Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product descr...
FDA Recall #Z-0442-2026 — Class I — October 10, 2025
Product Description
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;
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.
Recalling Firm
Medline Industries, LP — Northfield, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
96,406 total units
Distribution
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;
Code Information
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated