HIgH-Flo™ Needle Set RMS32414Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00659443000643), received between Sep 9, 2025 and Sep 9, 2025 — classified as 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K122404, K200176, K211206, K214045, K252015); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

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.

• MalfunctionSep 9, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  KORU MEDICAL WAS MADE AWARE THAT DURING INITIAL INCOMING INSPECTION AT A CUSTOMER WAREHOUSE IN JAPAN, UNIDENTIFIED BLACK DEBRIS/CONTAMINANT WAS FOUND INSIDE A SEALED STERILE NEEDLE SET POUCH INVOLVING RMS32409/LOT N.25B05N. MDR 1318360-2025-00020 IS BEING FILED FOR RMS32409/LOT N.25B05N. SUBSEQUENTLY, THE JAPANESE WAREHOUSE PERSONNEL COMPLETED INSPECTION ON THE REMAINING INVENTORY. UPON COMPLETION, AN ADDITIONAL SEALED POUCH WAS FOUND TO CONTAIN UNIDENTIFIED BLACK DEBRIS/CONTAMINANT INVOLVING RMS32414/LOT N.87033. THE CUSTOMER PROVIDED PHOTOS OF THE POUCHES CONFIRMING THE COMPLAINT. THERE WAS NO PATIENT INVOLVEMENT. A REVIEW OF THE DEVICE HISTORY RECORD FOR RMS32414/LOT N.87033 WAS PERFORMED AND NO NONCONFORMANCES OR ABERRANT CONDITIONS WERE NOTED. HIGH-FLO NEEDLE SETS ARE MANUFACTURED AND SEALED INTO THEIR PRIMARY STERILE BARRIER PACKAGING IN A CONTROLLED ENVIRONMENT. IN ADDITION, HIGH-FLO NEEDLE SETS ARE STERILIZED USING GAMMA IRRADIATION WHICH IS A HIGHLY PENETRATING AND EFFECTIVE STERILIZATION MODALITY. FURTHERMORE, VALIDATION OF THE STERILIZATION METHOD WAS PERFORMED USING A CONSERVATIVE METHOD (VDMAX25) WHICH PROVIDES A SAFETY MARGIN OVER ALTERNATE ACCEPTABLE VALIDATION METHO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23006864 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122404, K200176, K211206, K214045, K252015. One submission often covers many models, so check the product and lot details in each record.

• Z-0051-2020 · Aug 20, 2019 · Terminated
  20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606 - Product Usage: RMS HlgH-Flo Subcutaneous Safety Needle Sets are intended for the delivery
• Z-0318-2018 · Mar 10, 2016 · Terminated
  HIgH-Flo Subcutaneous Safety Needle Sets, 2-Needle Set/ 24 Gauge 9mm Needles, REF/Part Numbers RMS22606, RMS22609, RMS22612, RMS12606, RMS22409, RMS32609, RMS32609, RMS12409, RMS1