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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85786

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

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Event summary

Timeline bucket
May 29, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
TELEFLEX MEDICAL 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

RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 102004-000050 c) I.D. mm 6,0, Product Code 102004-000060 d) I.D. mm 7,0, Product Code 102004-000070 e) I.D. mm 8,0, Product Code 102004-000080 Product Usage: Tracheal intubation during laser surgery in the laryngeal area. The tube is resistant to the following kinds of laser: A R+ laser / ND/YAG laser / CO2 lasers (continuous-wave or pulsed) with a wave length ranging from 0.488 ¿m to 10.6 ¿m.

Z-2533-2020
Recall number
Z-2533-2020
Initiated
May 29, 2020
Classification
Class II
Status
Terminated
Recalling firm
TELEFLEX MEDICAL INC
Quantity
6014 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Teleflex is initiating a voluntary recall for the above-mentioned products due to reports indicating that the laser guard foil partially separated and/or slightly detached at the edges in the presence of moisture.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Teleflex is initiating a voluntary recall for the above-mentioned products due to reports indicating that the laser guard foil partially separated and/or slightly detached at the edges in the presence of moisture.

Code information

a) I.D. mm 4,0, Product Code 102004-000040, Lot numbers: 19491, 19501, 19511, 20021, 20041, 20091 b) I.D. mm 5,0, Product Code 102004-000050, Lot numbers: 19471, 19501, 19511, 20021, 20031, 20041, 20051, 20061, 20071, 20101, 20111, 20121 c) I.D. mm 6,0, Product Code 102004-000060, Lot numbers: 19481, 19491, 19501, 20081, 20091, 20101, 20111, 20121, 20131 d) I.D. mm 7,0, Product Code 102004-000070, Lot numbers: 19451, 19461, 19471, 19501, 20021, 20031, 20051, 20091, 20111 e) I.D. mm 8,0, Product Code 102004-000080, Lot numbers: 19451, 19481, 19501, 19511, 20041, 20111, 20121

Distribution pattern

US Nationwide distribution.