Agency classClass IIOur severity:High FDA (Devices)·Z-1292-2017·Announced 2017-03-08

Windstone Medical Recalls Dr. Landi EVLT Packs Due to Sterility Concerns

Windstone Medical Packaging is recalling 944 Dr. Landi EVLT Packs because the included Medtronic gloves may have splits or holes that 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 compromised sterility in a medical device, which poses a risk of harm even though no specific injuries are reported in the source text.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 944 units of the Dr. Landi EVLT Pack, part number AMS1483(E. The recall was initiated because the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in these custom Aligned Medical Solutions (AMS) kits may contain splits or holes. These defects could compromise the sterility of the product.

The affected kits 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. The recall covers specific lot numbers and expiration dates ranging from December 2017 to February 2019.

Healthcare providers and consumers should check their inventory for the affected lot numbers and expiration dates. If the product is found, it should be removed from use and returned to the distributor or manufacturer for credit or replacement.

The recalled product

Product: Dr. Landi EVLT Pack, part number AMS1483(E Dr. Landi EVLT Pack, part number AMS1483(E
Manufacturer: Windstone Medical Packaging, Inc.
Category: Medical Device — Surgical Kits
Hazard: sterility-compromise
defective-gloves
Affected units: 944

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 100007
2/26/2019 100008
2/3/2019 100009
2/10/2019 100322
4/2/2019 101129
2/21/2019 84854
12/26/2017 85111
12/1/2017 86047
12/19/2017 86791
5/7/2018 88616
5/13/2018 88617
6/11/2018 88845
6/12/2018 89076
10/22/2018 89175
10/7/2018 89568
11/9/2018 89715
11/25/2018 94567
10/23/2018 97120
12/7/2018 97562
11/27/2018 97771

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