FDA (Devices) recall action 83819
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
The sterile barrier of some devices may have been affected
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.
Xodus Medical Inc is recalling 460,000 Electrosurgical Tip Cleaners because the sterile barrier of some devices may have been affected.
Xodus Medical Inc is recalling 255,000 Cautery Tip Cleaners because the sterile barrier of some devices may have been affected.
Xodus Medical Inc is recalling 464,040 Electrosurgical Tip Cleaners because the sterile barrier of some devices may have been affected.