FDA Device recall Z-0688-2025
Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrica…
- 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: G85 Mini Incubator Model/Catalog Number: K22074 Software Version: N/A Product Description: An electrica… 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-0688-2025 |
| 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: G85 Mini Incubator Model/Catalog Number: K22074 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: No
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 | Version or Model: K22074; Primary DI Number: 00888937025057; Serial Numbers: 2244KH01 , 2244KH02 , 2244KH03 , 2244KH04…Version or Model: K22074; Primary DI Number: 00888937025057; Serial Numbers: 2244KH01 , 2244KH02 , 2244KH03 , 2244KH04 , 2244KH05 , 2244KH06 , 2244KH07 , 2244KH08 , 2244KH09 , 2244KH10 , 2313KH01 , 2313KH02 , 2313KH03 , 2313KH04 , 2313KH05 , 2313KH06 , 2313KH07 , 2313KH08 , 2313KH09 , 2313KH10 , 2320KH21 , 2320KH22 , 2320KH23 , 2320KH24 , 2320KH25 , 2320KH26 , 2320KH27 , 2320KH28 , 2320KH29 , 2320KH30 , 2321KH16 , 2321KH17 , 2321KH18 , 2321KH19 , 2321KH20, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Coopersurgical
- INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set
FDA Device · Class I · 2026-09-30 · Coopersurgical - INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set
FDA Device · Class I · 2026-09-30 · Coopersurgical - Endosee System Convenience Kit with IV Tube
FDA Device · Class II · 2025-07-30 · Coopersurgical - Endosee System Convenience Kit
FDA Device · Class II · 2025-07-30 · Coopersurgical - HSG Procedure Tray
FDA Device · Class II · 2025-07-30 · Coopersurgical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0688-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.