Home / Brands / Freudenberg Medical
Freudenberg Medical Recalls
4 recalls on record · May 4, 2022 to August 12, 2026 · Medical Devices
Recalls by year
22
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 12, 2026Medical DevicesFDA
Freudenberg Medical, LLC recalls Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
Hazard: 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.
August 12, 2026Medical DevicesFDA
Freudenberg Medical, LLC recalls Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Hazard: 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.
May 4, 2022Medical DevicesFDA
Freudenberg Medical, Llc recalls Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
Hazard: Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
May 4, 2022Medical DevicesFDA
Freudenberg Medical, Llc recalls Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
Hazard: Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia