MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET — Class III medical device recall Z-0202-2023
Terminated recall by Canadian Hospital Specialties, reported 2022-11-23. Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible barcode which
| Recall number | Z-0202-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Canadian Hospital Specialties, Oakville, N/A, Canada |
| Recall initiated | 2022-08-19 |
| Classified | 2022-11-11 |
| Reported by FDA | 2022-11-23 |
| Terminated | 2023-03-20 |
| Quantity | 9,100 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00628725001050 |
| Lot numbers | 159603, 166945 |
| Model numbers | 10-4001 |
| Expiration dates | 2026-12-01, 2027-06-01 |
Product
MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET, REF 10-4001
Reason for recall
Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible barcode which prevents successful scanning of the package.
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-0202-2023. 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.