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Browse Device Recalls

8 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 8 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 8 FDA device recalls.

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DateProductReasonClassFirm
Jul 26, 2021 Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impres... Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientatio... Class II Paltop Advanced Dental Solutions Ltd
Jul 26, 2021 Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impress... Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientatio... Class II Paltop Advanced Dental Solutions Ltd
Jul 26, 2021 Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impress... Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientatio... Class II Paltop Advanced Dental Solutions Ltd
Jul 26, 2021 Scan Abutment WP, Cat. No. 30-70106 - Product Usage: used to take an impress... Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientatio... Class II Paltop Advanced Dental Solutions Ltd
Jul 26, 2021 Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impressi... Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientatio... Class II Paltop Advanced Dental Solutions Ltd
Jul 26, 2021 Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impressi... Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientatio... Class II Paltop Advanced Dental Solutions Ltd
Nov 18, 2019 Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020 Some of the implants were packaged with a Standard Platform Cover Screw instead of a Narrow Platf... Class II Paltop Advanced Dental Solutions Ltd
May 30, 2019 Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P Surface micro/nano topography on some of the implants contained within this lot may not be consi... Class II Paltop Advanced Dental Solutions Ltd

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.