Channel Medsystems recalls Cerene Cryotherapy Device (FGS-7000) due to potential nitrous oxide leaks during endometrial ablation procedures. Affected units may drip liquid N2O from the handle, posing a risk of injury to healthcare providers.
Due to evaporator gasket not sealing which can cause liquid nitrous oxide to drip/leak from the bottom of the device handle during treatment or after treatment during venting of the device
Channel Medsystems recalls its Cerene Cryotherapy Device (model FGS-7000) because a faulty evaporator gasket can cause liquid nitrous oxide to leak from the device handle during or after treatment. This leak risk could expose healthcare providers to cold injuries or other hazards.
The device uses liquid nitrous oxide to freeze the endometrium. If the evaporator gasket fails to seal properly, liquid N2O can drip or leak from the handle during treatment or after venting the device. This poses a risk of cold injury or other hazards to healthcare providers handling the device.
Healthcare professionals who use the Cerene Cryotherapy Device for endometrial ablation procedures are most at risk. The device is intended for trained medical staff only.
Check for the Cerene Cryotherapy Device model FGS-7000. The device is used for endometrial ablation procedures and is sold to healthcare professionals. Lot numbers include 108638953, 108645585, 108645586, 108645587, 108866674, 108866675, 109493291, 109493292, and 109895874.
Inspect the handle for liquid nitrous oxide drips or leaks after use or during venting.
Reach out to Channel Medsystems for guidance on whether the device needs repair or replacement.
The device is safe for trained healthcare professionals when used correctly, but the recall indicates a potential leak risk that requires attention.
Check for leaks and contact Channel Medsystems for instructions on next steps.
Look for the Cerene Cryotherapy Device model FGS-7000 with lot numbers listed in the recall notice.
We’ve drafted a message you can send Cerene to request your refund or repair — edit it as you like.
Subject: Recall Z-1584-2025 — Cerene Cerene Hello, I own a Cerene that is covered by recall Z-1584-2025 from Cerene. 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.
