--- title: "Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Mu... — FDA record Z-0692-2025 | Is It on Recall" description: "The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired set value," url: https://isitonrecall.com/recall/fda-device-z-0692-2025-brand-name-k-systems-product-name-multiple-unknown-model-catalog-number-multiple-unknown-software-ve/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Pro... — FDA record Z-0692-2025 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Nov 15, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **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**: 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. - **Classification**: Class II - **Recalling firm**: CooperSurgical, Inc. - **Quantity**: 34 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0692-2025 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0692-2025%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | Unknown product distributed in India and Australia as lab equipment. Version or Model: Multiple/unknown; Primary DI Number: unknown; Serial Numbers: unknown. NOTE: These devices are one of the five (5) noted affected Part Numbers, so the intended use, etc. will be one of those other devices. As stated above, traceability was not a concern due to the classification of these devices in those regions. | Match all identifying details in the current notice. A brand name alone is not enough. ## 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 States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [California](https://isitonrecall.com/state/california/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New York](https://isitonrecall.com/state/new-york/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Texas](https://isitonrecall.com/state/texas/) - [Virginia](https://isitonrecall.com/state/virginia/) ## Dates in the source - **Report date**: Dec 25, 2024 - **Recall initiation date**: Nov 15, 2024 - **Center classification date**: Dec 18, 2024 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0692-2025%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [CooperSurgical, Inc. records](https://isitonrecall.com/brand/coopersurgical-inc/)