Bard Premature Infant Feeding Tube Recalled for Ineffective Fusion
C.R. Bard is recalling 42,200 units of Bard Premature Infant Feeding Tubes due to potentially ineffective fusion between the tubing and the ENFit connector.
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: The recall is classified as FDA Class II and involves a defect in a medical device used for feeding vulnerable patients (neonates/infants), representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
C.R. Bard, Inc. is recalling 42,200 units of Bard Premature Infant Feeding Tubes, ENFit, REF EN0036400. The affected lots are NGAXX216, NGAVX224, and NGBN2861. These products were distributed nationwide in the United States.
The recall was initiated because the U.S. Food and Drug Administration (FDA) identified that the product code and lot number combination may have ineffectively fused tubing and ENFit connector. The ENFit connector is designed to reduce the risk of enteral device misconnections, but the fusion defect may compromise this safety feature.
These feeding tubes are intended for the decompression of the stomach and the short-term administration of tube feeding, lavage fluid, and medications for neonates, infants, and adults. The FDA has classified this recall as Class II, which means there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Healthcare facilities and consumers should stop using the affected products and contact C.R. Bard, Inc. for further instructions or a replacement.
The recalled product
- Product
- Bard(R) Premature Infant Feeding Tube, ENFit(TM), REF EN0036400 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tub
- Manufacturer
- C.R. Bard, Inc.
- Affected units
- 42,200
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 (3)
- Lot Numbers: NGAXX216
- NGAVX224
- NGBN2861
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by C.R. Bard, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · C.R. Bard, Inc.
See all →- ModerateSilastic Brand Foley Catheters recalled due to surface stain
FDA (Devices) · 2026-05-27
- ModerateUreteral stent kits recalled because the stent size may not match the label
FDA (Devices) · 2025-12-17
- ModerateUreteral stent kits, 4.7 French, recalled over a size labeling discrepancy
FDA (Devices) · 2025-12-17
- ModerateShort ureteral stent kits recalled over a size labeling discrepancy
FDA (Devices) · 2025-12-17
- ModerateUreteral stent kits, 8 French, recalled over a size labeling discrepancy
FDA (Devices) · 2025-12-17