CLASS II ONGOING Device recall · Reported 2 Oct 2024 · FDA Enforcement Report
Origio Sperm Wash Medium Pack of Five bottles - Intended recalled
CooperSurgical is recalling Origio Sperm Wash Medium Pack of Five bottles - Intended for washing of spermatozoa, distributed nationwide in the US. The recall was initiated on 16 Feb 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3298-2024
- FDA event ID
- 95246
- Recalling firm
- CooperSurgical, Trumbull, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Feb 2024
- FDA classified
- 26 Sep 2024
- Reported
- 2 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 16 Feb 2024 | Recall initiated by company | |
| 26 Sep 2024 | Classified by FDA | +223 days |
| 2 Oct 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Low concentration of sodium pyruvate in the wash could compromise gamete development
Product as listed by the FDA
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D
Where it was distributed
Worldwide distribution - US Nationwide.
Questions about this recall
Why was it recalled?
Low concentration of sodium pyruvate in the wash could compromise gamete development
Which lots are affected?
UDI: 20888937816918 Lot 230922-018009 Expiration date: 20 September 2024
Where was it sold?
Worldwide distribution - US Nationwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 95246| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Origio Sperm Wash Medium Pack of Ten bottles - Intended recalled | CooperSurgical | Other | Nationwide | |
| CLASS II | Origio Sperm Wash Medium Pack of Five bottles - Intended recalled | CooperSurgical | Other | Nationwide |
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