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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98654

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

Open FDA event record

Event summary

Timeline bucket
March 23, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
TANGENT ENDOSCOPY, LLC

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

Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND. (2) TNG-4007-6pk.

Z-2209-2026
Recall number
Z-2209-2026
Initiated
March 23, 2026
Classification
Class II
Status
Ongoing
Recalling firm
TANGENT ENDOSCOPY, LLC
Quantity
53 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Affected devices exhibited fractures at the distal shaft tip without complete detachment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Affected devices exhibited fractures at the distal shaft tip without complete detachment.

Code information

(1) Model Number: TNG4002-IND; UDI-DI: (1) 00850061601001; Lot numbers: 2510900, 2512938, and 2601944. (2) Model Number: TNG-4007-6pk; UDI-DI: 00850061601001; Lot numbers: 2510900, 2512938, and 2601944

Distribution pattern

US Nationwide distribution in the states of North Carolina, Arizona, and Nevada.