Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number:… — Class II medical device recall Z-0691-2025
Ongoing recall by CooperSurgical, Inc., reported 2024-12-25, distributed in CA, IL, IN, MT, NC, NJ, NY, PA…. The warming surfaces or incubator well temperatures of the listed products may exceed the desired set temperat
| Recall number | Z-0691-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | CooperSurgical, Inc., Trumbull, CT, United States |
| Recall initiated | 2024-11-15 |
| Classified | 2024-12-18 |
| Reported by FDA | 2024-12-25 |
| Distributed | CA, IL, IN, MT, NC, NJ, NY, PA, SD, TX, VA |
| Countries outside the US | IQ |
| Quantity | 43 units |
| UPC / GTIN / UDI-DI | 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 and 60 more |
| Model numbers | K24012 |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0691-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.