Medline breathing circuits labeled as: 1) HUDSON RCI recall (Medline Industries, LP)
Medical deviceClass IIOngoing
Summary: Medline Industries, LP is recalling 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, D. Reason: Neonatal 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.
What is being recalled
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/SKU 780-13); 4) HUDSON RCI, DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4, Medline Product Number/SKU 780-14 (Teleflex Product Number/SKU 780-14); 5) HUDSON RCI, DBD-CIRCUIT, HTD, DUAL LIMB, NEONATE, Medline Product Number/SKU 780-15 (Teleflex Product Number/SKU 780-15); 6) HUDSON RCI, CIRCUIT,NEO,DUAL,WIRE,60 IN, Medline Product Number/SKU HUD78018) (Teleflex Product Number/SKU 780-18).
Why
Neonatal 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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution - US Nationwide and the country of Panama.
How to tell if yours is affected
1) Medline Product Number/SKU HUD78007, UDI/DI 10197344042463 (each) 20197344042460 (case), All lot numbers; 2) Medline Product Number/SKU HUD78009, UDI/DI Discontinued (each) Discontinued (case), All lot numbers; 3) Medline Product Number/SKU 780-13, UDI/DI Discontinued (each) Discontinued (case), All lot numbers; 4) Medline Product Number/SKU 780-14, UDI/DI Discontinued (each) Discontinued (case), All lot numbers; 5) Medline Product Number/SKU 780-15, UDI/DI Discontinued (each) Discontinued (case), All lot numbers; 6) Medline Product Number/SKU HUD78018, UDI/DI 10197344010660 (each) 20197344010667 (case), All lot numbers.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2992-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 13, 2026 |
| Reported | September 2, 2026 |
| Company | Medline Industries, LP |
| Company location | Northfield, IL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 145525 units |
More recalls from Medline Industries, LP · all medical device recalls · recalls from July 2026