Cardinal Health Salem Sump Stomach Tubes Recalled for Anti-Reflux Valve Breakage
Cardinal Health is recalling Salem Sump Dual Lumen Stomach Tubes due to reports of anti-reflux valve breakage caused by improper use. Product labeling has been updated.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves confirmed reports of equipment breakage in a medical device used in vulnerable patient populations. While breakage is attributed to improper use rather than a design defect, a non-functional anti-reflux valve presents a risk of serious harm. No injuries have been reported, placing this at High per the rubric criterion 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Cardinal Health 200, LLC is recalling four models of Salem Sump Dual Lumen Stomach Tubes due to reports of breakage in the anti-reflux valve caused by improper use. All lot numbers of the affected models are included in this recall.
The affected tubes were distributed nationwide, including Puerto Rico and Guam, through civilian and military channels. International distribution included Chile. A total of 24,761,100 units were distributed across all affected models and lot numbers.
The manufacturer has updated the product labeling in response to these reports. Healthcare providers and patients currently using these tubes should review the updated labeling for proper use and handling instructions. Questions regarding the recall should be directed to Cardinal Health 200, LLC.
The recalled product
- Product
- (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,
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- valve-breakage
- aspiration-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- 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.
Distribution
Distributed nationwide across the United States.
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