SURGUARD3 SG3-03L2525Recalls & reported problems
Terumo (Philippines) Corporation · SURGUARD3 Hypodermic Syringe with Safety 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 34806017508518), received between Feb 2, 2026 and Mar 10, 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
Patient problems
- Needle Stick/Puncture1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2026Malposition of Device
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE DEFECT WAS IN THE SAFETY LOCKING MECHANISM. THE NEEDLE TIP CAN REMAIN EXPOSED EVEN AFTER ATTEMPTING TO LOCK IT, WHICH POSED A SIGNIFICANT RISK FOR ACCIDENTAL NEEDLE STICKS. NO INJURIES OR BLOOD LOSS WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24560170 ↗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 24242772 ↗
Other SYRINGE, ANTISTICK devices
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- BD Integra 305271Becton, Dickinson And Company · SYRINGE, ANTISTICK106 reports
- BD Integra 305269Becton, Dickinson And Company · SYRINGE, ANTISTICK85 reports
- BD Luer-Lok, BD SafetyGlide 305924Becton, Dickinson And Company · SYRINGE, ANTISTICK1 recall28 reports
- BD Integra 305272Becton, Dickinson And Company · SYRINGE, ANTISTICK71 reports
- BD SafetyGlide 305945Becton, Dickinson And Company · SYRINGE, ANTISTICK63 reports
- BD SafetyGlide 305950Becton, Dickinson And Company · SYRINGE, ANTISTICK61 reports
- Medline SYRS101235FMedline Industries, Inc. · SYRINGE, ANTISTICK1 recall0 reports
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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