Channel Medsystems recalls

2 official recalls and safety alerts involving Channel Medsystems since 2024-05, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Channel Medsystems or the relevant agency.

  1. 2025-04-23
  2. US
    Drugs & medicalClass II

    Channel Medsystems, Inc. recalls Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product…

    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

    FDA · DeviceChannel Medsystems, Inc.U.S Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA,…Official notice →
  3. 2024-05-29
  4. US
    Drugs & medicalClass II

    Channel Medsystems, Inc. recalls Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product…

    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 · DeviceChannel Medsystems, Inc.Worldwide - US Nationwide distribution including in the states of Alabama,…Official notice →