SURGUARD3 SG3-2516Recalls & 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
- 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 34806017508198), received between Oct 20, 2023 and Mar 13, 2026 — classified as 2 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Malposition of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2026Malposition of Device
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING REPORTED INFORMATION: THE CUSTOMER ADVISED THAT 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 WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24590434 ↗MalfunctionOct 20, 2023Break; Break
THE USER FACILITY REPORTED THAT A 2-YEAR-OLD MALE CAT WAS SEDATED USING THE INVOLVED TERUMO SURGUARD 3, 25 GAUGE, 5/8 "LENGTH. THE CAT RECEIVED AN INTRAMUSCULAR INJECTION FOR SEDATION BEFORE THE START OF A SURGICAL PROCEDURE. THE INJECTION WAS GIVEN IN THE RIGHT HINDLEG. UPON REMOVAL OF THE NEEDLE, IT WAS NOTED THAT THE ENTIRE NEEDLE WAS LEFT IN THE MUSCLE AND THE NEEDLE BROKE AT THE HUB. THE CAT WAS REFERRED TO A LARGE SPECIALTY HOSPITAL AND THE NEEDLE WAS REMOVED USING FLUOROSCOPY. THE CAT SURVIVED THE PROCEDURE AND IS DOING WELL. SURGICAL REMOVAL OF THE NEEDLE FROM THE RIGHT HINDLEG USING FLUOROSCOPY. PATIENT INJURY AND/OR MEDICAL OR SURGICAL INTERVENTION REQUIRED. PATIENT CONDITION IS STABLE. THE EVENT OCCURRED INTRA-OPERATIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17981367 ↗
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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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