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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 1141

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

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800554, Sterile, GS0643 - Pediatric recall — FDA Z-0061-2016

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: 800553, Sterile, OR0642 - Total Knee recall — FDA Z-0060-2016

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: 800535, Sterile, LD0620 - C Section recall — FDA Z-0054-2016

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: 800615, Sterile, CV0741 - Peripheral recall — FDA Z-0075-2016

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: 800409, Sterile, GS0478 - LAP Chole recall — FDA Z-0032-2016

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

Beckman Coulter MICroSTREP plus 1 Panel, Part No recall — FDA Z-0108-2016

Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false…

Class IIFDA: TerminatedBeckman Coulter Inc.

Medical DeviceOct 14, 2015

Zimmer Universal Locking System, Titanium 3.5mm recall — FDA Z-0027-2016

It was found through review of open Complaints and stock investigations that a single lot of Zimmer Universal Locking System 3.5 mm Stainless Steel Base and Trays has incorrect silk…

Class IIFDA: TerminatedZimmer, Inc.

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800036002, Sterile, LD0274B - C recall — FDA Z-0085-2016

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: 800411, Sterile, NU0480 - Neuro Pk recall — FDA Z-0034-2016

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

Stryker Craniomaxillofacial Division Disposable Paper Filter for Sterilization Containers recall — FDA Z-0114-2016

Stryker has become aware that the inhomogeneity of the filter paper might potentially compromise the ability of the filter to maintain a sterile barrier during post-sterilization shelf-life.

Class IIFDA: TerminatedStryker Craniomaxillofacial Division

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800411002, Sterile, NU0480B - Neuro recall — FDA Z-0092-2016

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: 800533, Sterile, GS0606 - Abdominal recall — FDA Z-0053-2016

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: 880330, Sterile, OR0761 - Total Hip recall — FDA Z-0083-2016

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: 800560, Sterile, GS0649 - Lap Chole recall — FDA Z-0066-2016

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: 800532, Sterile, GY0616 - Vaginal recall — FDA Z-0052-2016

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: 800411001, Sterile, NU0480A - Neuro recall — FDA Z-0091-2016

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: 800597, Sterile, GY0688 - LAVH recall — FDA Z-0073-2016

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: 880327, Sterile, CV0758 - Open Heart recall — FDA Z-0081-2016

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: 800565, Sterile, CV0654 - Pediatric recall — FDA Z-0068-2016

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: 800566, Sterile, NU0655 - VP Shunt recall — FDA Z-0069-2016

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: 800549, Sterile, ET0638 - Head & Neck recall — FDA Z-0057-2016

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

DePuy Orthopaedics Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) recall — FDA Z-0111-2016

DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the Specialist 2 Intramedullary Rod 400mm Instrument (PN 96-6120) due to complaints of the rod fracturing and…

Class IIFDA: TerminatedDePuy Orthopaedics, Inc.

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800550, Sterile, OR0639 - Hip recall — FDA Z-0058-2016

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: 800531, Sterile, NU0615 - Neuro Pk recall — FDA Z-0051-2016

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.