CooperSurgical, Inc. recalls Brand Name: K-Systems Product Name: G73 Dry Bath Incubator

Hazard / Issue

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.

Issued by

FDA

Affected States: NC, NJ, TX, VA, IL, NY, CA, PA, DE, ID, IN, MA, MT, SD

Lot/Code Info: 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.