Irrisept OR — Class II medical device recall Z-0490-2019
Terminated recall by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, reported 2018-11-28, distributed in AZ, CA, CO, FL, GA, IA, ID, IL…. Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
| Recall number | Z-0490-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, Vernon Hills, IL, United States |
| Recall initiated | 2017-09-05 |
| Classified | 2018-11-20 |
| Reported by FDA | 2018-11-28 |
| Terminated | 2024-09-23 |
| Distributed | AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI |
| Quantity | 10,440 |
| Reason classes | sterility, packaging |
| Lot numbers | 4J006 |
| Model numbers | FB-A-400-107 |
Product
Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
Reason for recall
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
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-0490-2019. 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.