The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0243-2017·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.

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 product (sterility compromise) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140. These gloves are components of the custom AMS2685 convenience kits used for general surgery in hospital operating rooms. The recall was initiated by Windstone Medical Packaging, Inc.

The reason for the recall is that the gloves may contain splits or holes that compromise sterility. This defect poses a risk of infection or other adverse health consequences if the non-sterile gloves are used during surgical procedures.

The affected products were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. A total of 600 kits were involved. The specific lot numbers and expiration dates affected are: 64509 (1/4/2016), 63184 (1/24/2016), 68824 (9/2/2016), 69550 (9/5/2016), 71960 (1/2/2017), 72952 (3/12/2017), 73688 (4/5/2017), 73599 (4/20/2017), 74550 (5/7/2017), 74782 (5/22/2017), 75650 (7/29/2017), 80441 (8/9/2017), 78329 (9/23/2017), 76679 (10/4/2017), and 78742 (1/4/2018). Hospitals and healthcare facilities should stop using these specific kits and contact the recalling firm for instructions on return or disposal.

The recalled product

Product
Minor Tray AMS2685 convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
600

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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