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Open, Classified

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 Product Number/SKU 780-15 (Teleflex Product Number/SKU 780-15); 6) HUDSON RCI, CIRCUIT,NEO,DUAL,WIRE,60 IN, Medline Product Number/SKU HUD7801780-18) (Teleflex Product Number/SKU 780-18).

FDA Recall Z-2992-2026 · Posted 2026-08-21

Recalling FirmMedline Industries, LP
Recall StatusOpen, Classified
Product CodeBZO
Date Initiated2026-07-13
Product Quantity145525 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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Panama.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K903083NEONATAL VENTILATOR CIRCUITHudson Respiratory Care, Inc. · 1990-12-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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