Freudenberg Medical, Llc
Freudenberg Medical, Llc appears in FDA public data with 4 recalls, 3 510(k) clearances, 10 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2909-2026, Class II) was initiated on June 17, 2026. Its most recent 510(k) clearance was granted on December 18, 2024.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 3
- Inspections
- 10
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2909-2026 | Class II | Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF | June 17, 2026 |
| Z-2910-2026 | Class II | Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF | June 17, 2026 |
| Z-1016-2022 | Class II | Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US) | February 21, 2022 |
| Z-1017-2022 | Class II | Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS) | February 21, 2022 |