Freudenberg Medical recalls

2 official recalls and safety alerts involving Freudenberg Medical since 2022-05, 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 Freudenberg Medical or the relevant agency.

1. 2026-08-12
2. US
   Drugs & medicalClass II

   Freudenberg Medical, LLC recalls Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF

   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.

   FDA · DeviceFreudenberg Medical, LLCUS Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY…Official notice →
3. 2022-05-04
4. US
   Drugs & medicalClass II

   Freudenberg Medical, Llc recalls Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)

   Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia

   FDA · DeviceFreudenberg Medical, LlcUS distribution: GA, OH Foreign distribution: NetherlandsOfficial notice →