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Freudenberg Medical LLC

United States US-MF-000023823 Last updated 23 Oct 2026

Devices
348
Registries
EUDAMEDGUDIDFDA
FDA recalls
42 ongoing

Catalogue348

Page 1 of 7

Showing 1-50 of 348

FDA recalls4

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

  • 2026

    • 17 Jun 2026 Z-2909-2026 Class II Ongoing Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.
    • 17 Jun 2026 Z-2910-2026 Class II Ongoing Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.

  • 2022

    • 21 Feb 2022 Z-1016-2022 Class II Terminated Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemiavia FDA establishment Freudenberg Medical, SRL
    • 21 Feb 2022 Z-1017-2022 Class II Terminated Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemiavia FDA establishment Freudenberg Medical, SRL

FDA establishments2

Registered with the FDA under this company group, matched by name.

  • Freudenberg Medical, LLC CARPINTERIA, CA · US FEI 2025182
  • Freudenberg Medical, SRL La Garita Alajuela · CR FEI 3011241266

Information

Country
United States
Address
1110, Mark Avenue, CARPINTERIA, United States
Website
inhealth.com/
Phone
8055765317
PRRC contact
Michael Kilday
EUDAMED SRN
US-MF-000023823
FDA FEI number
3008581151
DUNS number
120981337