Medical Devices Recalls

The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety protection circuit board. Secondary to the recall, American Optisurgical, Inc. will be making a correction to add spacers between the valve and cassette to correct a small irrigation leak that can occur after the priming cycle. Use of this product may cause the device to lose power and stop wo

Based on an accelerated aging test for this product packaging, there is an indicator of potential for a breach in the sterile barrier in the header bag and potentially the blue sterilization wrap for togas within the second and third year of shelf life. The test method used involved high heat to accelerate the aging of the packaging. Stryker is conducting additional testing and assessing this pr

Philips has received one report from the field that there was an unexpected motion of the detector due to a failure of the mechanical assembly.

I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned.

Devices labeled for an intended use was not included in the existing 510(k) or PMA, in that, the Indications for use was modified.

During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.

Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262).

Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch.

Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrect O.D. size. The implant itself is etched with the correct O.D. size.

I-Flow initiated two voluntary product removals of the ON-Q Pain Relief System: T-Block Needle/Catheter Tray and T-Block Needle/Catheter Kit because they may have potentially malfunctioned.

iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability

Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity

An LPC Fine Mesh Cassette failed to stay closed during processing operations.

An EZ Wider bed (capacity of 1000 lb. safe working load collapsed during patient use, leaving the patient in a forward tilt position.

iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability

Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the

Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the

Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the

Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after receiving additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031), and the

Affected products have a labeled expiration date of one year too long.