Freudenberg Medical recalls Blom-Singer Classic Indwelling Voice Prosthesis (16Fr/10 mm REF: 1610-LEF) due to incorrect labeling that could lead to improper use. Affected units include specific lot numbers.
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 incorrect labeling. This could cause improper use if the wrong flange type is installed, potentially leading to complications.
The labeled boxes contain the wrong flange types. For example, the box for the Large Esophageal Flange includes a Large Esophageal and Tracheal Flange, and vice versa. This mismatch could lead to improper installation.
Patients using the Blom-Singer Classic Indwelling Voice Prosthesis with the specific model and lot numbers are affected. Those with the incorrect labeling may face improper use risks.
Check for the product name 'Blom-Singer Classic Indwelling Voice Prosthesis', model 16Fr/10 mm REF: 1610-LEF, and lot number 0000369233. The specific UDI code 00813307014133 is also associated with this recall.
Verify the product label for the correct flange type to ensure proper installation.
The recalled product is Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF.
Check for lot number 0000369233 or UDI code 00813307014133 on the product label.
The recall record does not specify a remedy; users should check labeling to ensure proper installation.
We’ve drafted a message you can send Freudenberg Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2909-2026 — Freudenberg Medical Freudenberg Medical Hello, I own a Freudenberg Medical that is covered by recall Z-2909-2026 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.
