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.

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DateProductReasonClassFirm
Jul 9, 2024 Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The ... The weld on the light head frame can crack which could lead to problems such as the light head fr... Class II DKK Dai-Ichi Shomei Co., Ltd.
Jul 9, 2024 Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The... The weld on the light head frame can crack which could lead to problems such as the light head fr... Class II DKK Dai-Ichi Shomei Co., Ltd.
Jul 9, 2024 Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The... The weld on the light head frame can crack which could lead to problems such as the light head fr... Class II DKK Dai-Ichi Shomei Co., Ltd.
Jul 9, 2024 Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The ... The weld on the light head frame can crack which could lead to problems such as the light head fr... Class II DKK Dai-Ichi Shomei Co., Ltd.
Aug 23, 2023 LFS Flat screen arm system with surgical lamp for Models Aurora series, Auror... The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the ... Class II DKK Dai-Ichi Shomei Co., Ltd.
Aug 23, 2023 LFS Flat screen support arm systems without surgical lamp for models Aurora s... The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the ... Class II DKK Dai-Ichi Shomei Co., 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.