Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom Aligned Medical Solutions kits are recalled because splits or holes may 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, posing a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES that are part of custom Aligned Medical Solutions (AMS) kits. The recall is being conducted because the gloves may contain splits or holes that compromise sterility.
The affected product is the Morris Hysto Pack, part number PSS3198(A. A total of 156 kits are involved in this recall. The products were distributed in Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia, and Washington.
The specific lot numbers and expiration dates for the affected units are 101121 (10/5/2019), 101680 (10/27/2019), 83882 (7/8/2018), 87088 (8/16/2018), 87496 (9/24/2018), 88351 (11/11/2018), 89549 (12/22/2018), 94996 (1/30/2019), 97899 (6/15/2019), and 98769 (6/25/2019). Consumers and healthcare facilities should check their inventory for these specific lot numbers and expiration dates and stop using the affected gloves if found.
The recalled product
- Product
- Morris Hysto Pack, part number PSS3198(A
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Gloves
- Affected units
- 156
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Lot number and expiration date 101121
- 10/5/2019 101680
- 10/27/2019 83882
- 7/8/2018 87088
- 8/16/2018 87496
- 9/24/2018 88351
- 11/11/2018 89549
- 12/22/2018 94996
- 1/30/2019 97899
- 6/15/2019 98769
- 6/25/2019
Distribution
Part of a larger recall action
This product is one of 124 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 124 products in this recall →Related recalls
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