NIPRO HYPODERMIC NEEDLE AH+2516Recalls & 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 00383790002066), received between Mar 3, 2020 and Jul 1, 2025 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient2
- Device Embedded In Tissue or Plaque1
- No Code Available1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2025Break; Break
DURING IM INJECTION IN THE RIGHT THIGH FOR PRE-OP MEDICATIONS DURING A NEUTER PROCEDURE, NEEDLE APPEARED TO SLIP OUT OF THE HUB. NEEDLE IS VISIBLE UPON X-RAY. THE CANINE APPEARS TO BE RECOVERING NORMALLY WITH NO PROBLEMS. HUB WAS DISCARDED. THE FACILITY CONTACTED A SURGICAL SPECIALIST WHEN THE INCIDENT OCCURRED AND THEY WERE ADVISED TO LEAVE THE NEEDLE IN PLACE. IT WAS EXPLAINED THAT ATTEMPTING TO FIND THE SMALL NEEDLE, IT COULD CAUSE MORE DAMAGE TO THE MUSCLE GROUP, RATHER THAN ALLOWING IT TO REMAIN AS IT MIGHT EVENTUALLY WORK ITS WAY OUT ON ITS OWN. FACILITY WAS INSTRUCTED TO HAVE AN X-RAY OF THE SITE AT LEAST ONE OR TWICE A YEAR, TO MONITOR THE POSITION OF THE NEEDLE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 22378378 ↗InjuryJul 1, 2025Break; Break
DURING IM INJECTION IN THE RIGHT THIGH FOR PRE-OP MEDICATIONS DURING A NEUTER PROCEDURE, NEEDLE APPEARED TO SLIP OUT OF THE HUB. NEEDLE IS VISIBLE UPON X-RAY. THE CANINE APPEARS TO BE RECOVERING NORMALLY WITH NO PROBLEMS. HUB WAS DISCARDED. THE FACILITY CONTACTED A SURGICAL SPECIALIST WHEN THE INCIDENT OCCURRED AND THEY WERE ADVISED TO LEAVE THE NEEDLE IN PLACE. IT WAS EXPLAINED THAT ATTEMPTING TO FIND THE SMALL NEEDLE, IT COULD CAUSE MORE DAMAGE TO THE MUSCLE GROUP, RATHER THAN ALLOWING IT TO REMAIN AS IT MIGHT EVENTUALLY WORK ITS WAY OUT ON ITS OWN. FACILITY WAS INSTRUCTED TO HAVE AN X-RAY OF THE SITE AT LEAST ONE OR TWICE A YEAR, TO MONITOR THE POSITION OF THE NEEDLE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 22378171 ↗InjuryMar 3, 2020Break; Break
NEEDLE BROKE OFF IN PATIENT DURING USE. NEEDLE ALSO BROKE AGAIN WHEN BEING SURGICALLY REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED. ((B)(6) YEAR OLD FEMALE SPAYED, AUSSIE SHEPHERD MIX, (B)(6) POUNDS).
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9782282 ↗InjuryMar 3, 2020Break; Detachment of Device or Device Component
NEEDLE BROKE OFF IN PATIENT DURING USE. NEEDLE ALSO BROKE AGAIN WHEN BEING SURGICALLY REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED. ((B)(6) FEMALE SPAYED, AUSSIE SHEPHERD MIX, (B)(6)).
Patient problems: No Code Available
MAUDE report 9782207 ↗
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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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