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Surgical Instruments

🏥 Medical Devices • 7,015 recalls

Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smoke, particles, and body and casual fluids from the point of surgical activity during surgical procedures that use ESU for cutting and cauterizing.

Stryker Instruments Div. of Stryker

Class I - Dangerous

During packaging verification testing, a failure occurred due to cuts in the packaging potentially causing a breach in the sterile barrier. Additional testing identified microscopic aluminum metal shavings and foreign particles estimated in size to be between 0.01inches x 0.015 inches to 0.03 inches x 0.04 inches that were introduced during the manufacturing process and were sterilized within the

Mar 26, 2014 Surgical Instruments Nationwide View Details →

CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 In Line Valve with Catheter and Accessories 82-8802 In Line Valve with Unitized Catheter and Accessories 82-8803 In line Valve with Unitized BACTISEAL Catheter and Accessories 82-8804 In Line Valve only with SIPHONGUARD Device 82-8805 In Line Valve with SIPHONGUARD Device, Catheter and Accessories 82-8806 In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories 82-8807 In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories 82-8850 Certas Therapeutic Management System

Codman & Shurtleff

Class I - Dangerous

Ensuring all customers have the tools to assist in verifying the setting of the valve on x-ray images and the location and orientation of implanted CODMAN CERTAS Programmable Valves.

Dec 13, 2013 Surgical Instruments Nationwide View Details →

5X300 MM Curved Cannula, Arm 2 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 →

5X250 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 →

5X250 MM Curved Cannula, Arm 2 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 →

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 →

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 →

Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Ethicon

Class I - Dangerous

The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.

Feb 19, 2014 Surgical Instruments View Details →

Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation.

Teleflex Medical

Class I - Dangerous

The products are being recalled because they did not meet minimum needle attachment strength requirements.

Mar 11, 2014 Surgical Instruments Nationwide View Details →

Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation.

Teleflex Medical

Class I - Dangerous

The products are being recalled because they did not meet minimum needle attachment strength requirements.

Mar 11, 2014 Surgical Instruments Nationwide View Details →

Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature.

Biocardia

Class I - Dangerous

Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.

Mar 3, 2014 Surgical Instruments Nationwide View Details →

Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature.

Biocardia

Class I - Dangerous

Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.

Mar 3, 2014 Surgical Instruments Nationwide View Details →

Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural non-absorbable silk surgical suture is indicated for use in soft tissue approximation. Natural non-absorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Non-absorbable Surgical Suture (class I). Natural non-absorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.

Teleflex Medical

Class I - Dangerous

The products are being recalled because they did not meet minimum needle attachment strength requirements.

Mar 11, 2014 Surgical Instruments Nationwide View Details →

Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage: Non-absorbable poly(ethylene terephthalate) surgical suture is a multifilament, non-absorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation.

Teleflex Medical

Class I - Dangerous

The products are being recalled because they did not meet minimum needle attachment strength requirements.

Mar 11, 2014 Surgical Instruments Nationwide View Details →

JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.

Convatec

Class I - Dangerous

The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.

Feb 7, 2014 Surgical Instruments View Details →
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