SURGUARD2 10180094Recalls & reported problems
Terumo (Philippines) Corporation · SURGUARD2 Safety Hypodermic Needle · Class 2
All models of SURGUARD2 (3)
Data updated Oct 16, 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 34806017512942), received between Jan 11, 2024 and Aug 20, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- Insufficient Information1
- 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.
MalfunctionAug 20, 2026Break
Patient problems: Insufficient Information
MAUDE report 50350597 ↗MalfunctionJan 11, 2024Break; Break
THE USER FACILITY REPORTED THAT THE PATIENT GAVE HIMSELF THE INJECTION AND THE INVOLVED NEEDLE BROKE OFF WHEN HE WAS INJECTING IT AND THE LIQUID LEAKED OUT ON THE FLOOR. THE EVENT OCCURRED INTRA-OPERATIVE. NO HARM REPORTED. POTENTIAL HARM DUE TO BROKEN CANNULA. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL/SURGICAL INTERVENTION WAS NOT NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18500214 ↗
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- 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 SYRS103225Medline 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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