Bard Nasogastric Sump Tubes Recalled for Reduced Suction and Drainage
C.R. Bard is recalling 26,100 nasogastric sump tubes due to user complaints of inadequate suction and reduced drainage. The malfunction could prevent proper stomach decompression.
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: FDA Class II medical device recall with user-reported functional malfunction (inadequate suction and drainage) affecting critical patient care. No reported injuries or hospitalizations, but the malfunction creates clear risk of patient harm through aspiration or inability to decompress the stomach, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
C.R. Bard is recalling 26,100 units of the Bard Nasogastric Sump Tube with PreVent Anti-Reflux Filter with ENFit connector (12Fr., 48 inches long). The affected units were distributed in the United States and can be identified by the following lot numbers: NGDT1998, NGDZ3287, NGEU0889, NGEU2134, NGEV2411, NGEW2655, NGEY1506, NGEZ0664, NGFN4265, NGFU4024, NGFV3514, NGFW1857, NGFX0168, NGFX2645, NGGQ8458, NGGR2705, NGGX4777.
The company has received user complaints reporting that these tubes experience inadequate or reduced suction, decompression, and drainage during use. This malfunction prevents proper stomach decompression and creates a risk of aspiration.
Healthcare providers and patients using these tubes should stop use of affected lot numbers and contact C.R. Bard for replacement units and further guidance. Patients should consult with their healthcare provider about appropriate care during the recall period.
The recalled product
- Product
- Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120
- Manufacturer
- C.R. Bard Inc
- Hazard
- suction-failure
- drainage-failure
- 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 (18)
- UDI/DI 00801741113239
- Lot/Serial Numbers: NGDT1998
- NGDZ3287
- NGEU0889
- NGEU2134
- NGEV2411
- NGEW2655
- NGEY1506
- NGEZ0664
- NGFN4265
- NGFU4024
- NGFV3514
- NGFW1857
- NGFX0168
- NGFX2645
- NGGQ8458
- NGGR2705
- NGGX4777
Distribution
Distribution scope not specified by the agency.
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