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Lower risk Medical device recall · FDA · Published July 24, 2024

Cardinal Health Stomach Tube Recall: Anti-Reflux Valve Breakage Risk

Cardinal Health recalls stomach tubes with anti-reflux valves that may break due to improper use. Affected models include 12-18 French sizes. No immediate action needed as labeling changes address the issue.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3302-2024Medical deviceCardinal Health ›
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Contact the company

Recalling firmCardinal Health 200, LLC3651 Birchwood Dr · Waukegan, IL 60085-8337
✎ GovInfoNow plain-language explainer

Cardinal Health is recalling stomach tubes with anti-reflux valves that may break if used improperly. This could lead to leaks or infections, but the recall involves only labeling updates to prevent misuse. Read more at govinfonow.com/recall/54557-cardinal-health-stomach-tube-recall-anti-reflux-valve-breakage-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/54557-cardinal-health-stomach-tube-recall-anti-reflux-valve-breakage-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3302-2024

Cite this page

“Cardinal Health Stomach Tube Recall: Anti-Reflux Valve Breakage Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54557-cardinal-health-stomach-tube-recall-anti-reflux-valve-breakage-risk. Based on FDA recall #Z-3302-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3302-2024%22&limit=1).

Cardinal Health 200, LLC recalled CardinalHealth Salem Sump Dual Lumen Stomach Tubes with Anti-Reflux Valve due to potential breakage of the valve from improper use. The Food and Drug Administration announced the Class II recall on July 24, 2024.

How to tell if you have it

  • Brand: Cardinal Health
  • Product: CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve
  • Model #8888266114, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Sterile; UDI-DI 10192253012781
  • Model #8888266122, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Sterile; UDI-DI 10192253012804
  • Model #8888266130, 16 Fr/Ch (5.3 mm) x 48 in. (122 cm), Sterile; UDI-DI 10192253012828
  • Model #8888266148, 18 Fr/Ch (6.0 mm) x 48 in. (122 cm), Sterile; UDI-DI 10192253012842
  • All lot numbers
  • Distribution: Nationwide, including Puerto Rico and Guam; government/military distribution; foreign distribution to Chile

The hazard

The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.

Context

GovInfoNow's records show Cardinal Health 200, LLC has 58 other recalls on record since June 27, 2017. Other recent recalls of similar products include Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets (Aug. 18, 2026), Presource Convenience Kits (Aug. 10, 2026), and Presource Packs with Contaminated Wipes (July 29, 2026). Other recent recalls of similar products include B. Braun Medical CESK Harris Methodist Recall (Jan. 29, 2026), B. Braun Medical CESK SHANDS Jackson 20055717 Recall (Jan. 29, 2026), and Argon Medical Devices L-Cath Midline Catheter Recall (June 15, 2026).

How to tell if you have this one

Check for model numbers 8888266114, 8888266122, 8888266130, or 8888266148 on the tube packaging. The tubes are 48 inches long and come in 12-18 French sizes.

  • Brand
    Cardinal Health
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Distribution was nationwide, including Puerto Rico and Guam. There was also government/military distribution. Foreign distribution was made to Chile.
Recall numberProduct, codes & lots
Z-3301-2024(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8888264945, Sterile; (c) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 16 Fr/Ch (5.3 mm) x 48 in. (122 cm), Model #8888264960, Sterile; and (d) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 18 Fr/Ch (6.0 mm) x 48 in. (122 cm), Model #8888264986, Sterile;; All lot numbers. UDI-DI numbers: (a) 8888264929, UDI-DI 10192253012477; (b) 8888264945, UDI-DI 10192253012491; (c) 8888264960, UDI-DI 10192253012514; and (d) 8888264986, UDI-DI 10192253012538;
Z-3302-2024(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888266114, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8888266122, Sterile; (c) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 16 Fr/Ch (5.3 mm) x 48 in. (122 cm), Model #8888266130, Sterile; and (d) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 18 Fr/Ch (6.0 mm) x 48 in. (122 cm), Model #8888266148, Sterile.; All lot numbers. UDI-DI numbers: (a) 8888266114, UDI-DI 10192253012781; (b) 8888266122, UDI-DI 10192253012804; (c) 8888266130, UDI-DI 10192253012828; and (d) 8888266148, UDI-DI 10192253012842.
Based on the official FDA remedy

What to do — step by step

  1. Check Labeling

    Look for updated labeling on the tube packaging that addresses the breakage risk.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “Distribution was nationwide, including Puerto Rico and Guam. There was also government/military distribution. Foreign distribution was made to Chile.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Jul 24, 202412. FDA classified it Class II: Sep 26, 202423. Published in FDA’s Enforcement Report: Oct 2, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Cardinal Health 200, LLC recalls Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive,
March 2, 2026Cardinal Health 200, LLC recalls Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
September 25, 2024

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-3302-2024 (July 24, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3302-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA