Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering… — Class II medical device recall Z-0502-2024
Ongoing recall by CooperSurgical, Inc., reported 2023-12-13, distributed nationwide. Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component p
| Recall number | Z-0502-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2022-03-31 |
| Classified | 2023-12-06 |
| Reported by FDA | 2023-12-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, CH, ES, MY, NL, SE |
| Quantity | 73 units |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 60888937016408 |
| Model numbers | 61-3005 |
Product
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency of fallopian tubes. Model: 61-3005
Reason for recall
Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure
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-0502-2024. 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.