FDA (Devices) recall action 76280
The FDA (Devices) publishes a recall like this one as 124 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 124 pages.
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits 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 123 Lumbar Laminectomy Packs because the included gloves may have splits or holes that compromise sterility.
Windstone Medical Packaging is recalling 1,125 Open Procedure Packs because the disposable gloves included may have splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom Aligned Medical Solutions kits are recalled because splits or holes may compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom AMS kits are recalled because splits or holes may compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom Aligned Medical Solutions kits are recalled because splits or holes may compromise sterility.
Windstone Medical Packaging is recalling 174 Angio Pack kits because the Medtronic gloves inside may have splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom Aligned Medical Solutions kits are recalled because splits or holes may compromise sterility.
Windstone Medical Packaging is recalling 84 Ortho Pack kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in AMS kits are recalled because splits or holes may compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in Aligned Medical Solutions kits are recalled because splits or holes may compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in Aligned Medical Solutions kits are recalled because splits or holes may compromise sterility.
Windstone Medical Packaging is recalling 1,787 Upper Extremity Packs because the Medtronic gloves inside may have splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom kits are recalled because splits or holes may compromise sterility.
Windstone Medical Packaging is recalling 39 Major Pack kits containing Medtronic gloves that may have splits or holes compromising sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom AMS kits are recalled because splits or holes may compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom kits are recalled because splits or holes may compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in AMS kits are recalled because splits or holes may compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom Aligned Medical Solutions kits are recalled because splits or holes may compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in Aligned Medical Solutions kits are recalled because splits or holes may compromise sterility.
Windstone Medical Packaging is recalling 252 Lap Band kits because the included Medtronic gloves may have splits or holes that compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in Aligned Medical Solutions kits are recalled because splits or holes may compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in Aligned Medical Solutions kits are recalled because splits or holes may compromise sterility.
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom kits are being recalled because splits or holes may compromise sterility.
Medtronic Cover Light Handle Disposable Gloves in custom Aligned Medical Solutions kits are being recalled because splits or holes may compromise sterility.
Windstone Medical Packaging is recalling 156 Knee Scope Packs because the disposable gloves included may have splits or holes that compromise sterility.