HydroSil Go Intermittent Urinary Catheters — Class II medical device recall Z-1701-2023
Ongoing recall by C.R. Bard Inc, reported 2023-06-14. Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pou
| Recall number | Z-1701-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.R. Bard Inc, Covington, GA, United States |
| Recall initiated | 2023-04-20 |
| Classified | 2023-06-08 |
| Reported by FDA | 2023-06-14 |
| Quantity | 308,520 devices |
| Reason classes | labeling, sterility |
| Lot numbers | JUGT0236, JUGT0288, JUGT1689, JUGT2702, JUGT3326, JUGT9154, JUGU1955, JUGU1968, JUGU9022, JUGU9023, JUGU9026, JUGU9053, JUGV9130, JUGV9133, JUGV9158 |
| Model numbers | 71808, 71810, 71812, 71814, 71816, 71818 |
Product
HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818
Reason for recall
Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.
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-1701-2023. 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.