COMPANY ANNOUNCEMENT
Medline Industries, LP Issues Nationwide Recall of Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
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- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Medical Devices
- Reason for Announcement:
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Recall Reason DescriptionDue to heated wire connector (pigtail) at the Neptune humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage
- Company Name:
- Medline Industries, LP
- Brand Name:
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Brand Name(s)Medline, Teleflex
- Product Description:
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Product DescriptionHudson RCI Neonatal/Infant Heated Wire Breathing Circuits
Company Announcement
On July 13, 2026, Medline Industries, LP initiated a nationwide recall of Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits. Medline 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. To date, reported events have occurred infrequently relative to the number of devices distributed, with the observed occurrence rate of 0.011% across the distributed population. Refer to the below photographs of the product and a defect that was reported to Medline.
The Neptune humidifier is designed with safety features that continually monitor the heated wire circuit and automatically discontinues 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.
Consumers who have the affected Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits should stop using and discard the device. Consumers should not return product to Medline.
Medline voluntarily recalled product after thorough investigation of reports received for this issue and notified the FDA of this action. At this time, Medline is not aware of any serious health consequences which have occurred due to use of the device.
Recalled Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits were manufactured on or before July 8, 2026 and distributed from June 28, 2021, to July 31, 2026.
Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits within the scope of the recall can be identified by their product labeling, which includes the name of the device, item number, and manufacturing date. The labeling of products affected by the recall include either a Teleflex or Medline item number, depending on the manufacturing date. Affected products manufactured before January 2024 display a Teleflex label and item number, while products manufactured starting January 2024 or later display a Medline label and item number. Please refer to the example labels below to identify the manufacturing date (red) and item number (blue) on the product label.
The following item numbers are included in the scope of the recall:
Medline Item Number | Teleflex Item Number |
|---|---|
HUD78001KIT | 780-01KIT |
HUD78007 | 780-07 |
HUD78007KIT | 780-07KIT |
HUD78008KIT | 780-08KIT |
HUD78009 | 780-09 |
HUD78009KIT | 780-09KIT |
HUD78013 | 780-13 |
HUD78014 | 780-14 |
HUD78015 | 780-15 |
HUD78017KIT | 780-17KIT |
HUD78018 | 780-18 |
HUD78018KIT | 780-18KIT |
HUD78019 | 780-19 |
HUD88001KIT | 880-01KIT |
HUD88013KIT | 880-13KIT |
HUD88014KIT | 880-14KIT |
HUD88015KIT | 880-15KIT |
HUD88017KIT | 880-17KIT |
All product manufactured on or after July 9, 2026 are not under scope of the recall and may continue to be used.
Medline is notifying its distributors and customers by email and/or first-class mail and is arranging for credit of all recalled product(s).
Consumers with questions regarding this recall can contact Medline by phone at 866-359-1704 Monday through Friday between the hours of 8am and 5pm CST or recalls@medline.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this medical device.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-3321088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
