The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1379-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom Aligned Medical Solutions kits 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury (such as infection from compromised sterility) are categorized as Severe.

Plain-English summary

The U.S. Food and Drug Administration has issued a Class II recall for Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES. These gloves are part of custom Aligned Medical Solutions (AMS) kits manufactured by Windstone Medical Packaging, Inc. The recall involves 222 kits distributed across 27 states, including Arizona, California, and Texas.

The recall was initiated because the gloves may contain splits or holes that could compromise their sterility. This defect poses a risk of infection or other adverse health consequences if the non-sterile gloves are used in clinical settings. The agency has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

Healthcare facilities and consumers who have these specific kits should stop using the gloves immediately. The source text does not provide specific instructions for disposal or return, but standard protocol for compromised sterile medical devices is to quarantine the product and contact the manufacturer or distributor for further guidance.

The recalled product

Product
Upper Torso Tray, part number PSS1554(B
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
222

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 (11)

  • Lot number and expiration date 100669
  • 7/6/2019 83865
  • 5/24/2018 85348
  • 7/3/2018 87940
  • 8/12/2018 88676
  • 8/12/2018 89622
  • 9/4/2018 95648
  • 12/5/2018 96352
  • 2/8/2019 98061
  • 4/18/2019 98969
  • 6/18/2019

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.

See all →

Same hazard · sterility compromise

See all →

Similar recalls