Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic is recalling disposable gloves used in custom surgical kits because they 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 involves a medical device where sterility is compromised, creating a risk of harm (infection) even though no injuries have been reported, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, which are components of custom AMS kits. The recall is being conducted because the gloves may contain splits or holes that compromise sterility.
These gloves are part of the Body Contour Pack, Kit part number PSS1749, which are convenience custom kits used for general surgery in hospital operating rooms. The affected kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
The source text does not specify instructions for consumers or healthcare facilities regarding the handling of these products. No illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Body Contour Pack, Kit part number PSS1749 convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Gloves
- Affected units
- 288
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.
See all 150 products in this recall →Related recalls
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