Davol recalls Ventrallight ST 4" x 6" Ellipse with Echo PS (Catalog 5955460) due to potential balloon failure during hernia repair, risking procedure delays, mesh issues, or infection.
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 4" x 6" Ellipse with Echo PS surgical devices because the balloon might not inflate properly during hernia repair. This could lead to longer surgeries, improper mesh placement, or infections. Patients using these devices should contact Davol for guidance.
The balloon in the device may not inflate as intended during surgery. If it fails to inflate, the procedure could be delayed or prolonged, leading to inadequate mesh placement, erosion/migration of the mesh, pain, or infection.
Patients who received the Ventrallight ST 4" x 6" Ellipse with Echo PS (Catalog Number 5955460) for laparoscopic ventral hernia repair are affected. Those with the specific lot numbers listed in the recall are at highest risk.
Check for the Catalog Number 5955460 on the device. The lot numbers include HUGS0481 through HUGT1989. This product was sold with specific UDI-DI codes.
Reach out to Davol directly for instructions on how to handle the device.
The recall states the balloon may not inflate as intended, which could cause procedure delays or complications. Do not use the device until contacting Davol for guidance.
The affected lot numbers are HUGS0481, HUGS0549, HUGS1019, HUGS2031, HUGS2079, HUGT1627, HUGS2025, and HUGT1989.
Look for the Catalog Number 5955460 and check the lot numbers listed in the recall notice.
We’ve drafted a message you can send Davol to request your refund or repair — edit it as you like.
Subject: Recall Z-2241-2023 — Davol Davol Hello, I own a Davol that is covered by recall Z-2241-2023 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.
