The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0247-2017·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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 is classified as FDA Class II, and the hazard involves a risk of harm (compromised sterility) in a medical setting where injury has not yet been reported.

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, which is used in the Morris Lap Pack (Kit numbers PSS3199 and PSS3199(A)) for general surgery in hospital operating rooms.

The recall was initiated because the gloves may contain splits or holes that could compromise sterility. The affected products were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The recall involves 80 kits with specific lot numbers and expiration dates ranging from November 2015 to February 2018.

Healthcare facilities and users of these kits should stop using the affected gloves and contact the recalling firm, Windstone Medical Packaging, Inc., for further instructions.

The recalled product

Product
Morris Lap Pack, Kit number PSS3199 and PSS3199(A convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Supplies
Hazard
Affected units
80

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 →

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