InHealth Technologies; Blom-Singer; ClassicRecalls & reported problems across all models

We found 4 models of InHealth Technologies; Blom-Singer; Classic by Freudenberg Medical, LLC in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between Dec 5, 2019 and Sep 8, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

InHealth Technologies; Blom-Singer; Classic recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 17, 2026Class IIOpen, Classified

   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.

   Z-2910-2026 · Root cause: Labeling mix-ups · Recall details · FDA record ↗

2. Jun 17, 2026Class IIOpen, Classified

   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.

   Z-2909-2026 · Root cause: Labeling mix-ups · Recall details · FDA record ↗

Most reported InHealth Technologies; Blom-Singer; Classic problems

InHealth Technologies; Blom-Singer; Classic models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• InHealth Technologies; Blom-Singer; Classic IN 1610-LEF

  Prosthesis, Laryngeal (Taub)
  1 recall0 reports
• InHealth Technologies; Blom-Singer; Classic IN 1610-LF

  Prosthesis, Laryngeal (Taub)
  1 recall0 reports
• InHealth Technologies; Blom-Singer; Classic IN 1606-NS

  Prosthesis, Laryngeal (Taub)
  1 report
• InHealth Technologies; Blom-Singer; Classic IN 1608-NS

  Brush, Cleaning, Tracheal Tube
  1 report

Recent InHealth Technologies; Blom-Singer; Classic adverse event reports

The 2 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 8, 2025Difficult to Insert; Migration; Difficult to Insert; Migration

  INCIDENT DESCRIPTION: " A 67-YEAR-OLD PATIENT WITH A TRACHEOSTOMY AND A VOICE PROSTHESIS FOLLOWING A TOTAL LARYNGECTOMY FOR RECURRENT INVASIVE SQUAMOUS CELL CARCINOMA OF THE RIGHT GLOTTIC CAVITY EXPERIENCED A COMPLICATION DURING IMPLANT REPLACEMENT ON (B)(6). THE REPLACEMENT ATTEMPT FAILED, AND DURING THE PROCEDURE, THE VOICE IMPLANT FLANGE WAS ASPIRATED. A SHILEY 8 TRACHEOSTOMY TUBE WITH AN INFLATED CUFF WAS INSERTED SUBSEQUENTLY." PATIENT IMPACT: " THE PATIENT EXPERIENCED CHOKING DURING THE INCIDENT. THERE WAS NO BUZZER IN THE CUBICLE, AND THE SURGEON HAD TO CALL FOR HELP VOCALLY. THE FLANGE WAS NOT VISUALIZED IN THE ESOPHAGUS DURING ENDOSCOPY. AN ATTEMPT TO INSERT A LONGER 8 MM IMPLANT FAILED, AS THE FLANGE COULD NOT BE DEPLOYED. THE PATIENT UNDERWENT REPLACEMENT SURGERY UNDER GENERAL ANESTHESIA WITH A 10 MM BLOM-SINGER IMPLANT ON (B)(6) AND WAS DISCHARGED WITHOUT FURTHER COMPLICATIONS ON (B)(6). NO RETAINED EVIDENCE WAS KEPT BY THE FACILITY."

  Patient problems: Airway Obstruction; Aspiration/Inhalation; Choking; Foreign Body In Patient

  MAUDE report 22991909 ↗
• InjuryDec 5, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE VOICE PROSTHESIS WAS INSERTED ON (B)(6) 2019 AND WAS REPORTED TO BE LEAKING ON (B)(6) 2019. THE DEVICE WAS INSPECTED BY A PHYSICIANS ASSISTANT WHO DETERMINED IT WAS FINE AND DID NOT REMOVE IT. THE PATIENT VISITED THE ER ON (B)(6) 2019 AND WAS ADMITTED TO THE HOSPITAL THE SAME DAY. THE PATIENT WAS DIAGNOSED WITH ASPIRATION PNEUMONIA. ALTHOUGH IT WAS INITIALLY REPORTED THAT THE PATIENT HAD BEEN DIAGNOSED WITH PNEUMONIA, IT WAS NOT UNTIL (B)(6) 2019 THAT INFORMATION WAS RECEIVED WHICH ALLEGED THE DEVICE CONTRIBUTED TO THE PNEUMONIA SPECIFICALLY THE PHYSICIAN'S ASSISTANT REPORTED THAT THE PATIENT HAD HIS TEP CHANGED SEVERAL TIMES DURING THE MONTH OF MAY. THE PATIENT WAS TREATED WITH BROAD-SPECTRUM ANTIBIOTICS (ZOSYN AND VANCOMYCIN). THE DEVICES WERE DISCARDED AND ARE NOT AVAILABLE FOR EVALUATION.

  Patient problems: Pneumonia

  MAUDE report 9419237 ↗