Blom-Singer Classic Indwelling Voice Prosthesis Recall Issued
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Freudenberg Medical, LLC is recalling 40 units of Blom-Singer Classic Indwelling Voice Prosthesis due to incorrect labeling of esophageal and tracheal flanges.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 18, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Freudenberg Medical, LLC initiated a voluntary recall due to 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.
Which Products Are Affected
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm, REF: 1610-LF. Lot #0000369205 (UDI: 00813307014232). 40 units distributed nationwide in the United States (IN, OH, AZ, WA, FL, MO, KY, NY) and to GBR and FRA.
What You Should Do
Consumers should check product labeling against contents and contact the recalling firm for further guidance.
Why This Matters
This Class II recall involves a labeling mix-up that could lead to incorrect device selection during use.
Source
FDA recall number Z-2910-2026, Event ID 99299.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (865 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 18, 2026.
Frequently Asked Questions
Common questions about this FDA recall.