FDA Device recall Z-0503-2024
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedur…
- FDA Device
- Class II
- ongoing
- Published 2023-12-13
On 2023-12-13 the FDA classified a Class II recall of Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedur… by Coopersurgical, citing 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 dela….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0503-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-31 |
| Published | 2023-12-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Coopersurgical |
| Distribution | US |
Product
Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-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: 61-4005
Reason
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
Identifiers
| code_info | UDI-DI:60888937016446 S/N: 313121, 313568 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Coopersurgical
- INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set
FDA Device · Class I · 2026-09-30 · Coopersurgical - INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set
FDA Device · Class I · 2026-09-30 · Coopersurgical - Endosee System Convenience Kit with IV Tube
FDA Device · Class II · 2025-07-30 · Coopersurgical - Endosee System Convenience Kit
FDA Device · Class II · 2025-07-30 · Coopersurgical - HSG Procedure Tray
FDA Device · Class II · 2025-07-30 · Coopersurgical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0503-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.