Hudson RCI Sheridan Preformed: a) 3.0 mm
Medical device recall Z-2314-2019. 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
- 278142 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 Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, REF 5-22107 c) 4.0 mm, REF 5-22008, REF 5-22108, REF 5-22208 d) 4.5 mm, REF 5-22009, REF 5-22109, REF 5-22209 e) 5.0 mm, REF 5-22010, REF 5-22110, REF 5-22210 f) 5.5 mm, REF 5-22011, REF 5-22111, REF 5-22211 g) 6.0 mm, REF 5-22212, REF 5-22312, REF 5-22112 h) 6.5 mm, REF 5-22313, REF 5-22213, REF 5-22013, REF 5-22113 i) 7.0 mm, REF 5-22214, REF 5-22314, REF 5-22014, REF 5-22114 j) 7.5 mm, REF 5-22215, REF 5-22315 k) 8.0 mm, REF 5-22216, REF 5-22316 l) 8.5 mm, REF 5-22217 m) 9.0 mm, REF 5-22218 Product Usage: Tracheal tube/airway management
278142 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
a) REF 5-22006 Batch numbers: 73E1700489 73G1700128 73K1700075 73L1700176 73C1800361 73E1800241 73F1800556 73G1800589 73G1800932 73L1800417 73L1800418 73M1800194 73M1800195 REF 5-22106 Batch numbers: 73E1700719 73M1700260 73E1800567…
Every code shown here, 2,000 characters
a) REF 5-22006 Batch numbers: 73E1700489 73G1700128 73K1700075 73L1700176 73C1800361 73E1800241 73F1800556 73G1800589 73G1800932 73L1800417 73L1800418 73M1800194 73M1800195 REF 5-22106 Batch numbers: 73E1700719 73M1700260 73E1800567 73J1800524 73K1800731 b) REF 5-22007 Batch numbers: 73L1600002 73K1700426 73A1800460 73D1800648 73E1800565 REF 5-22107 Batch numbers: 73L1600864 73F1700166 73E1800088 73K1800772 c) REF 5-22008 Batch numbers: 73C1700413 73F1700164 73G1700129 73J1700300 73A1800461 73B1800362 73F1800183 REF 5-22108 Batch numbers: 73K1600590 73M1600152 73A1700110 73D1700629 73F1700028 73B1800133 73E1800089 73G1800933 73J1800100 REF 5-22208 Batch numbers: 73L1600360 73A1700112 73D1700258 73F1700032 73F1700725 73G1700605 73H1700786 73J1700478 73K1700275 73K1700740 73L1700508 73M1700263 73A1800316 73A1800816 73B1800493 73C1800365 73D1800147 73E1800091 73E1800569 73F1800557 73H1800679 d) REF 5-22009 Batch numbers: 73L1600003 73C1700414 73D1700640 73F1700026 73G1700130 73H1700610 73K1700274 73A1800066 73C1800464 73D1800649 73E1800566 73F1800340 73L1800633 73L1800822 REF 5-22109 Batch numbers: 73L1600160 73L1600865 73M1600153 73A1700275 73B1700310 73C1700563 73D1700423 73F1700029 73H1700613 73J1700475 73K1700428 73M1700261 73B1800363 73C1800362 73D1800652 73E1800568 73G1800819 73H1800444 73J1800525 73K1800762 73L1800823 REF 5-22209 Batch numbers: 73L1600127 73L1600509 73M1600156 73A1700279 73B1700311 73D1700132 73D1700424 73E1700720 73F1700169 73G1700606 73H1700338 73J1700479 73K1700276 73K1700429 73L1700177 73L1700509 73M1700264 73A1800024 73A1800300 73B1800135 73B1800454 73C1800491 73D1800148 73E1800092 73E1800395 73F1800719 73H1800194 73J1800103 e) REF 5-22010 Batch numbers: 73A1700109 73B1700414 73D1700627 73H1700611 73A1800044 73C1800550 73E1800393 73G1800590 REF 5-22110 Batch numbers: 73K1600591 73L1600161 73L1600866 73A1700111 73A1700276 73B1700416 73C1700251 73C1700693 73F1700030 73G1700425 73J1700476 73L1700333 73M1700262 73B1800453 73C1800363 73E1800090…
FDA’s list runs to 6,737 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 6,737 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.