Recall archive / FDA device enforcement
Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB, HTD,COLUMN, Medline Product Nu... — FDA record Z-2993-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 13, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- 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.
- Classification
- Class II
- Recalling firm
- Medline Industries, LP
- Quantity
- 271406 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2993-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the country of Panama.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 2, 2026
- Recall initiation date
- Jul 13, 2026
- Center classification date
- Aug 21, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.