Hudson RCI Sheridan LTS recallZ-2311-2019 · Teleflex Medical · initiated Jul 30, 2019
Class I Terminated All recalls posted in September 2019
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Teleflex Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.
FDA root cause category: Process control
What the company is doing
Teleflex sent an Urgent Medical Device Recall Notification letter dated July 30, 2019 to affected customers. The letter explains the problem and requests the consignee discontinue use and quarantine of any of the recalled products then to notify Teleflex. The firm is requesting the return of the affected products. For questions, contact your local sales representative or Customer Service at 1-866-396-2111.
Recall details
- Recall number
- Z-2311-2019
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Jul 30, 2019
- Posted by the FDA
- Sep 9, 2019
- Recalling firm
- Teleflex Medical
- Quantity
- 7963 units
- Product code
- BTR
- FDA submissions
- K822082
- Distribution
- US Nationwide Distribution
Product description
Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tube/airway management
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
a) REF 5-11108 Batch numbers: 73L1600010 73A1700644 73C1700236 73D1700438 73E1700473 73F1700385 73K1700066 73L1700501 73B1800123 73D1800137 73F1800172 73G1800124 73G1800925 73H1800731 b) REF 5-11110 Batch numbers: 73K1600368 73K1600727 73A1700645 73B1700410 73C1700237 73D1700624 73E1700474 73F1700386 73H1700040 73H1700482 73H1700599 73J1700291 73K1700067 73L1700502 73M1700452 73B1800124 73D1800313 73F1800173 73G1800125 73K1800170 73L1800224 c) REF 5-11112 Batch numbers: 73K1600369 73L1600011 73A1700646 73C1700238 73D1700625 73E1700475 73F1700387 73H1700041 73H1700483 73J1700292 73L1700503 73M1700453 73A1800671 73B1800350 73D1800138 73F1800174 73G1800126 73G1800806 73J1800308 73K1800173 73L1800225 73K1800172
Other devices under the same FDA submission
60 devices cleared under K822082 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- HUDSON RCI IPN044731Teleflex Incorporated · Tube, tracheal (w/wo connector)42 reports
- HUDSON RCI IPN048896Teleflex Incorporated · Tube, tracheal (w/wo connector)2 deaths32 reports
- HUDSON RCI IPN044767Teleflex Incorporated · Tube, tracheal (w/wo connector)31 reports
- HUDSON RCI IPN048895Teleflex Incorporated · Tube, tracheal (w/wo connector)1 death27 reports
- HUDSON RCI IPN046756Teleflex Incorporated · Tube, tracheal (w/wo connector)25 reports
- HUDSON RCI IPN048873Teleflex Incorporated · Tube, tracheal (w/wo connector)25 reports
- HUDSON RCI IPN044732Teleflex Incorporated · Tube, tracheal (w/wo connector)21 reports
- HUDSON RCI IPN044730Teleflex Incorporated · Tube, tracheal (w/wo connector)20 reports
- HUDSON RCI IPN048874Teleflex Incorporated · Tube, tracheal (w/wo connector)20 reports
- HUDSON RCI IPN046759Teleflex Incorporated · Tube, tracheal (w/wo connector)19 reports
- HUDSON RCI IPN044768Teleflex Incorporated · Tube, tracheal (w/wo connector)17 reports
- HUDSON RCI IPN048897Teleflex Incorporated · Tube, tracheal (w/wo connector)15 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 83461).
- Z-2312-2019 · TerminatedHudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, REF 5-10109 e) 5.0 mm, REF 5-10110, REF 5-10…
- Z-2313-2019 · TerminatedHudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm, REF 5-22514 d) 7.5 mm, REF 5-22515 e) 8.0 mm, REF 5-22516 f) 8.5 mm, REF 5-22517 g) 9.0…
- Z-2314-2019 · TerminatedHudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, REF 5-22107 c) 4.0 mm, REF 5-22008, REF 5-22108, REF 5-22208 d) 4.5 mm, REF 5-22009, …
- Z-2315-2019 · TerminatedHudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm, REF 5-10406 d) 3.5 mm, REF 5-10407 e) 4.0 mm, REF 5-10408 f) 4.5 mm, REF 5-10409 g) …
- Z-2316-2019 · TerminatedHudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10312 d) 6.5 mm, REF 5-10313 e) 7.0 mm, REF 5-10314 f) 7.5 mm, REF 5-10315 g) 8.0 mm,…
- Z-2317-2019 · TerminatedSheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management
- Z-2318-2019 · TerminatedSheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF V5-10316 d) 8.5 mm, REF V5-10317 Product Usage: Tracheal tube/airway management
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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