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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.

29,496medical device recall records

2,407FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1143

29,496 detailed records are currently available in this category.

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800418, Sterile, GY0487 - Major recall — FDA Z-0040-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 880331, Sterile, OR0762 - Total Knee recall — FDA Z-0084-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800527, Sterile, OR0611 - Hip recall — FDA Z-0049-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800557, Sterile, LD0646 - C-Section recall — FDA Z-0063-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800555, Sterile, HT0644 - Pediatric recall — FDA Z-0062-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800559, Sterile, ET0648 - Head & Neck recall — FDA Z-0065-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800526, Sterile, ET0610 - Head and recall — FDA Z-0048-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800408, Sterile, LD0477 - C-Section recall — FDA Z-0031-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800548, Sterile, OR0637 - Extremity recall — FDA Z-0056-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800407, Sterile, OR0476 - Ortho Pk recall — FDA Z-0030-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800419, Sterile, GY0488 - D&C Pk recall — FDA Z-0041-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Integra LifeSciences Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the recall — FDA Z-0025-2016

Integra identified that the UCHRAP component (Arc Adapter Plate) would not assemble properly to the UCHRAR component (ARC Adapter Ring) of the Compact Head Ring Adapter due to an error in…

Class IIFDA: TerminatedIntegra LifeSciences Corp.

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800417, Sterile, GY0486 - Laparoscopy recall — FDA Z-0039-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800508, Sterile, LD0586 - C Section recall — FDA Z-0044-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800524, Sterile, LD0608 - C Section recall — FDA Z-0046-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800036003, Sterile, LD0274C - C recall — FDA Z-0086-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West recall — FDA Z-0026-2016

Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. The locking thread feature of the screw was not manufactured to specification. As a consequence there is a…

Class IIFDA: TerminatedOrtho Solutions Inc.

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800560001, Sterile, GS0649A - Lap recall — FDA Z-0099-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800546, Sterile, GS0635 - Abdominal recall — FDA Z-0055-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800528, Sterile, GS0612 - Lap Chole recall — FDA Z-0050-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800422001, Sterile, OR0491A recall — FDA Z-0094-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800525, Sterile, OR0609 - Extremity recall — FDA Z-0047-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800567, Sterile, GY0656 - Robotic recall — FDA Z-0070-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800425, Sterile, CV0494 - AV Access recall — FDA Z-0043-2016

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Class IIFDA: TerminatedResource Optimization & Innovation LLC

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.