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Browse Device Recalls

13 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 13 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 13 FDA device recalls.

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DateProductReasonClassFirm
Sep 29, 2023 EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.1. Phakic Toric Intraocu... Their is a potential that intraocular implant devices may not meet specifications. Class II Staar Surgical Company
Sep 29, 2023 EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_13.2. Phakic Toric Intraoc... Their is a potential that intraocular implant devices may not meet specifications. Class II Staar Surgical Company
Sep 29, 2023 EVO+VISIAN Implantable Collamer Lens, REF:VICM5_12.1. Phakic Intraocular lens. Their is a potential that intraocular implant devices may not meet specifications. Class II Staar Surgical Company
Sep 29, 2023 EVO VISIAN Implantable Collamer Lens, REF: VICMO12.1. Phakic Intraocular lens. Their is a potential that intraocular implant devices may not meet specifications. Class II Staar Surgical Company
Sep 29, 2023 EVO+VISIAN Implantable Collamer Lens, REF: VTICM5_12.6. Phakic Toric Intraocu... Their is a potential that intraocular implant devices may not meet specifications. Class II Staar Surgical Company
Sep 29, 2023 EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocul... Their is a potential that intraocular implant devices may not meet specifications. Class II Staar Surgical Company
Sep 29, 2023 EVO+VISIAN Implantable Collamer Lens, REF: VICM5_12.6. Phakic Intraocular lens. Their is a potential that intraocular implant devices may not meet specifications. Class II Staar Surgical Company
Sep 29, 2023 EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens. Their is a potential that intraocular implant devices may not meet specifications. Class II Staar Surgical Company
Sep 29, 2023 EVO VISIAN Implantable Collamer Lens REF: VICMO13.2. Phakic Intraocular lens. Their is a potential that intraocular implant devices may not meet specifications. Class II Staar Surgical Company
Sep 29, 2023 EVO +VISIAN Implantable Collamer Lens, REF: VICM5_13.7.Phakic Intraocular lens. Their is a potential that intraocular implant devices may not meet specifications. Class II Staar Surgical Company
Sep 29, 2023 EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens. Their is a potential that intraocular implant devices may not meet specifications. Class II Staar Surgical Company
Jun 10, 2013 Afinity CQ2015A Intraocular Lens The visual correction of aphakia in perso... STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intr... Class II Staar Surgical Co.
Jun 10, 2013 nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of a... STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intr... Class II Staar Surgical Co.

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.