Freudenberg Medical, LLC FDA Recalls

4 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEFClass IIJun 17, 2026Incorrect labeling- The labeled box for the Large Esophageal	Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal F	Class IIDevices	Jun 17, 2026
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LFClass IIJun 17, 2026Incorrect labeling- The labeled box for the Large Esophageal	Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal F	Class IIDevices	Jun 17, 2026
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)Class IIFeb 21, 2022Non-intended glue from the hub/shaft bond on the inside ID o	Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to	Class IIDevices	Feb 21, 2022
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)Class IIFeb 21, 2022Non-intended glue from the hub/shaft bond on the inside ID o	Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to	Class IIDevices	Feb 21, 2022