Recall Z-0442-2026
Medline Industries, LP · initiated October 10, 2025
Class I – dangerous or defective products that could cause serious health problems or death
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;
Codes / lots: 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…
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 taken
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.
Details
- Recall number
- Z-0442-2026
- Initiated
- October 10, 2025
- Posted by FDA
- November 13, 2025
- Product code
- CAI – Circuit, Breathing (W Connector, Adaptor, Y Piece)
- 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;
- Recalling firm
- Medline Industries, LP, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0443-2026 Class I | Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits…Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing.… | 10/10/2025Open, Classified |
| Z-0444-2026 Class I | Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN…Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing.… | 10/10/2025Open, Classified |
| Z-0445-2026 Class I | Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; ENT…Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing.… | 10/10/2025Open, Classified |
| Z-0446-2026 Class I | DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL…Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing.… | 10/10/2025Open, Classified |
| Z-0447-2026 Class I | Convenience Kit, BREAST HERNIA DYNJ909125GFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing.… | 10/10/2025Open, Classified |
| Z-0448-2026 Class I | Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F…Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing.… | 10/10/2025Open, Classified |
| Z-0449-2026 Class I | Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing.… | 10/10/2025Open, Classified |
| Z-0450-2026 Class I | Convenience kits; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATEFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing.… | 10/10/2025Open, Classified |
| Z-0451-2026 Class I | Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR…Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing.… | 10/10/2025Open, Classified |