Henry Schein 1126148Recalls & reported problems
Henry Schein, Inc. · NDL 30G*1/2 · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00304040003084), received between May 8, 2024 and Apr 22, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (3 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
- Complete Blockage3
- Fracture2
- Material Puncture/Hole2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Needle Stick/Puncture3
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2026Complete Blockage
THE CUSTOMER ADVISED THAT THEIR CLINICAL STAFF, INCLUDING THE PHYSICIAN, HAVE REPORTED THAT THE NEEDLES SEEM TO BE CLOGGED, MAKING IT DIFFICULT FOR PRODUCT TO FLOW THROUGH PROPERLY DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24949209 ↗MalfunctionMar 31, 2026Break; Fracture
THE CUSTOMER IS GETTING POKED THROUGH THE CAP. LEFT A VOICE MESSAGE FOR IVRIL, THE NURSE TO ANSWER ADDITIONAL QUESTIONS ABOUT THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24740492 ↗MalfunctionSep 11, 2025Material Puncture/Hole; Material Puncture/Hole
CUSTOMER REPORTED THAT THE STERILE NEEDLE HAS PIERCED THROUGH THE PROTECTIVE CAP. PLEASE INVESTIGATE.
Patient problems: Needle Stick/Puncture
MAUDE report 23023584 ↗MalfunctionSep 11, 2025Fracture; Fracture
THE CUSTOMER REPORTS THAT THEY HAD ONE NEEDLE "EXPLODE" OFF THE SYRINGE ONTO THE PATIENT'S FACE. NO MEDICAL ATTENTION REQUIRED. AT THIS TIME NO PATIENT SPECIFICS OR UDI# PROVIDED BY THE CUSTOMER.
Patient problems: Needle Stick/Puncture
MAUDE report 23023557 ↗MalfunctionSep 11, 2025Material Puncture/Hole; Material Puncture/Hole
THE CAPS ARE NOT STAYING ON THE NEEDLES. THEY HAD A PATIENT GET POKED THROUGH THE UV BAG THAT THEY DELIVER THE MEDS THROUGH. WE ARE CONTINUING TO FOLLOW UP FOR ADDITIONAL INFORMATION INCLUDING PATIENT SPECIFICS, LOT NUMBER, UDI AND ANY POTENTIAL FOLLOW UP TREATMENT PROVIDED.
Patient problems: Needle Stick/Puncture
MAUDE report 23023547 ↗MalfunctionJul 10, 2024Complete Blockage; Complete Blockage
THE CUSTOMER ADVISED THAT THE PRODUCT IS CLOGGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19709370 ↗MalfunctionMay 8, 2024Complete Blockage; Complete Blockage
CUSTOMER ADVISED THAT ONE BOX OF SYRINGES ARE CLOGGING UP. NO ADVERSE EVENTS CAUSED. SYRINGES JUST WONT DISPENSE THE FLUIDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19266041 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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