Bard Ventralight ST Mesh Recall for Potential Sterility Compromise
Davol, Inc. is recalling specific lots of Bard Ventralight ST Mesh because the sterile packaging may be open or have a weak seal, potentially compromising sterility.
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 sterility compromise (packaging defect) without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
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"x8" (Reorder Number 5955680). The recall is due to a defect where the pouch holding the sterile inflation assembly and inflation adapter may be open or have a weak seal. This defect could compromise the sterility of the components.
The affected lots are HUXH0688, HUXK0743, HUXL0803, and HUXL0804. 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. The mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Healthcare providers and facilities should stop using the affected lots and contact the manufacturer for instructions on return or replacement. Patients who have had this specific mesh implanted should consult their healthcare provider if they have concerns regarding the sterility of the device components.
The recalled product
- Product
- Bard¿ Ventralight" ST Mesh with Echo PS" 6"x8" Reorder Number: 5955680 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: HUXH0688
- HUXK0743
- HUXL0803
- HUXL0804
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.
See all 15 products in this recall →Related recalls
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