStar 60A Plus Filter. Bidirectionally breathing system filter. Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filt... Class I Draeger, Inc.
Jun 16, 2025 SafeStar 55 Plus Filter. Bidirectionally breathing system filter. Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filt... Class I Draeger, Inc.
Jun 16, 2025 SafeStar 90 Plus Filter. Bidirectionally breathing system filter. Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filt... Class I Draeger, Inc.
Mar 12, 2025 Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Numb... The potential for cracks forming in the breathing circuit hose. Class I Draeger, Inc.
Mar 12, 2025 Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... The potential for cracks forming in the breathing circuit hose. Class I Draeger, Inc.
Mar 12, 2025 Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... The potential for cracks forming in the breathing circuit hose. Class I Draeger, Inc.
Mar 12, 2025 Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... The potential for cracks forming in the breathing circuit hose. Class I Draeger, Inc.
Mar 12, 2025 Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... The potential for cracks forming in the breathing circuit hose. Class I Draeger, Inc.
Mar 12, 2025 Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... The potential for cracks forming in the breathing circuit hose. Class I Draeger, Inc.
Mar 12, 2025 Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: ... The potential for cracks forming in the breathing circuit hose. Class I Draeger, 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.