Windstone Medical Recalls Foot Pack Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 85 Foot Pack kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
What this means for you
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 compromised sterility in a surgical setting, which poses a risk of harm (infection) even though no specific injuries are reported in the source text.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 85 Foot Pack kits (Kit number AMS3637) used for general surgery in hospital operating rooms. The recall is due to a defect in the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES (Part # 13140) included in the custom kits. The gloves may contain splits or holes that compromise sterility.
The affected kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The recall covers specific lot numbers and expiration dates: 73044 (1/27/2016), 74133 (4/16/2016), and 76510 (10/9/2016).
Hospitals and healthcare facilities should stop using these kits and contact Windstone Medical Packaging for instructions on returning or disposing of the affected products.
The recalled product
- Product
- Foot Pack, Kit number AMS3637 convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Affected units
- 85
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
Same manufacturer · Windstone Medical Packaging, Inc.
See all →- HighRitmed Neurological Sponges Recalled Due to Potential Endotoxin Level Variability
FDA (Devices) · 2026-08-05
- 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 →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12