Henry Schein 9007842Recalls & reported problems
Henry Schein, Inc. · Tray Syringe w/NDL LL 3cc · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00304040017203), received between Jul 24, 2020 and May 27, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- May 9, 2024Open, Classified
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
Z-3075-2024 · Root cause: Other · Recall details · FDA record ↗
Most reported problems
Device problems
- Contamination1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2026Contamination
CUSTOMER REPORTED THAT THEY RECEIVED THE PRODUCT WITH A FOREIGN MATTER ENCASED IN THE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25298861 ↗MalfunctionJul 24, 2020Fluid/Blood Leak
CUSTOMER REPORTED THAT THERE WAS LIQUID IN THE MIDDLE PORTION OF THE RUBBER GROMMET (GASKET) ON THE PLUNGER PART OF THE SYRINGE. THE LIQUID WAS RADIOACTIVE AT THE TIME. PER FOLLOW UP INFORMATION RECEIVED, THE CUSTOMER SAID THAT THE LIQUID DID LEAK OUT OF THE BARREL BEYOND THE PLUNGER. THE RADIOPHARMACEUTICAL LIQUID LEAKED ON THE HAND OF THE HEALTHCARE WORKER WHILE THEY WERE INJECTING INTO PATIENT. THE CUSTOMER CONFIRMED THAT THERE WAS NO REPORT OF SKIN CONTAMINATION OF THE HEALTHCARE WORKER DUE TO THE RADIOACTIVE DRUG LEAKAGE ON THE HAND AS THE HEALTHCARE WORKER WAS WEARING PROTECTIVE GLOVES. NO RADIOACTIVE LIQUID SPILL CLEAN-UP PROCEDURE WAS NEEDED AT THE HOSPITAL. NO INJURY WAS REPORTED BY HEALTHCARE WORKER . THERE WAS ALSO NO DELAY OR INTERRUPTION OF PATIENT THERAPY AS THE ADMINISTRATION WAS CONSIDERED COMPLETED. ALTHOUGH NO INJURY WAS REPORTED, THIS REPORT WILL BE FILED DUE TO THE POTENTIAL FOR OCCURENCE OF A SERIOUS INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10323714 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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