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FDA public records

Medical Device Recalls in the United States

Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.

21,924medical device recall records
2,160FDA Class I records
8firms with 5+ records
MEDLINE INDUSTRIES, LP…730 records
Database records

Records — page 131

21,924 detailed records are currently available in this category.

Medical DeviceJun 18, 2025

Philips SmartPath to dStream for 1.5T recall — FDA Z-1936-2025

identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If…

Class IIFDA: OngoingPhilips North America
Medical DeviceJun 18, 2025

Guardian System 2 Controller recall — FDA Z-1967-2025

A software issue where "low" and "terminal" battery alerts did not display on the screen to the user in specific circumstances when the device was not running patient therapy.

Class IIFDA: OngoingTurncare, Inc.

How to use this medical device recall index

Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.

Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.

What the database can and cannot tell you

This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.