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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
Feb 1, 2021 Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter ... Outer coating of the catheter may deteriorate and result in the coating to crack and/or potential... Class II Epimed International, Inc.
Jun 18, 2019 Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 uni... Mislabeled - The product's labeling contains an incorrect size for the catheter included in the k... Class II Epimed International, Inc.
Jun 18, 2019 Versa - Kath Mini Kit, with plastic L.O.R Syringe 12g X 12in (30.5 cm), 5 uni... Mislabeled - The product's labeling contains an incorrect size for the catheter included in the... Class II Epimed International, Inc.
Apr 22, 2016 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the ep... There is a possibility that the needles may have the potential to skive a catheters outer coatin... Class II Epimed International, 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.