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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

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DateProductReasonClassFirm
Jun 25, 2025 NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662 Engaging titanium base was manufactured 180 degrees around the post from where it should be locat... Class II Preat Corp
Jun 24, 2025 Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 90... Due to manufacturing error, digital analog rotational feature is 180 degrees off. Class II Preat Corp
Apr 2, 2025 Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat... Due to manufacturing issues, abutment products were manufactured with screw seat located too high... Class II Preat Corp
Jun 25, 2024 Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatibl... Due to a manufacturing issue, the product has a out of specification rotation of the digital anal... Class II Preat Corp
Apr 10, 2024 9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too b... Due to incorrect milled titanium abutment being packaged and labeled. Class II Preat Corp
Feb 9, 2024 Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967 Due to a manufacturing issue, the screw seat location on the abutment product may be too high, ca... Class II Preat Corp
Jul 18, 2023 Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, S... The healing abutments contain a dimensional condition that may lead to a gap between the healing ... Class II Preat Corp
Jul 18, 2023 Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Ste... The healing abutments contain a dimensional condition that may lead to a gap between the healing ... Class II Preat Corp
Jul 18, 2023 Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, S... The healing abutments contain a dimensional condition that may lead to a gap between the healing ... Class II Preat Corp
Feb 21, 2023 Neodent GM X 6mm Engaging Titanium Base, REF: 9007162 Engaging titanium base contains a dimensional condition that allows vertical movement of the tita... Class II Preat Corp
Feb 1, 2023 PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials... Product is labeled with an incorrect expiration date. Class III Preat Corp

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.