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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 1142

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

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800623, Sterile, NU0787 - Neuro recall — FDA Z-0077-2016

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: 800514, Sterile, LD0592 - C Section recall — FDA Z-0045-2016

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

Olympus Corporation of the Americas MAJ-1606 Instrument Channel Adaptor recall — FDA Z-0113-2016

small puncture marks in a sterile package for an accessory to an Olympus device

Class IIFDA: TerminatedOlympus Corporation of the Americas

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800551, Sterile, GS0640 - Lap Chole recall — FDA Z-0059-2016

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: 800091001, Sterile, LD0692A - C recall — FDA Z-0087-2016

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

Siemens Medical Solutions USA SOMATOM Definition Edge recall — FDA Z-0019-2016

software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction…

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number 800568001, Sterile, OR0658A - Titanium recall — FDA Z-0102-2016

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: 800569001, Sterile, CV0659A - Open recall — FDA Z-0103-2016

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: 800410, Sterile, CV0479 - Open Heart recall — FDA Z-0033-2016

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: 800554002, Sterile, GS0643B recall — FDA Z-0098-2016

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: 800413001, Sterile, CV0482A recall — FDA Z-0093-2016

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 800565001, Sterile, CV0654A recall — FDA Z-0100-2016

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: 800554001, Sterile, GS0643A recall — FDA Z-0097-2016

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: 800568, Sterile, OR0658 - Titanium recall — FDA Z-0071-2016

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: 880328, Sterile, HT0759 - Pacemaker recall — FDA Z-0082-2016

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

Siemens Medical Solutions USA SOMATOM Definition AS, intended to produce cross-sectional recall — FDA Z-0021-2016

software bug issues for SW-Version VA48A_SP0. The following safety issues were resolved: 1) Correction to improve visual warning and error indication son the gantry display. 2) Correction…

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceOct 14, 2015

Resource Optimization & Innovation regard Item Number: 800401, Sterile, GS0470 - Lap Pk recall — FDA Z-0029-2016

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: 800617, Sterile, NU0768 - Neuro Pk recall — FDA Z-0076-2016

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: 800091, Sterile, LD0692 - C Section recall — FDA Z-0028-2016

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: 880326, Sterile, GS0757 - Major Basin recall — FDA Z-0080-2016

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: 800558, Sterile, OR0647 - Extremity recall — FDA Z-0064-2016

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: 800415, Sterile, OR0484 - Shoulder recall — FDA Z-0037-2016

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: 800562, Sterile, NU0651 - Neuro recall — FDA Z-0067-2016

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: 880321, Sterile, GS0752 - Breast Pk recall — FDA Z-0078-2016

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.