InHealth Technologies; Blom-Singer; Classic recallZ-2909-2026 · Freudenberg Medical, LLC · initiated Jun 17, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Freudenberg Medical, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Labeling mix-ups
What the company is doing
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: [email protected]
Recall details
- Recall number
- Z-2909-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 17, 2026
- Posted by the FDA
- Aug 6, 2026
- Recalling firm
- Freudenberg Medical, LLC
- Quantity
- 12 units
- Product code
- EWL
- FDA submissions
- K932120
- Distribution
- US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.
Product description
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Code information (models, lots, serial numbers)
Lot #0000369233/UDI: 00813307014133
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- InHealth Technologies; Blom-Singer; Classic IN 1610-LEFFreudenberg Medical, LLC · Prosthesis, Laryngeal (Taub)1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 99299).
- Z-2910-2026 · Open, ClassifiedBlom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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