Manufacturer
2 recalls in our database name Helix Medical LLC as the manufacturing or recalling firm.
Of the 2 recalls from Helix 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 0 (0%) 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.
Helix Medical LLC is recalling 47 units of the Blom-Singer Adjustable Tracheostoma Valve II because the essential body component is missing from the packaging, rendering the device unusable.
Helix Medical LLC is recalling the Blom-Singer indwelling TEP Occluder due to an invalid expiration date. The recall covers devices distributed in the US and UK.