Olympus Fine Needle Aspiration Needles Recalled for Angle Non-Conformance
Olympus is recalling 1,297 boxes of fine needle aspiration needles due to a manufacturing defect where the needle angle does not meet specifications, resulting in slight resistance during needle advancement and retraction.
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: This is an FDA Class III recall involving a manufacturing non-conformance affecting device operation, with no reported injuries or illnesses. Per the rubric, FDA Class III recalls without reported harm typically score as 1-2; the functional impact warrants a Moderate rating.
Plain-English summary
Olympus Corporation of the Americas is recalling 1,297 boxes (5 needles per box) of its fine needle aspiration (FNA) needles used with ultrasound endoscopes (Models NA-U401SX-4022 and NA-U401SX-4022-A). These devices are used for ultrasound-guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and gastrointestinal tract.
The needles are being recalled due to a manufacturing defect where the needle angle does not meet specifications and remains unbent. This results in slight resistance when advancing and retracting the needle during the procedure.
The affected products were distributed nationwide and internationally to Canada and Germany. Affected lot numbers include: KR248740, KR248746, KR252863, KR253666, KR253681, KR260854, KR260865, KR260873, KR260875, KR260876, KR260877, KR260896, KR260917, and KR260937.
Healthcare facilities should check for affected lot numbers and contact Olympus Corporation of the Americas for further instructions. The FDA has classified this recall as Class III.
The recalled product
- 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
- 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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