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Browse Device Recalls

16 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 16 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 16 FDA device recalls.

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DateProductReasonClassFirm
Dec 17, 2019 VitreQ 27G Blunt Needles with luer-lock connector-REF: CN27.D05 GTIN:871921... Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 (1) VitreQ 20G BF Blunt Needles-Ref: BF20.D51 GTIN: 8719214221089 (2) Vitre... Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 VitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461 Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 VitreQ 25G Blunt Needles with luer-lock connector-REF : CN25.D05 GTIN: 8719... Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508 Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 VitreQ 25G Pick Needles-REF: CN25.D04 GTIN: 8719214221607 Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386 Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 (1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25... Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 VitreQ 25G Silicone Tipped Cannula-REF: CN25.D01 GTIN: 8719214221522 Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362 Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 VitreQ 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485 Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 VitreQ 25G VFI Cannula-REF: CN25.D03 GTIN: 8719214221447 Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 VitreQ 23G VFI Cannula-REF: CN23.D03 GTIN: 8719214221423 Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 (1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23... Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 VitreQ 23G Blunt Needles with luer-lock connector-REF: CN23.D05 GTIN: 8719... Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv
Dec 17, 2019 VitreQ 23G Pick Needles-REF: CN23.D04 GTIN: 8719214221584 Microscopic tears of the sterile pouch may compromise sterility Class II Vitreq Bv

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.