The Recall Desk

FDA (Devices) recall action 76280

Windstone Medical Packaging, Inc. recalled 124 products on 2017-03-08

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.

Products
124
Announced
2017-03-08
Critical
0
Units
42,406

Why these products were recalled

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.

States named across these recalls

26–50 of 124