Medline Industries, Inc. PAIN9024Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889942448708), received between Aug 28, 2023 and Aug 28, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 reports).

2 FDA recall records name this device's identifier, 2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 21, 2026Class IIOpen, 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-2541-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Oct 16, 2024Class IIOpen, Classified

   The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

   Z-0513-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionAug 28, 2023Connection Problem; Connection Problem

  CATHETER BECAME DISCONNECTED.

  Patient problems: Pain

  MAUDE report 17633733 ↗
• MalfunctionAug 28, 2023Connection Problem; Connection Problem

  CATHETER BECAME DISCONNECTED.

  Patient problems: Pain

  MAUDE report 17631345 ↗