FDA Recalls Mislabeled Bard Ventralight ST Mesh Surgical Products
Davol, Inc. is recalling 49 units of Bard Ventralight ST Mesh due to size mislabeling on the packaging.
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 minor labeling error (size mismatch) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Davol, Inc., a subsidiary of C. R. Bard, Inc., is recalling 49 units of Bard Ventralight ST Mesh, Product Code 5954810, Lot # HUWE1779. The device is a dual-component sterile prosthesis intended for the reconstruction of soft tissue deficiencies, such as hernia repair. The recall is due to a labeling error where the 8" x 10" package contains 7" x 9" mesh, and the 7" x 9" package contains 8" x 10" mesh.
The affected products were distributed nationwide. The source text does not specify specific dates of distribution or the number of units sold to end-users, only the total quantity of 49 units involved in the recall.
Consumers and healthcare providers should stop using the affected mesh and contact the recalling firm for instructions on return or replacement. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. 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 # HUWE1779
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.
See all 2 products in this recall →Related recalls
Same manufacturer · Davol, Inc., Subs. C. R. Bard, Inc.
See all →- ModerateBard PerFix Light Plug Recalled for Labeling Mismatch
FDA (Devices) · 2014-11-19
- ModerateBard Ventralight ST Mesh Recall Due to Potential Pouch Seal Failure
FDA (Devices) · 2014-06-11
- HighBard Composix LIP Mesh Recall Due to Potential Sterility Compromise
FDA (Devices) · 2014-06-11
- ModerateBard Ventralight ST Mesh Recall Due to Potential Sterile Pouch Seal Defects
FDA (Devices) · 2014-06-11
- ModerateBard Ventralight ST Mesh Recall Due to Potential Sterile Pouch Seal Failure
FDA (Devices) · 2014-06-11
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- HighFDA Recalls Bard Ventralight ST Mesh Due to Potential Sterility Compromise
FDA (Devices) · 2014-06-11
- ModerateBard Ventralight ST Mesh Recall for Potential Sterility Compromise
FDA (Devices) · 2014-06-11
- HighBard Ventralight ST Mesh Recall Due to Potential Sterility Compromise
FDA (Devices) · 2014-06-11
- ModerateBard Ventralight ST Mesh Recall Due to Potential Pouch Seal Failure
FDA (Devices) · 2014-06-11
- ModerateBard Ventralight ST Mesh Recalled for Potential Sterile Pouch Seal Defects
FDA (Devices) · 2014-06-11
- ModerateBard Ventralight ST Mesh Recall Due to Potential Sterile Pouch Seal Failure
FDA (Devices) · 2014-06-11