Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm
Medical device recall Z-2313-2019. 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
- 57181units 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 EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm, REF 5-22514 d) 7.5 mm, REF 5-22515 e) 8.0 mm, REF 5-22516 f) 8.5 mm, REF 5-22517 g) 9.0 mm, REF 5-22518 h) 6.0 mm, REF 5-22512 i) 6.5 mm, REF 5-22513 Product Usage: Tracheal tube/airway management
57181units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
a) REF 5-22510 Batch numbers: 73B1700556 73D1700650 73H1700346 73H1800449 b) REF 5-22511 Batch numbers: 73C1700261 73K1700609 73C1800370 c) REF 5-22514 Batch numbers: 73A1700118 73C1700569 73E1700722 73F1700175 73F1700405 73G1700433…
Every code shown here, 1,325 characters
a) REF 5-22510 Batch numbers: 73B1700556 73D1700650 73H1700346 73H1800449 b) REF 5-22511 Batch numbers: 73C1700261 73K1700609 73C1800370 c) REF 5-22514 Batch numbers: 73A1700118 73C1700569 73E1700722 73F1700175 73F1700405 73G1700433 73H1700349 73H1700494 73H1700711 73J1700143 73K1700081 73K1700610 73L1700181 73M1700273 73D1800653 73F1800562 73F1800720 73H1800450 73J1800531 73K1800328 73K1800786 d) REF 5-22515 Batch numbers: 73B1700316 73C1700262 73C1700418 73E1700723 73E1700104 73F1700176 73F1700406 73G1700434 73H1700350 73J1700302 73J1700497 73K1700747 73M1700274 73A1800068 73A1800683 73B1800502 73C1800201 73D1800154 73E1800402 73F1800565 73G1800591 73H1800451 73H1800686 73J1800113 73K1800736 e) REF 5-22516 Batch numbers: 73K1600594 73A1700282 73B1700158 73B1700317 73C1700570 73F1700036 73F1700177 73F1700407 73G1700614 73H1700495 73J1700487 73K1700082 73A1800684 73B1800503 73C1800371 73E1800577 73G1800232 73J1800532 73K1800327 f) REF 5-22517 Batch numbers: 73J1600767 73C1800202 g) REF 5-22518 Batch numbers: 73K1600595 73E1800459 73M1800288 h) REF 5-22512 Batch numbers: 73K1600152 73M1600163 73A1700280 73C1700567 73E1700496 73F1700403 73H1700347 73M1700272 73E1800401 73E1800575 73F1800354 i) REF 5-22513 Batch numbers: 73J1600766 73B1700155 73C1700568 73F1700404 73G1700432 73H1700348 73E1800576 73F1800355
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.”
- 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.