The Recall Desk
HighFDA (Devices)·Z-1293-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom AMS kits are recalled because splits or holes may compromise sterility.

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 is classified as FDA Class II, and the hazard involves a risk of harm (compromised sterility) without reported injuries or illnesses, fitting the 'High' severity criteria.

Plain-English summary

The U.S. Food and Drug Administration has issued a recall for Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES. These gloves are part of custom Aligned Medical Solutions (AMS) kits. The recall is due to the possibility that the gloves may contain splits or holes, which could compromise their sterility.

The affected product is identified by lot number 88547 and an expiration date of 1/7/2018. The recall involves 24 kits. The product was distributed in Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia, and Washington.

Healthcare providers and consumers should stop using these gloves immediately. They should contact the manufacturer or the FDA for further instructions on how to return or dispose of the affected product.

The recalled product

Product
Dr. Newman Surgical Procedure Pack, part number PSS1689(A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
24

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot number and expiration date 88547
  • 1/7/2018

Distribution

Distributed in 26 states:

Part of a larger recall action

This product is one of 124 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 124 products in this recall →

Related recalls

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · sterility compromise

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