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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
May 30, 2024 Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part numb... Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow... Class II Dental EZ Group Star Dental Division
May 30, 2024 Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is ... Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow... Class II Dental EZ Group Star Dental Division
Jun 13, 2014 Titan T 5K Motor Product Usage: Low-speed motor is used with various att... The housing of 5K motor was laser marked incorrectly as a 20K motor. The recall was expanded i... Class II Dental EZ Group Star Dental Division

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.