🏥 Medical Devices • 7,015 recalls
Arrow International
Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
Arrow International
Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
Arrow International
Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster Technical Services, as described in the Instructions for Use (IFU).
During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
Tip Breakage at the glue joint between the obturator body and tip
Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.
Post Market Surveillance cases reported to Maquet showing instances in which the welded joint between the square mount and the first fixable swivel joint of Maquet's Connecting Bracket (Fixture) Device is broken.
Shipping carton labeling error.
Arrow International
Shipping carton labeling error.
Polypropylene Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.
After receiving a complaint the firm disclosed that Conventional Stainless Steel Surgical Blade catalog number 371712 lot 0088464 was incorrectly identified in the single unit foil pack as 12 instead of 12B.
Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening.
DeRoyal Industries
The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's sterility.
Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening.
DeRoyal Industries
The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's sterility.
Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening.
WaisMed received a report in which during the operation of the NIO-A, the needle was not released from the device as expected. The device was placed on the floor and after several minutes the needle was released spontaneously. NIO-A and the NIO-P models have the same activation mechanism. However, none of the affected lots of the NIO-A are distributed in the US, and thus the company is only recalling a single lot of NIO-P in the US.
The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.