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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Jun 23, 2020 TTDEYE (brand) Flower Brown, B16112210 - Product Usage: Colored contact lenses Colored contact lenses were distributed without FDA clearance. Class II Chengdu Ai Qin E-commerce Co., Ltd
Jun 23, 2020 TTDEYE (brand) Flower Grey, B16112231 - Product Usage: Colored contact lenses Colored contact lenses were distributed without FDA clearance. Class II Chengdu Ai Qin E-commerce Co., Ltd
Jun 23, 2020 TTDEYE (brand) Diamonds Starlight, B16112203 - Product Usage: Colored contact... Colored contact lenses were distributed without FDA clearance. Class II Chengdu Ai Qin E-commerce Co., Ltd
Jun 23, 2020 TTDEYE (brand) Devil Red, B16112201 - Product Usage: Colored contact lenses Colored contact lenses were distributed without FDA clearance. Class II Chengdu Ai Qin E-commerce Co., Ltd
Jun 23, 2020 TTDEYE (brand) Black Starshine, B16112100 - Product Usage: Colored contact le... Colored contact lenses were distributed without FDA clearance. Class II Chengdu Ai Qin E-commerce Co., Ltd
Jun 23, 2020 TTDEYE (brand) Radial Pink, B16112110 - Product Usage: Colored contact lenses Colored contact lenses were distributed without FDA clearance. Class II Chengdu Ai Qin E-commerce Co., Ltd
Jun 23, 2020 TTDEYE (brand) Radial Brown, B16112109 - Product Usage: Colored contact lenses Colored contact lenses were distributed without FDA clearance. Class II Chengdu Ai Qin E-commerce 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.