Class II — IrriMAX Corporation
| Recalling firm | IRRIMAX CORPORATION |
|---|---|
| Registered facility | IRRIMAX CORPORATION (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance. |
| Product | Irrisept Wound Debridement and Cleansing System. 12 units per case. |
| Quantity | 1,031 cases (12,372 units) |
| Distribution | Nationwide distribution to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV. |
| Initiated | 2019-08-16 |
| Classified | 2019-10-23 |
| Terminated | 2020-09-25 |
| Recall number | Z-0191-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — IrriMAX Corporation (Z-0191-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83599/
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