SURGUARD3 SG3-1838Recalls & 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 34806017508082), received between Sep 4, 2019 and Sep 4, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 4, 2019Break; Break
THE USER FACILITY REPORTED THAT THE ISSUE OCCURRED DURING A PROCEDURE WHEN THE PHYSICIAN WAS USING THE NEEDLE ATTACHED TO A 30CC SYRINGE AND THAT THEY HEARD A CRACK AND THE NEEDLE BROKE OFF. ADDITIONAL INFORMATION WAS RECEIVED 12AUGUST2019: IT WAS REPORTED THAT THEY HEARD A CRACK AND THE NEEDLE BROKE WITH IT REMAINING IN THE ANTICOAGULANT BOTTLE. ADDITIONAL INFORMATION WAS RECEIVED 20AUGUST2019: THE NEEDLE DID NOT BREAK INSIDE THE PATIENT. THE CUSTOMER WAS DRAWING ACDA FROM A VIAL AND THE NEEDLE BROKE OFF AND REMAINED IN THE VIAL.
Patient problems: No Patient Involvement
MAUDE report 8959957 ↗
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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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