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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

CooperSurgical, Inc.: Origio Sperm Wash Medium Recalled for Potential Gamete Development Risk

Agency Publication Date: September 26, 2024
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Summary

CooperSurgical, Inc. is recalling 4,430 units of Origio Sperm Wash Medium due to low concentrations of sodium pyruvate in the solution. This medium is used in clinical settings to wash sperm cells; however, the chemical imbalance could compromise the development of gametes (reproductive cells). The recall affects three specific product variants sold in 10ml and 60ml bottle packs with expiration dates in September 2024.

Risk

A low concentration of sodium pyruvate in the wash solution can fail to provide necessary nutrients to sperm cells, potentially leading to unsuccessful fertilization or impaired development of the embryo.

What You Should Do

  1. Identify if you have the affected Origio Sperm Wash Medium by checking the labels for Part Numbers 84051010A, 84055060A, or 84055060D.
  2. Check for the following specific Lot Numbers and expiration dates: Lot 230922-018006 (Exp 20 September 2024), Lot 230922-018008 (Exp 20 September 2024), or Lot 230922-018009 (Exp 20 September 2024).
  3. Confirm the Universal Device Identifier (UDI) on the packaging matches: 20888937816536, 20888937816543, or 20888937816918.
  4. Immediately stop using any remaining product from these specific lots and quarantine the inventory to prevent clinical use.
  5. Contact your healthcare provider or CooperSurgical, Inc. at 1-800-243-2974 for further instructions on returning the product and obtaining a potential refund.
  6. Healthcare professionals should contact the manufacturer to discuss any concerns regarding previous use of these lots in clinical procedures.
  7. For additional questions, contact the FDA hotline at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Origio Sperm Wash Medium (Pack of Ten 10ml bottles)
Model / REF:
84051010A
UPC Codes:
20888937816536
Lot Numbers:
230922-018006 (Exp 20 September 2024)
Date Ranges: 20 September 2024
Product: Origio Sperm Wash Medium (Pack of Five 60ml bottles)
Model / REF:
84055060A
UPC Codes:
20888937816543
Lot Numbers:
230922-018008 (Exp 20 September 2024)
Date Ranges: 20 September 2024
Product: Origio Sperm Wash Medium (Pack of Five 60ml bottles)
Model / REF:
84055060D
UPC Codes:
20888937816918
Lot Numbers:
230922-018009 (Exp 20 September 2024)
Date Ranges: 20 September 2024

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95246
Status: Active
Manufacturer: CooperSurgical, Inc.
Sold By: CooperSurgical, Inc. distributors
Manufactured In: United States
Units Affected: 3 products (980 units; 2680 units; 770 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.