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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92129

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 31, 2023
Product types
Device
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
Olympus Corporation of the Americas

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-1615-2023
Recall number
Z-1615-2023
Initiated
March 31, 2023
Classification
Class III
Status
Ongoing
Quantity
2058 (Boxes; 5 per Box)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Natiowide Foreign: Canada, Germany

device · product 2 of 2

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

Z-1616-2023
Recall number
Z-1616-2023
Initiated
March 31, 2023
Classification
Class III
Status
Ongoing
Quantity
1297 (Boxes; 5 per Box)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI: 04953170388286 Lot numbers: KR248740 KR248746 KR252863 KR253666 KR253681 KR260854 KR260865 KR260873 KR260875 KR260876 KR260877 KR260896 KR260917 KR260937

Distribution pattern

Natiowide Foreign: Canada, Germany