# FDA recall Z-1348-2023

> **CooperSurgical, Inc.** · Class II · device recall initiated 2023-02-13.

## Product

Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060

## Reason for recall

It has come to CooperSurgical's attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and development.

## Distribution

Worldwide - US Nationwide distribution in the states of NY, UT and the countries of  Argentina, Belgium, Bulgaria, Ecuador, France, Germany, Hong Kong, Italy, Malaysia, Mexico, Peru, Singapore, Spain, Switzerland, Thailand, Turkey, the United Kingdom.

## Key facts

- **Recall number:** Z-1348-2023
- **Recalling firm:** CooperSurgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-13
- **Report date:** 2023-04-12

- **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-1348-2023

## Citation

> AI Analytics. FDA recall Z-1348-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1348-2023. Source: US FDA. Licensed CC0.

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