FDA (Devices) recall action 99299
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Freudenberg Medical is recalling 12 Blom-Singer Classic Indwelling Voice Prosthesis devices because the boxes are mislabeled, swapping Large Esophageal Flange and Large Esophageal and Tracheal Flange contents.
Freudenberg Medical recalls 40 Blom-Singer Classic Indwelling Voice Prostheses due to labeling errors that could cause confusion about product contents.