Freudenberg Medical, LLC recalls Blom-Singer Classic Indwelling Voice Prosthesis
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF:1610-LEFUDI 00813307014133Affected lot00813307014133
What the firm is doing
On 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
DistributionShow detailsHide
US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2909-2026
- FDA 510(k) clearance · K932120The device's official FDA premarket clearance record
- FDA device classification · EWLOfficial FDA classification for this device type
- CFR regulation · 21 CFR 874.3730The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Freudenberg Medical, LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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