Medtronic Disposable Gloves Recalled for Sterility Compromise in Surgery Kits
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in 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 is classified as FDA Class II, and the hazard involves a risk of harm (infection due to compromised sterility) without reported illnesses or injuries in the source text, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration has issued a recall for Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES. These gloves are part of custom Aligned Medical Solutions (AMS) kits, specifically the General Surgery Pack (part number PSS1380(A). The recall is being conducted by Windstone Medical Packaging, Inc.
The recall was initiated because the gloves may contain splits or holes that compromise sterility. This defect poses a risk of infection if the compromised sterile barrier is used during surgical procedures.
The affected 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 recall involves 80 kits with specific lot numbers and expiration dates ranging from May 2018 to August 2019. Healthcare facilities and consumers should stop using these products and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- General Surgery Pack, part number PSS1380(A
- Manufacturer
- Windstone Medical Packaging, Inc.
- Affected units
- 80
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 (5)
- Lot number and expiration date 84680
- 5/19/2018 85462
- 8/6/2018 86849
- 8/16/2018 87483
- 8/11/2019
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
Same manufacturer · Windstone Medical Packaging, Inc.
See all →- HighWindstone Medical Packaging Recalls AMS Convenience Kits Due to Foreign Material
FDA (Devices) · 2026-09-16
- ModerateAMS Medical Convenience Kits Recalled Due to Supplier Quality Issues
FDA (Devices) · 2026-08-05
- HighMedical convenience kits recalled due to potential endotoxin level variability
FDA (Devices) · 2026-08-05
- ModerateMedical Convenience Kits Recalled Over Lidocaine Supplier Quality Issue
FDA (Devices) · 2026-08-05
- ModerateMedical Convenience Kits Containing Lidocaine Injection Recalled Due to Supplier Quality Issues
FDA (Devices) · 2026-08-05
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighMedtronic Disposable Gloves Recalled for Potential Sterility Compromise
FDA (Devices) · 2016-10-26
- HighMedtronic Disposable Gloves Recalled for Sterility Compromise in Custom Kits
FDA (Devices) · 2016-10-26
- HighMedtronic Disposable Surgical Gloves Recalled for Potential Sterility Compromise
FDA (Devices) · 2016-10-26
- HighMedtronic Disposable Gloves Recalled for Sterility Compromise in Surgical Kits
FDA (Devices) · 2016-10-26