Data Foundry

Medical device recalls 2015

HUDSON RCI — Class I medical device recall Z-2367-2015

Terminated recall by Teleflex Medical, reported 2015-08-26, distributed nationwide. The double swivel connector may crack or separate on the endobronchial tube.

Recall numberZ-2367-2015
Product typeMedical device
ClassificationClass I
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmTeleflex Medical, Research Triangle Park, NC, United States
Recall initiated2015-06-01
Classified2015-08-19
Reported by FDA2015-08-26
Terminated2018-04-16
DistributedNationwide (US)
Countries outside the USAR, BE, BS, CA, CN, IN, JP, KR, MX, NZ, VN
Quantity188,195 units
Reason classespackaging
Lot numbers01A1400121, 01A1400122, 01A1400194, 01A1400226, 01A1400227, 01A1400432, 01A1400433, 01A1400453, 01A1400574, 01A1400575, 01A1400576, 01B1400083, 01B1400084, 01B1400115, 01B1400242, 01B1400243, 01B1400356, 01B1400357, 01B1400478, 01C1400087, 01C1400088, 01C1400260, 01C1400261, 01C1400285, 01C1400406, 01J1300471, 01J1300472, 01K1300050, 01K1300073, 01K1300143, 01K1300144, 01K1300346, 01K1300347, 01K1300469, 01K1300578, 01K1300579, 01L1300081, 01L1300082, 01L1300083, 01L1300155 and 132 more

Product

HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring bronchial intubation.

Reason for recall

The double swivel connector may crack or separate on the endobronchial tube.

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-2367-2015. 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.