Facility

CHANNEL MEDSYSTEMS

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3012018285
Establishment type	Manufacture Medical Device
Location	2919 7th Street Berkeley, CA, US 94710
Registration status	Active · expires 2026
Parent company	Channel Medsystems (owner-operator 10055277)
Brand names	Exhaust Collection Bag; Cerene Cryotherapy Device

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

Device, Thermal Ablation, Endometrial
Product code MNB (opens in a new tab) · Class III · Unknown

Recalls & enforcement

Class IIOngoing2025-03-20
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
Class IIOngoing2024-05-03
Error code 003 was not listed in certain rows of the Device Instructions for Use Troubleshooting section (i.e., Table 22. Summary of LCD Messages and Error Codes).

FDA inspections (1)

NAI2019-02-01
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Channel Medsystems

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “CHANNEL MEDSYSTEMS (FEI 3012018285) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012018285-channel-medsystems/

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