CLASS I Device recall · Reported 26 Jun 2019 · FDA Enforcement Report
Hudson RCI Sheridan LTS, Product recalled by Teleflex Medical
Teleflex Medical is recalling Hudson RCI Sheridan LTS, distributed nationwide in the US. The recall was initiated on 24 May 2019 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1759-2019
- FDA event ID
- 82964
- Recalling firm
- Teleflex Medical, Morrisville, NC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 24 May 2019
- FDA classified
- 19 Jun 2019
- Reported
- 26 Jun 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 24 May 2019 | Recall initiated by company | |
| 19 Jun 2019 | Classified by FDA | +26 days |
| 26 Jun 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.
Product as listed by the FDA
Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
Where it was distributed
Worldwide - US Nationwide Distribution
Questions about this recall
Why was it recalled?
This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.
Which lots are affected?
Lot Numbers: 73K1600369, 73L1600011, 73A1700646, 73C1700238, 73D1700625, 73E1700475, 73F1700387, 73H1700041, 73H1700483, 73J1700292, 73L1700503, 73M1700453, 73A1800671, 73B1800350, 73D1800138, 73F1800174, 73G1800126, 73G1800806, 73J1800308, 73K1800173, 73L1800225, 73K1800172
Where was it sold?
Worldwide - US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 82964This product is part of a recall event; the main page for the event is Hudson RCI Sheridan: Ez-endo, Product recalled by Teleflex Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Hudson RCI Sheridan: Ez-endo, Product recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide | |
| CLASS I | Hudson RCI Sheridan: CF, Product Codes: 5-10112, 5-10212 CF recalled | Teleflex Medical | Other | Nationwide | |
| CLASS I | Hudson RCI Sheridan: HVT, Product recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide | |
| CLASS I | Sheridan/CF Novaplus, Product recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide | |
| CLASS I | Sheridan/HVT: Novaplus, Product recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide | |
| CLASS I | Hudson RCI Sheridan: Preformed, Product Codes: a) recalled | Teleflex Medical | Other | Nationwide | |
| CLASS I | Hudson RCI Sheridan: Uncuffed, Product recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Teleflex Flex tube, Product #20011, sterile recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
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| Device | CLASS I | Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device) recalled | Teleflex Medical | Other | Nationwide |
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