Windstone Medical Minor Procedure Packs Recalled for Sterility Compromise
Windstone Medical Packaging is recalling 365 Minor Procedure Packs 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 and involves a risk-of-harm product (sterility compromise) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 365 units of the Minor Procedure Pack, part number AMS4799. These kits were distributed across 27 states, including Arizona, California, and Texas.
The recall was initiated because the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in the custom Aligned Medical Solutions (AMS) kits may contain splits or holes. These defects can compromise the sterility of the medical devices.
Healthcare facilities and consumers should stop using these specific kits immediately. Affected lots include 100253, 88213, 88671, 88876, 89097, 89205, 94555, 94588, 95305, 96331, 97150, and 98711. Users should contact Windstone Medical Packaging for instructions on returning the product.
The recalled product
- Product
- Minor Procedure Pack, part number AMS4799
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 365
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 (13)
- Lot number and expiration date 100253
- 3/31/2018 88213
- 4/30/2017 88671
- 4/13/2017 88876
- 4/22/2017 89097
- 4/30/2017 89205
- 4/15/2017 94555
- 3/31/2017 94588
- 3/31/2017 95305
- 3/31/2017 96331
- 10/26/2017 97150
- 11/30/2017 98711
- 11/30/2017
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 Recalls Ortho Minor Packs Due to Sterility Compromise
FDA (Devices) · 2016-10-26
- HighWindstone Medical Recalls Minor Lithotomy Packs Due to Sterility Concerns
FDA (Devices) · 2016-10-26
- HighWindstone Medical Recalls Minor Arthroscopy Packs Due to Sterility Concerns
FDA (Devices) · 2016-10-26
- HighWindstone Medical Recalls Minor Surgery Kits Due to Sterility Concerns
FDA (Devices) · 2016-10-26
- HighWindstone Medical Recalls Surgical Kits Due to Potential Sterility Compromise
FDA (Devices) · 2016-10-26
- HighWindstone Medical Recalls Abdominoplasty Packs Due to Sterility Concerns
FDA (Devices) · 2016-10-26