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Surgical Instruments

🏥 Medical Devices • 6,839 recalls

regard Item Number: 800560001, Sterile, GS0649A - 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: 800546, Sterile, GS0635 - Abdominal - 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: 800528, Sterile, GS0612 - Lap Chole 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: 800422001, Sterile, OR0491A - Arthroscopy 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: 800525, Sterile, OR0609 - Extremity 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 →

regard Item Number: 800567, Sterile, GY0656 - Robotic Hysterectomy - 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: 800425, Sterile, CV0494 - AV Access Pk -Spohn 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 800567001, Sterile, GY0656A - Robotic Hysterectomy - 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: 800413, Sterile, CV0482 - 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: 800528001, Sterile, GS0612A - Lap Chole 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: 800599, Sterile, GS0694 - Robotic Lap - 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: 800569, Sterile, CV0659 - 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 →

Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system. They are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field. Radiology.

Brainlab AG

Class I - Dangerous

Disposable Reflective Marker Spheres (DRMS) for Brainlab Image Guided Surgery (IGS) Systems: DRMS spheres may separate at the mid-point where the two halves of the sphere are sealed together.

Aug 18, 2015 Surgical Instruments Nationwide View Details →

PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15

Zien Medical Technologies

Class I - Dangerous

Cracks were discovered in the PET tray of a small population of sterile product. These cracks create a risk of loss of sterile barrier for the product. Sampling and root cause analysis indicated that the risk could extend throughout the lots manufactured from September 2014-July 2015. This led to the decision to recall the product.

Aug 18, 2015 Surgical Instruments Nationwide View Details →

Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.

Lumenis

Class I - Dangerous

There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation procedure resulting in damage to non-target tissue.

Jul 30, 2015 Surgical Instruments View Details →
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