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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.

Clear
DateProductReasonClassFirm
Nov 20, 2023 KeySplint Hard Clear - Indicated for the fabrication of orthodontic and denta... Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instr... Class II Keystone Industries
Jul 21, 2023 Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide ... A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish ... Class II Keystone Industries
Apr 10, 2023 Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relinin... The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reli... Class II Keystone Industries

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.