Home / Recalls / Medical Devices
Olympus Corporation of the Americas recalls To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural le
Recalled May 31, 2023 · FDA recall Z-1616-2023 · Olympus Corporation of the Americas
Hazard
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction. · FDA Class III
Units
1297 (Boxes; 5 per Box)
Sold at
Natiowide Foreign: Canada, Germany
Description
Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.
Product
To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A
Manufacturer(s)
Olympus Corporation of the Americas
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →