CLASS III ONGOING Device recall · Reported 31 May 2023 · FDA Enforcement Report

ViziShot Use Aspiration Needle- To be used recalled

Olympus Corporation of the Americas is recalling ViziShot Use Aspiration Needle- To be used with ultrasound endoscopes for ultrasound. The recall was initiated on 31 Mar 2023 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesUDI: 04953170388248 Lot numbers: KR243729 KR248648 KR248652 KR248673 KR248784 KR248785 KR248808 KR249160 KR251593 KR257313 KR257314 KR264662 KR264697 KR264708 KR264711 KR264726 KR264732 KR264746 KR264751 KR264778 KR264806 KR276770

Quantity recalled2058 (Boxes; 5 per Box)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1615-2023
FDA event ID: 92129
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class III
Status: Ongoing
Recall initiated: 31 Mar 2023
FDA classified: 19 May 2023
Reported: 31 May 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

31 Mar 2023	Recall initiated by company
19 May 2023	Classified by FDA	+49 days
31 May 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Natiowide Foreign: Canada, Germany

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI: 04953170388248 Lot numbers: KR243729 KR248648 KR248652 KR248673 KR248784 KR248785 KR248808 KR249160 KR251593 KR257313 KR257314 KR264662 KR264697 KR264708 KR264711 KR264726 KR264732 KR264746 KR264751 KR264778 KR264806 KR276770

Where was it sold?

Natiowide Foreign: Canada, Germany

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 92129

Reported	Class	Recall	Company	Reason	Where
31 May 2023	CLASS III	To be used with ultrasound endoscopes recalled	Olympus Corporation of the Americas	Device Malfunction	PA

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