Windstone Medical Packaging Recalls Peri Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 115 Peri Kits (PSS1037) because the included Medtronic gloves may contain splits or holes that compromise sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (splits/holes) in sterile surgical gloves, which poses a significant risk of infection or injury during surgery.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 115 units of the Peri Kit, Kit number PSS1037. These are convenience custom kits 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 AMS kit.
The gloves may contain splits or holes, which compromises the sterility of the kit. The affected lots have the following expiration dates: 7/20/2016, 9/12/2015, 11/7/2015, 11/20/2015, 1/22/2016, and 11/22/2015.
The products were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The FDA has classified this as a Class II recall. Healthcare facilities should stop using the affected kits and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Peri Kit, Kit number PSS1037 convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 115
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