Stradis Healthcare Foley Catheter Insertion Tray with preconnected… — Class II medical device recall Z-0931-2023
Ongoing recall by Stradis Healthcare, reported 2023-01-18, distributed nationwide. Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility
| Recall number | Z-0931-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stradis Healthcare, Waukegan, IL, United States |
| Recall initiated | 2022-12-15 |
| Classified | 2023-01-11 |
| Reported by FDA | 2023-01-18 |
| Distributed | Nationwide (US) |
| Quantity | 920 units |
| Reason classes | sterility, packaging |
| Lot numbers | 220551558, 222145412, 222438660, 222508466, 222519530, 222782334 |
Product
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
Reason for recall
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
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-0931-2023. 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.