NIPRO SYRINGE JD+03L2525Recalls & reported problems
Nipro Medical Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00383790000833), received between Jan 22, 2019 and Jan 22, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Disintegration” (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.
Most reported problems
Device problems
- Material Disintegration1
- Material Fragmentation1
Patient problems
- Inflammation2
- Pain2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 22, 2019Material Disintegration
WE RECEIVED SEVERAL EMAILS FROM THE CUSTOMER REPORTING INFLAMMATION AND PAIN IN THE LEG. CUSTOMER EXPLAINED IN THE EMAILS THAT DURING MEDICINE ADMINISTRATION THE PLUNGER FALLS APART, HIS LEG BECAME SEVERELY INFLAMMED AND THE PATIENT HAD TO TAKE ANTI-INFLAMMATORY ORDERED BY HIS DOCTOR. HE IS WAITING FOR THE DOCTOR TO CONFIRM WHETHER OR NOT HE HAS PIECES OF THE PLUNGER IN HIS LEG. NOTE: CUSTOMER DID NOT PROVIDE DATE OF OCCURRENCE, DID NOT PROVIDE THE NAME OF THE MEDICATION USED DURING THE ADMINISTRATION, DID NOT ADVISE TYPE OF TESTING PERFORMED TO CONFIRM WHETHER OR NOT PIECES OF THE PLUNGER WERE IN HIS LEG. CUSTOMER PURCHASED OUR SYRINGES FROM AN UNAUTHORIZED DISTRIBUTOR ON-LINE. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Inflammation; Pain
MAUDE report 8269136 ↗InjuryJan 22, 2019Material Fragmentation; Material Fragmentation
WE RECEIVED SEVERAL EMAILS FROM THE CUSTOMER REPORTING INFLAMMATION AND PAIN IN THE LEG. CUSTOMER EXPLAINED IN THE EMAILS THAT DURING MEDICINE ADMINISTRATION THE PLUNGER FALLS APART, HIS LEG BECAME SEVERELY INFLAMMED AND THE PATIENT HAD TO TAKE ANTI-INFLAMMATORY ORDERED BY HIS DOCTOR. HE IS WAITING FOR THE DOCTOR TO CONFIRM WHETHER OR NOT HE HAS PIECES OF THE PLUNGER IN HIS LEG. NOTE: CUSTOMER DID NOT PROVIDE DATE OF OCCURRENCE, DID NOT PROVIDE THE NAME OF THE MEDICATION USED DURING THE ADMINISTRATION, DID NOT ADVISE TYPE OF TESTING PERFORMED TO CONFIRM WHETHER OR NOT PIECES OF THE PLUNGER WERE IN HIS LEG. CUSTOMER PURCHASED OUR SYRINGES FROM AN UNAUTHORIZED DISTRIBUTOR ONLINE. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Inflammation; Pain
MAUDE report 8269127 ↗
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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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