FDA (Devices) recall action 98550
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Potential for detachment of a distal tip component of the device during use.
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.
Olympus Corporation of the Americas is recalling Olympus Thunderbeat II Shears (Model TB2-0520FC) because the distal tip component may detach during use.
Olympus is recalling Thunderbeat II Shears with Ultrasonic Mode, 5 mm and 25 cm, because a distal tip component may detach during use. 365 units are affected.
Olympus is recalling Thunderbeat II Shears with Ultrasonic Mode, 5 mm and 35 cm, because a distal tip component may detach during use. 3,360 units are affected.
Olympus is recalling Thunderbeat II Shears (5mm, 45cm) because the distal tip component may detach during use, potentially causing patient harm.