Olympus Expands ViziShot 2 FLEX Needle Recall to All Lots

Olympus has expanded its recall of ViziShot 2 FLEX (19G) EBUS-TBNA needles, used to sample lesions in and around the airways, to cover every lot of the device. The company's announcement, dated January 16 and posted by the FDA as a public service, says the action supersedes an August 2025 notice in which only certain lots were being recalled. The American Hospital Association reported the expansion on January 22.

Olympus said it expanded the global removal "after receiving and investigating complaints of device components ejecting or detaching during procedures." The complaints included adverse event reports of patient injury and one death, according to the company.

New contributing factors

Since the August notice, internal investigations of complaints have identified additional contributing factors to hypotube component ejection, "including device heat-shrink material degradation and use errors, which affect all lots of the ViziShot 2 FLEX device," the announcement says. The heat-shrink material that seals the needle can degrade during clinical use and may result in difficulty extracting or expelling samples, fluid leakage, impaired needle deployment or retraction, or breakage of device components, according to the company.

A detached component carries the risk of unintended device parts within the tracheobronchial tree that may require bronchoscopic extraction or surgical removal, Olympus said. The company directed users to cease use immediately, quarantine all ViziShot 2 FLEX devices and return them following the instructions in its removal communication. Other EBUS-TBNA needles are not affected, it said.

The earlier Class I action

The FDA had identified the earlier, lot-limited removal as the most serious type of recall. The agency's notice on that action, dated September 30, 2025, said Olympus sent affected customers an urgent medical device removal letter on August 6, 2025, covering lots distributed from August 4, 2022, to April 25, 2025.

That notice attributed the earlier recall to a potentially deformed a-traumatic tip on devices manufactured before May 12, 2025, which could cause hypotube component ejection or detached plastic components that could enter the airways. "There have been 40 reported injuries and one death related to this issue," the September notice said.

The ViziShot 2 FLEX is designed for use with ultrasound endoscopes for ultrasound-guided fine needle aspiration and fine needle biopsy of submucosal and extramural lesions of the tracheobronchial tree, according to Olympus. The FDA's September notice describes the device as made up of four main parts: a handle, a sheath, a needle and a stylet.

The AHA noted that the FDA also issued early alerts on January 22 for certain Olympus High Flow Insufflation Units, among other products. Olympus directed US customers with questions about identifying affected product to its Technical Assistance Center.