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Lower risk Medical device recall · FDA · Published December 15, 2022

CooperSurgical BIOPSY MEDIUM 10ML Recall: Risk of Embryo Degradation

CooperSurgical recalls BIOPSY MEDIUM 10ML (Lot 220506-006557) due to potential embryo degradation from incorrect medium. Affected units may cause embryo damage during IVF procedures.

🇺🇸 FDA recall #Z-1044-2023Medical deviceCooperSurgical ›
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Contact the company

Recalling firmCooperSurgical, Inc.95 Corporate Dr · Trumbull, CT 06611-1350
✎ GovInfoNow plain-language explainer

CooperSurgical is recalling a specific batch of BIOPSY MEDIUM 10ML used in IVF embryo testing because it might contain the wrong medium, which could damage embryos. This affects fertility treatments where precise medium quality is critical. Read more at govinfonow.com/recall/59121-coopersurgical-biopsy-medium-10ml-recall-risk-of-embryo-degradation.

Source Summary by GovInfoNow · govinfonow.com/recall/59121-coopersurgical-biopsy-medium-10ml-recall-risk-of-embryo-degradation · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1044-2023

Cite this page

“CooperSurgical BIOPSY MEDIUM 10ML Recall: Risk of Embryo Degradation.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59121-coopersurgical-biopsy-medium-10ml-recall-risk-of-embryo-degradation. Based on FDA recall #Z-1044-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1044-2023%22&limit=1).

CooperSurgical, Inc. recalled BIOPSY MEDIUM 10ML (Ref No. 10620010 A) globally on Dec. 15, 2022, according to the FDA. The device may contain the wrong medium, risking embryo degradation.

How to tell if you have it

  • Brand: CooperSurgical
  • Product: BIOPSY MEDIUM 10ML
  • Reference Number: 10620010 A
  • Lot Number: 220506-006557
  • Units affected: 489

The hazard

The product may contain a medium other than the Biopsy Medium. Use of the product from this lot could cause degradation of the embryo.

Context

GovInfoNow's records show CooperSurgical, Inc. has issued 37 other recalls since Oct. 6, 2017. Recent brand recalls include an Infant Nasal CPAP set recalled on Aug. 11, 2026, and a Convenience Kit recalled on June 11, 2025. Other recent recalls of similar products include the Hologic Brevera Breast Biopsy Needle Recall (Dec. 15, 2025) and the AVID Medical Haylard Basic Biopsy Tray Recall (Aug. 10, 2026).

How to tell if you have this one

Check for the lot number 220506-006557 on the BIOPSY MEDIUM 10ML container. This product is used in IVF treatments for cleavage-stage embryos during Pre-implantation Genetic Diagnosis.

  • Brand
    CooperSurgical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Lot Number

    Verify the lot number on the container is 220506-006557 to confirm if it's affected.

How this recall unfolded

Recall timeline

FDA published this recall 55 days after the firm started it.

1. Firm started the recall: Dec 15, 202212. FDA classified it Class II: Jan 31, 202323. Published in FDA’s Enforcement Report: Feb 8, 2023320222023
  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.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall indicates potential embryo degradation risk, so it's not recommended for use until confirmed safe.

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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-1044-2023 (December 15, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1044-2023 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