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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 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 10 FDA device recalls.

Clear
DateProductReasonClassFirm
Mar 9, 2015 TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Compon... The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... Class II Specialty Appliance Works, Inc.
Mar 9, 2015 Upper Right Telescope Unibodies (5/pk) and Upper Left Telescope Unibodies (54... The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... Class II Specialty Appliance Works, Inc.
Mar 9, 2015 Herbst Universal Nut which is used in a Herbst Appliance A Herbst Appliance ... The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... Class II Specialty Appliance Works, Inc.
Mar 9, 2015 LR Telescoping Cantilever Arms (5/pk) and LL Telescoping Cantilever Arms (5/p... The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... Class II Specialty Appliance Works, Inc.
Mar 9, 2015 HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 2... The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... Class II Specialty Appliance Works, Inc.
Mar 9, 2015 M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst Appliance is us... The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... Class II Specialty Appliance Works, Inc.
Mar 9, 2015 MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient... The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... Class II Specialty Appliance Works, Inc.
Mar 9, 2015 TS Herbst Nuts with Backing (10/pk) and TS Herbst Nuts Universal (10/pk) A H... The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... Class II Specialty Appliance Works, Inc.
Mar 9, 2015 Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21,... The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... Class II Specialty Appliance Works, Inc.
Mar 9, 2015 TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC ... The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not t... Class II Specialty Appliance Works, 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.