Recall Z-0210-2026— Cardinal Health 200, LLC

Name: FDA recall Z-0210-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-18

Class II · Ongoing

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2025-09-18. It names one FDA 510(k) clearance: K880850. 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-Reflux Valve, 18 Fr/Ch 8888266106 Salem Sump" Dual Lumen Stomach Tube, Anti-Reflux Valve 10Fr/Ch (3.3 mm), 36" 266130CN Salem Sump" Tube 16FR with CONFIRM NOW, Nonsterile 266148CN Salem Sump" Tube 8 FR with CONFIRM NOW, Nonsterile. Reason: 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..

Recalling firm: Cardinal Health 200, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-09-18
Firm location: Waukegan, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K880850 — KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVEKmb Medical Products Co.·cleared 1988-05-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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-Reflux Valve, 18 Fr/Ch 8888266106 Salem Sump" Dual Lumen Stomach Tube, Anti-Reflux Valve 10Fr/Ch (3.3 mm), 36" 266130CN Salem Sump" Tube 16FR with CONFIRM NOW, Nonsterile 266148CN Salem Sump" Tube 8 FR with CONFIRM NOW, Nonsterile

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.