Hudson RCI Sheridan/CF: a) 3.0 mm
Medical device recall Z-2312-2019. 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
- 1805730 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/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, REF 5-10109 e) 5.0 mm, REF 5-10110, REF 5-10210 f) 5.5 mm, REF 5-10111 g) 6.0 mm, REF 5-10112, REF 5-10212 h) 6.5 mm, REF 5-10113, REF 5-10213 I) 7.0 mm, REF 5-10114, REF 5-10214 j) 7.5 mm, REF V5-10115, REF 5-10115, REF 5-10215 k) 8.0 mm, REF 5-10116, REF 5-10216, REF V5-10116 l) 8.5 mm, REF 5-10117, REF 5-10217 m) 9.0 mm, REF 5-10118, REF5-10218 n) 9.5 mm, REF 5-10119 o) 10.0 mm, REF 5-10120, REF 5-10220 Product Usage: Tracheal tube/airway management
1805730 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
a) REF 5-10106 Batch numbers: 73L1600638 73L1600825 73M1600121 73A1700079 73C1700394 73D1700234 73D1700235 73D1700436 73E1700214 73E1700450 73F1700366 73G1700211 73G1700579 73H1700309 73H1700461 73H1700583 73H1700768 73J1700119 73J1700585…
Every code shown here, 1,998 characters
a) REF 5-10106 Batch numbers: 73L1600638 73L1600825 73M1600121 73A1700079 73C1700394 73D1700234 73D1700235 73D1700436 73E1700214 73E1700450 73F1700366 73G1700211 73G1700579 73H1700309 73H1700461 73H1700583 73H1700768 73J1700119 73J1700585 73K1700245 73K1700718 73L1700302 73L1700654 73M1700232 73A1800276 73A1800428 73B1800112 73B1800472 73B1800614 73C1800332 73D1800120 73D1800446 73E1800373 73E1800775 73G1800111 73H1800174 73H1800711 73J1800313 73J1800492 73K1800151 73K1800320 73K1800356 73K1800708 73L1800210 73L1800386 73M1800158 REF 5-10206 Batch numbers: 73H1700470 73J1700455 73L1700647 73B1800338 73F1800704 73K1800012 73K1800364 b) REF 5-10107 Batch numbers: 73K1600124 73K1600348 73K1600560 73K1600718 73L1600480 73L1600639 73L1600826 73A1700080 73A1700241 73C1700395 73C1700538 73C1700670 73D1700404 73E1700215 73E1700451 73F1700139 73F1700367 73F1700695 73G1700212 73G1700400 73G1700580 73H1700029 73H1700462 73H1700584 73H1700769 73J1700120 73J1700273 73J1700586 73K1700246 73K1700399 73K1700706 73K1700719 73L1700303 73L1700497 73L1700655 73M1700233 73M1700417 73A1800277 73A1800436 73A1800804 73B1800473 73B1800696 73C1800333 73C1800449 73C1800465 73D1800122 73D1800447 73D1800619 73D1800679 73E1800542 73E1800543 73F1800154 73F1800525 73F1800694 73G1800208 73G1800559 73K1800532 73K1800743 73L1800211 73L1800512 c) REF 5-10108 Batch numbers: 73K1600719 73L1600128 73L1600321 73L1600481 73L1600827 73A1700081 73A1700242 73B1700285 73B1700612 73C1700221 73C1700539 73D1700119 73D1700606 73E1700216 73E1700452 73E1700694 73F1700006 73F1700140 73F1700368 73F1700529 73G1700133 73G1700401 73G1700581 73H1700030 73H1700310 73H1700463 73H1700585 73H1700770 73J1700121 73J1700274 73J1700587 73K1700049 73K1700247 73K1700400 73L1700161 73L1700519 73M1700129 73M1700234 73M1700418 73M1700443 73A1800278 73A1800654 73B1800113 73B1800697 73C1800176 73C1800466 73D1800123 73D1800296 73D1800620 73D1800621 73E1800067 73E1800374 73E1800700 73F1800155 73F1800321 73F1800526 73G1800112 73G1800209…
FDA’s list runs to 11,856 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 11,856 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.