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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

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DateProductReasonClassFirm
Jun 1, 2018 Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured b... Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions... Class II Nakanishi Inc.
Jun 1, 2018 Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc. The S... Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions... Class II Nakanishi Inc.
Jun 1, 2018 Surgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc. The... Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions... Class II Nakanishi Inc.
Jun 1, 2018 Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by... Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions... Class II Nakanishi Inc.
Jun 1, 2018 Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by:... Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions... Class II Nakanishi Inc.
Jun 1, 2018 Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured b... Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions... Class II Nakanishi Inc.
Jun 1, 2018 Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The S... Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions... Class II Nakanishi Inc.
Jun 1, 2018 Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SG... Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions... Class II Nakanishi Inc.
Jul 8, 2016 Diamond Coated Tips and Burs are accessories to the air powered Bone drill (V... Through an error, the labeling failed to include the symbol or other text indicating that the di... Class II Nakanishi Inc.
Jul 8, 2016 Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS... Through an error, the labeling failed to include the symbol or other text indicating that the di... Class II Nakanishi Inc.
Jul 8, 2016 Diamond Coated Tips and Burs are accessories to the air powered dental handpi... Through an error, the labeling failed to include the symbol or other text indicating that the di... Class II Nakanishi 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.