Z-2991-2026Class II

Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex...

Name: Z-2991-2026 Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex...
Creator: Medline Industries, LP
Published: 2026-07-13
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-07-13 / Open, Classified

FDA source

Medline Industries, LP began a recall of Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuit on 2026-07-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2991-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-13
Posted: 2026-08-21
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuit
Product code: BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
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.
FDA root cause: Under Investigation by firm
Action: Medline issued an Urgent Medical Device notice it its consignees on 7/13/2026 via email and USPS. The notice explained the issue, potential risk, and provided actions and precautions for healthcare providers. If evidence of connector overheating or thermal damage is observed: " Assess the patient and ensure continued respiratory support. " Replace the affected circuit as soon as clinically appropriate. " Remove the affected circuit from service and retain it for investigation." For questions, contact the Recall Department at 866-359-1704 or [email protected]. Follow up notice sent on 7/27/2026 to clarify the item numbers. *** Updated customer communication was sent out on 8/5/26. Consignees were instructed to destroy affected inventory. The firm has begun distributing corrected product.
Quantity in commerce: 20 units
Distribution: Worldwide distribution - US Nationwide and the country of Panama.
Product codes and lots: All lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2991-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2991-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-21
Z-2992-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-21
Z-2993-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-02	2026-08-21

Product code BTT

K031383Class IIModel 780Hudson Respiratory Care, Inc. / cleared 2003-07-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)