FDA Device recall Z-0692-2025
Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An e…
- FDA Device
- Class II
- ongoing
- Published 2024-12-25
On 2024-12-25 the FDA classified a Class II recall of Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown Software Version: N/A Product Description: An e… by Coopersurgical, citing 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 al….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0692-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-15 |
| Published | 2024-12-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Coopersurgical |
| Distribution | CA, DE, ID, IL, IN, MA, MT, NC, NJ, NY, PA, SD, TX, VA |
Product
Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: Multiple/unknown 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
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.
Identifiers
| code_info | Unknown product distributed in India and Australia as lab equipment. Version or Model: Multiple/unknown; Primary DI Num…Unknown product distributed in India and Australia as lab equipment. Version or Model: Multiple/unknown; Primary DI Number: unknown; Serial Numbers: unknown. NOTE: These devices are one of the five (5) noted affected Part Numbers, so the intended use, etc. will be one of those other devices. As stated above, traceability was not a concern due to the classification of these devices in those regions. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0692-2025%22
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