Class 1 Device Recall Medline

• Date Initiated by Firm: October 10, 2025
• Date Posted: November 13, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0442-2026
• Recall Event ID: 97882
• Product Classification: Circuit, breathing (w connector, adaptor, y piece) - Product Code CAI
• Product: 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
• 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
• Recalling Firm/ Manufacturer: Medline Industries, LP; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Haley Barclay; 866-359-1704
• Manufacturer 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.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Safety notice was provided to customers on 10/10/2025. Follow-up "URGENT MEDICAL DEVICE RECALL" notification dated 10/21/2025 was sent out on 10/21/2025. Notification was through email and first-class mail. Customers were instructed to Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product and destroy affected kits on hand. No products are to be returned to Medline. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.com Recall Reference #: R-25-215-FG Recall Code: If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. An expanded "URGENT MEDICAL DEVICE RECALL" notification dated 10/24/2025 was provided to customers on 10/24/25, which included additional affected products. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
• Quantity in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.