Hudson RCI Sheridan: 1) Preformed 6.0 mm
Medical device recall Z-1762-2019. Published in FDA’s Enforcement Report on Jun 26, 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 Jun 26, 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
- 186592 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?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Hudson 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) 5-22213, c) 5-22013, d) 5-22113, 3) Preformed 7.0 mm, Product Codes: a) 5-22214, b) 5-22314, c) 5-22014, d) 5-22114, 4) Preformed 7.5 mm, Product Codes: a) 5-22215, b) 5-22315, 5) Preformed 8.0 mm, Product Codes: a) 5-22216, b) 5-22316, 6) Preformed 8.5 mm, Product Codes: 5-22217 Product Usage: Tracheal tube/airway management
186592 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, Lot Numbers: 73J1600378 73K1600730 73L1600665 73M1600158 73B1700049 73B1700313 73C1700416 73D1700643 73F1700034 73F1700171 73F1700728 73G1700609 73H1700341 73J1700481…
Every code shown here, 1,993 characters
Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, Lot Numbers: 73J1600378 73K1600730 73L1600665 73M1600158 73B1700049 73B1700313 73C1700416 73D1700643 73F1700034 73F1700171 73F1700728 73G1700609 73H1700341 73J1700481 73J1700681 73K1700431 73L1700179 73L1700511 73M1700267 73A1800302 73A1800450 73B1800138 73C1800551 73D1800150 73E1800570 73F1800345 73H1800196 73J1800290 73K1800186 b) 5-22312, Lot Numbers: 73K1600151 73L1600512 73M1600159 73A1700737 73B1700423 73C1700697 73D1700426 73E1700561 73E1700721 73F1700173 73F1700730 73G1700612 73H1700620 73J1700141 73J1700484 73K1700078 73K1700433 73K1700744 73L1700516 73A1800023 73B1800140 73B1800500 73C1800328 73D1800474 73E1800398 73F1800561 73G1800139 73H1800683 73J1800109 73K1800188 c) 5-22112, Lot Numbers: 73L1600359 73M1600155 73A1700278 73C1700415 73F1700168 73G1700426 73H1700615 73L1700650 73B1800492 73H1800678 73K1800326 73K1800374 d) 5-22012, Lot Numbers: 73L1600863 73E1700491 73L1700332 73D1800651 73J1800335 2) Preformed 6.5 mm, Product Codes: a) 5-22313, Lot Numbers: 73J1600382 73K1600384 73K1600732 73L1600668 73M1600160 73A1700116 73A1700738 73C1700698 73D1700647 73E1700760 73F1700401 73G1700613 73H1700621 73J1700485 73K1700079 73K1700434 73K1700745 73M1700270 73A1800304 73B1800367 73C1800368 73D1800292 73E1800399 73F1800351 73G1800140 73G1800821 b) 5-22213, Lot Numbers: 73K1600149 73L1600666 73A1700114 73B1700314 73C1700694 73D1700644 73F1700400 73G1700428 73H1700342 73H1700788 73J1700482 73K1700277 73L1700180 73L1700512 73M1700268 73A1800451 73B1800496 73D1800151 73E1800571 73F1800346 c) 5-22013, Lot Numbers: 73A1700274 73H1700612 73J1700474 d) 5-22113, Lot Numbers: 73G1700427 73E1800394 3) Preformed 7.0 mm, Product Codes: a) 5-22214, Lot Numbers: 73J1600379 73K1600593 73L1600667 73B1700315 73C1700695 73D1700425 73E1700493 73G1700429 73H1700493 73J1700137 73K1700076 73K1700608 73L1700335 73M1700269 73M1700459 73A1800452 73B1800364 73B1800497 73C1800366 73D1800472 73E1800572 73F1800347…
FDA’s list runs to 3,891 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.
Worldwide - 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.
The words say it went outside the United States too.
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 May 24, 2019.
- FDA classified it on Jun 19, 2019.
- FDA’s Enforcement Report published it on Jun 26, 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: E-Mail.
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 3,891 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.