Cerene Cryotherapy Device Recalled Due to Gasket Seal Failure Risk
Channel Medsystems is recalling 281 Cerene Cryotherapy Devices (model FGS-7000) due to potential gasket failure that can cause liquid nitrous oxide leakage during treatment. No injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device with potential for injury from cryogenic liquid leakage during patient treatment, but no injuries or illnesses have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Channel Medsystems, Inc. is recalling 281 units of the Cerene Cryotherapy Device (model FGS-7000), an endometrial ablation device used during gynecological procedures to reduce menstrual bleeding. The device is a single-use, disposable medical device that delivers cryothermic energy through liquid nitrous oxide (N2O) to freeze and ablate endometrial tissue.
The recall is issued because the evaporator gasket may not seal properly. When the gasket fails to seal, liquid nitrous oxide can drip or leak from the bottom of the device handle during the treatment procedure or after treatment during the venting process.
The recalled devices were distributed nationwide to healthcare facilities in Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Missouri, North Carolina, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, and Texas. The affected lot numbers are 108638953, 108645585, 108645586, 108645587, 108866674, 108866675, 109493291, 109493292, and 109895874.
Healthcare providers should identify devices with the affected lot numbers and discontinue use. Patients with questions about their treatment should consult their healthcare provider. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The Cerene Cryotherapy Device is an endometrial ablation device that uses nitrous oxide (N2O) to freeze and ablate the endometrium to r
- Manufacturer
- Channel Medsystems, Inc.
- Hazard
- device-leak
- burn-injury
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot Code: Model No: FGS-7000 UDI-DI: 00850008595035 Lot Numbers: 108638953
- 108645585
- 108645586
- 108645587
- 108866674
- 108866675
- 109493291
- 109493292 and 109895874
Distribution
Distributed nationwide across the United States.
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