Class II — Potential Health Hazard

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...

Date: August 16, 2019
Company: IrriMAX Corporation
Status: Terminated
Source: FDA (Device)

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.

Affected (51 states)Not affected

About IrriMAX Corporation

IrriMAX Corporation has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report