MEDLINE ECVC8215Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10653160358992), received between Feb 18, 2026 and Feb 18, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (1 report).

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. May 21, 2026Open, Classified

   The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site.

   Z-2536-2026 · Root cause: Nonconforming Material/Component · 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.

• MalfunctionFeb 18, 2026Crack

  ACCORDING TO THE FACILITY, ON (B)(6) 2026, A CENTRAL LINE WAS BEING PLACED BY THE SURGEON, AND THE NEEDLE HUB WAS FOUND TO HAVE A CRACK AT THE BASE, THEREFORE UNABLE TO DRAW SUCTION FROM THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24381914 ↗