Data Foundry

Medical device recalls 2015

Hudson RCI Adult Universal Ventilator Circuit — Class II medical device recall Z-0419-2016

Terminated recall by Teleflex Medical, reported 2015-12-23, distributed in AL, AZ, CA, GA, IL, KY, LA, MA…. Product is being recalled due to complaints that the inspiratory and expiratory tubes are transposed.

Recall numberZ-0419-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmTeleflex Medical, Durham, NC, United States
Recall initiated2014-04-17
Classified2015-12-15
Reported by FDA2015-12-23
Terminated2015-12-16
DistributedAL, AZ, CA, GA, IL, KY, LA, MA, MI, MN, NC, NJ, NY, OH, OK, OR, PA, TN, TX, WA
Quantity2,600 units
Lot numbers02K1300128, 02L1302324

Product

Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column

Reason for recall

Product is being recalled due to complaints that the inspiratory and expiratory tubes are transposed.

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-0419-2016. 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.