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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
Jul 27, 2017 iVue 500 with iScan, D216606. Product non-contact, high resolution tomogr... FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). Class II Optovue, Inc.
Jul 27, 2017 iVue with Normative Database, Device Listing Number D185549. Product Usage... FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). Class II Optovue, Inc.
Jul 27, 2017 iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-... FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). Class II Optovue, Inc.
Mar 16, 2016 iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0... A software anomaly was detected that affects Optovue iVue and iVue 500 with Normative Database th... Class II Optovue, Inc.
May 14, 2013 Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1.... Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in i... Class III Optovue, Inc.
Sep 7, 2012 Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped ... Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "Th... Class II Optovue Inc.

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.