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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

regard Item Number: 800091, Sterile, LD0692 - 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 →

regard Item Number: 880326, Sterile, GS0757 - Major Basin - 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: 800558, Sterile, OR0647 - Extremity - 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: 800415, Sterile, OR0484 - Shoulder System 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: 800562, Sterile, NU0651 - Neuro - 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: 880321, Sterile, GS0752 - Breast Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, 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: 800418, Sterile, GY0487 - Major Vaginal 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: 880331, Sterile, OR0762 - Total Knee - 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: 800527, Sterile, OR0611 - Hip Shoulder 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 →

regard Item Number: 800557, Sterile, LD0646 - 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 →

regard Item Number: 800555, Sterile, HT0644 - Pediatric Card Cath - 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: 800559, Sterile, ET0648 - Head & Neck - 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: 800526, Sterile, ET0610 - Head and Neck - 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: 800408, Sterile, LD0477 - C-Section 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: 800548, Sterile, OR0637 - Extremity - 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: 800407, Sterile, OR0476 - Ortho 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: 800419, Sterile, GY0488 - D&C 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 →

Celesteion PCA-9000A/2 PET/CT System

Toshiba American Medical Systems

Class I - Dangerous

It was found that if specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved due to a software problem.

May 8, 2015 Other Medical Devices View Details →

Universal Compact Head Ring Adapter Plate (UCHRAP), a component of the Universal Compact Head Ring Adapter, UCHRA. The UCHRA is a component of the Integra¿ CRW¿ Precision Arc Stereotactic System.

Integra LifeSciences

Class I - Dangerous

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 the manufacturing drawing.

Aug 21, 2015 Infusion Pumps View Details →

regard Item Number: 800417, Sterile, GY0486 - Laparoscopy 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 →