ViziShot 2 Aspiration Needle recalled for manufacturing angle defect
ViziShot 2 Aspiration Needles are being recalled because the needle angle does not meet specifications and remains unbent, causing resistance during use. No illnesses or injuries have been reported.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III classification for manufacturing defect affecting device function (improper needle angle causing resistance). No reported illnesses or injuries. Defect is functional but not immediately hazardous.
Plain-English summary
Olympus Corporation of the Americas is recalling ViziShot 2 Single Use Aspiration Needles (Models NA-U401SX-4021 and NA-U401SX-4021-A). These 21-gauge needles are used with ultrasound endoscopes for fine needle aspiration of submucosal and extramural lesions. The recall was initiated because the needle angle does not meet manufacturing specifications and remains unbent, causing slight resistance during needle advancement and retraction.
A total of 2,058 boxes (5 needles per box) have been distributed nationwide in the United States, as well as in Canada and Germany. Affected lot numbers include: KR243729, KR248648, KR248652, KR248673, KR248784, KR248785, KR248808, KR249160, KR251593, KR257313, KR257314, KR264662, KR264697, KR264708, KR264711, KR264726, KR264732, KR264746, KR264751, KR264778, KR264806, and KR276770.
Patients and healthcare providers should immediately stop using needles from the affected lots. Contact your healthcare facility to obtain replacement units.
The recalled product
- Product
- ViziShot 2 Single Use Aspiration Needle, 21G- 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. Model: NA-U401SX-4021, NA-U401SX-4021-A
- Manufacturer
- Olympus Corporation of the Americas
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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