Class I U.S. Food and Drug Administration

Medline Industries, LP Anesthesia Circuit Kits and other various kits that contain recall: Firm received multiple complaints of anesthesia circuit leaks due to cracks

Recall published 11 months ago

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.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0442-2026
Published
November 19, 2025
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
96,406 total units
Distribution
Nationwide
Made in
United States
Lot / code info
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 (case), 10198459301889 (ea) Lots 25FBQ442 25GBO675; DYNJAA10971A UDI-DI 40195327298167 (case), 10195327298166 (ea) Lots 25GBA751; DYNJAA10973A UDI-DI 40195327372423 (case), 10195327372422 (ea) Lots 25FBQ349; DYNJAA11030A UDI-DI 40195327341030 (case), 10195327341039 (ea) Lots 25FBQ346; DYNJAA11087 UDI-DI 40195327694402 (case), 10195327694401 (ea) Lots 25FBG942 25FBG944; DYNJAA11095 UDI-DI 40195327520992 (case), 10195327520991 (ea) Lots 25GBY361; DYNJAA11126 UDI-DI 40195327695508 (case), 10195327695507 (ea) Lots 25EBV629 25GBL211; DYNJAA6555G UDI-DI 40195327214648 (case), 10195327214647 (ea) Lots 25EBG518 25FBS747 25FBS748 25HBE691
UPC codes
40193489400268, 10193489400267, 40193489419000, 10193489419009, 40195327092550, 10195327092559, 40195327478286, 10195327478285, 40198459320706, 10198459320705, 40193489430784, 10193489430783, 40198459320720, 10198459320729, 40888277962201, 10888277962200, 40193489832052, 10193489832051, 40193489603188, 10193489603187

Products covered by this recall

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;

Check your product

The notice names 41 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 40193489400268
  • 10193489400267
  • 40193489419000
  • 10193489419009
  • 40195327092550
  • 10195327092559
  • 40195327478286
  • 10195327478285
  • 40198459320706
  • 10198459320705
  • 40193489430784
  • 10193489430783
  • 40198459320720
  • 10198459320729
  • 40888277962201
  • 10888277962200
  • 40193489832052
  • 10193489832051
  • 40193489603188
  • 10193489603187

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 25EBU353 25GBI473
  • 25EBU304 25GBQ732
  • 25GBH582
  • 25FBB950 25FBT875 25GBX623
  • 25EBH621 25EBQ391
  • 25FBJ760
  • 25GBY374 25IBK072
  • 25FBN032
  • 25FBW335 25IBH048
  • 25FBD876 25FBD877 25GBJ254 25GBJ256
  • 25FBN184 25HBM893
  • 25FBN043
  • 25EBK360
  • 25FBN055
  • 25EBJ456
  • 25FBL121 25FBT898 25FBT899
  • 25FBH921 25GBK879 25GBN124 25GBN125
  • 25EBK364 25FBQ326 25HBA472
  • 25GBY311 25IBD803
  • 25GBO619

Package size

Match the net weight or the piece count on the front of the pack.

  • 3 L

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medline Industries, LP — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline Industries, LP medical devices 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. 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 40193489400268, 10193489400267, 40193489419000; lot code 25EBU353 25GBI473, 25EBU304 25GBQ732, 25GBH582. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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