Agency classClass IIOur severity:High FDA (Devices)·Z-1272-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for Sterility Compromise in AMS Kits

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. The hazard involves compromised sterility in medical gloves, which poses a risk of infection, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

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 due to the possibility that the gloves may contain splits or holes, which could compromise the sterility of the product.

The affected product is the Basin Pack, part number AMS2497. A total of 648 kits were distributed to facilities 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 should stop using the affected gloves and contact Windstone Medical Packaging, Inc. for instructions on return or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product: Basin Pack, part number AMS2497
Manufacturer: Windstone Medical Packaging, Inc.
Category: Medical Device — Surgical Gloves
Hazard: sterility-compromise
infection-risk
Affected units: 648

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 (14)

Lot number and expiration date 84187
5/14/2018 84938
6/30/2018 85835
9/12/2018 86871
8/14/2019 87444
9/30/2018 88377
11/15/2018 88626
10/8/2018 89025
12/10/2018 89575
1/30/2019 94929
3/6/2019 96912
5/5/2019 97575
6/22/2019 97652
9/27/2019

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.

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