FDA (Devices) recall action 97127
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.
Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and infection.
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.
One-piece Guedel airways, size 2, are being recalled because of potential contamination with small burrs which, if they detach, could be inhaled. 2,800 pieces are affected.
One-piece Guedel airways, size 3, are being recalled because of potential contamination with small burrs which, if they detach, could be inhaled. 8,640 pieces are affected.