Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part...
FDA Device Recall #Z-3298-2024 — Class II — February 16, 2024
Recall Summary
| Recall Number | Z-3298-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 16, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | CooperSurgical, Inc. |
| Location | Trumbull, CT |
| Product Type | Devices |
| Quantity | 770 units |
Product Description
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D
Reason for Recall
Low concentration of sodium pyruvate in the wash could compromise gamete development
Distribution Pattern
Worldwide distribution - US Nationwide.
Lot / Code Information
UDI: 20888937816918 Lot 230922-018009 Expiration date: 20 September 2024
Other Recalls from CooperSurgical, Inc.
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|---|---|---|---|
| Z-2137-2025 | Class II | Endosee System Convenience Kit with IV Tube. Mo... | Jun 11, 2025 |
| Z-2136-2025 | Class II | Endosee System Convenience Kit. Model Number: E... | Jun 11, 2025 |
| Z-2135-2025 | Class II | HSG Procedure Tray. Model Number: 6050T. Th... | Jun 11, 2025 |
| Z-0687-2025 | Class II | Brand Name: K-Systems Product Name: G73 Dry Ba... | Nov 15, 2024 |
| Z-0692-2025 | Class II | Brand Name: K-Systems Product Name: Multiple/u... | Nov 15, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.