MEDLINE LF2019CRRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20193489189688), received between Dec 3, 2025 and Dec 3, 2025 — classified as 1 injury.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 1, 2025Open, Classified

   Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.

   Z-0467-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DEVICE WAS USED DURING A PROCEDURE. NO ISSUES WERE NOTED DURING THE PROCEDURE. A FEW DAYS LATER, THE PATIENT PRESENTED TO THE ER WITH AN INFECTION, WAS HOSPITALIZED FOR 4 DAYS, UNDERWENT A NECK I&D, AND WAS DISCHARGED ON IV ANTIBIOTICS.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23706688 ↗