FDA Recalls Mislabeled Bard Ventralight ST Mesh Surgical Products
Davol, Inc. is recalling 49 units of Bard Ventralight ST Mesh due to packaging mislabeling where product sizes do not match package labels.
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 error where the physical product size does not match the package label. This is a significant labeling error that could lead to improper surgical use, fitting the criteria for a moderate severity recall.
Plain-English summary
Davol, Inc., a subsidiary of C. R. Bard, Inc., is recalling 49 units of Bard Ventralight ST Mesh, Product Code 5954790, Lot # HUWE1780. The recall is due to mislabeling of the product packaging. Specifically, the 8" x 10" packages contain 7" x 9" mesh, and the 7" x 9" packages contain 8" x 10" mesh.
The Bard Ventralight ST Mesh is a sterile, dual-component prosthesis intended for the reconstruction of soft tissue deficiencies, such as hernia repair. The affected units were distributed nationwide.
Healthcare providers and patients should stop using the affected lots and contact the manufacturer for instructions on return or replacement. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use…
- Manufacturer
- Davol, Inc., Subs. C. R. Bard, Inc.
- Category
- Medical Device — Surgical Mesh
- Hazard
- Affected units
- 49
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 # HUWE1780
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Davol, Inc., Subs. 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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