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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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,
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- CooperSurgical, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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
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:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0689-2025
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