FDA (Devices) recall action 71968
The FDA (Devices) publishes a recall like this one as 150 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 150 pages.
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom kit were recalled because gloves may contain splits or holes compromising sterility.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Windstone Medical Packaging is recalling 40 Dr. Fetters Hand Packs because the included Medtronic gloves may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 360 Minor/General/Ortho Packs because Medtronic gloves inside may have splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 1,243 Basin Packs (kit AMS2497) because included Medtronic gloves may contain splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 1,528 laparotomy packs because disposable gloves inside may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 50 laparoscopy kits because the disposable gloves included may contain splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 123 ENT surgical kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 99 Universal Pack surgery kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 304 Endoscopy Packs because disposable gloves in the kits may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 852 Major General Packs because Medtronic gloves inside may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling General Pack II surgical kits because the Medtronic gloves included may contain splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 30 Hall SAP surgical kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 48 Dr. Casey Pack kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in custom surgical kits.
Windstone Medical Packaging is recalling 1,124 shoulder arthroscopy kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 32 Laparotomy Tray kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
Medtronic is recalling disposable gloves included in Windstone Medical custom surgical kits because splits or holes may compromise sterility.
Windstone Medical Packaging is recalling 64 surgical kits because Medtronic gloves inside may have splits or holes, compromising sterility.
Windstone Medical Packaging is recalling 765 Hernia Packs because the included Medtronic gloves may contain splits or holes that compromise sterility.
Windstone Medical Packaging is recalling Virginia Custom Pack kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 175 Major Kits (PHC1307A) because the Medtronic gloves inside may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling Major Lithotomy Packs because the included Medtronic gloves may have splits or holes that compromise sterility.