Class I - Dangerous
Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added instruction for use of these additional Single Site instruments including indication, warnings and precautions.
A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added instruction for use of these additional Single Site instruments including indication, warnings and precautions.
Class I - Dangerous
Changes were implemented to the UNITRAC instructions for use to ensure safe use and potentially extend the life of the product. This included recommending the use of Sterile Cover JG901 and new Quick Release Coupling RT02OR to eliminate the need to sterilize the UNITRAC and a functional check was added prior to use to ensure optimal functionality of the UNITRAC system.
Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.
Merit Medical Systems
Class I - Dangerous
4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.
Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
Convergent Dental
Class I - Dangerous
Specific error condition could lead to unintended laser emission during laser activation.
Class I - Dangerous
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.
Class I - Dangerous
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 Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.
Becton Dickinson & Company
Class I - Dangerous
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.
TWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with Needles; Part Number: 72202616 Biodegradable suture anchor
Smith & Nephew, Inc. Endoscopy Division
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.
Class I - Dangerous
Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled.
RAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number: 72201805 Biodegradable suture anchor
Smith & Nephew, Inc. Endoscopy Division
Class I - Dangerous
Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier.