Stainless Steel Sims Uterine Sound — Class II medical device recall Z-3189-2024
Ongoing recall by CooperSurgical, Inc., reported 2024-10-02, distributed nationwide. During the manufacturing process the devices were laser-marked with the incorrect part number.
| Recall number | Z-3189-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2024-07-31 |
| Classified | 2024-09-20 |
| Reported by FDA | 2024-10-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | BH, CA, HK, IN, NZ, QA, SE |
| Quantity | 657 units |
| UPC / GTIN / UDI-DI | 00888937017779 |
| Model numbers | 64-600, 64-601 |
Product
Stainless Steel Sims Uterine Sound, Part Number 64-601
Reason for recall
During the manufacturing process the devices were laser-marked with the incorrect part number.
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-3189-2024. 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.