Ureteral stent kits, 8 French, recalled over a size labeling discrepancy
C.R. Bard is recalling 116 BD InLay Optima Ureteral Stent Kits, 8 Fr x 26 cm, because the actual stent size may not match the product label.
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: Scored 2 because the record cites a size labeling discrepancy with no stated clinical consequence or reported harm.
Plain-English summary
The BD InLay Optima Ureteral Stent Kit, size 8 Fr x 26 cm, REF 78826, from C.R. Bard Inc, is being recalled.
The reason given in the enforcement record is a labeling discrepancy: the ureteral stent actual size may not match the actual product label.
The recall covers 116 units from lot NGJU4328, UDI (01)00801741015922. Distribution was worldwide, including nationwide in the United States across Arizona, California, Colorado, Florida, Georgia, Iowa, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri and North Dakota among other states. The FDA has classified the action as Class II.
The record describes a mismatch between the stated and actual size, and states no injuries. Facilities should quarantine the affected lot and follow the firm's instructions.
The recalled product
- Product
- BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826
- Manufacturer
- C.R. Bard Inc
- Category
- Medical Device — Ureteral stent
- Affected units
- 116
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 (1)
- Lot# NGJU4328/UDI: (01)00801741015922
Distribution
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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