Where's it on?
FDA · Medical devices ·

Medline breathing circuits labeled as recall

Medline Industries, LP recalled Medline breathing circuits labeled as on September 2, 2026 because of neonatal and infant heated wire breathing circuits may experience sporadic failure. It was sold nationwide.

Why it was recalled

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 con…

What's 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…

Quantity: 145525 units

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Medline Industries, LP, Northfield, IL
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Worldwide distribution - US Nationwide and the country of Panama.
Status
Ongoing
Recall number
Z-2992-2026
Source
U.S. Food and Drug Administration

More medical devices recalls

Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector
· Olympus Corporation of the AmericasMedline convenience kits containing Healthmark Instrument Channel Brushes
· Medline Industries, LPMidmark IQvitals Zone
· Midmark CorporationAchieva 3.0T; Model Numbers (REF)
· Philips North America LlcAutomated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1
· Abiomed, Inc.INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set
· CooperSurgical, Inc.