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Henry Schein 9004472Recalls & reported problems

Henry Schein, Inc. · NDL 25G*1 1/2 · Class 2

Adverse event reports
7
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00304040002841), received between Sep 11, 2025 and Sep 30, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (5 reports).

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 2 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 5 reportsOct 2026: 0 reports2024202520265
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Complete Blockage5
  • Dull, Blunt2

Patient problems

  • No Clinical Signs, Symptoms or Conditions7

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 30, 2026Complete Blockage

    The customer advised that some of the needles have plungers that are clogged and not working.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50943117 ↗
  • MalfunctionSep 23, 2026Complete Blockage

    When administering liquid, it doesn't seem to pass thru the needles like it is clogged.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50864197 ↗
  • MalfunctionSep 23, 2026Complete Blockage

    When administering liquid, it doesn't seem to pass thru the needles like it is clogged.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50864196 ↗
  • MalfunctionSep 23, 2026Complete Blockage

    When administering liquid, it doesn't seem to pass thru the needles like it is clogged.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50864195 ↗
  • MalfunctionSep 23, 2026Complete Blockage

    When administering liquid, it doesn't seem to pass thru the needles like it is clogged.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50864194 ↗
  • MalfunctionSep 11, 2025Dull, Blunt; Dull, Blunt

    THE CUSTOMER REPORTS THAT THE NEEDLE POINT WAS DULL AND AS A RESULT THIS CAUSED DISCOMFORT FOR THEIR PATIENTS DURING INJECTIONS INCLUDING STEROID INJECTIONS, INJECTIONS FOR PAIN AND B12 INJECTIONS. THESE WERE PRIMARILY USED IN THE HIP AREA OR BUTT. NO MEDICAL ATTENTION OR SERIOUS INJURY WAS EXPERIENCED. AS OF NOW NO UDI# INFORMATION NOR PATIENT SPECIFICS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23023601 ↗
  • MalfunctionSep 11, 2025Dull, Blunt; Dull, Blunt

    THE CUSTOMER ADVISED THAT WHEN USING THE NEEDLE, IT WAS NOT PUNCTURING THE SKIN AND WAS JUST CAUSING PATIENT DISCOMFORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23023533 ↗

Other Needle, hypodermic, single lumen devices

All Needle, hypodermic, single lumen devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.