Agency classClass IIOur severity:High FDA (Devices)·Z-1323-2017·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 the hazard involves a risk of harm (sterility compromise) where no specific injuries or illnesses have been reported in the source text.

Plain-English summary

The U.S. Food and Drug Administration is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES that were included in custom Aligned Medical Solutions (AMS) kits. The recall was initiated because the gloves may contain splits or holes that could compromise sterility.

The affected product is the Laminectomy Pack, part number PSS1844(B, manufactured by Windstone Medical Packaging, Inc. A total of 291 kits were distributed across 27 states, including 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. Specific lot numbers and expiration dates are listed in the agency's recall record.

Healthcare facilities and consumers who have these specific kits should stop using the gloves and contact the recalling firm or the FDA for further instructions on how to return or dispose of the product.

The recalled product

Product: Laminectomy Pack, part number PSS1844(B
Manufacturer: Windstone Medical Packaging, Inc.
Category: Medical Device — Surgical Supplies
Hazard: sterility-compromise
infection-risk
Affected units: 291

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 (15)

Lot number and expiration date 83287
8/9/2017 87158
7/10/2017 88004
10/5/2017 88548
10/14/2017 89055
11/16/2017 89903
12/28/2017 95142
2/12/2018 95314
2/9/2018 95839
2/12/2018 96468
3/26/2018 96630
4/11/2018 96820
6/12/2018 98748
10/20/2017 99774
6/24/2018

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 →

Same manufacturer · Windstone Medical Packaging, Inc.

See all →

High
Windstone Medical Packaging Recalls AMS Convenience Kits Due to Foreign Material
FDA (Devices) · 2026-09-16
Moderate
AMS Medical Convenience Kits Recalled Due to Supplier Quality Issues
FDA (Devices) · 2026-08-05
High
Medical convenience kits recalled due to potential endotoxin level variability
FDA (Devices) · 2026-08-05
Moderate
Medical Convenience Kits Recalled Over Lidocaine Supplier Quality Issue
FDA (Devices) · 2026-08-05
Moderate
Medical Convenience Kits Containing Lidocaine Injection Recalled Due to Supplier Quality Issues
FDA (Devices) · 2026-08-05

Same hazard · sterility compromise