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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98696

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

Open FDA event record

Event summary

Timeline bucket
April 09, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Stryker Corporation

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

Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.

Z-2166-2026
Recall number
Z-2166-2026
Initiated
April 09, 2026
Classification
Class II
Status
Ongoing
Recalling firm
Stryker Corporation
Quantity
10 tube sets

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to nonconforming products being inadvertently distributed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to nonconforming products being inadvertently distributed.

Code information

Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601

Distribution pattern

U.S. Nationwide distribution in the state of GA.