CLASS I Device recall · Reported 26 Jun 2019 · FDA Enforcement Report
Hudson RCI Sheridan: Uncuffed, Product recalled by Teleflex Medical
Teleflex Medical is recalling Hudson RCI Sheridan: Uncuffed, 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-1763-2019
- 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: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm, Product Code 5-10413 3) Uncuffed 7.0 mm, Product Code 5-10414 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?
1) Uncuffed 6.0 mm, Product Code 5-10412 Lot Numbers: 73J1600363 73K1600581 73L1600347 73L1600552 73L1600850 73M1600138 73A1700264 73B1700300 73C1700688 73E1700098 73E1700712 73G1700132 73H1700327 73J1700290 73K1700065 73K1700415 73L1700169 73L1700320 73M1700250 73A1800060 73B1800348 73B1800487 73C1800349 73C1800482 73D1800464 73E1800389 73F1800171 73G1800923 2) Uncuffed 6.5 mm, Product Code 5-10413 Lot Numbers: 73M1600139 73B1700301 73E1700472 73G1700127 73K1700416 73A1800061 73B1800349 73B1800488 73D1800634 73F1800544 73G1800924 3) Uncuffed 7.0 mm, Product Code 5-10414 Lot Numbers: 73A1700100 73F1700064 73L1800406
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 | Hudson RCI Sheridan LTS, 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 |
More recalls from Teleflex Medical
All 235| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Teleflex Flex tube, Product #20011, sterile recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS II | Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile recalled | 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 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 |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |