CooperSurgical recalls K-Systems incubators that may overheat, causing temperature control failures. Affected units could risk improper biological material storage during assisted reproduction procedures.
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.
CooperSurgical recalls K-:Systems incubators that may overheat, causing temperature control failures. This could lead to improper storage of reproductive biological materials like embryos during assisted reproduction procedures.
The incubators may exceed the set temperature, triggering alarms but potentially causing improper storage conditions. This could affect the viability of reproductive biological materials like embryos during assisted reproduction procedures.
Users of K-Systems incubators in India and Australia for assisted reproductive procedures. Those handling embryos or gametes during fertility treatments are most at risk.
K-Systems incubators sold in India and Australia for assisted reproductive procedures. The exact model numbers are unknown due to the recall covering multiple products.
Monitor the incubator for temperature alarms or unusual readings.
The incubators may exceed the desired set temperature, causing potential temperature control failures during assisted reproductive procedures.
K-Systems incubators sold in India and Australia for assisted reproductive procedures are affected. Exact model numbers are unknown due to the recall covering multiple products.
The device will alarm appropriately if temperatures exceed the set value. Check the temperature and ensure it's within the safe range.
We’ve drafted a message you can send K-Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0692-2025 — K-Systems K-Systems Hello, I own a K-Systems that is covered by recall Z-0692-2025 from K-Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.