Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Numbe
Summary
The FDA issued a Class II for Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Num by Medline Industries, LP. Reason: Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit .
Details
Source
Device Recall
External ID
Z-2991-2026
Action Date
2026-09-02
Status
Ongoing
Category
device
Product Description
Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuit. Respiratory gas humidifier.
Lot/Code Info: All lot codes
Quantity Affected: 20 units
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide and the country of Panama.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-13
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Medline Industries, LP has 577 FDA actions in our database, including 553 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medline Industries, LP have FDA actions?
Medline Industries, LP has 577 FDA actions in our database, including 553 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2991-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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