--- title: "Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K... — FDA record Z-0689-2025 | 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-0689-2025-brand-name-k-systems-product-name-t47-warming-plate-model-catalog-number-k23054-software-version-n-a/ 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: T47 Warming Plate Model/Catalog Number: K23054 Software Version: N/A Product Desc... — FDA record Z-0689-2025 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: T47 Warming Plate Model/Catalog Number: K23054 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: No - **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**: 22 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0689-2025 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0689-2025%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: K23054; Primary DI Number: 00888937025071; Serial Numbers: 2218KH46 , 2218KH47 , 2218KH48 , 2218KH49 , 2218KH50 , 2218KH51 , 2218KH52 , 2218KH53 , 2218KH54 , 2218KH55 , 2218KH56 , 2218KH57 , 2218KH58 , 2218KH59 , 2218KH60 , 2233KH11 , 2233KH12 , 2233KH13 , 2233KH14 , 2233KH15 , 2233KH16 , 2233KH17 , 2233KH18 , 2233KH19 , 2233KH20 , 2235KH31 , 2235KH32 , 2235KH33 , 2235KH34 , 2235KH35 , 2235KH36 , 2235KH37 , 2235KH38 , 2235KH39 , 2235KH40 , 2237KH11 , 2237KH12 , 2237KH13 , 2237KH14 , 2237KH15 , 2237KH16 , 2237KH17 , 2237KH18 , 2237KH19 , 2237KH20 , 2242KH01 , 2242KH02 , 2242KH03 , 2242KH04 , 2242KH05 , 2242KH06 , 2242KH07 , 2242KH08 , 2242KH09 , 2242KH10 , 2250KH01 , 2250KH02 , 2250KH03 , 2250KH04 , 2250KH05 , 2250KH06 , 2250KH07 , 2250KH08 , 2250KH09 , 2250KH10 , 2309KH41 , 2309KH42 , 2309KH43 , 2309KH44 , 2309KH45 , 2309KH46 , 2309KH47 , 2309KH48 , 2309KH49 , 2309KH50 , 2320KH01 , 2320KH02 , 2320KH03 , 2320KH04 , 2320KH05 , 2320KH06 , 2320KH07 , 2320KH08 , 2320KH09 , 2320KH10 , 2322KH01 , 2322KH02 , 2322KH03 , 2322KH04 , 2322KH05 , 2322KH06 , 2322KH07 , 2322KH08 , 2322KH09 , 2322KH10 , 2337KH01, 2337KH02, 2337KH03, 2337KH04, 2337KH05, 2337KH06, 2337KH07, 2337KH08, 2337KH09, 2337KH10, | 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-0689-2025%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [CooperSurgical, Inc. records](https://isitonrecall.com/brand/coopersurgical-inc/)