The Recall Desk
HighFDA (Devices)·Z-0235-2017·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

Windstone Medical Packaging, Inc. is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, which are included in custom AMS kits. The recall is due to the possibility that the gloves may contain splits or holes that compromise sterility.

The affected products are Major Ortho Pack kits, specifically kit numbers 002647-12 and 002647-13, used for general surgery in hospital operating rooms. A total of 1,200 kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

Hospitals and healthcare facilities should check their inventory for these specific kit numbers and lot numbers. If found, the kits should be removed from use and returned to the distributor or manufacturer according to recall instructions.

The recalled product

Product
Major Ortho Pack, kit number 002647-12 and 002647-13 convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
1,200

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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