Irrisept Wound Debridement and Cleansing System — Class II medical device recall Z-0191-2020
Terminated recall by IrriMAX Corporation, reported 2019-10-30, distributed nationwide. Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.
| Recall number | Z-0191-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | IrriMAX Corporation, Lawrenceville, GA, United States |
| Recall initiated | 2019-08-16 |
| Classified | 2019-10-23 |
| Reported by FDA | 2019-10-30 |
| Terminated | 2020-09-25 |
| Distributed | Nationwide (US) |
| Reason classes | sterility, packaging |
| Lot numbers | 19CAB939, 19DAB431 |
| Model numbers | ISEPT-450-USA |
| Expiration dates | 2021-04-30 |
Product
Irrisept Wound Debridement and Cleansing System. 12 units per case.
Reason for recall
Potential defect in the sterile pouch seal, which may result in a lack of sterility assurance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0191-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.