The Recall Desk
HighFDA (Devices)·Z-0265-2017·Announced 2016-10-26

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.

What this means for you

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
Hazard
Affected units
3,142

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 →

Related recalls

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · sterility compromise

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