FDA Device recall Z-3298-2024
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa
- FDA Device
- Class II
- ongoing
- Published 2024-10-02
On 2024-10-02 the FDA classified a Class II recall of Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa by Coopersurgical, citing low concentration of sodium pyruvate in the wash could compromise gamete development.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3298-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-16 |
| Published | 2024-10-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Coopersurgical |
| Distribution | US |
Product
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D
Reason
Low concentration of sodium pyruvate in the wash could compromise gamete development
Identifiers
| code_info | UDI: 20888937816918 Lot 230922-018009 Expiration date: 20 September 2024 |
|---|
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-3298-2024%22
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