Breathing Circuit Recall: Medline Removes Neonatal and Infant Heated Wire Breathing Circuits

The FDA has since determined that this device may cause temporary or reversible health problems, or—though unlikely—serious health problems. The affected products and recommendations for what to do with the devices below have not changed. This recall involves removing devices from where they are used or sold.Affected Product The FDA is aware that Medline has issued a letter to affected customers recommending all lots of affected Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits be removed from where they are used or sold.

Affected devices: Device NameMedline Item NumberTeleflex Item NumberCIRCUIT, NEO, SING LIMB, HTD,COLUMNHUD78001KIT780-01KITCIRCUIT, HTD, DL, NEONATE, 48"HUD78007780-07CIRCUIT, NEO, DUAL LIMB HTD, COLUMNHUD78007KIT780-07KITDBD-CIRCUIT, NEO, DUAL LIMB HTD, COLUMNHUD78008KIT780-08KITDBM-CIRCUIT,VENT,NEONATAL,21 VHUD78009780-09DBD-CIRCUIT, NEO, DUAL LIMB HTD, COLUMNHUD78009KIT780-09KITDBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4HUD78013780-13DBM-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4HUD78014780-14DBD-CIRCUIT, HTD, DUAL LIMB, NEONATEHUD78015780-15CIRCUIT, NEO, DUAL LIMB, HTD,COLUMNHUD78017KIT780-17KITCIRCUIT,NEO,DUAL,WIRE,60 INHUD78018780-18CIRCUIT, NEO, DUAL HTD, DUAL LIMB,COLUMNHUD78018KIT780-18KITDBM-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO,HUD78019780-19CIRCUIT,ISO-SHIELD SINGLE LIMB,INFANTHUD88001KITHUD88001KITCIRCUIT,ISO-SHIELD,INFANT,HTD,COLUMN,DRNHUD88013KIT880-13KITISO-SHIELD CIRCUIT,INFNT,HTD,DL,DRAINHUD88014KIT880-14KITISO-SHIELD CIRCUIT,INFNT,HTD DL,DRAINHUD88015KIT880-15KITISO-SHIELD CIRCUIT,INFNT,HTD,DL,DRAINHUD88017KIT880-17KITFull List of Affected ProductWhat to DoImmediately identify and quarantine affected breathing circuits. Destroy affected product after recall actions are complete. On July 13, July 27, and August 5, Medline sent affected customers letters recommending the following actions:Immediately check your stock for affected item and lot numbers.

Quarantine all affected product. Upon completion of the recall response form, please destroy affected product. Be aware that some Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits display different item numbers than the item numbers provided in Medline’s July 13 recall notice.

Affected products display either a Teleflex or Medline item number depending on the manufacturing date. Refer to the example labels below to identify the manufacturing date and item number on the product label. Affected products manufactured before January 2024 display a Teleflex label and item number.

Affected products manufactured starting January 2024 or later display a Medline label and item number.If you are a distributor or have resold or transferred this product to another company or individual, notify them of this recall communication.Request that customers destroy any affected product.Include your customers’ quantities on your response form.Example Labeling Example 1 – Teleflex Label: The Teleflex label identifies the product using the Teleflex item number, such as 780-07 or 880-14KIT, and appears on products manufactured before January 2024. Example 2 – Medline Label: The Medline label identifies the product using the Medline item number, such as HUD78007 or HUD88014KIT, and includes Medline branding, with a manufacturing date on or after January 2024.Reason for Recall Medline has received reports of sporadic failures involving the electrical connector of certain neonatal and infant heated wire breathing circuits. In affected circuits, the heated wire connector (pigtail) at the Neptune humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage.

The Neptune humidifier is designed with safety features that continually monitor the heated wire circuit and automatically discontinue power to the heated wires when electrical abnormalities are detected. When power to the heated wires is disconnected, respiratory gas flow to the patient continues. The disconnection of power is limited to the heated wire function.Continued delivery of inadequately heated or unconditioned gas can desiccate and damage the airway epithelium, predisposing the infant to bronchospasm, inspissated secretions, and airway obstruction.

Potential continued loss of heated wire function may result in increased circuit condensation (rainout), which can cause inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the infant's airway. Reduced humidity and delivery of cold, dry gas increases the risk of cold stress, leading to elevated oxygen consumption and worsening respiratory distress. Increased vigilance is recommended for monitoring your ventilator, circuit, and humidification systems.As of July 31, Medline has not reported any serious injuries or deaths associated with this issue.Device UseThe Hudson Heated Wire Ventilator Circuits are intended as a conduit for respiratory gas between a neonatal patient and a ventilator.

They include heated wires for use with a humidifier. The heated wires are intended to minimize condensation in the ventilator tubing and to maintain heating and humidification of the air in the gas pathway.Contact InformationCustomers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Medline at 866-359-1704 or recalls@medline.com.Additional FDA ResourcesFDA Enforcement ReportCDRH Medical Device Recall DatabaseAdditional Company ResourcesCompany-provided information is posted here by the FDA as a public service.Product Recalls - Medline [08/05/2026]Unique Device Identifier (UDI)The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use.

The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.How do I recognize a UDI on a label?AccessGUDID database - Identify Your Medical DeviceBenefits of a UDI SystemHow do I report a problem?Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.Timeline of Communication UpdatesDateActions09/01/2026The FDA updated this communication to inform the public that this issue has been classified as a Class II Recall.08/21/2026The FDA issued an Early Alert communication to notify the public of a potentially high-risk device issue.