Windstone Medical Packaging Recalls Augmentation Packs with Defective Gloves
Windstone Medical Packaging is recalling 60 Augmentation Packs because the disposable 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 involves a medical device where a defect (splits or holes) compromises sterility, posing a risk of harm, but the source text does not report any specific illnesses or injuries.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 60 kits of the Augmentation Pack, part number AMS6370. The recall involves the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in the custom Aligned Medical Solutions (AMS) kits.
The recall was initiated because the gloves may contain splits or holes that compromise sterility. The affected lot number is 101499, with an expiration date of 10/13/2019.
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. Consumers and healthcare facilities should stop using the affected products and contact the manufacturer for instructions.
The recalled product
- Product
- Augmentation Pack, part number AMS6370
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Gloves
- Affected units
- 60
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 (2)
- Lot number and expiration date 101499
- 10/13/2019
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
- HighWindstone Medical Packaging Recalls Augmentation Mammoplasty Kits Due to Sterility Concerns
FDA (Devices) · 2016-10-26
- HighWindstone Medical Breast Augmentation Kits Recalled for Sterility Compromise
FDA (Devices) · 2016-10-26
- HighMedtronic Disposable Gloves Recalled for Potential Sterility Compromise
FDA (Devices) · 2016-10-26
- HighWindstone Medical Recalls Custom Breast Augmentation Kits Due to Sterility Risk
FDA (Devices) · 2016-10-26
- HighWindstone Medical Recalls Abdominoplasty Packs Due to Sterility Concerns
FDA (Devices) · 2016-10-26
- SevereWindstone Medical Recalls Plastic Packs with Defective Gloves
FDA (Devices) · 2016-10-26