# FDA recall Z-1044-2023

> **CooperSurgical, Inc.** · Class II · device recall initiated 2022-12-15.

## Product

BIOPSY MEDIUM 10ML, Reference Number 10620010 A, used for blastomere biopsy of cleavage stage embryos for Pre-implantation Genetic Diagnosis (PGD)

## Reason for recall

The affected product may contain a medium other than the Biopsy Medium.  There is a risk that use of the Product from this lot could cause degradation of the embryo.

## Distribution

Global Distribution including countries of: Bahrain, Belgium, Bulgaria, Egypt, France, Georgia, Greece, Hong Kong, Iran, Iraq, Israel, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Libya, Nigeria, Oman, Pakistan, Poland, Republic of North Macedonia, Saudi Arabia, Slovenia, Spain, Thailand, Turkey, Turkmenistan, and United Arab Emirates.

## Key facts

- **Recall number:** Z-1044-2023
- **Recalling firm:** CooperSurgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-15
- **Report date:** 2023-02-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Trumbull, CT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1044-2023

## Citation

> AI Analytics. FDA recall Z-1044-2023. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1044-2023. Source: US FDA. Licensed CC0.

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