--- title: "Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 ... — FDA record Z-0691-2025 | 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-0691-2025-brand-name-k-systems-product-name-r65-trolley-model-catalog-number-k24012-software-version-n-a-produ/ 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: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Descriptio... — FDA record Z-0691-2025 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: R65 Trolley Model/Catalog Number: K24012 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**: 43 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0691-2025 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0691-2025%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 | Version or Model: K24012; Primary DI Number: 00888937025026; Serial Numbers: 2234KH01, 2234KH02, 2234KH03, 2234KH04, 2234KH05, 2234KH06, 2234KH07, 2234KH08, 2234KH09, 2234KH10, 2235KH41, 2235KH42, 2235KH43, 2235KH44, 2235KH45, 2235KH46, 2235KH47, 2235KH48, 2235KH49, 2235KH50, 2235KH51, 2235KH52, 2235KH53, 2235KH54, 2235KH55, 2235KH56, 2235KH57, 2235KH58, 2235KH59, 2235KH60, 2243KH01, 2243KH02, 2243KH03, 2243KH04, 2243KH05, 2243KH06, 2243KH07, 2243KH08, 2243KH09, 2243KH10, 2243KH11, 2243KH12, 2243KH13, 2243KH14, 2243KH15, 2243KH16, 2243KH17, 2243KH18, 2243KH19, 2243KH20, 2307KH01, 2307KH02, 2307KH03, 2307KH04, 2307KH05, 2307KH06, 2307KH07, 2307KH08, 2307KH09, 2307KH10, 2320KH11, 2320KH12, 2320KH13, 2320KH14, 2320KH15, 2320KH16, 2320KH17, 2320KH18, 2320KH19, 2320KH20, 2337KH11, 2337KH12, 2337KH13, 2337KH14, 2337KH15, 2337KH16, 2337KH17, 2337KH18, 2337KH19, 2337KH20, 2340KH01, 2340KH02, 2340KH03, 2340KH04, 2340KH05, | 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-0691-2025%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [CooperSurgical, Inc. records](https://isitonrecall.com/brand/coopersurgical-inc/)