CLASS I Device recall · Reported 18 Sep 2019 · FDA Enforcement Report

Hudson RCI Sheridan Uncuffed: a) recalled by Teleflex Medical

Teleflex Medical is recalling Hudson RCI Sheridan Uncuffed: a), distributed nationwide in the US. The recall was initiated on 30 Jul 2019 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesa) REF 5-10404 Batch numbers: 73L1600844 73A1700096 73A1700260 73B1700298 73C1700405 73F1700381 73F1700710 73H1700323 73H1700478 73M1700246 73A1800055 73B1800120 73E1800552 73J1800091 73L1800610 b) REF 5-10405 Batch numbers: 73L1600845 73A1700097 73A1700725 73B1700299 73F1700712 73G1700418 73H1700038 73H1700479 73J1700287 73A1800056 73A1800462 73B1800121 73E1800553 73F1800713 73H1800423 73H1800664 73K1800376 c) REF 5-10406 Batch numbers: 73L1600495 73B1700621 73D1700622 73E1700710 73F1700152 73G1700131 73H1700480 73J1700128 73J1700599 73K1700594 73L1700318 73M1700139 73M1700415 73A1800057 73A1800463 73A1800811 73B1800484 73C1800192 73D1800310 73D1800462 73E1800386 73E1800790 73F1800541 73G1800576 73H1800189 73H1800665 73J1800092 73L1800209 73L1800404 73L1800513 73L1800611 73L1800727 73M1800178 73M1800342 d) REF 5-10407 Batch numbers: 73K1600366 73L1600643 73A1700261 73D1700408 73G1700419 73H1700039 73K1700261 73K1700595 73M1700416 73A1800812 73C1800175 73E1800229 73F1800542 73G1800921 73K1800549 e) REF 5-10408 Batch numbers: 73K1600725 73L1600656 73B1700143 73C1700554 73D1700409 73E1700226 73E1700711 73F1700383 73F1700714 73H1700481 73J1700288 73J1700600 73M1700248 73B1800122 73B1800485 73B1800705 73D1800311 73D1800463 73E1800387 73F1800331 73G1800805 73H1800667 73J1800324 f) REF 5-10409 Batch numbers: 73K1600726 73L1600847 73A1700098 73A1700262 73C1700233 73C1700685 73D1700410 73E1700227 73F1700154 73F1700715 73H1700324 73J1700129 73J1700289 73K1700062 73K1700730 73M1700140 73A1800058 73B1800329 73B1800486 73B1800706 73C1800480 73D1800312 73E1800059 73E1800554 73F1800169 g) REF 5-10410 Batch numbers: 73K1600579 73L1600146 73L1600848 73A1700099 73B1700145 73B1700389 73C1700234 73C1700686 73D1700411 73E1700470 73F1700155 73F1700384 73F1700716 73H1700325 73J1700130 73K1700063 73K1700731 73M1700141 73B1800346 73B1800707 73C1800481 73E1800230 73E1800791 73F1800543 h) REF 5-10411 Batch numbers: 73J1600685 73K1600580 73L1600849 73A1700263 73C1700235 73C1700687 73D1700623 73E1700471 73F1700156 73F1700717 73G1700420 73H1700326 73J1700131 73K1700064 73K1700732 73L1700319 73M1700249 73A1800059 73B1800347 73B1800708 73D1800633 73E1800388 73F1800170 73G1800223 73G1800922 73H1800730 i) REF 5-10412 Batch 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 j) REF 5-10413 Batch numbers: 73M1600139 73B1700301 73E1700472 73G1700127 73K1700416 73A1800061 73B1800349 73B1800488 73D1800634 73F1800544 73G1800924 k) REF 5-10414 Batch numbers: 73A1700100 73F1700064 73L1800406

Quantity recalled170740 units

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-2315-2019
FDA event ID: 83461
Recalling firm: Teleflex Medical, Morrisville, NC
Classification: Class I
Status: Terminated
Recall initiated: 30 Jul 2019
FDA classified: 9 Sep 2019
Reported: 18 Sep 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

30 Jul 2019	Recall initiated by company
9 Sep 2019	Classified by FDA	+41 days
18 Sep 2019	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

Hudson 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) 5.0 mm, REF 5-10410 h) 5.5 mm, REF 5-10411 i) 6.0 mm, REF 5-10412 j) 6.5 mm, REF 5-10413 k) 7.0 mm, REF 5-10414 Product Usage: Tracheal tube/airway management

