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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.

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DateProductReasonClassFirm
Oct 4, 2024 CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101. Potential failure of affected units to recharge the battery of the oxygen concentrators. Class II Caire, Inc.
Oct 4, 2024 CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1. Potential failure of affected units to recharge the battery of the oxygen concentrators. Class II Caire, Inc.
Oct 4, 2024 CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103. Potential failure of affected units to recharge the battery of the oxygen concentrators. Class II Caire, Inc.
Oct 4, 2024 CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2. Potential failure of affected units to recharge the battery of the oxygen concentrators. Class II Caire, Inc.
Oct 10, 2022 CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the... Class I Caire, Inc.
Oct 10, 2022 CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the... Class I Caire, Inc.
Oct 10, 2022 CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the... Class I Caire, Inc.
Oct 10, 2022 CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the... Class I Caire, Inc.
Mar 25, 2022 CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense... The device was not cleared for U.S. distribution. Class II Caire, Inc.
Nov 21, 2019 CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeS... Four units of European version FreeStyle Comfort were distributed in the US, but were not cleared... Class II Caire, Inc.
Sep 16, 2019 SAROS Oxygen System Model 3000 There is an electronics control issue that causes the unit to not power on with battery power only. Class II Caire, 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.