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.
What this means for you
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
- Hazard
- manufacturing-defect
- device-malfunction
Distribution
Distribution scope not specified by the agency.
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