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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Aug 8, 2023 Oculus Pentacam AXL Wave, Ref 70020, CE 0123 Their is a potential that optical devices with insufficient anti-reflective coating may lead to... Class II Oculus Optikgeraete GMBH
Aug 8, 2023 Oculus Myopia Master , Ref 68100, CE 0123 Their is a potential that optical devices with insufficient anti-reflective coating may lead to... Class II Oculus Optikgeraete GMBH
Aug 8, 2023 Oculus Pentacam AXL , Ref 70100, CE 0123 Their is a potential that optical devices with insufficient anti-reflective coating may lead to... Class II Oculus Optikgeraete GMBH
Jul 8, 2022 Pentacam HR REF 70900. Used to image the anterior segment of the eye. Due to a software issue, IOL calculator printout often does not accurately reflect the alignment ... Class II Oculus Optikgeraete GMBH
Jul 8, 2022 Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye. Due to a software issue, IOL calculator printout often does not accurately reflect the alignment ... Class II Oculus Optikgeraete GMBH
Jul 8, 2022 Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior... Due to a software issue, IOL calculator printout often does not accurately reflect the alignment ... Class II Oculus Optikgeraete GMBH
Nov 21, 2017 OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11... The device software versions have an anomaly which may produce an erroneous marking for the quali... Class II Oculus Optikgeraete GMBH

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.