The Recall Desk

FDA (Devices) recall action 97539

Cardinal Health 200, LLC recalled 6 products on 2025-10-29

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2025-10-29
Critical
0
Units
—

Why these products were recalled

Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–6 of 6

  • HighFDA (Devices)··2025-10-29

    Dual lumen stomach tubes recalled after anti-reflux valve breakage complaints

    Cardinal Health is recalling all lots of Salem Sump dual lumen stomach tubes with anti-reflux valve after complaints of valve breakage due to excessive force during use.

    Product
    Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm) 266130 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 16 Fr/Ch (5.3 mm) 266148 Salem Sump" Stomach Tube, Dual Lumen with Anti
    Category
    Distribution
    53 states
  • HighFDA (Devices)··2025-10-29

    Gastric sump anti-reflux valves recalled after breakage complaints from excessive force

    Cardinal Health is recalling all lots of Salem Sump Anti-Reflux Valves after complaints of valve breakage due to excessive force during use, and is providing additional guidance for use.

    Product
    Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux Valve
    Category
    Distribution
    53 states
  • HighFDA (Devices)··2025-10-29

    Silicone stomach tubes recalled after anti-reflux valve breakage complaints

    Cardinal Health is recalling all lots of Salem Sump silicone dual lumen stomach tubes after complaints of anti-reflux valve breakage due to excessive force during use.

    Product
    Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3.3 mm), 36 (91 cm) 8888265116 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 12 Fr/Ch (4.0 mm), 48 (122 cm) 8888265124 Salem
    Category
    Distribution
    53 states
  • HighFDA (Devices)··2025-10-29

    PVC stomach tubes recalled after anti-reflux valve breakage complaints

    Cardinal Health is recalling all lots of Salem Sump dual lumen stomach tubes after complaints of anti-reflux valve breakage due to excessive force during use.

    Product
    Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264945 Salem Sump" Stomach Tube, Dual Lumen, 14 Fr/Ch (4.7 mm) 264960 Salem Sump" Stomach Tube, Dual Lumen, 16 Fr/Ch (5.3 mm) 264986 Salem Sump" Stomach Tube, Du
    Category
    Distribution
    53 states
  • HighFDA (Devices)··2025-10-29

    Gastroduodenal sump tubes recalled after anti-reflux valve breakage complaints

    Cardinal Health is recalling all lots of Salem Sump PVC gastroduodenal tubes after complaints of anti-reflux valve breakage due to excessive force during use.

    Product
    Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 1180264416 Salem Sump" PVC Gastroduodenal Tube, 12 Fr/Ch (4.0 mm) x 114 cm 1180264424 Salem Sump" PVC Gastroduodenal Tube, 14 Fr/Ch (4.7 mm) x 114 cm
    Category
    Distribution
    53 states
  • HighFDA (Devices)··2025-10-29

    ENFit sump tubes recalled after anti-reflux valve breakage complaints

    Cardinal Health is recalling all lots of ENFit Salem Sump PVC tubes after complaints of anti-reflux valve breakage due to excessive force during use.

    Product
    Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN 8888264960E ENFit" Salem Sump" PVC Tube 16Fr 48IN 8888264986E ENFit" SA
    Category
    Distribution
    53 states