Data Foundry

Medical device recalls 2020

RUSCH LASERTUBE — Class II medical device recall Z-2533-2020

Terminated recall by TELEFLEX MEDICAL INC, reported 2020-07-15, distributed nationwide. Teleflex is initiating a voluntary recall for the above-mentioned products due to reports indicating that the

Recall numberZ-2533-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmTELEFLEX MEDICAL INC, Morrisville, NC, United States
Recall initiated2020-05-29
Classified2020-07-07
Reported by FDA2020-07-15
Terminated2025-06-17
DistributedNationwide (US)
Quantity6,014 devices
Reason classesdevice malfunction
Lot numbers19451, 19461, 19471, 19481, 19491, 19501, 19511, 20021, 20031, 20041, 20051, 20061, 20071, 20081, 20091, 20101, 20111, 20121, 20131

Product

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2533-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.