PROLITE ULTRA 30802Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00650862308020), received between Sep 26, 2018 and Sep 26, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K002093, K151437); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2018Contamination /Decontamination Problem; Packaging Problem

  WHEN THE OUTER PACKING WAS OPENED THEY FOUND SOME FOREIGN MATTER INSIDE THE WRAP. THE MATTER WAS FAINT YELLOW AND AT THE EDGE OF THE MESH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7911891 ↗
• MalfunctionSep 26, 2018Device Contamination with Chemical or Other Material

  WHEN THE OUTER PACKING WAS OPENED THEY FOUND SOME FOREIGN MATTER INSIDE THE WRAP. THE MATTER WAS FAINT YELLOW AND AT THE EDGE OF THE MESH.

  Patient problems: No Information

  MAUDE report 7911887 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002093, K151437. One submission often covers many models, so check the product and lot details in each record.

• Z-0712-2018 · Nov 22, 2017 · Terminated
  ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds and chest wall reconstr