SURGUARD3 SG3+2713Recalls & 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
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 14806017509719), received between Aug 27, 2021 and Nov 24, 2024 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Activation Problem” (5 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
- Activation Problem5
- Tear, Rip or Hole in Device Packaging4
Patient problems
- Insufficient Information5
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 24, 2024Activation Problem; Activation Problem
THE USER FACILITY REPORTED THAT OVER THE PAST MONTH AND A HALF, THERE HAVE BEEN FIVE COMPLAINTS REGARDING BENT NEEDLES, BROKEN NEEDLES, OR INOPERABLE SAFETY NEEDLE FEATURES IN THE PRODUCT FAMILY INVOLVED. ALL THESE COMPLAINTS ARE LINKED TO NEEDLE BATCH: 230313D.
Patient problems: Insufficient Information
MAUDE report 20768993 ↗MalfunctionNov 24, 2024Activation Problem; Activation Problem
THE USER FACILITY REPORTED THAT OVER THE PAST MONTH AND A HALF, THERE HAVE BEEN FIVE COMPLAINTS REGARDING BENT NEEDLES, BROKEN NEEDLES, OR INOPERABLE SAFETY NEEDLE FEATURES IN THE PRODUCT FAMILY INVOLVED. ALL THESE COMPLAINTS ARE LINKED TO NEEDLE BATCH 230313D.
Patient problems: Insufficient Information
MAUDE report 20768992 ↗MalfunctionNov 24, 2024Activation Problem; Activation Problem
THE USER FACILITY REPORTED THAT OVER THE PAST MONTH AND A HALF, THERE HAVE BEEN FIVE COMPLAINTS REGARDING BENT NEEDLES, BROKEN NEEDLES, OR INOPERABLE SAFETY NEEDLE FEATURES IN THE PRODUCT FAMILY INVOLVED. ALL THESE COMPLAINTS ARE LINKED TO NEEDLE BATCH 230313D.
Patient problems: Insufficient Information
MAUDE report 20768991 ↗MalfunctionNov 24, 2024Activation Problem; Activation Problem
THE USER FACILITY REPORTED THAT OVER THE PAST MONTH AND A HALF, THERE HAVE BEEN FIVE COMPLAINTS REGARDING BENT NEEDLES, BROKEN NEEDLES, OR INOPERABLE SAFETY NEEDLE FEATURES IN THE PRODUCT FAMILY INVOLVED. ALL THESE COMPLAINTS ARE LINKED TO NEEDLE BATCH 230313D.
Patient problems: Insufficient Information
MAUDE report 20768989 ↗MalfunctionNov 24, 2024Activation Problem; Activation Problem
THE USER FACILITY REPORTED THAT OVER THE PAST MONTH AND A HALF, THERE HAVE BEEN FIVE COMPLAINTS REGARDING BENT NEEDLES, BROKEN NEEDLES, OR INOPERABLE SAFETY NEEDLE FEATURES IN THE PRODUCT FAMILY INVOLVED. ALL THESE COMPLAINTS ARE LINKED TO NEEDLE BATCH 230313D.
Patient problems: Insufficient Information
MAUDE report 20768988 ↗MalfunctionApr 26, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE USER FACILITY REPORTED THAT DURING INCOMING INSPECTION OF COMPONENT BATCH 2001531698 ((B)(4)), IT WAS NOTICED THAT TWO SAMPLES OF SURGUARD 3 NEEDLES HAD A PERFORATION IN THE BLISTER ON THE NON-PRINTED SIDE. THESE TWO DEFECTS WERE FOUND WITHIN A SAMPLE POOL OF (B)4) SAMPLES WHICH WERE TAKEN FROM TWO SAMPLE BOXES: BOX #(B)(4) AND BOX #(B)(4). THE DEFECTS CANNOT BE TRACED BACK TO ONE SPECIFIC SAMPLE BOX. THIS DEFECT HAS AN IMPACT ON THE STERILITY OF THE NEEDLE AND IS THEREFORE CLASSIFIED AS A CRITICAL DEFECT ((B)(4)) ACCORDING TO FORM-(B)(4) AND SPEC-(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14204955 ↗MalfunctionOct 15, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE USER FACILITY REPORTED THAT THERE WAS A HOLE THE POUCH DURING PRODUCTION OF FD9264. THERE WAS NO 100% MVI CHECK. A SAMPLE SET OF 800 PIECES HAS BEEN FOUND WITH NO ADDITIONAL DEFECTS. THE HOLE ON THE BLISTER AFFECTING STERILITY WAS NOT VISIBLE TO THE USER, HENCE, PROBABILITY OF USING THE UNSTERILE PRODUCT IS HIGH. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12639179 ↗MalfunctionOct 15, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE USER FACILITY REPORTED THAT THERE WAS A HOLE THE POUCH DURING PRODUCTION OF FD9264. THERE WAS NO 100% MVI CHECK. A SAMPLE SET OF 800 PIECES HAS BEEN FOUND WITH NO ADDITIONAL DEFECTS. THE HOLE ON THE BLISTER AFFECTING STERILITY WAS NOT VISIBLE TO THE USER, HENCE, PROBABILITY OF USING THE UNSTERILE PRODUCT IS HIGH. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12639178 ↗MalfunctionAug 27, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
THE USER FACILITY REPORTED THAT THERE WAS A HOLE IN THE POUCH. ONE DEFECT WAS FOUND DURING PRODUCTION OF (B)(4). THERE WAS NO 100% MVI CHECK. A SAMPLE SET OF 800 PIECES HAS BEEN FOUND. THERE WAS NO ADDITIONAL DEFECTS FOUND. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12380413 ↗
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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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