Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits
Medical device recall Z-0442-2026. Published in FDA’s Enforcement Report on Nov 19, 2025.
- 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 Nov 19, 2025. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 34 states named
- 96,406 total 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?
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120” expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product description/Product numbers: ADULT 120 EXPANDABLE W/MASK DYNJAA10591; ANES CIRC 120IN EXP-LF DYNJAA6555G; ANES CIRCUIT ADULT 120”-LF DYNJAA10817; ANESTHESIA 120” ADLT-LF DYNJAA10775; ANESTHESIA CIRC ADULT 120-LF DYNJAA10601; ANESTHESIA CIRCUIT - LF DYNJAA10261B; ANESTHESIA CIRCUIT 120EXP-LF DYNJAA10741A; ANESTHESIA CIRCUIT ADULT-LF DYNJAA0380A DYNJAA10641 DYNJAA10706B DYNJAA10851 DYNJAA10922B DYNJAA10971A DYNJAA11030A DYNJAA11087 DYNJAA11126; ANESTHESIA CIRCUIT-LF DYNJAA0309A DYNJAA0368A DYNJAA10368A DYNJAA10392 DYNJAA10430A DYNJAA10547A DYNJAA10639A DYNJAA10656A DYNJAA10685A DYNJAA10685B; CIRC 120” EXP 1 BV HMEF 3L GSL DYNJAA10920; EXPANDABLE CIRCUIT-LF DYNJAA11095; NM ANESTHESIA TURNOVER KIT DYNJAA0433; PROV HEALTH HEPA CIRC #2-LF DYNJAA0360; SPTMPX01IA CIRCUIT ADULT-LF DYNJAA10973A;
96,406 total units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
DYNJAA0309A UDI-DI 40193489400268 (case), 10193489400267 (ea) Lots 25EBU353 25GBI473; DYNJAA0360 UDI DI 40193489419000 (case), 10193489419009 (ea) Lots 25EBU304 25GBQ732; DYNJAA0368A UDI-DI 40195327092550 (case), 10195327092559 (ea) Lots…
Every code shown here, 1,999 characters
DYNJAA0309A UDI-DI 40193489400268 (case), 10193489400267 (ea) Lots 25EBU353 25GBI473; DYNJAA0360 UDI DI 40193489419000 (case), 10193489419009 (ea) Lots 25EBU304 25GBQ732; DYNJAA0368A UDI-DI 40195327092550 (case), 10195327092559 (ea) Lots 25GBH582; DYNJAA0380A UDI-DI 40195327478286 (case), 10195327478285 (ea) Lots 25FBB950 25FBT875 25GBX623; DYNJAA0433 UDI-DI 40198459320706 (case), 10198459320705 (ea) Lots 25EBH621 25EBQ391; DYNJAA10261B UDI- DI 40193489430784 (case), 10193489430783 (ea) Lots 25FBJ760; DYNJAA10368A UDI-DI 40198459320720 (case), 10198459320729 (ea) Lots 25GBY374 25IBK072; DYNJAA10392 UDI-DI 40888277962201 (case), 10888277962200 (ea) Lots 25FBN032; DYNJAA10430A UDI-DI 40193489832052 (case), 10193489832051 (ea) Lots 25FBW335 25IBH048; DYNJAA10547A UDI-DI 40193489603188 (case), 10193489603187 (ea) 25FBT853; DYNJAA10591 UDI-DI 40889942632535 (case), 10889942632534 (ea) Lots 25FBD876 25FBD877 25GBJ254 25GBJ256; DYNJAA10601 UDI-DI 40889942655435 (case), 10889942655434 (ea) Lots 25FBN184 25HBM893; DYNJAA10639A UDI-DI 40888277761958 (case), 10888277761957 (ea) Lots 25FBN043; DYNJAA10641 UDI-DI 40889942841227 (case), 10889942841226 (ea) Lots 25EBK360; DYNJAA10656A UDI-DI 40193489455527 (case), 10193489455526 (ea) Lots 25FBN055; DYNJAA10685A UDI-DI 40195327279142 (case), 10195327279141 (ea) Lots 25EBJ456; DYNJAA10685B UDI-DI 40198459372293 (case), 10198459372292 (ea) Lots 25FBL121 25FBT898 25FBT899; DYNJAA10706B UDI-DI 40193489485982 (case), 10193489485981 (ea) Lots 25FBH921 25GBK879 25GBN124 25GBN125; DYNJAA10741A UDI-DI 40193489250573 (case), 10193489250572 (ea) Lots 25EBK364 25FBQ326 25HBA472; DYNJAA10775 UDI-DI 40193489348102 (case), 10193489348101 (ea) Lots 25GBY311 25IBD803; DYNJAA10817 UDI-DI 40193489365338 (case), 10193489365337 (ea) Lots 25GBO619; DYNJAA10851 UDI-DI 40193489429467 (case), 10193489429466 (ea) Lots 25GBE789 25IBL075; DYNJAA10920 UDI-DI 40193489463386 (case), 10193489463385 (ea) Lots 25FBT844 25GBP694; DYNJAA10922B UDI-DI 40198459301880…
FDA’s list runs to 2,636 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.
International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI;
The states and territories these words name
34 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Massachusetts
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- New Jersey
- New York
- Ohio
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Washington
- Wisconsin
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Oct 10, 2025.
- FDA classified it on Nov 13, 2025.
- FDA’s Enforcement Report published it on Nov 19, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medline Industries, LP, of Northfield, IL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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 2,636 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
-
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.