Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ventralight ST w EchoPS 4"x6" Ellipse- A low profile Recalled by Davol, Inc. Due to Balloon may not inflate as intended. If the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Davol, Inc. directly.
Affected Products
Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955460G (EU Only)
Quantity: N/A
Why Was This Recalled?
Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Davol, Inc.
Davol, Inc. has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report