Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84298

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

Open FDA event record

Event summary

Timeline bucket
October 30, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Teleflex Medical

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

HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in Thoracic surgery, brochospirometry, adminitration of endobronchial anesthesia and other uses commonly requiring endobronchial intubation. The Sheridan Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.

Z-0703-2020
Recall number
Z-0703-2020
Initiated
October 30, 2019
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
53 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incorrectly labeled

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

The tracheal and brochial swivel connectors are incorrectly labeled.

Code information

Catalog: 5-16135; Manufacturing Lot: 73G1600257

Distribution pattern

US Nationwide distribution in the states of CT, OK, LA, IL, GA, NY, CA, MT, MI, MA, FL.