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

a) REF 5-10404 Batch numbers: 73L1600844 73A1700096 73A1700260 73B1700298 73C1700405 73F1700381 73F1700710 73H1700323 73H1700478 73M1700246 73A1800055 73B1800120 73E1800552 73J1800091 73L1800610 b) REF 5-10405 Batch numbers: 73L1600845 73A1700097 73A1700725 73B1700299 73F1700712 73G1700418 73H1700038 73H1700479 73J1700287 73A1800056 73A1800462 73B1800121 73E1800553 73F1800713 73H1800423 73H1800664 73K1800376 c) REF 5-10406 Batch numbers: 73L1600495 73B1700621 73D1700622 73E1700710 73F1700152 73G1700131 73H1700480 73J1700128 73J1700599 73K1700594 73L1700318 73M1700139 73M1700415 73A1800057 73A1800463 73A1800811 73B1800484 73C1800192 73D1800310 73D1800462 73E1800386 73E1800790 73F1800541 73G1800576 73H1800189 73H1800665 73J1800092 73L1800209 73L1800404 73L1800513 73L1800611 73L1800727 73M1800178 73M1800342 d) REF 5-10407 Batch numbers: 73K1600366 73L1600643 73A1700261 73D1700408 73G1700419 73H1700039 73K1700261 73K1700595 73M1700416 73A1800812 73C1800175 73E1800229 73F1800542 73G1800921 73K1800549 e) REF 5-10408 Batch numbers: 73K1600725 73L1600656 73B1700143 73C1700554 73D1700409 73E1700226 73E1700711 73F1700383 73F1700714 73H1700481 73J1700288 73J1700600 73M1700248 73B1800122 73B1800485 73B1800705 73D1800311 73D1800463 73E1800387 73F1800331 73G1800805 73H1800667 73J1800324 f) REF 5-10409 Batch numbers: 73K1600726 73L1600847 73A1700098 73A1700262 73C1700233 73C1700685 73D1700410 73E1700227 73F1700154 73F1700715 73H1700324 73J1700129 73J1700289 73K1700062 73K1700730 73M1700140 73A1800058 73B1800329 73B1800486 73B1800706 73C1800480 73D1800312 73E1800059 73E1800554 73F1800169 g) REF 5-10410 Batch numbers: 73K1600579 73L1600146 73L1600848 73A1700099 73B1700145 73B1700389 73C1700234 73C1700686 73D1700411 73E1700470 73F1700155 73F1700384 73F1700716 73H1700325 73J1700130 73K1700063 73K1700731 73M1700141 73B1800346 73B1800707 73C1800481 73E1800230 73E1800791 73F1800543 h) REF 5-10411 Batch numbers: 73J1600685 73K1600580 73L1600849 73A1700263 73C1700235 73C1700687 73D1700623 73E1700471 73F1700156 73F1700717 73G1700420 73H1700326 73J1700131 73K1700064 73K1700732 73L1700319 73M1700249 73A1800059 73B1800347 73B1800708 73D1800633 73E1800388 73F1800170 73G1800223 73G1800922 73H1800730 i) REF 5-10412 Batch 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 j) REF 5-10413 Batch numbers: 73M1600139 73B1700301 73E1700472 73G1700127 73K1700416 73A1800061 73B1800349 73B1800488 73D1800634 73F1800544 73G1800924 k) REF 5-10414 Batch numbers: 73A1700100 73F1700064 73L1800406

Where was it sold?

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 83461

This product is part of a recall event; the main page for the event is Hudson RCI Sheridan Ez-endo: a) recalled by Teleflex Medical.

Reported	Class	Recall	Company	Reason	Where
18 Sep 2019	CLASS I	Hudson RCI Sheridan Ez-endo: a) recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
18 Sep 2019	CLASS I	Hudson RCI Sheridan/HVT: a) recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
18 Sep 2019	CLASS I	Hudson RCI Sheridan/CF: a) recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
18 Sep 2019	CLASS I	Hudson RCI Sheridan Preformed: a) recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
18 Sep 2019	CLASS I	Hudson RCI Sheridan LTS: a) recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
18 Sep 2019	CLASS I	Sheridan/HVT Novaplus: a) recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide
18 Sep 2019	CLASS I	Sheridan/CF Novaplus recalled by Teleflex Medical	Teleflex Medical	Other	Nationwide

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All 235

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