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Browse Device Recalls

12 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 12 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 12 FDA device recalls.

Clear
DateProductReasonClassFirm
Mar 8, 2019 Olympus Diego Elite Console MDCONS 100 Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB... Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4... Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB40... Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4... Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A P... Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Aug 3, 2017 Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system "Chattering" when cutting burrs are used in bone. Class II Gyrus ACMI, Inc.
May 24, 2013 GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 13071... lack of sterility assurance Class II Gyrus Acmi, Incorporated

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.