Windstone Medical Knee Arthroscopy Kits Recalled for Sterility Compromise
Windstone Medical Packaging is recalling knee arthroscopy kits because the included Medtronic gloves may contain 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. The hazard involves a risk-of-harm product (sterile surgical kits) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling specific knee arthroscopy convenience custom kits used for general surgery in hospital operating rooms. The affected kits include the AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(A models.
The recall was initiated because the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, included in these custom kits may contain splits or holes. These defects can compromise the sterility of the medical devices, posing a risk to patients during surgical procedures.
The affected products were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. Various lot numbers and expiration dates are involved, ranging from January 2014 to January 2018. Healthcare facilities should check their inventory for these specific lot numbers and stop using the affected kits immediately.
The recalled product
- Product
- Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(A convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
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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