Food, drugs, devices › Teleflex Medical
Device recall: HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are in
Teleflex Medical (Morrisville, NC) initiated this device recall on 30 Oct 2019; FDA lists 1 product record under event 84298, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 30 Sep 2021. Initiation: voluntary: firm initiated. Teleflex Medical has 82 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Teleflex Medical, Morrisville, NC.
Reason for recall
"The tracheal and brochial swivel connectors are incorrectly labeled."
Distribution
"US Nationwide distribution in the states of CT, OK, LA, IL, GA, NY, CA, MT, MI, MA, FL."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0703-2020 | 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… | 53 units | Class II | Terminated | 25 Dec 2019 |
Context
Other enforcement events for Teleflex Medical
All 82 events for Teleflex Medical
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The tracheal and brochial swivel connectors are incorrectly labeled."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of CT, OK, LA, IL, GA, NY, CA, MT, MI, MA, FL."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Sep 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.