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U.S. Department of Health and Human Services

Class 2 Device Recall BlomSinger Classic Indwelling Voice Prosthesis

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 Class 2 Device Recall BlomSinger Classic Indwelling Voice Prosthesissee related information
Date Initiated by FirmJune 17, 2026
Date PostedAugust 06, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2909-2026
Recall Event ID 99299
510(K)NumberK932120 
Product Classification Prosthesis, laryngeal (taub) - Product Code EWL
ProductBlom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF
Code Information Lot #0000369233/UDI: 00813307014133
FEI Number 2025182
Recalling Firm/
Manufacturer		 Freudenberg Medical, LLC
1110 Mark Ave
Carpinteria CA 93013-2918
For Additional Information ContactMs. Rhonda M. Kops
805-684-3304
Manufacturer 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.
FDA Determined
Cause 2		Labeling mix-ups
ActionOn June 26, 2026, Inhealth Technologies issued a Urgent Medical Device Recall Notification via FedEx to affected consignees. Inhealth ask consignees to take the following actions: 1. Do not use, ship, or distribute affected products 2. Identify and isolate all affected inventory 3. Destroy all affected devices 4. Complete the attached response form 5. Return confirmation no later than: July 8, 2026 6. Email confirmation of product destruction to: regulatoryaffairs@freudenbergmedical.com
Quantity in Commerce12 units
DistributionUS Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = EWL
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