CooperSurgical, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0691-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 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: N/A

Product Classification:

Class II

Date Initiated: November 15, 2024

Date Posted: December 25, 2024

Recall Number: Z-0691-2025

Event ID: 95741

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.

Status: Ongoing

Product Quantity: 43 units

Code Information:

Version or Model: K24012; Primary DI Number: 00888937025026; Serial Numbers: 2234KH01, 2234KH02, 2234KH03, 2234KH04, 2234KH05, 2234KH06, 2234KH07, 2234KH08, 2234KH09, 2234KH10, 2235KH41, 2235KH42, 2235KH43, 2235KH44, 2235KH45, 2235KH46, 2235KH47, 2235KH48, 2235KH49, 2235KH50, 2235KH51, 2235KH52, 2235KH53, 2235KH54, 2235KH55, 2235KH56, 2235KH57, 2235KH58, 2235KH59, 2235KH60, 2243KH01, 2243KH02, 2243KH03, 2243KH04, 2243KH05, 2243KH06, 2243KH07, 2243KH08, 2243KH09, 2243KH10, 2243KH11, 2243KH12, 2243KH13, 2243KH14, 2243KH15, 2243KH16, 2243KH17, 2243KH18, 2243KH19, 2243KH20, 2307KH01, 2307KH02, 2307KH03, 2307KH04, 2307KH05, 2307KH06, 2307KH07, 2307KH08, 2307KH09, 2307KH10, 2320KH11, 2320KH12, 2320KH13, 2320KH14, 2320KH15, 2320KH16, 2320KH17, 2320KH18, 2320KH19, 2320KH20, 2337KH11, 2337KH12, 2337KH13, 2337KH14, 2337KH15, 2337KH16, 2337KH17, 2337KH18, 2337KH19, 2337KH20, 2340KH01, 2340KH02, 2340KH03, 2340KH04, 2340KH05,

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

Voluntary or Mandated:

Voluntary: Firm initiated