Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Irrisept Wound Debridement and Cleansing System. 12 units per case. Recalled by IrriMAX Corporation Due to Potential defect in the sterile pouch seal, which...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact IrriMAX Corporation directly.
Affected Products
Irrisept Wound Debridement and Cleansing System. 12 units per case.
Quantity: 1,031 cases (12,372 units)
Why Was This Recalled?
Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About IrriMAX Corporation
IrriMAX Corporation has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report