FDA Device recall Z-3188-2024
Silver-Plated Copper Sims Uterine Sound, Part Number 64-600
- FDA Device
- Class II
- ongoing
- Published 2024-10-02
On 2024-10-02 the FDA classified a Class II recall of Silver-Plated Copper Sims Uterine Sound, Part Number 64-600 by Coopersurgical, citing during the manufacturing process the devices were laser-marked with the incorrect part number.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3188-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-31 |
| Published | 2024-10-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Coopersurgical |
| Distribution | US |
Product
Silver-Plated Copper Sims Uterine Sound, Part Number 64-600
Reason
During the manufacturing process the devices were laser-marked with the incorrect part number.
Identifiers
| code_info | UDI-DI: 00888937017762; Part Numbers: 64-600 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3188-2024%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.