Bard Fluoro-4 Silicone Ureteral Stent Recall for Labeling Update
C.R. Bard is recalling 75,089 units of Bard Fluoro-4 Silicone 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 classified as FDA Class II and involves a labeling update to address a potential handling issue (knotting) during removal. It is a voluntary precautionary labeling correction without reported injuries or illnesses, fitting the Moderate severity criteria for minor labeling errors or low-risk issues.
Plain-English summary
C.R. Bard, Inc. is recalling 75,089 units of Bard Fluoro-4 Silicone Ureteral Stents, Bard Fluoro-4 Silicone Ureteral Coil Stents, and Bard Silicone Ureteral Coil Stents with Figure Four Ends. The affected products were distributed nationwide in the United States.
The recall is a Class II labeling action. A statement was added to the Warnings/Precautions section of the product labeling to request that end users consider the presence of a knot if significant resistance is encountered during attempts at removal. This update is intended to inform healthcare providers of a specific handling consideration during the removal process.
Healthcare providers and facilities should check their inventory for the affected product codes: 277405, 277406, 277407, 277408, 288405, 288406, 288407, and 288408. Users should refer to the updated labeling for guidance on managing resistance during stent removal.
The recalled product
- Product
- Bard Fluoro-4 Silicone Ureteral Stent, Bard¿ Fluoro-4", Silicone Ureteral Coil Stent; Bard¿ Silicone Uretera l Coil Stent with Figure Four, End, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
- Manufacturer
- C.R. Bard, Inc.
- Category
- Medical Device — Ureteral Stents
- 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 (7)
- Product Codes: 277405
- 277406
- 277407
- 277408
- 288405
- 288406
- 288407 and 288408.
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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