Blom-Singer Classic Voice Prosthesis Recall: Incorrect Labeling Hazard
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.
Lower-risk recall
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.
What happened, in plain English
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. Read more at govinfonow.com/recall/314335-blom-singer-classic-voice-prosthesis-recall-incorrect-labeling-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/314335-blom-singer-classic-voice-prosthesis-recall-incorrect-labeling-hazard · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2910-2026
Cite this page
“Blom-Singer Classic Voice Prosthesis Recall: Incorrect Labeling Hazard.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/314335-blom-singer-classic-voice-prosthesis-recall-incorrect-labeling-hazard. Based on FDA recall #Z-2910-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2910-2026%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Freudenberg Medical- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2909-2026 | Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF; Lot #0000369233/UDI: 00813307014133 | 12 units |
| Z-2910-2026 | Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF; Lot #0000369205/UDI: 00813307014232 | 40 units |
What to do — step by step
Check Product Labeling
Verify the product's lot number and UDI code to confirm if it matches the recalled units (lot #0000369205 or UDI: 008133070142322).
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 8 states.
FDA distribution: “US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Florida, Indiana, Kentucky, Missouri, New York, Ohio, Washington.
Recall timeline
FDA published this recall 56 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using this product?
No, the recall is for incorrect labeling, not a safety hazard. If your product has the correct labeling, it is safe to use.
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Where this comes from
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.
- Official source: FDA Recall #Z-2910-2026 (June 17, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2910-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.