Aspiration biopsy needles recalled over undetected deformed atraumatic tips
ViziShot 2 FLEX single use aspiration needles, model NA-U403SX-4019, are recalled because of the potential for undetected, deformed atraumatic tips. The FDA classified the action as Class I. 104,508 units are affected.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The rubric assigns 5 to any FDA Class I recall, and the FDA classified this aspiration needle action as Class I.
Plain-English summary
The ViziShot 2 FLEX single use aspiration needle, model number NA-U403SX-4019, UDI-DI 00821925043060, is being recalled for all lots manufactured after the date given in the recall notice. The tissue biopsy device is made up of four main parts: a handle, a sheath, a needle and a stylet. The recall covers 104,508 units distributed in the United States and in Australia, Germany, Canada, Chile, China, Hong Kong and other countries.
The recall was issued because of the potential for undetected, deformed atraumatic tips. The FDA classified the action as Class I, its most serious category.
Hospitals and endoscopy units holding affected lots should quarantine them and follow the manufacturer's instructions for return.
The recalled product
- Product
- ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is…
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Biopsy Device
- Affected units
- 104,508
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Olympus Corporation of the Americas
See all →- ModerateOlympus DisplayPort Cable Recalled for Video Dropout Risk
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Foroblique Telescope Recalled for Sterilization Labeling Discrepancy
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Lateral Telescope 70 Recalled for Sterilization Labeling Discrepancies
FDA (Devices) · 2026-10-07
- ModerateOlympus Endoscopic Balloon Dilator Recalled for Incorrect Inflation Chart Label
FDA (Devices) · 2026-09-30
- SevereOlympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateViziShot 2 Aspiration Needle recalled for manufacturing angle defect
FDA (Devices) · 2023-05-31
- HighAomori Olympus Recalls ViziShot Aspiration Needles Due to Seal Defects
FDA (Devices) · 2021-02-17
- HighAomori Olympus Recalls Aspiration Needles Due to Inadequate Package Seals
FDA (Devices) · 2021-02-17
- HighAomori Olympus Vizishot Aspiration Needle Recall for Package Seal Defects
FDA (Devices) · 2021-02-17
- HighAomori Olympus Recalls Aspiration Needles Due to Seal Defects
FDA (Devices) · 2021-02-17
- ModerateOlympus Fine Needle Aspiration Needles Recalled for Angle Non-Conformance
FDA (Devices) · 2023-05-31