Surgical Kit with Saline Recalled Over Sterility Assurance Issue
Windstone Medical Packaging is recalling a surgical kit due to inability to guarantee sterility of the included saline. The recall affects 1,528 units distributed in Florida, Illinois, and California.
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: FDA Class I classification indicates serious potential for adverse health consequences. Loss of sterility assurance in saline for surgical use creates significant risk of post-operative infection. No illnesses or deaths are reported.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling the Aligned Medical Solutions Local Lower Extremity Pack I, a surgical kit containing saline. The recall affects 1,528 units distributed in the United States.
The FDA classified this as a Class I recall because sterility assurance cannot be guaranteed for the saline included in the surgical kits. Non-sterile saline poses a risk of infection when used in surgical procedures.
The affected product was distributed in Florida, Illinois, and California. Multiple lot numbers are involved in the recall. Healthcare facilities and providers should immediately discontinue use of affected units and contact Windstone Medical Packaging for instructions on return or replacement.
More information is available from the FDA regarding this recall.
The recalled product
- Product
- Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kit
- Affected units
- 1,528
Distribution
Part of a larger recall action
This product is one of 4 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 4 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 assurance
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2026-07-08
- SevereArrow drainage and thoracentesis kits contain recalled supplier drugs
FDA (Devices) · 2026-06-24