Cerene Cryotherapy Device recalled for defective gasket seal
Channel Medsystems is recalling the Cerene Cryotherapy Device (Model FGS-7000) due to a defective evaporator gasket that may fail to seal, causing liquid nitrous oxide to leak during or after treatment.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II medical device recall. The defective gasket poses a risk of unintended liquid nitrous oxide leakage during a gynecological procedure, which could result in serious injury or adverse health consequences to patients. Although no reported illnesses are stated in the source, the nature of the hazard and the invasive context of use justify a Severe classification under the Class II criterion.
Plain-English summary
Channel Medsystems, Inc. is recalling the Cerene Cryotherapy Device (Model FGS-7000), an endometrial ablation device used to reduce menstrual bleeding. The device uses nitrous oxide to freeze and ablate the endometrium during a procedure lasting approximately 7 minutes.
The recall was initiated because the evaporator gasket may not seal properly, which can cause liquid nitrous oxide to drip or leak from the bottom of the device handle during treatment or during the venting process after treatment.
Approximately 281 units have been distributed nationwide across the following states: 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 professionals who have received these devices should stop using them and contact Channel Medsystems or the FDA for guidance on proper handling and return procedures.
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
- gasket-defect
- liquid-gas-leakage
- nitrous-oxide
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.
Related recalls
Same category
- HighMedtronic DLP One-Piece Pediatric Arterial Cannula Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- HighMobile Digital Radiographic System Arm Drop Risk During Patient Exams
FDA (Devices) · 2026-07-22