Henry Schein 9007655Recalls & reported problems
Henry Schein, Inc. · Needle Disposable Safety · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00304040017296), received between May 16, 2025 and May 16, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Defective Component” (2 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
Most reported problems
Device problems
- Defective Component2
Patient problems
- Needle Stick/Puncture1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2025Defective Component; Defective Component
"CUSTOMER REPORTED: THE CUSTOMER REPORTED THAT THE PROTECTIVE ORANGE PLASTIC COVER SNAPPED OFF AS THEY ATTEMPTED TO COVER THE NEEDLE WITH IT, CAUSING THEIR FINGER TO BE STUCK BY THE NEEDLE. NEEDLE HAD ALREADY BEEN USED ON A PATIENT FOR A ROUTINE VACCINE INJECTION."
Patient problems: Needle Stick/Puncture
MAUDE report 22035593 ↗MalfunctionMay 16, 2025Defective Component; Defective Component
CUSTOMER REPORTED: THE NEEDLES TOOK OUT FRAGMENTS OF THE SILICONE IN THE VIAL WHEN HANDLED. THERE WERE FRAGMENTS OF SILICONE THAT REMAINED FLOATING IN THE MEDICATION AND THAT COULD BE ASPIRATED DURING THE LOADING OF THE DOSE BY NURSES AND REACH THE PATIENT. THE OCCURRENCE OF THIS EVENT WAS DURING THE IMMEDIATE USE OF THE PRODUCT AND THERE IS NO PATIENT INVOLVEMENT. THE SAMPLE IS AVAILABLE FOR EVALUATION. AS PER THE REPORT THERE WAS NO OTHER PERTINENT PRODUCT IN USE DURING THE INCIDENT, THE INCIDENT WAS NOT REPORTED TO ANY REGULATORY AGENCY OR COMPETENT BODY, AND THERE WAS NO REPORTED HARM OR MEDICAL INTERVENTION REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035518 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.