Manufacturer
4 recalls in our database name Freudenberg Medical, LLC as the manufacturing or recalling firm.
Of the 4 recalls from Freudenberg Medical, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (25%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
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.
Freudenberg Medical is recalling the Empower Introducer Sheath due to defective adhesive on the catheter shaft that could cause blood clots and tissue damage.
Freudenberg Medical is recalling Empower Introducer Sheath devices (Model 668782-200) due to potential adhesive residue inside the catheter shaft that may cause blood clots and tissue damage. Affected devices were distributed in the US and Netherlands.