EXEL Hypodermic Disposable Needles 26419Recalls & reported problems
Exel International · EXEL Hypodermic Needle, 18Gx1" · Class 2
Data updated Oct 18, 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 10020221264194), received between May 1, 2024 and May 1, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination1
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.
MalfunctionMay 1, 2024Contamination; Contamination
ON (B)(6) 2024, BLACK RUBBER PARTICLE WAS FOUND FLOATING IN SYRINGE OF PROPOFOL AFTER WITHDRAWING FROM VIAL USING 18G NEEDLE. THE PROVIDER OBSERVED THE PARTICLE IN THE SYRINGE AFTER DRAWING UP THE PROPOFOL. SHE HAPPENED TO SEE IT FLOATING AGAINST THE WALL OF THE SYRINGE, THEN ADHERING TO IT. UNFORTUNATELY, THE PRODUCT WAS DISPOSED AND CANNOT BE RETURNED FOR FURTHER EVALUATION. THERE ARE NO SIMILAR COMPLAINT TYPE EVENTS FROM THIS LOT. PER INVESTIGATION, 10PCS OF RETAINED SAMPLES PASSED TESTING FOR NEEDLE INTRACAVITY CLEANLINESS. AS NO IMAGES OR SAMPLES WERE RETAINED THE FOLLOWING ARE POSSIBLE CAUSES: PUNCTURE DEBRIS FROM THE PROPOFOL VIAL WHEN USING THE DISPOSABLE NEEDLE, FOREIGN MATTER IN THE SYRINGE RUBBER GASKET
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19226909 ↗
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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
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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