The Recall Desk
HighFDA (Devices)·Z-0227-2017·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 custom 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 risk-of-harm product (sterile surgical gloves) where injury has not yet been reported, fitting the High severity criteria for potential sterility compromise.

Plain-English summary

The U.S. Food and Drug Administration has issued a recall for Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140. These gloves are components of the custom AMS kit (Kit number AMS1544), which is used for general surgery in hospital operating rooms. The recall was initiated because the gloves may contain splits or holes that compromise sterility.

Windstone Medical Packaging, Inc. is the recalling firm. A total of 190 kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The affected lots include 65460 (exp. 11/11/2015), 66427 (exp. 11/28/2015), 63176 (exp. 12/28/2015), 63803 (exp. 1/12/2016), and 67585 (exp. 8/10/2016).

Healthcare facilities should stop using the affected gloves and kits immediately. Patients who have had surgery using these specific kits should contact their healthcare provider if they have concerns about infection or other complications.

The recalled product

Product
Local Pack, Kit number AMS1544 convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
190

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 →

Related recalls

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · sterility compromise

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