The Recall Desk
HighFDA (Devices)·Z-0148-2017·Announced 2016-10-26

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because splits or holes may compromise sterility in surgical kits.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a defect (splits/holes) could compromise sterility, posing a risk of infection or harm in a surgical setting, but no injuries or illnesses have been reported.

Plain-English summary

Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, which are included in the Windstone Medical Packaging Basic Setup Pack (kit part number AMS1787(A)). The recall is due to the possibility that the gloves may contain splits or holes that could compromise sterility.

The affected gloves are part of convenience custom kits used for general surgery in hospital operating rooms. The recall involves 256 kits distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

Healthcare facilities should stop using the affected gloves and contact the manufacturer or distributor for instructions on return or replacement.

The recalled product

Product
Basic Setup Pack, kit part number AMS1787(A convenience custom kits used for general surgery in hospital operating room
Affected units
256

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 150 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 150 products in this recall →