SURGUARD3 SG3+2525Recalls & reported problems
Terumo (Philippines) Corporation · SURGUARD3 Safety Hypodermic Needle · Class 2
All models of SURGUARD3 (19)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14806017509252), received between Jan 10, 2025 and Jan 16, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (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
- Malposition of Device2
Patient problems
- Needle Stick/Puncture2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 16, 2025Malposition of Device; Malposition of Device
THE USER FACILITY REPORTED THAT THE NEEDLES BEND AFTER ADMINISTRATION, RESULTING IN TWO NEEDLE STICK ACCIDENTS. THESE ACCIDENTS OCCURRED POST-TREATMENT DUE TO THE BENDING OF THE NEEDLES. THE IMPACT ON THE USER IS CURRENTLY UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED ON 20 DEC 2024: THE OCCURRENCE DATE OF BOTH NEEDLE STICK INJURIES IS ON (B)(6) WHEN WE WERE NOTIFIED ABOUT THE INCIDENT. FOR EACH INCIDENT, WE DO NOT HAVE INFORMATION ABOUT WHETHER THE PATIENT WHO RECEIVED THE INJECTION WAS INFECTED WITH HIV, HEPATITIS B, OR ANOTHER INFECTIOUS DISEASE. CONSEQUENTLY, IT IS NOT POSSIBLE FOR US TO DETERMINE IF THERE IS A RISK THAT THE USER GOT INFECTED AFTER THE NEEDLE STICK, AS THIS INVOLVES PRIVATE DATA THAT WE CANNOT ACCESS.
Patient problems: Needle Stick/Puncture
MAUDE report 21173354 ↗MalfunctionJan 10, 2025Malposition of Device; Malposition of Device
THE USER FACILITY REPORTED THAT THE SAFETY NEEDLES BEND AFTER ADMINISTRATION. ADDITIONAL INFORMATION WAS RECEIVED ON 19 DEC 2024: THE NEEDLE STICK INJURY IS CONNECTED TO THE BENT NEEDLE, AS THE ACCIDENT OCCURRED DUE TO THE BENDING OF THE NEEDLE. NO INFORMATION IS AVAILABLE ABOUT WHETHER THE PATIENT WHO RECEIVED THE INJECTION WAS INFECTED WITH HIV, HEPATITIS B, OR ANOTHER INFECTIOUS DISEASE. DUE TO PRIVATE DATA, IT IS NOT POSSIBLE TO DETERMINE IF THE USER WAS INFECTED AFTER THE NEEDLE STICK.
Patient problems: Needle Stick/Puncture
MAUDE report 21130374 ↗
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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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