Agency classClass IIOur severity:High FDA (Devices)·Z-1366-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in Aligned Medical Solutions kits are 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 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 involves a risk of harm (compromised sterility) where no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES that are part of custom Aligned Medical Solutions (AMS) kits. The recall is being conducted because the gloves may contain splits or holes that could compromise sterility.

The affected product is the Set Up Pack, part number PSS3574(A. A total of 820 kits are involved in this recall. The products were 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 facilities and consumers should stop using these specific gloves and contact the recalling firm for further instructions. The FDA has classified this as a Class II recall.

The recalled product

Product: Set Up Pack, part number PSS3574(A
Manufacturer: Windstone Medical Packaging, Inc.
Category: Medical Device — Surgical Gloves
Hazard: sterility-compromise
infection-risk
Affected units: 820

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 (20)

Lot number and expiration date 100490
8/7/2019 84969
5/27/2018 85341
6/15/2018 85566
6/8/2018 86926
8/2/2018 86927
7/16/2018 87263
10/10/2018 89647
11/23/2018 89913
10/2/2018 94889
11/28/2018 95156
11/14/2018 95674
12/27/2018 96088
1/25/2019 96849
3/7/2019 96990
5/7/2019 97637
5/27/2019 98073
5/23/2019 98373
5/30/2019 99444
6/24/2019

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 →

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · sterility compromise