SURGUARD3 SG3+2325Recalls & 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 14806017509269), received between Mar 10, 2023 and Mar 10, 2023 — 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
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2023Activation Failure; Activation Failure
ADDITIONAL INFORMATION WAS RECEIVED ON 27 FEB 2023: THE NURSE EXPLAINED THAT SHE INJECTED THE PATIENT AND AS SHE WAS PUTTING THE SAFETY ON THE NEEDLE, SHE PRESSED DOWN ON THE SHIELD AND THERE WAS RESISTANCE. THE NEEDLE DID NOT CLOSE. THE TIP OF THE NEEDLE REMAINED EXPOSED, AND SHE PRICKED HERSELF WITH HER THUMB. SHE HAD TRIED TO CLOSE THE NEEDLE WITH HER HAND AND NOT ON A TABLE. HOWEVER, WHEN SHE RETURNED THE SYRINGE TO THE PHARMACY, THE PHARMACIST TRIED TO CLOSE IT WITH THE TABLE BUT HAD GREAT DIFFICULTY. A BLOOD TEST WAS PERFORMED ON BOTH THE NURSE AND THE PATIENT PERFORMED. THE BLOOD TEST RESULTS WERE BOTH NEGATIVE.
Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions
MAUDE report 16526584 ↗
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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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