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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
May 21, 2015 Sure T, contact, contact detach, neria, neria detach, neria multi and thalase... Unomedical has found that in rare cases the steel needle can break during use, interrupting the d... Class II Unomedical As
Nov 7, 2014 Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm,... Tubing detachment Class II Unomedical As
Nov 7, 2014 Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Par... Tubing detachment Class II Unomedical As
Nov 7, 2014 SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm... Tubing detachment Class II Unomedical As
Nov 7, 2014 Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach,... Tubing detachment Class II Unomedical As
Nov 7, 2014 AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/... Tubing detachment Class II Unomedical As
Nov 7, 2014 Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 ... Tubing detachment Class II Unomedical As

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.