ClearanceBrief
Recall Z-2992-2026 ยท BZO Set, Tubing And Support, Ventilator (W Harness)

Medline Industries, LP

Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product Number/SKU 780-07); 2) HUDSON RCI, DBM-CIRCUIT,VENT,NEONATAL,21 V, Medline Product Number/SKU HUD78009 (Teleflex Product Number/SKU 780-09); 3) HUDSON RCI, DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4, Medline Product Number/SKU 780-13 (Teleflex Product Number/

DateAug 21, 2026 (initiated Jul 13, 2026)
StatusOpen, Classified
ReasonNeonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.
Root causeUnder Investigation by firm
ActionMedline issued an Urgent Medical Device notice it its consignees on 7/13/2026 via email and USPS. The notice explained the issue, potential risk, and provided actions and precautions for healthcare providers. If evidence of connector overheating or thermal damage is observed: " Assess the patient and ensure continued respiratory support. " Replace the affected circuit as soon as clinically appropriate. " Remove the affected circuit from service and retain it for investigation." For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. Follow up notice sent on
Quantity145525 units
DistributionWorldwide distribution - US Nationwide and the country of Panama.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K903083NEONATAL VENTILATOR CIRCUIT
Hudson Respiratory Care, Inc., Dec 27, 1990