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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with difficulty walking and weighing 225 lbs. or less.

Central Purchasing LLC

Class I - Dangerous

Harbor Freight Tools intiaited a recall of Sit/Stand Rolling Walker (SKU/Item Number 66838, sold June 2009 to March 2014) because, over time, there is the possibility that a walker wheel may come off this product following repeated use without tightening the wheel bolt to the frame, presenting a potential hazard for the user.

Mar 27, 2014 Other Medical Devices Nationwide View Details →

5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation,clip- ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators,monopolar cautery, bipolar cautery, 5mm curved cannulae,5mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.

Intuitive Surgical

Class I - Dangerous

Intuitive Surgical has become aware of the potential for certain lots of the Single-Site 5mm Curved Cannulae to become damaged during use. The second part of this action is to update Single-Site labeling. These labeling changes instruct users how to inspect cannulae prior to use and to appropriately handle cannulae during use.

Mar 13, 2014 Surgical Instruments View Details →

7mm Drain Kit Flat 3/4 Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) 10 FR Drain Kit 3/4 Fluted with Trocar and 100ml S-Vac Bulb Sterile (10/case) 10mm Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System Sterile (10/case)

Aspen Surgical Products

Class I - Dangerous

The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.

Mar 20, 2014 Other Medical Devices Nationwide View Details →

GLOBAL¿ Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019, Non-Sterile, DePuy, Johnson & Johnson Product Usage: Usage: The GLOBAL APG+ 2.5mm Guide Pin is a single-use instrument that is used to assist the surgeon in the orientation of the cannulated reamer(s) and cannulated central drills in the preparation of the glenoid surface. The GLOBAL APG+ 2.5mm Guide Pin is validated for use with the GLOBAL APG+, GLOBAL STEPTECH APG, and DELTA XTEND Systems. The guide pin is scored in three locations, which allows the surgeon to select a desired pin length. The single-use shoulder instrument is made from 316L Stainless Steel.

DePuy Orthopaedics

Class I - Dangerous

Urgent Device Correction notifications are being sent to USA distributors with follow-up to surgeons concerning updated surgical techniques stressing the possibility of the shoulder pin guide breaking and potentially being left in the patient.

Mar 28, 2014 Surgical Instruments Nationwide View Details →