FDA Medical devices recall ·
K-Systems Product Name: T47 Warming Plate Model recall
- Recall number
- Z-0689-2025
- Date
- (initiated November 15, 2024)
- Company / brand
- CooperSurgical, Inc.
95 Corporate Dr, Trumbull, CT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 22 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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,
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: California Delaware Idaho Illinois Indiana Massachusetts Montana North Carolina New Jersey New York Pennsylvania South Dakota Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0689-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.