K-Systems G73 Dry Bath Incubator (CooperSurgical) – Temperature Excess (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 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
Brand
CooperSurgical, Inc.
Lot Codes / Batch Numbers
Version or Model: K22065, Primary DI Number: 00888937025040, Serial Numbers: 2202KH46, 2202KH47, 2202KH48, 2202KH49, 2202KH50, 2202KH51, 2202KH52, 2202KH53, 2202KH54, 2202KH55, 2208KH01, 2208KH02, 2208KH03, 2208KH04, 2208KH05, 2208KH06, 2208KH07, 2208KH08, 2208KH09, 2208KH10, 2208KH11, 2208KH12, 2208KH13, 2208KH14, 2208KH15, 2208KH16, 2208KH17, 2208KH18, 2208KH19, 2208KH20, 2235KH01, 2235KH02, 2235KH03, 2235KH04, 2235KH05, 2235KH06, 2235KH07, 2235KH08, 2235KH09, 2235KH10, 2235KH11, 2235KH12, 2235KH13, 2235KH14, 2235KH15, 2235KH16, 2235KH17, 2235KH18, 2235KH19, 2235KH20, 2239KH11, 2239KH12, 2239KH13, 2239KH14, 2239KH15, 2239KH16, 2239KH17, 2239KH18, 2239KH19, 2239KH20, 2242KH11, 2242KH12, 2242KH13, 2242KH14, 2242KH15, 2242KH16, 2242KH17, 2242KH18, 2242KH19, 2242KH20, 2242KH21, 2242KH22, 2242KH23, 2242KH24, 2242KH25, 2246KH01, 2246KH02, 2246KH03, 2246KH04, 2246KH05, 2246KH06, 2246KH07, 2246KH08, 2246KH09, 2246KH10, 2246KH11, 2246KH12, 2246KH13, 2246KH14, 2246KH15, 2246KH16, 2246KH17, 2246KH18, 2246KH19, 2246KH20, 2246KH21, 2246KH22, 2246KH23, 2246KH24, 2246KH25, 2246KH26, 2246KH27, 2246KH28, 2246KH29, 2246KH30, 2246KH31, 2246KH32, 2246KH33, 2246KH34, 2246KH35, 2246KH36, 2246KH37, 2246KH38, 2246KH39, 2246KH40, 2246KH41, 2246KH42, 2246KH43, 2246KH44, 2246KH45, 2246KH46, 2246KH47, 2246KH48, 2246KH49, 2246KH50, 2246KH51, 2246KH52, 2246KH53, 2246KH54, 2246KH55, 2303KH01, 2303KH02, 2303KH03, 2303KH04, 2303KH05, 2303KH06, 2303KH07, 2303KH08, 2303KH09, 2303KH10, 2303KH11, 2303KH12, 2303KH13, 2303KH14, 2303KH15, 2303KH16, 2303KH17, 2303KH18, 2303KH19, 2303KH20, 2303KH21, 2303KH22, 2303KH23, 2303KH24, 2303KH25, 2303KH26, 2303KH27, 2303KH28, 2303KH29, 2303KH30, 2303KH31, 2303KH32, 2303KH33, 2303KH34, 2303KH35, 2303KH36, 2303KH37, 2303KH38, 2303KH39, 2303KH40, 2311KH01, 2311KH02, 2311KH03, 2311KH04, 2311KH05, 2311KH06, 2311KH07, 2311KH08, 2311KH09, 2311KH10, 2311KH11, 2311KH12, 2311KH13, 2311KH14, 2311KH15, 2313KH11, 2313KH12, 2313KH13, 2313KH14, 2313KH15, 2313KH16, 2313KH17, 2313KH18, 2313KH19, 2313KH20, 2313KH21, 2313KH22, 2313KH23, 2313KH24, 2313KH25, 2316KH01, 2316KH02, 2316KH03, 2316KH04, 2316KH05, 2316KH06, 2316KH07, 2316KH08, 2316KH09, 2316KH10, 2316KH11, 2316KH12, 2316KH13, 2316KH14, 2316KH15, 2322KH11, 2322KH12, 2322KH13, 2322KH14, 2322KH15, 2322KH16, 2322KH17, 2322KH18, 2322KH19, 2322KH20, 2322KH21, 2322KH22, 2322KH23, 2322KH24, 2322KH25, 2326KH01, 2326KH02, 2326KH03, 2326KH04, 2326KH05, 2326KH06, 2326KH07, 2326KH08, 2326KH09, 2326KH10, 2326KH11, 2326KH12, 2326KH13, 2326KH14, 2326KH15, 2326KH16, 2326KH17, 2326KH18, 2326KH19, 2326KH20, 2327KH30, 2327KH31, 2327KH32, 2327KH33, 2327KH34, 2327KH35, 2327KH36, 2327KH37, 2327KH38, 2327KH39, 2327KH40, 2327KH41, 2327KH42, 2327KH43, 2327KH44, 2332KH11, 2332KH12, 2332KH13, 2332KH14, 2332KH15, 2332KH16, 2332KH17, 2332KH18, 2332KH19, 2332KH20.
