Jeffersonville, IN, United States
Freudenberg Medical, Llc recalls
2 recalls recorded since 2018, most recently on 17 June 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 17 June 2026
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2909-2026, Z-2910-2026
- Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
- Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
Terminated Class II Medical devices
- Recall started
- 21 February 2022
- Terminated
- 18 April 2024
- Reason
- Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
- Distribution
- US distribution: GA, OH Foreign distribution: Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1016-2022, Z-1017-2022
- Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
- Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.