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Lower risk Medical device recall · FDA · Published February 16, 2024

CooperSurgical Origio Sperm Wash Bottles Recall: Low Sodium Pyruvate Risk

CooperSurgical recalls Origio Sperm Wash Medium Pack of Five 60ml bottles due to potential low sodium pyruvate concentration affecting gamete development. No remedy specified in the recall notice.

🇺🇸 FDA recall #Z-3298-2024Medical deviceCooperSurgical ›
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Recalling firmCooperSurgical, Inc.95 Corporate Dr · Trumbull, CT 06611-1350
✎ GovInfoNow plain-language explainer

What happened, in plain English

CooperSurgical is recalling Origio Sperm Wash Medium Packs of five 60ml bottles because the low sodium pyruvate concentration might harm sperm development. This recall affects people using the product for sperm washing, and the issue is not urgent but requires attention for reproductive health. Read more at govinfonow.com/recall/56148-coopersurgical-origio-sperm-wash-bottles-recall-low-sodium-pyruvate-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/56148-coopersurgical-origio-sperm-wash-bottles-recall-low-sodium-pyruvate-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3298-2024

Cite this page

“CooperSurgical Origio Sperm Wash Bottles Recall: Low Sodium Pyruvate Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56148-coopersurgical-origio-sperm-wash-bottles-recall-low-sodium-pyruvate-risk. Based on FDA recall #Z-3298-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3298-2024%22&limit=1).

Why it’s dangerous

The product contains a low concentration of sodium pyruvate, which is essential for sperm development. If the concentration is too low, it could compromise the health of sperm cells during washing procedures.

Who’s affected

People using the Origio Sperm Wash bottles for sperm washing are affected. Those with reproductive health concerns may be at higher risk due to potential impacts on gamete development.

How to tell if you have this one

Check for the product name 'Origio Sperm Wash Medium Pack of Five 60ml bottles' with part number 84055060D. The expiration date is September 20, 2024, and the lot number is 230922-018009.

  • Brand
    CooperSurgical
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide distribution - US Nationwide.
Recall numberProduct, codes & lotsQuantity
Z-3296-2024Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A; UDI: 20888937816536 Lot 230922-018006 Expiration date: 20 September 2024980 units
Z-3297-2024Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A; UDI: 20888937816543 Lot 230922-018008 Expiration date: 20 September 20242680 units
Z-3298-2024Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D; UDI: 20888937816918 Lot 230922-018009 Expiration date: 20 September 2024770 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the product by checking the part number (84055060D) and expiration date (September 20, 2024).

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 8 months after the firm started it.

1. Firm started the recall: Feb 16, 202412. FDA classified it Class II: Sep 26, 202423. Published in FDA’s Enforcement Report: Oct 2, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-3298-2024 (February 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3298-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA