Freudenberg Medical recalls Blom-Singer Classic Indwelling Voice Prosthesis (16Fr/10 mm REF: 1610-LF) due to incorrect labeling that could lead to improper use. Affected units have specific lot numbers and UDI codes.
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.
Freudenberg Medical is recalling Blom-Singer Classic Indwelling Voice Prosthesis models with specific lot numbers because the labeling is incorrect. This could lead to improper use if the wrong flange type is installed, potentially causing complications for patients.
The product's labeled box contains the wrong flange type. For example, the box for the Large Esophageal Flange includes a Large Esophageal and Tracheal Flange, which could lead to improper installation and potential complications.
Patients using the Blom-Singer Classic Indwelling Voice Prosthesis with lot numbers starting with 0000369205 or UDI codes 008133070142322 are affected. Those with the correct labeling are not at risk.
Check for the product name 'Blom-Singer Classic Indwelling Voice Prosthesis', size 16Fr/10 mm, and reference number 1610-LF. Look for lot numbers starting with 0000369205 or UDI code 008133070142322.
Verify the product's lot number and UDI code to confirm if it matches the recalled units (lot #0000369205 or UDI: 008133070142322).
The recalled model is Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF with lot number 0000369205 or UDI code 008133070142322.
No, the recall is for incorrect labeling, not a safety hazard. If your product has the correct labeling, it is safe to use.
Check the product label for lot number starting with 0000369205 or UDI code 008133070142322.
We’ve drafted a message you can send Freudenberg Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2910-2026 — Freudenberg Medical Freudenberg Medical Hello, I own a Freudenberg Medical that is covered by recall Z-2910-2026 from Freudenberg Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
