Agency classClass IIOur severity:High FDA (Devices)·Z-0213-2017·Announced 2016-10-26

Windstone Medical Recalls Knee Scope Packs Due to Sterility Concerns

Windstone Medical Packaging is recalling 272 Knee Scope 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 involves a medical device where a defect (glove splits/holes) compromises sterility, creating a risk of harm (infection) to patients, but the source text does not report any specific illnesses or injuries.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 272 units of the Knee Scope Pack, Kit number AMS2498 and AMS2498(A. These are convenience custom kits used for general surgery in hospital operating rooms. The recall is due to a defect in the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, which are included in the custom AMS kit.

The FDA determined that the gloves may contain splits or holes that compromise sterility. This defect poses a risk of infection to patients during surgical procedures. The affected kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

Healthcare facilities should stop using the affected Knee Scope Packs immediately. The specific lot numbers and expiration dates for the recalled units are 62085 (11/12/2015), 64546 (1/4/2016), 67402 (7/13/2016), 67696 (8/21/2016), 68498 (9/18/2016), 70496 (9/23/2016), 74549 (5/9/2017), 76677 (7/19/2017), 75582 (7/22/2017), and 77685 (no expiration date provided).

The recalled product

Product: Knee Scope Pack, Kit number AMS2498 and AMS2498(A convenience custom kits used for general surgery in hospital operating room
Manufacturer: Windstone Medical Packaging, Inc.
Category: Medical Device — Surgical Kits
Hazard: sterility-compromise
infection-risk
Affected units: 272

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 150 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 150 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