Covidien recalls Salem Sump Dual Lumen Stomach Tubes with incorrect packaging that may cause decreased fluid collection and affect patient care, especially in emergencies.
This voluntary recall is being conducted due to incorrect packaging. In one lot of Salem Sump Dual Lumen Stomach Tubes the 10Fr product was packaged in a 16Fr pouch. The use of a 10 Fr Salem Sump Tube when a 16Fr is needed could result in decreased fluid collection, with the potential to affect patient care, particularly in an emergency situation where the correct size is not readily available.
Take action
Contact the company
📍Recalling firmCOVIDIEN LLC15 Hampshire St · Mansfield, MA 02048-1113
“Covidien Salem Sump Dual Lumen Stomach Tube Recall: Incorrect Packaging Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69541-covidien-salem-sump-dual-lumen-stomach-tube-recall-incorrect-packaging. Based on FDA recall #Z-0597-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0597-2019%22&limit=1).
The FDA announced on October 31, 2018, that Covidien LLC voluntarily recalled Salem Sump Dual Lumen Stomach Tubes due to incorrect packaging. The hazard involves a 10 Fr product being packaged in a 16 Fr pouch, which could affect patient care.
How to tell if you have it
Brand: Covidien
Product: Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm)
Product Code: 8888264911
Lot Code: 1812115564
The hazard
The recall is due to incorrect packaging where a 10 Fr Salem Sump Tube was placed in a 16 Fr pouch. This error could result in decreased fluid collection if the smaller tube is used when a larger one is needed, potentially affecting patient care in emergencies.
Context
GovInfoNow's records show Covidien LLC has 52 other recalls on record since August 7, 2017. Other recent recalls of similar products include the Covidien EndoFLIP System recall (May 13, 2026), the Covidien Mon-a-Therm Temperature Probe Recall (April 23, 2026), and the Covidien Shiley Disposable Decannulation Plug Recall (April 23, 2026). Additional recent recalls include the Covidien EndoStitch Polysorb Loading Unit Recall (April 15, 2026), the Stryker FluidSmart Urology Tube Set Recall (April 9, 2026), and the Medtronic Octopus Nuvo Tissue Stabilizer Recall (January 13, 2026).
How to tell if you have this one
Check for the product code 8888264911 on the packaging. The Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm) was sold with incorrect packaging in one lot.
Brand
Covidien
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Packaging
Verify the product code on the packaging to confirm it matches 8888264911.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide Distribution - US Nationwide and foreign distribution to Canada.” 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 terminated this recall 19 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0597-2019 (October 31, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0597-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.