Products Sold
Version or Model: K22065; Primary DI Number: 00888937025040; Serial Numbers: 2202KH46, 2202KH47, 2202KH48, 2202KH49, 2202KH50, 2202KH51, 2202KH52, 2202KH53, 2202KH54, 2202KH55, 2208KH01, 2208KH02, 2208KH03, 2208KH04, 2208KH05, 2208KH06, 2208KH07, 2208KH08, 2208KH09, 2208KH10, 2208KH11, 2208KH12, 2208KH13, 2208KH14, 2208KH15, 2208KH16, 2208KH17, 2208KH18, 2208KH19, 2208KH20, 2235KH01, 2235KH02, 2235KH03, 2235KH04, 2235KH05, 2235KH06, 2235KH07, 2235KH08, 2235KH09, 2235KH10, 2235KH11, 2235KH12, 2235KH13, 2235KH14, 2235KH15, 2235KH16, 2235KH17, 2235KH18, 2235KH19, 2235KH20, 2239KH11, 2239KH12, 2239KH13, 2239KH14, 2239KH15, 2239KH16, 2239KH17, 2239KH18, 2239KH19, 2239KH20, 2242KH11, 2242KH12, 2242KH13, 2242KH14, 2242KH15, 2242KH16, 2242KH17, 2242KH18, 2242KH19, 2242KH20, 2242KH21, 2242KH22, 2242KH23, 2242KH24, 2242KH25, 2246KH01, 2246KH02, 2246KH03, 2246KH04, 2246KH05, 2246KH06, 2246KH07, 2246KH08, 2246KH09, 2246KH10, 2246KH11, 2246KH12, 2246KH13, 2246KH14, 2246KH15, 2246KH16, 2246KH17, 2246KH18, 2246KH19, 2246KH20, 2246KH21, 2246KH22, 2246KH23, 2246KH24, 2246KH25, 2246KH26, 2246KH27, 2246KH28, 2246KH29, 2246KH30, 2246KH31, 2246KH32, 2246KH33, 2246KH34, 2246KH35, 2246KH36, 2246KH37, 2246KH38, 2246KH39, 2246KH40, 2246KH41, 2246KH42, 2246KH43, 2246KH44, 2246KH45, 2246KH46, 2246KH47, 2246KH48, 2246KH49, 2246KH50, 2246KH51, 2246KH52, 2246KH53, 2246KH54, 2246KH55, 2303KH01, 2303KH02, 2303KH03, 2303KH04, 2303KH05, 2303KH06, 2303KH07, 2303KH08, 2303KH09, 2303KH10, 2303KH11, 2303KH12, 2303KH13, 2303KH14, 2303KH15, 2303KH16, 2303KH17, 2303KH18, 2303KH19, 2303KH20, 2303KH21, 2303KH22, 2303KH23, 2303KH24, 2303KH25, 2303KH26, 2303KH27, 2303KH28, 2303KH29, 2303KH30, 2303KH31, 2303KH32, 2303KH33, 2303KH34, 2303KH35, 2303KH36, 2303KH37, 2303KH38, 2303KH39, 2303KH40, 2311KH01, 2311KH02, 2311KH03, 2311KH04, 2311KH05, 2311KH06, 2311KH07, 2311KH08, 2311KH09, 2311KH10, 2311KH11, 2311KH12, 2311KH13, 2311KH14, 2311KH15, 2313KH11, 2313KH12, 2313KH13, 2313KH14, 2313KH15, 2313KH16, 2313KH17, 2313KH18, 2313KH19, 2313KH20, 2313KH21, 2313KH22, 2313KH23, 2313KH24, 2313KH25, 2316KH01, 2316KH02, 2316KH03, 2316KH04, 2316KH05, 2316KH06, 2316KH07, 2316KH08, 2316KH09, 2316KH10, 2316KH11, 2316KH12, 2316KH13, 2316KH14, 2316KH15, 2322KH11, 2322KH12, 2322KH13, 2322KH14, 2322KH15, 2322KH16, 2322KH17, 2322KH18, 2322KH19, 2322KH20, 2322KH21, 2322KH22, 2322KH23, 2322KH24, 2322KH25, 2326KH01, 2326KH02, 2326KH03, 2326KH04, 2326KH05, 2326KH06, 2326KH07, 2326KH08, 2326KH09, 2326KH10, 2326KH11, 2326KH12, 2326KH13, 2326KH14, 2326KH15, 2326KH16, 2326KH17, 2326KH18, 2326KH19, 2326KH20, 2327KH30, 2327KH31, 2327KH32, 2327KH33, 2327KH34, 2327KH35, 2327KH36, 2327KH37, 2327KH38, 2327KH39, 2327KH40, 2327KH41, 2327KH42, 2327KH43, 2327KH44, 2332KH11, 2332KH12, 2332KH13, 2332KH14, 2332KH15, 2332KH16, 2332KH17, 2332KH18, 2332KH19, 2332KH20.
