FDA Medical Device Recalls (openFDA)
Teleflex Medical: 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 indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.
- Recall number
- Z-0703-2020
- Recalling firm
- Teleflex Medical
- Product
- 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 indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.
- Status
- Terminated
- Initiated
- 2019-10-30
- Posted
- not on file
- Terminated
- 2021-09-30
- Reason
- The tracheal and brochial swivel connectors are incorrectly labeled.
- Root cause
- Process control
- Action
- An Urgent Medical Device Recall letter was sent to customers via FedEx 2-day service notifying consignees of the recall. Customers are asked to immediately discontinue use and quarantine any products with the affected product code and lot number identified in the letter. Consignees are asked to complete a Recall Acknowledgement Form and fax or email it to the recalling firm. Additional questions may be directed to Customer Service at 1-866-396-2111.
- Quantity
- 53 units
- Distribution
- US Nationwide distribution in the states of CT, OK, LA, IL, GA, NY, CA, MT, MI, MA, FL.
- Lot, serial or model codes
- Catalog: 5-16135; Manufacturing Lot: 73G1600257
- 510(k) numbers
- ["K851856"]
- PMA numbers
- not on file
- Product code
- CBI
- Firm FEI
- 3005747797
- Firm city
- Morrisville
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28