CLASS I ONGOING Device recall · Reported 19 Nov 2025 · FDA Enforcement Report
Anesthesia circuit kit recalled by Medline Industries
Medline Industries is recalling Anesthesia circuit kit, distributed nationwide in the US. The recall was initiated on 10 Oct 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0449-2026
- FDA event ID
- 97882
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 10 Oct 2025
- FDA classified
- 13 Nov 2025
- Reported
- 19 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 10 Oct 2025 | Recall initiated by company | |
| 13 Nov 2025 | Classified by FDA | +34 days |
| 19 Nov 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230
Where it was distributed
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;
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIllinoisKansasKentuckyMassachusettsMichiganMinnesotaMissouriMississippiMontanaNorth Carolina
Stores named: Walmart
Questions about this recall
Is Anesthesia circuit kit recalled?
Yes. Medline Industries recalled Anesthesia circuit kit on 10 Oct 2025. The recall is Class I and its status is Ongoing. Recall number Z-0449-2026.
Why was it recalled?
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.
Which lots are affected?
CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230 UDI-DI 40884389688589 (case), 10884389688588 (ea) Lots 25EBV570 25FBT843
Where was it sold?
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;
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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