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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91909

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
March 02, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Angiodynamics, Inc.

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

1 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 1

NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN: H787204001110

Z-1381-2023
Recall number
Z-1381-2023
Initiated
March 02, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Angiodynamics, Inc.
Quantity
10 boxes( 5 probes/box)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoKnife generator resulting in a delay in procedure

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoKnife generator resulting in a delay in procedure

Code information

UDI-DI: 15051684029643 Lot Number: 5762110

Distribution pattern

US Nationwide Distribution: CA,CO, FL, IA, NY, OH