SURGUARD3 SG3+2238Recalls & 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
- 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 14806017509665), received between May 4, 2021 and May 4, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation Failure” (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
- Activation Failure1
Patient problems
- Needle Stick/Puncture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 4, 2021Activation Failure; Activation Failure
THE USER FACILITY REPORTED THE NEEDLE DID NOT RECAP COMPLETELY (STIFF), THE PATIENT WAS STUCK IN THE LEFT INDEX FINGER. THE NEEDLE IS PART OF THE ABILIFY MAINTENA 400 MG KIT. ADDITIONAL INFORMATION WAS RECEIVED ON 15APRIL2021: THE NEEDLE STICK INJURY WAS TO HEALTHCARE WORKER ON COMPLETION OF ADMINISTRATION OF THE MED. HEALTHCARE WORKER HAD MINIMAL BLOOD LOSS. THE CONDITION OF THE PATIENT WAS NOT DISCLOSED. THE COMPLETE DOSE WAS PROVIDED. HEALTHCARE WORKER WAS FOLLOWED UP BY (B)(6) FOR TESTING AFTER NEEDLE STICK INJURY. RESULTS UNKNOWN. THE NEEDLE PERTAINS TO THE CAP, THE SAFETY SHEATH. IT IS UNKNOWN WHAT METHOD OF ACTIVATION WAS USED.
Patient problems: Needle Stick/Puncture
MAUDE report 11770280 ↗
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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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