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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Jun 19, 2018 VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108... Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver Class II Vascular Technology, Inc.
May 28, 2014 VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4, REF 108660 The Doppl... Report of the product penetrating the sterile barrier; this could render the product unsterile. Class II Vascular Technology, Inc.
May 28, 2014 07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler pr... Report of the product penetrating the sterile barrier; this could render the product unsterile. Class II Vascular Technology, Inc.
May 28, 2014 07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe ... Report of the product penetrating the sterile barrier; this could render the product unsterile. Class II Vascular Technology, Inc.
May 28, 2014 07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler prob... Report of the product penetrating the sterile barrier; this could render the product unsterile. Class II Vascular Technology, 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.