Hudson RCI Sheridan recallZ-1763-2019 · Teleflex Medical · initiated May 24, 2019
Class I Terminated All recalls posted in June 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
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.
FDA root cause category: Process control
What the company is doing
Teleflex sent an Urgent Medical Device Recall letter dated May 24, 2019 to customers. The letter identified the affected product, problem and actions to be taken. The letter directed customers to discontinue use, quarantine the product, and contact Teleflex for return of the product. Distributors were directed to notify their customers and request the customer return the recalled products to them for consolidation and subsequent return to Teleflex.. For questions contact your local sales representative or Customer Service at 1-866-396-2111
Recall details
- Recall number
- Z-1763-2019
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- May 24, 2019
- Posted by the FDA
- Jun 19, 2019
- Recalling firm
- Teleflex Medical
- Quantity
- 14357
- Product code
- BTR
- FDA submissions
- K822082
- Distribution
- Worldwide - US Nationwide Distribution
Product description
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
Code information (models, lots, serial numbers)
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
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 82964).
- Z-1759-2019 · TerminatedHudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
- Z-1760-2019 · TerminatedHudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Codes: 5-10114, 5-10214 4) CF 7.5 mm, …
- Z-1761-2019 · TerminatedHudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Code 5-22513 3) EZ-ENDO 7.0 mm, Product Code 5-22514 4) EZ-ENDO 7.5 mm, Product Code 5-2…
- Z-1762-2019 · TerminatedHudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c) 5-22112, d) 5-22012, 2) Preformed 6.5 mm, Product Codes: a) 5-22313, b) 5-222…
- Z-1764-2019 · TerminatedHudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-10313 3) HVT 7.0 mm, Product Code 5-10314 4) HVT 7.5 mm, Product Code 5-10315 5) HVT 8.0…
- Z-1765-2019 · TerminatedSheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway management
- Z-1766-2019 · TerminatedSheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code V5-10315 3) Novaplus 8.0 mm, Product Code V5-10316 4) Novaplus 8.5 mm, Product Code V5-…
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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