Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Summary
The FDA issued a Class II for Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF by Freudenberg Medical, LLC. Reason: Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large.
Details
Source
Device Recall
External ID
Z-2909-2026
Action Date
2026-08-12
Status
Ongoing
Category
device
Product Description
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Lot/Code Info: Lot #0000369233/UDI: 00813307014133
Quantity Affected: 12 units
Reason for 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.
Distribution
US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-17
Company
Carpinteria, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 156 device recalls issued in the same week, part of 400 device-related FDA actions this month.
Freudenberg Medical, LLC has 5 FDA actions in our database, including 4 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Freudenberg Medical, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Freudenberg Medical, LLC have FDA actions?
Freudenberg Medical, LLC has 5 FDA actions in our database, including 4 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2909-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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