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
- 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 34806017508167), received between Dec 11, 2024 and Feb 2, 2026 — 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
- Activation Failure1
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.
MalfunctionFeb 2, 2026Malposition of Device
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE CAP WOULD NOT GO BACK ON THE NEEDLE. ADDITIONAL INFORMATION WAS RECEIVED ON 08JAN2026: THERE WAS A DEFECT IN THE SAFETY LOCKING MECHANISM. THE NEEDLE TIP CAN REMAIN EXPOSED EVEN AFTER ATTEMPTING TO LOCK IT, WHICH POSES A SIGNIFICANT RISK FOR ACCIDENTAL NEEDLE STICKS. ADDITIONAL INFORMATION WAS RECEIVED ON 09JAN2026: THE EVENT WAS INITIALLY NOTIFIED ON 09/01/25. THE PRODUCT WAS USED DURING THE NEEDLE SAFETY TRAINING WITH A DETAILED EXPLANATION OF HOW THE PRODUCT FUNCTIONS. THE STAFF WAS PROVIDED WITH AT LEAST 2 SAMPLES TO DEMONSTRATE THE USE OF THE PRODUCT USING HARD SURFACE ACTIVATION AND THUMB ACTIVATION AND THEN HAVE THE STAFF RETURN TO DEMONSTRATE. IF NOT SATISFIED WITH RETURN DEMONSTRATION, TRAINING IS REPEATED. NEEDLE STICK OCCURRED. BLOOD LOSS IS VERY MINIMAL. LAB WORK WAS COLLECTED FROM THE PATIENT.
Patient problems: Needle Stick/Puncture
MAUDE report 24242769 ↗MalfunctionDec 11, 2024Malposition of Device; Activation Failure; Malposition of Device; Activation Failure
THE USER FACILITY REPORTED THAT THE PRODUCT SG3-2238, A TERUMO SURGAURD3 22G NEEDLE, FAILED. THE DOCTOR EXPERIENCED AN ISSUE WHERE, UPON PRESSING THE NEEDLE DOWN TO SECURE THE PLASTIC SAFETY GUARD, THE GUARD POPPED OPEN AND STUCK HIS FINGER WHEN HE LIFTED IT BACK UP. ADDITIONAL INFORMATION PROVIDED ON 12 NOV 2024: THE EVENT OCCURRED DURING A KNEE JOINT INJECTION PROCEDURE WITH A 5CC SYRINGE ATTACHED. THERE WAS NO IMPACT ON THE PATIENT AT THE TIME OF THE SAFETY ACTIVATION. THE DOCTOR WAS ACTIVATING THE NEEDLE AGAINST A HARD SURFACE WHEN THE NEEDLE STICK OCCURRED ON HIS LEFT INDEX FINGER. TESTING FOR BBP EXPOSURE RISK WAS PERFORMED, AND THE NEEDLE STICK DID NOT CAUSE BLOOD LOSS OR REQUIRE MEDICAL INTERVENTION. THE DOCTOR IS IN STABLE CONDITION AND HAS RETURNED TO NORMAL DUTIES. DURING ACTIVATION, THE OUTSIDE CAP DID NOT CLICK CLOSED OVER THE NEEDLE AND FELT IT POPPED OPEN, LEAVING THE NEEDLE EXPOSED. THE DOCTOR DID NOT HEAR AN AUDIBLE CLICK BEFORE ACTIVATING AGAINST THE HARD SURFACE AND DID NOT CHECK IF THE CANNULA WAS CAPTURED UNDER THE SHEATH TOOTH BEFORE LIFTING THE DEVICE. THE DOCTOR ALSO DID NOT WAIT UNTIL THE SHEATH WAS CLOSED AS HE WAS REACHING FOR STERILE GAUZE WITH HIS LEFT
Patient problems: Needle Stick/Puncture
MAUDE report 20901687 ↗
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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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