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Browse Device Recalls

813 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 813 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 813 FDA device recalls in PR.

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DateProductReasonClassFirm
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 13, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indica... Units may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
May 5, 2014 ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: T... "Advocate Redi-Code + BMB-BA006A Blood Glucose test strips" are inappropriately labeled and marke... Class I DIABETIC SUPPLY OF SUNCOAST, INC.
Jan 28, 2014 AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002, diopte... Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power. Class II AMO Puerto Rico Manufacturing, Inc.
Nov 9, 2012 AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses The lenses exceeded the acceptance limit for silicone oil residual. Class II Cooper Vision Caribbean Corp.
Aug 15, 2012 "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties ... Potential for bent tips. Class II Surgical Specialties Puerto Rico Inc. dba Angio...
Aug 15, 2012 "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties ... Potential for bent tips. Class II Surgical Specialties Puerto Rico Inc. dba Angio...
Aug 15, 2012 "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties ... Potential for bent tips. Class II Surgical Specialties Puerto Rico Inc. dba Angio...
Aug 15, 2012 "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties ... Potential for bent tips. Class II Surgical Specialties Puerto Rico Inc. dba Angio...

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.