Hudson RCI Sheridan: 1) CF 6.0 mm
Medical device recall Z-1760-2019. 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
- 1101073 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) 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, Product Codes: V5-10115, 5-10115, 5-10215 5) CF 8.0 mm, Product Codes: 5-10116, 5-10216, V5-10116 6) CF 8.5 mm, Product Codes: 5-10117, 5-10217 Product Usage: Tracheal tube/airway management
1101073 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
1) CF 6.0 mm, Product Codes: a) 5-10112, Lot Numbers: 73J1600560 73J1600743 73K1600130 73K1600565 73L1600008 73L1600325 73L1600642 73L1600830 73M1600126 73A1700085 73A1700246 73A1700717 73B1700288 73B1700395 73B1700615 73C1700223…
Every code shown here, 1,994 characters
1) CF 6.0 mm, Product Codes: a) 5-10112, Lot Numbers: 73J1600560 73J1600743 73K1600130 73K1600565 73L1600008 73L1600325 73L1600642 73L1600830 73M1600126 73A1700085 73A1700246 73A1700717 73B1700288 73B1700395 73B1700615 73C1700223 73C1700397 73C1700541 73D1700236 73D1700610 73E1700217 73E1700454 73E1700698 73F1700532 73G1700137 73G1700214 73G1700585 73H1700033 73H1700466 73J1700125 73J1700277 73J1700588 73K1700053 73K1700249 73K1700394 73K1700582 73L1700166 73L1700306 73L1700521 73L1700659 73M1700133 73M1700445 73A1800042 73A1800281 73A1800662 73B1800114 73B1800474 73B1800700 73C1800183 73C1800469 73D1800300 73D1800624 73E1800061 73E1800225 73E1800779 73F1800157 73F1800529 73F1800697 73G1800115 73G1800212 73G1800562 73G1800791 73H1800178 73H1800652 73J1800082 73J1800317 73J1800496 73J1800656 73K1800359 73L1800193 b) 5-10212, Lot Numbers: 73J1600749 73J1800345 73K1800367 2) CF 6.5 mm, Product Codes: a) 5-10113, Lot Numbers: 73J1600561 73J1600744 73K1600131 73K1600352 73K1600566 73K1600567 73L1600132 73L1600326 73L1600482 73L1600831 73M1600127 73A1700086 73A1700247 73A1700400 73A1700640 73A1700718 73B1700289 73B1700396 73B1700616 73C1700542 73C1700672 73D1700122 73D1700237 73D1700405 73E1700455 73E1700699 73F1700533 73F1700697 73G1700215 73G1700403 73H1700312 73H1700589 73H1700775 73J1700126 73J1700278 73J1700450 73J1700589 73K1700250 73K1700402 73K1700583 73L1700167 73L1700307 73L1700522 73L1700660 73M1700134 73M1700446 73A1800038 73A1800663 73B1800115 73B1800475 73B1800701 73C1800184 73C1800336 73C1800559 73D1800060 73D1800301 73D1800625 73E1800069 73E1800226 73E1800376 73E1800780 73F1800158 73F1800324 73F1800530 73F1800698 73G1800213 73H1800179 73J1800318 73K1800360 b) 5-10213, Lot Numbers: 73A1700252 73D1700241 73J1700458 73B1800339 3) CF 7.0 mm, Product Codes: a) 5-10114, Lot Numbers: 73J1600745 73J1600746 73J1600747 73K1600132 73K1600720 73L1600327 73L1600328 73L1600832 73L1600833 73M1600272 73A1700087 73A1700088 73B1700290 73B1700291 73B1700292 73B1700293…
FDA’s list runs to 6,080 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 6,080 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.