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.

29,963medical device recall records
2,598FDA Class I records
8firms with 5+ records
Zimmer Biomet, Inc.784 records
Database records

Records — page 1199

29,963 detailed records are currently available in this category.

Medical DeviceApr 22, 2015

Hansen Medical Magellan Robotic System recall — FDA Z-1449-2015

Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Model No. 11132 and 11139) may experience an unexpected event during a retraction operation of…

Class IIFDA: TerminatedHansen Medical Inc.
Medical DeviceApr 22, 2015

Hardy Diagnostics cat no recall — FDA Z-1444-2015

The firm is recalling HardyCHROM SS, Cat. no. G327 Lot no. 15037 due to a report of possible lack of color development in Shigella organisms in the referenced lot.

Class IIFDA: TerminatedHardy Diagnostics
Medical DeviceApr 22, 2015

Biomet LOW PROFILE NON-LOCK SCREW recall — FDA Z-1446-2015

A Biomet investigation found that the Low Profile Non-Locking Screw 2.7mmx22mm screw (Part Number: 131227222 Lot: RM105E) was anodized green and should have been anodized gold per the print.

Class IIFDA: TerminatedBiomet, 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.