Bard Ventralight ST Mesh Recall Due to Potential Sterile Pouch Seal Defects
Davol, Inc. is recalling Bard Ventralight ST Mesh with Echo PS 6" Circle due to potential defects in the sterile inflation assembly pouch seal.
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 the hazard involves a potential packaging defect (weak seal) that could compromise sterility, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
Davol, Inc., a subsidiary of C. R. Bard, Inc., is recalling specific lots of Bard Ventralight ST Mesh with Echo PS 6" Circle. The product is indicated for the reconstruction of soft tissue deficiencies, such as the repair of hernias. The recall is being conducted because the pouch holding the sterile inflation assembly and inflation adapter may be open or have a weak seal.
The affected lots are HUXH0694, HUXL1149, HUXL1150, and HUYA1005. The product was distributed nationwide in the United States and internationally to Austria, Belgium, Canada, Cyprus, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, South Africa, Spain, Sweden, Switzerland, and the United Kingdom.
Healthcare providers and facilities should check their inventory for these specific lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or distributor according to their instructions. Patients who have already received the device should contact their healthcare provider for guidance.
The recalled product
- Product
- Bard¿ Ventralight" ST Mesh with Echo PS" 6" CircleReorder Number: 5955600 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
- Manufacturer
- Davol, Inc., Subs. C. R. Bard, Inc.
- Category
- Medical Device — Surgical Mesh
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)
- Lot Number: HUXH0694
- HUXL1149
- HUXL1150
- HUYA1005
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 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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