NIPRO HYPODERMIC NEEDLE AH+3013Recalls & reported problems
Nipro Medical Corporation · Class 2
All models of NIPRO HYPODERMIC NEEDLE (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00383790002141), received between Mar 13, 2020 and Oct 9, 2025 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 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. 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
- Patient-Device Incompatibility2
- Break1
- Detachment of Device or Device Component1
- Difficult to Remove1
Patient problems
- Foreign Body In Patient2
- Rash2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryOct 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
FOUR PATIENTS DEVELOPED RASHES FOLLOWING GLP-1 MEDICATION INJECTIONS ADMINISTERED FOR THE TREATMENT OF OBESITY. NONE OF THE PATIENTS HAD A HISTORY OF KNOWN ALLERGIES, AND NO INJURIES, MEDICAL INTERVENTIONS, OR HOSPITALIZATIONS WERE REQUIRED AS A RESULT OF THE REACTIONS. THE FACILITY SUBSEQUENTLY SWITCHED TO A DIFFERENT LOT OF THE PRODUCT. ALL AFFECTED PATIENTS RECOVERED FULLY, AND THE USED PRODUCT WAS DISCARDED BY THE FACILITY.
Patient problems: Rash
MAUDE report 23258827 ↗InjuryOct 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
FOUR PATIENTS DEVELOPED RASHES FOLLOWING GLP-1 MEDICATION INJECTIONS ADMINISTERED FOR THE TREATMENT OF OBESITY. NONE OF THE PATIENTS HAD A HISTORY OF KNOWN ALLERGIES, AND NO INJURIES, MEDICAL INTERVENTIONS, OR HOSPITALIZATIONS WERE REQUIRED AS A RESULT OF THE REACTIONS. THE FACILITY SUBSEQUENTLY SWITCHED TO A DIFFERENT LOT OF THE PRODUCT. ALL AFFECTED PATIENTS RECOVERED FULLY, AND THE USED PRODUCT WAS DISCARDED BY THE FACILITY.
Patient problems: Rash
MAUDE report 23258273 ↗MalfunctionMar 13, 2020Break; Break
PATIENT WAS INJECTING THE LEFT SIDE OF THE NECK, DURING THE EPIDERMAL INCLUSION CYST EXCISION, USING NEEDLE. WHEN RETRACTING, THE SYRINGE, THE NEEDLE BECAME DETACHED FROM THE NEEDLE HUB AND WAS NO LONGER ATTACHED TO CAP. INSTEAD IT REMAINED IN INJECTION SITE WITH NO WAY OF RETRIEVING. PATIENT SAW A PLASTIC SURGEON, WHO WAS UNABLE TO REMOVE THE NEEDLE. PATIENT IS SCHEDULED FOR A SECOND VISIT WITH A PLASTIC SURGEON. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 9832557 ↗InjuryMar 13, 2020Difficult to Remove; Detachment of Device or Device Component
PATIENT WAS INJECTING THE LEFT SIDE OF THE NECK, DURING THE EPIDERMAL INCLUSION CYST EXCISION, USING NEEDLE. WHEN RETRACTING, THE SYRINGE, THE NEEDLE BECAME DETACHED FROM THE NEEDLE HUB AND WAS NO LONGER ATTACHED TO CAP. INSTEAD IT REMAINED IN INJECTION SITE WITH NO WAY OF RETRIEVING. PATIENT SAW A PLASTIC SURGEON, WHO WAS UNABLE TO REMOVE THE NEEDLE. PATIENT IS SCHEDULED FOR A SECOND VISIT WITH A PLASTIC SURGEON. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 9832498 ↗
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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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