Hudson RCI Sheridan Uncuffed: a) 2.0 mm
Medical device recall Z-2315-2019. Published in FDA’s Enforcement Report on Sep 18, 2019.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 18, 2019. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 170740 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
170740 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 2,000 characters
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…
FDA’s list runs to 2,760 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide Distribution
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 30, 2019.
- FDA classified it on Sep 9, 2019.
- FDA’s Enforcement Report published it on Sep 18, 2019.
- FDA terminated it on Feb 15, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Teleflex Medical, of Morrisville, NC.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,760 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.