🏥

Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

regard Item Number: 800550, Sterile, OR0639 - Hip Shoulder - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

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

Apr 22, 2015 Implants & Prosthetics View Details →

regard Item Number: 800531, Sterile, NU0615 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

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

Apr 22, 2015 Surgical Instruments View Details →

regard Item Number: 800623, Sterile, NU0787 - Neuro - surgical kit containing light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

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

Apr 22, 2015 Surgical Instruments View Details →

regard Item Number: 800514, Sterile, LD0592 - C Section Pack - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

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

Apr 22, 2015 Surgical Instruments View Details →

MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.

Olympus Corporation of the Americas

Class I - Dangerous

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

Sep 11, 2015 Surgical Instruments Nationwide View Details →

regard Item Number: 800551, Sterile, GS0640 - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

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

Apr 22, 2015 Surgical Instruments View Details →

regard Item Number: 800091001, Sterile, LD0692A - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

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

Apr 22, 2015 Surgical Instruments View Details →

SOMATOM Definition Edge; intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.

Siemens Medical Solutions USA

Class I - Dangerous

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 to improve acquisition data in order to optimize image quality. 3) Correction to improve robustness and general system behavior in some exception handling procedures. 4) Correction to improve auto post processin

Aug 14, 2015 Other Medical Devices Nationwide View Details →

regard Item Number 800568001, Sterile, OR0658A - Titanium Rib - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

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

Apr 22, 2015 Surgical Instruments View Details →

regard Item Number: 800569001, Sterile, CV0659A - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

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

Apr 22, 2015 Surgical Instruments View Details →

regard Item Number: 800410, Sterile, CV0479 - Open Heart Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

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

Apr 22, 2015 Surgical Instruments View Details →

regard Item Number: 800554002, Sterile, GS0643B - Pediatric Basic - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

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

Apr 22, 2015 Surgical Instruments View Details →

regard Item Number: 800413001, Sterile, CV0482A - Vascular Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

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

Apr 22, 2015 Surgical Instruments View Details →

regard Item Number 800565001, Sterile, CV0654A - Pediatric Heart - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

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

Apr 22, 2015 Surgical Instruments View Details →

regard Item Number: 800554001, Sterile, GS0643A - Pediatric Basic - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

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

Apr 22, 2015 Surgical Instruments View Details →

regard Item Number: 800568, Sterile, OR0658 - Titanium Rib - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

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

Apr 22, 2015 Surgical Instruments View Details →

regard Item Number: 880328, Sterile, HT0759 - Pacemaker Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

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

Apr 22, 2015 Implants & Prosthetics View Details →

SOMATOM Definition AS, intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.

Siemens Medical Solutions USA

Class I - Dangerous

Aug 14, 2015 Other Medical Devices Nationwide View Details →

regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

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

Apr 22, 2015 Surgical Instruments View Details →

regard Item Number: 800617, Sterile, NU0768 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

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

Apr 22, 2015 Surgical Instruments View Details →