Hudson RCI Sheridan/HVT: a) 5.0 mm
Medical device recall Z-2316-2019. 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
- 3375808 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/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10312 d) 6.5 mm, REF 5-10313 e) 7.0 mm, REF 5-10314 f) 7.5 mm, REF 5-10315 g) 8.0 mm, REF 5-10316 h) 8.5 mm, REF 5-10317 i) 9.0 mm, REF 5-10318 j) 10.0 mm, REF 5-10320 Product Usage: Tracheal tube/airway management
3375808 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
a) REF 5-10310 Batch numbers: 73K1600356 73L1600336 73L1600486 73L1600836 73M1600132 73B1700134 73C1700227 73C1700676 73D1700243 73E1700091 73F1700013 73F1700145 73F1700702 73G1700410 73H1700471 73H1700777 73J1700593 73K1700254 73K1700723…
Every code shown here, 1,990 characters
a) REF 5-10310 Batch numbers: 73K1600356 73L1600336 73L1600486 73L1600836 73M1600132 73B1700134 73C1700227 73C1700676 73D1700243 73E1700091 73F1700013 73F1700145 73F1700702 73G1700410 73H1700471 73H1700777 73J1700593 73K1700254 73K1700723 73L1700661 73A1800282 73A1800664 73B1800341 73C1800186 73C1800563 73D1800303 73D1800454 73E1800071 73E1800378 73F1800706 73G1800567 73K1800540 73K1800541 b) REF 5-10311 Batch numbers: 73K1600357 73L1600337 73L1600487 73L1600837 73A1700253 73C1700677 73D1700126 73E1700092 73E1700459 73E1700221 73F1700374 73G1700411 73G1700590 73H1700472 73J1700459 73K1700255 73K1700724 73M1700239 73A1800283 73A1800809 73C1800187 73D1800132 73D1800304 73D1800455 73E1800379 73E1800784 73F1800536 73H1800183 c) REF 5-10312 Batch numbers: 73J1600355 73J1600564 73J1600751 73K1600137 73K1600571 73L1600138 73L1600338 73L1600488 73L1600650 73L1600838 73M1600133 73A1700091 73A1700254 73A1700721 73B1700136 73B1700296 73B1700402 73B1700617 73C1700402 73C1700678 73D1700127 73E1700093 73E1700460 73F1700137 73F1700538 73F1700703 73G1700218 73G1700591 73H1700318 73H1700473 73H1700778 73J1700127 73J1700460 73J1700594 73K1700057 73K1700409 73K1700587 73K1700725 73L1700498 73M1700240 73M1700450 73A1800284 73A1800442 73A1800665 73A1800810 73B1800342 73B1800702 73C1800188 73C1800564 73D1800059 73D1800133 73D1800305 73D1800456 73D1800629 73E1800072 73E1800381 73E1800785 73F1800163 73F1800707 73G1800118 73G1800218 73G1800568 73G1800799 73G1800911 73H1800184 73H1800420 73J1800072 73H1800724 73J1800663 73K1800163 73K1800369 73K1800456 73L1800799 d) REF 5-10313 Batch numbers: 73J1600356 73J1600357 73J1600565 73J1600752 73K1600138 73K1600572 73K1600573 73L1600139 73L1600339 73L1600489 73L1600651 73M1600134 73A1700092 73A1700255 73A1700404 73A1700643 73A1700722 73B1700137 73B1700403 73B1700618 73C1700228 73C1700550 73C1700679 73D1700615 73E1700094 73E1700222 73E1700461 73F1700014 73F1700375 73F1700539 73F1700704 73G1700412 73H1700319 73H1700474 73H1700594 73J1700283…
FDA’s list runs to 6,624 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 6,624 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.