Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
Dec 26, 2018 Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag ... Class I WEST PHARMA. SERVICES IL, LTD
Dec 26, 2018 Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag ... Class I WEST PHARMA. SERVICES IL, LTD
Dec 26, 2018 Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only Adverse events have been reported with the use of oxytocin in conjunction with the product in pre... Class I WEST PHARMA. SERVICES IL, 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.