Windstone Medical Podiatry Kits Recalled for Potential Sterility Compromise
Windstone Medical Packaging is recalling specific podiatry kits because 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 risk-of-harm product (surgical gloves) where sterility is compromised, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 3,142 units of Podiatry Pack kits (Kit numbers AMS1541, AMS2778, PSS2645, and PSS3422). These convenience custom kits are used for general surgery in hospital operating rooms. The recall is limited to specific lot numbers and expiration dates listed in the agency's structured data.
The recall was initiated because the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES (Part # 13140) included in the custom AMS kit may contain splits or holes. These defects could compromise the sterility of the gloves, posing a risk 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 check their inventory for the specific lot numbers and expiration dates identified in the recall notice and stop using the affected kits immediately.
The recalled product
- Product
- Podiatry Pack, Kit number AMS1541, AMS2778, PSS2645, and PSS3422 convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 3,142
Distribution
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.
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