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.

28,535medical device recall records
2,363FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records

Records — page 1023

28,535 detailed records are currently available in this category.

Medical DeviceOct 26, 2016

Merge Healthcare CADstream software recall — FDA Z-0137-2017

The software was not presenting the PURE filter user interface message on DICOM transfer studies. If a site starts using PURE filter, the user interface message will not display. This may…

Class IIFDA: TerminatedMerge Healthcare, Inc.
Medical DeviceOct 26, 2016

SenTec AG SDMS recall — FDA Z-0088-2017

Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is a risk that a fastening screw could become loose under certain circumstances. A…

Class IIFDA: TerminatedSenTec AG

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.