Surgical Instruments

4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.

Specific error condition could lead to unintended laser emission during laser activation.

Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible overheating.

Potential for leur connector to leak or have cracks.

During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia machines, some units did not pass the high voltage test and the minimum clearance between an electrical component and the unit housing was not maintained for some from a specific batch.

Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier.

Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.

Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.

CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number 13016314, because of an incorrect filter was assembled on this lot. The correct filter is a 1.2 micron filter (blue color) but a 0.2 micron filter (clear color) may have been added instead.

MAQUET has identified a potential issue that might occur because of the lack of an emergency stop button on a secondary touch screen display on the TEGRIS System.

CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date. The affected lot numbers of the Gravity Set are labeled with a 5 year expiration instead of three (3) years.

BD has received several reports indicating that the plunger of the 7 mL BD Epilor plastic BD Luer-Lok Loss of Resistance Syringe may stall or stick within the syringe preventing the user from detecting a loss of resistance upon entering the epidural space.

Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems are recalled due to lacking 510K and and without a validated cleaning protocol for reprocessing the used manifolds.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.

Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin

The brake in the Z axis and/or brakes in the AB and C axes failed during installation.