Henry Schein 9004469Recalls & reported problems
Henry Schein, Inc. · NDL 18G*1 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00304040002810), received between Aug 6, 2025 and Aug 6, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination of Device Ingredient or Reagent” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Contamination of Device Ingredient or Reagent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2025Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent
VOLUNTARY REPORT #'S MW5172340 AND MW5172341 WERE SENT TO HENRY SCHEIN. PER BOTH REPORTS STATED BY THE 25-YEAR-OLD FEMALE PATIENT: "I WENT TO DO MY HORMONE INJECTION TONIGHT AND NOTICED METAL SHARDS IN TWO DIFFERENT NEEDLES FROM THE SAME LOT. I NOTICED THE FIRST BEFORE PUSHING THE AIR INTO THE VIAL. I TOOK IT OUT, TOOK A PICTURE OF THE WRAPPER, AND DISPOSED IT IN MY SHARPS BOX. I CHECKED THE VIAL FOR ANYTHING FLOATING AND THEN OPENED A NEW NEEDLE AND ATTACHED IT TO THE SYRINGE. I DREW UP THE AIR, INJECTED IT SLOWLY INTO THE VIAL TO WATCH FOR ANYTHING COMING OUT OF THE NEEDLE AND SAW A SMALL SHARD OF METAL COME OUT OF THE NEEDLE. I SUCKED IT INTO THE SYRINGE AND TOOK PICTURES OF THE SHARD IN SYRINGE BEFORE DISPOSING THE NEEDLE AND SYRINGE IN MY SHARPS BOX. THIS HAPPENED TWO WEEKS AGO, AND MY PHARMACIST AND PHYSICIAN HAD ME DISPOSE OF THE VIAL AND PURCHASE A NEW ONE. I WILL NOTIFY THEM IN THE MORNING. THE NEEDLES WERE: HENRY SCHEIN HYPODERMIC NEEDLE REF (B)(4) SIZE 18GX1" LOT 20240728 2029-07-27."ITEM # 9004469. REFERENCE VOLUNTARY REPORT #'S MW5172340 AND MW5172341.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22724067 ↗
Other Needle, hypodermic, single lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page