Home › Freudenberg Medical, LLC › InHealth Technologies; Blom-Singer®
InHealth Technologies; Blom-Singer®
Freudenberg Medical, LLC · Model TP 2208-LEF · UDI-DI 00848253003115
EWL
Prescription
10
510(k) clearances
174
Adverse events (3 deaths)
4
Recalls
5
Facilities
Description
Blom-Singer® FirstFit Surgical Kit with 22.5Fr Voice Prosthesis, 8mm length
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-17 | Freudenberg Medical, LLC | 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 Flang |
| 2026-06-17 | Freudenberg Medical, LLC | 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 Flang |
| 2013-10-01 | Helix Medical LLC | InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV II) because the body component of the device is missing from the packaging. The ATS |
| 2012-03-08 | Helix Medical LLC | Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.