The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0215-2017·Announced 2016-10-26

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

The FDA is recalling Medtronic disposable gloves used in Lap Band kits 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 involves a risk-of-harm product (sterile 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 (FDA) is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, which are included in the custom AMS1785(A) Lap Band Pack kits. The recall was initiated because the gloves may contain splits or holes that could compromise their sterility.

The affected kits were distributed nationwide to hospitals in California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The recall involves 390 kits with various lot numbers and expiration dates ranging from October 2014 to August 2016.

Healthcare facilities should stop using the affected gloves and contact the recalling firm, Windstone Medical Packaging, Inc., for further instructions. Consumers are not directly affected as these are professional medical devices used in hospital operating rooms.

The recalled product

Product
Lap Band Pack, Kit number AMS1785(A convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
390

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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Same manufacturer · Windstone Medical Packaging, Inc.

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