Z-0687-2025 Class II Ongoing
FDA device recall Z-0687-2025 was initiated by CooperSurgical, Inc. on November 15, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 106 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2024
- Initiation Date
- November 15, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 106 units
Product Description
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) concentration]; it typically has adjustment and monitoring controls. Component: N/A
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.
Distribution Pattern
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
Code Information
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.