Bard Inlay Ureteral Stent Recalled for Labeling Update
C.R. Bard is recalling 75,089 Bard Inlay Ureteral Stents to add a warning about potential knots during removal.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is for a labeling error (missing warning) rather than a physical defect or contamination, which aligns with the rubric for minor labeling errors.
Plain-English summary
C.R. Bard, Inc. is recalling 75,089 units of Bard Inlay Ureteral Stents with Suture. The recall is limited to a labeling correction where a statement was added to the Warnings/Precautions section. The new text requests end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.
The affected product codes are 776400, 776600, 776700, and 776800. The recall is distributed nationwide in the United States. This action is classified as Class II by the FDA, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
- Manufacturer
- C.R. Bard, Inc.
- Hazard
- Affected units
- 75,089
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 (4)
- Product Codes: 776400
- 776600
- 776700
- and 776800.
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.
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