CooperSurgical, Inc. is recalling Brand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number: K22065 Product Desc due to The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperature. If temperatures exceed the desired. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On November 15, 2024 URGENT MEDICAL DEVICE RECALL emails were sent to customers. On November 20, 2024 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions that should be taken by the customer/user/distributor in order to prevent risks for patients or users: G85 Mini Incubators with serial numbers listed in the Appendix are impacted and require repair. 1. Inspect your inventory, identify, and discontinue use. 2. Complete the attached Urgent Medical Device Recall Response Form and return the form to CooperSurgical as indicated at the top of the form. Note: Please complete and return the form even if you do not have any affected product in your inventory so that we may document receipt of this Urgent Medical Device Recall. 3. Contact your local Service Representative to arrange a repair at no cost to you. T45, T47, R65, and G73 with serial numbers listed in the Appendix may be impacted and require inspection to determine the need for repair. 1. Inspect your inventory, identify, and discontinue use. 2. Complete the attached Urgent Medical Device Recall Response Form and return the form to CooperSurgical as indicated at the top of the form. Note: Please complete and return the form even if you do not have any affected product in your inventory so that we may document receipt of this Urgent Medical Device Recall. 3. Contact your local Service Representative to arrange an inspection of the affected product. If your product is affected, the product will be repaired at no cost to you. 6. Actions planned by CooperSurgical to correct the problem CooperSurgical is currently investigating this issue and determined a field action notice to customers is needed to inspect and repair all affected products in the field. CooperSurgical is committed to high-quality, safe, and effective products. This corrective action has been initiated to ensure this failure mode does not reoccur and future potential patient harm can be avoided. If you need any further
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, DE, ID, IL, IN, MA, MT, NJ, NY, NC, OR, PA, SD, TX, VA
Page updated: Jan 10, 2026