Davol recalls Ventralight ST 4.5" Circle with Echo PS mesh for laparoscopic ventral hernia repair due to potential balloon inflation issues that could cause procedure delays or complications.
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 4.5" Circle with Echo PS mesh used in laparoscopic ventral hernia repairs because the balloon may not inflate properly. This could lead to longer surgeries, improper mesh placement, or infections. Patients should contact the manufacturer 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 inadequate mesh placement, erosion, migration, pain, or infection.
Patients who received this mesh during laparoscopic ventral hernia repair procedures are affected. Those with the specific lot numbers listed in the recall are most at risk.
Check the product label for the catalog number 5955450 or the lot numbers: HUGS0922, HUGS2026, HUGS2061, HUGS2020, HUGS2044, HUGS2015, HUGS2076, HUGT1582, HUGU0750, HUGU0748.
Look for the catalog number 5955450 or the listed lot numbers on the product.
The balloon may not inflate as intended during laparoscopic ventral hernia repair, which could cause procedure delays, inadequate mesh placement, erosion, migration, pain, or infection.
Check the product label for catalog number 5955450 or lot numbers: HUGS0922, HUGS2026, HUGS2061, HUGS2020, HUGS2044, HUGS2015, HUGS2076, HUGT1582, HUGU0750, HUGU0748.
Contact Davol directly for instructions on how to proceed with the recall.
We’ve drafted a message you can send Davol to request your refund or repair — edit it as you like.
Subject: Recall Z-2242-2023 — Davol Davol Hello, I own a Davol that is covered by recall Z-2242-2023 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.
