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Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stomach Tube, Dual Lumen ...

FDA Device Recall #Z-0210-2026 — Class II — September 18, 2025

Recall Summary

Recall Number Z-0210-2026
Classification Class II — Moderate risk
Date Initiated September 18, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cardinal Health 200, LLC
Location Waukegan, IL
Product Type Devices
Quantity all lots

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.

Distribution Pattern

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR, GU and the countries of Australia, Austria, Bahrain, Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Africa, Kuwait, Luxembourg, Mexico Monaco, Netherlands, New Zealand, Northern Ireland, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Taiwan, UAE, United Kingdom, Vietnam.

Lot / Code Information

Product Code/Product Name/UDI-DI: 266122 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm) 10884521065024 266130 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 16 Fr/Ch (5.3 mm) 10884521065031 266148 Salem Sump" Stomach Tube, Dual Lumen with Anti-Reflux Valve, 18 Fr/Ch 10884521065055 8888266106 Salem Sump" Dual Lumen Stomach Tube, Anti-Reflux Valve 10Fr/Ch (3.3 mm), 36" 20884521004655 266130CN Salem Sump" Tube 16FR with CONFIRM NOW, Nonsterile 10884521141292 266148CN Salem Sump" Tube 8 FR with CONFIRM NOW, Nonsterile 20884521141305 All Lots

Other Recalls from Cardinal Health 200, LLC

Recall # Classification Product Date
Z-1203-2026 Class II Chest Drainage Units and Accessories: Produc... Dec 26, 2025
Z-0897-2026 Class II ChemoPlus gowns: Product Code Product Descript... Nov 12, 2025
Z-0207-2026 Class II Salem Sump PVC Tubes: Product Code/Product N... Sep 18, 2025
Z-0208-2026 Class II Salem Sump PVC Tubes: Product Code/Product N... Sep 18, 2025
Z-0211-2026 Class II Salem Sump PVC Tubes: Product Code/Product N... Sep 18, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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