Recall Z-2909-2026 ยท EWL Prosthesis, Laryngeal (Taub)
Freudenberg Medical, LLC
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
| Date | Aug 6, 2026 (initiated Jun 17, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Labeling mix-ups |
| Action | On June 26, 2026, Inhealth Technologies issued a Urgent Medical Device Recall Notification via FedEx to affected consignees. Inhealth ask consignees to take the following actions: 1. Do not use, ship, or distribute affected products 2. Identify and isolate all affected inventory 3. Destroy all affected devices 4. Complete the attached response form 5. Return confirmation no later than: July 8, 2026 6. Email confirmation of product destruction to: regulatoryaffairs@freudenbergmedical.com |
| Quantity | 12 units |
| Distribution | US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932120 | BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES Helix Medical, Inc., Apr 15, 1994 |