Origio Sperm Wash Medium Pack of Five 60ml bottles — Class II medical device recall Z-3297-2024
Ongoing recall by CooperSurgical, Inc., reported 2024-10-02, distributed nationwide. Low concentration of sodium pyruvate in the wash could compromise gamete development
| Recall number | Z-3297-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2024-02-16 |
| Classified | 2024-09-26 |
| Reported by FDA | 2024-10-02 |
| Distributed | Nationwide (US) |
| Quantity | 2,680 units |
| UPC / GTIN / UDI-DI | 20888937816543 |
| Lot numbers | 230922-018008 |
| Model numbers | 84055060A |
| Expiration dates | 2024-09-20 |
Product
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A
Reason for recall
Low concentration of sodium pyruvate in the wash could compromise gamete development
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-3297-2024. 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.