# FDA recall Z-0692-2025

> **CooperSurgical, Inc.** · Class II · device recall initiated 2024-11-15.

## Product

Brand Name: K-Systems  Product Name: Multiple/unknown  Model/Catalog Number: Multiple/unknown  Software Version: N/A  Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls.  Component: N/A

## Reason for recall

The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature.  If temperatures exceed the desired set value, the device will alarm appropriately.

## Distribution

States: NC, NJ, TX, VA, IL, NY, CA, PA  Please note: The countries below, excluding Iraq, all consider these devices to be "lab equipment", not medical devices and are not subject to classification or recall guidelines.   Countries: AT, AU, BE, BH, BR, CA, CH, CN, CZ, DE, EG, ES, ET, FR, GB, GH, HU, ID, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, MA, MK, MT, NL, NO, PE, PH, PK, PT, QA, RO, RS, SA, SD, SE, SO,TR, TW, TZ, US, ZA

## Key facts

- **Recall number:** Z-0692-2025
- **Recalling firm:** CooperSurgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-15
- **Report date:** 2024-12-25

- **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-0692-2025

## Citation

> AI Analytics. FDA recall Z-0692-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0692-2025. Source: US FDA. Licensed CC0.

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