Olympus Recalls Lung Biopsy Needles After Reports of Injuries and Death
Olympus has recalled specific lots of its ViziShot 2 FLEX (19G) needles, used in lung cancer biopsies, after reports of patient harm and one death. The devices, produced before May 12, may have damaged sheaths that allow the hypotube and plastic parts to detach during procedures. Detached components cannot be seen on X-rays and may require bronchoscopic or surgical removal.
The company said the defect likely occurred during manufacturing and has now introduced automated inspections to replace visual checks. The FDA reposted Olympus’ alert and listed the recall in its database on Sept. 5, noting it affects over 103,000 units. Olympus first notified customers on Aug. 6.
This recall adds to the firm’s recent safety issues. Earlier in 2025, Olympus pulled endoscope sheath kits over tips detaching in patients, and in 2024 it expanded a recall of bronchoscopes following reports of injuries.
02-10-2025
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