Davol recalls Ventrallight ST w EchoPS 4"x6" Ell: Balloon may not inflate during hernia repair, risking procedure delays, mesh issues, or infection. Check catalog number 5955460G (EU) or UDI-DI for affected units.
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
Davol is recalling Ventralight ST w EchoPS 4"x6" Ellipse mesh for laparoscopic hernia repairs because the balloon might not inflate properly. This could cause surgery delays, improper mesh placement, pain, or infection. Patients should contact Davol for details.
The balloon in the mesh may not inflate as intended during surgery. If it fails to inflate, the procedure could be delayed or prolonged, leading to improper mesh placement, erosion, migration, pain, or infection.
Patients who received this mesh during laparoscopic ventral hernia repair. Those with the catalog number 5955460G (EU) or UDI-DI (01)00801741201967(17)240428(10) are most at risk.
Check if your mesh has the catalog number 5955460G (EU only) or UDI-DI (01)00801741201967(17)240428(10). This product was sold for laparoscopic ventral hernia repairs.
Identify your mesh using the catalog number 5955460G (EU) or UDI-DI (01)00801741201967(17)240428(10) from the product packaging.
The recall states the balloon may not inflate as intended, which could cause procedure delays, improper mesh placement, pain, or infection. Patients should contact Davol for guidance.
The recall does not specify a remedy, so contact Davol directly for instructions on next steps.
Check for catalog number 5955460G (EU only) or UDI-DI (01)00801741201967(17)240428(10) on the product packaging.
We’ve drafted a message you can send Davol to request your refund or repair — edit it as you like.
Subject: Recall Z-2244-2023 — Davol Davol Hello, I own a Davol that is covered by recall Z-2244-2023 from Davol. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.