Z-2993-2026 Class II Ongoing
FDA device recall Z-2993-2026 was initiated by Medline Industries, LP on July 13, 2026 and is designated Class II. 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 ot… The recall status is ongoing. Affected quantity: 271406 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2026
- Initiation Date
- July 13, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 271406 units
Product Description
Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB, HTD,COLUMN, Medline Product Number/SKU HUD78001KIT (Teleflex Product Number/SKU 780-01KIT); 2) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78007KIT (Teleflex Product Number/SKU 780-07KIT); 3) MEDLINE HUDSON RCI, DBD-CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78008KIT (Teleflex Product Number/SKU 780-08KIT); 4) MEDLINE HUDSON RCI, DBD-CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU HUD78009KIT (Teleflex Product Number/SKU 790-09KIT); 5) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL LIMB, HTD,COLUMN, Medline Product Number/SKU HUD78017KIT (Teleflex Product Number/SKU 780-17KIT); 6) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL HTD, DUAL LIMB,COLUMN, Medline Product Number/SKU HUD78018KIT (Teleflex Product Number/SKU 780-18KIT); 7) MEDLINE HUDSON RCI, CIRCUIT,ISO-SHIELD SINGLE LIMB,INFANT, Medline Product Number/SKU HUD88001KIT (Teleflex Product Number/SKU 880-01KIT); 8) MEDLINE HUDSON RCI, CIRCUIT,ISO-SHIELD,INFANT,HTD,COLUMN,DRN, Medline Product Number/SKU HUD88013KIT (Teleflex Product Number/SKU 880-13KIT); 9) MEDLINE HUDSON RCI, ISO-SHIELD CIRCUIT,INFNT,HTD,DL,DRAIN, Medline Product Number/SKU HUD88014KIT (Teleflex Product Number/SKU 880-14KIT); 10) MEDLINE HUDSON RCI,ISO-SHIELD CIRCUIT,INFNT,HTD,DL,DRAIN, Medline Product Number/SKU HUD88015KIT (Teleflex Product Number/SKU 880-15KIT); 11) MEDLINE HUDSON RCI, ISO-SHIELD CIRCUIT,INFNT,HTD,DL,DRAIN, Medline Product Number/SKU HUD88017KIT (Teleflex Product Number/SKU 880-17KIT).
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 Pattern
Worldwide distribution - US Nationwide and the country of Panama.
Code Information
1) Medline Product Number/SKU HUD78001KIT (Teleflex Product Number/SKU 780-01KIT), UDI/DI 10197344010752 (each) 20197344010759 (case), All lot numbers; 2) Medline Product Number/SKU HUD78007KIT (Teleflex Product Number/SKU 780-07KIT), UDI/DI 10197344010738 (each) 20197344010735 (case), All lot numbers; 3) Medline Product Number/SKU HUD78008KIT (Teleflex Product Number/SKU 780-08KIT), UDI/DI 10197344010721 (each) 20197344010728 (case), All lot numbers; 4) Medline Product Number/SKU HUD78009KIT (Teleflex Product Number/SKU 790-09KIT), UDI/DI 10197344010714 (each) 20197344010711 (case), All lot numbers; 5) Medline Product Number/SKU HUD78017KIT (Teleflex Product Number/SKU 780-17KIT), UDI/DI 10197344010677 (each) 20197344010674 (case), All lot numbers; 6) Medline Product Number/SKU HUD78018KIT (Teleflex Product Number/SKU 780-18KIT), UDI/DI 10197344010905 (each) 20197344010902 (case), All lot numbers; 7) Medline Product Number/SKU HUD88001KIT (Teleflex Product Number/SKU 880-01KIT), UDI/DI 10197344010929 (each) 20197344010926 (case), All lot numbers; 8) Medline Product Number/SKU HUD88013KIT (Teleflex Product Number/SKU 880-13KIT), UDI/DI 10197344010493 (each) 20197344010490 (case), All lot numbers; 9) Medline Product Number/SKU HUD88014KIT (Teleflex Product Number/SKU 880-14KIT), UDI/DI 10197344010486 (each) 20197344010483 (case), All lot numbers; 10) Medline Product Number/SKU HUD88015KIT (Teleflex Product Number/SKU 880-15KIT), UDI/DI 10197344010479 (each) 20197344010476 (case), All lot numbers; 11) Medline Product Number/SKU HUD88017KIT (Teleflex Product Number/SKU 880-17KIT), UDI/DI 10197344010462 (each) 20197344010469 (case), All lot numbers;