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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
Feb 25, 2020 Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Tri... An issue within production process used to package trial kits let to the inclusion of the incorr... Class II Kerr/Pentron, DBA Kerr Corporation and Pentron ...
Jul 13, 2018 Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution Immersion time stated on the bottle is 45 minutes while the product instructions say 90 minutes. Class II Kerr/Pentron, DBA Kerr Corporation and Pentron ...
May 29, 2014 Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3... Kerr Corporation is recalling one (1) lot of Tytin Regular Set ( Part Number 29948, Lot Number 3-... Class II Kerr Corporation
Sep 13, 2013 NX3 Try-In Gel. The product is used as a tooth shade resin material. Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of the NX3 Try-... Class II Kerr/Pentron, DBA Kerr Corporation and Pentron ...
Feb 22, 2013 Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 3... Kerr Corporation is initiating this recall because raw material used to produce the Maxcem Elite... Class II Kerr/Pentron, DBA Kerr Corporation and Pentron ...
Oct 25, 2012 BioPlant, a dental bone grafting material. BioPlant has been assigned the pr... The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may ... Class II Kerr Corporation
Apr 10, 2012 The brand name of the device is Laser Loupes, a dentalloupe with laser eye ... The firm initiated the recall for Laser Loupes because the ink used to mark which laser frequency... Class II Kerr Corporation
Feb 21, 2012 The brand name of the device is AlgiNot, a dental impression material. Produ... The firm recalled the product because it may cure harder than expected within the shelf life, wh... Class II Kerr Corporation
Nov 17, 2011 Freedom Cordless LED Light System. Freedom System, Standard Length, Part Numb... The firm recalled the Freedom Cordless LED Headlight because some units were assembled with an in... Class II Kerr Corporation

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.