SURGUARD2Recalls & reported problems across all models

We found 3 models of SURGUARD2 by Terumo (Philippines) Corporation in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Mar 19, 2020 and Aug 20, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SURGUARD2 problems

SURGUARD2 models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SURGUARD2 SG2+2525

  SYRINGE, ANTISTICK
  15 reports
• SURGUARD2 SG2+2238

  SYRINGE, ANTISTICK
  5 reports
• SURGUARD2 10180094

  SYRINGE, ANTISTICK
  2 reports

Recent SURGUARD2 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50350597 ↗
• MalfunctionJun 23, 2026Activation Failure

  TERUMO RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE SAFETY SLIDE DID NOT ENGAGE POST ADMINISTRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25596449 ↗
• MalfunctionJun 23, 2026Activation Failure

  TERUMO RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE SAFETY SLIDE DID NOT ENGAGE POST ADMINISTRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25596448 ↗
• MalfunctionJun 19, 2026Activation Failure

  TERUMO RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE SAFETY SLIDE DID NOT ENGAGE POST ADMINISTRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25561133 ↗
• MalfunctionJan 1, 2026Activation Failure

  TERUMO EUROPE RECEIVED THE FOLLOWING REPORTED INFORMATION: THE NEEDLE SAFETY COVER DID NOT LOCK. ADDITIONAL INFORMATION WAS RECEIVED ON 04DEC2025: AN ACTUAL PICTURE OF THE SYRINGE OR NEEDLE USED CANNOT BE PROVIDED BECAUSE IT HAS ALREADY BEEN DISPOSED OF. THE PARTICULAR DOSE THAT WAS GIVEN WAS A 240MG DOSE GIVEN IN 2 SEPARATE SQ INJECTIONS OF 120MG EACH. THE PACKAGE INCLUDES A 25GX1-INCH NEEDLE TO USE FOR ADMINISTRATION. THE NEEDLE ITSELF HAS ONE OF THOSE SAFETY COVERS THAT YOU HAVE TO FLIP DOWN TO ENGAGE OVER THE NEEDLE. THIS TIME, THE SAFETY COVER DID NOT LOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23940849 ↗
• MalfunctionDec 9, 2025Activation Failure; Activation Failure

  TERUMO EUROPE RECEIVED THE REPORTED INFORMATION. THE NEEDLE ITSELF HAD A SAFETY COVER THAT THE USER HAD TO FLIP DOWN TO ENGAGE OVER THE NEEDLE. THIS TIME, THE SAFETY COVER DID NOT LOCK. THERE WAS NO PATIENT INVOLVEMENT. THE EVENT OCCURRED POST-TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756788 ↗
• MalfunctionNov 24, 2025Activation Failure; Activation Failure

  TERUMO EUROPE RECEIVED THE REPORTED INFORMATION. A PATIENT RECENTLY PRESENTED WITH FIRMAGON 80MG. THE BUNG ON THE SYRINGE CAME OFF WHILE INJECTING THE 4.2 ML OF SOLVENT INTO THE POWDER, IN TURN MAKING THE SYRINGE UNUSABLE TO USE FOR INJECTION. THE MAIN CONCERN WAS AS FOLLOWS, AND THIS WAS THE SECOND TIME. THE SAFETY NEEDLE COVER DOES NOT STAY IN PLACE. THINKING THE SHARP IS SAFELY COVERED, THE GREEN COVER THEN FALLS BACK, UNCOVERING THE SHARP. THIS COULD LEAD TO SHARP INJURIES, PUTTING BOTH THE PATIENT AND THE PERSON ADMINISTERING FIRMAGON AT RISK FOR BLOOD-BORNE INFECTION. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED ON 03NOV2025: THE ISSUE HAPPENED AFTER USE, AND NOT BEFORE USE, AS INITIALLY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632403 ↗
• MalfunctionNov 24, 2025Activation Failure; Activation Failure

  TERUMO EUROPE RECEIVED THE REPORTED INFORMATION. THE SAFETY NEEDLE COVER DID NOT STAY IN PLACE. THINKING THE SHARP WAS SAFELY COVERED, THE GREEN COVER THEN FELL BACK, UNCOVERING THE SHARP. ADDITIONAL INFORMATION WAS RECEIVED ON 03NOV2025: THE NURSE HAD THE SAME ISSUE WITH THE PROTECTIVE COVERING THAT WAS NOT CLICKING IN PLACE. THE COVER KEPT DROPPING, AND THE NEEDLE WAS EXPOSED. THE SYRINGE CAME OUT OF THE BUNG, AND THE BUNG STAYED IN THE HAT OF THE VIAL. SHE MANAGED TO PUT IT BACK ON THE NEEDLE AND WAS ABLE TO SUCCESSFULLY ADMINISTER THE DOSE TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR MISSED DOSES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632396 ↗
• MalfunctionJan 10, 2025Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT THE NURSE ADMINISTERING THE PRODUCT NOTICED THAT THE SAFETY MECHANISM DID NOT ENGAGE AND ATTEMPTED AGAIN TO ENGAGE THE SAFETY MECHANISM. IT STILL DID NOT WORK. THE EVENT OCCURRED POST-TREATMENT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21130636 ↗
• MalfunctionJan 10, 2025Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT AFTER COMPOUNDING AND ADMINISTERING THE PRODUCT, THE SAFETY MECHANISMS ON BOTH NEEDLES DID NOT PROPERLY ENGAGE. THE NURSE ADMINISTERING THE PRODUCT NOTICED THIS ISSUE AND ATTEMPTED TO ENGAGE THE SAFETY MECHANISM AGAIN, BUT IT STILL DID NOT WORK. THE EVENT OCCURRED POST-TREATMENT, AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21130373 ↗
• MalfunctionJan 21, 2024Activation Problem; Activation Problem

  THE HOSPITAL PHARMACY REPORTED ON BEHALF OF A PHYSICIAN THAT TWO (2) NEEDLES WERE DEFECTIVE OF 2 X 120 MG LOADING DOSE INJECTIONS. AFTER THE DOCTOR GAVE THE INJECTIONS, THE SAFETY WOULD NOT CLICK THEREFORE THE NEEDLES WERE EXPOSED WHEN THEY WERE DISCARDED IN THE SAFETY CONTAINER. THE FLAP DID NOT COVER THE NEEDLE, EXPOSING POTENTIAL HARM TO THE NURSES AND PHYSICIANS. THE PATIENT WAS NOT INJURED, AND MEDICAL/SURGICAL INTERVENTION WAS NOT NEEDED. THERE WAS NO AR REPORTED HARM OR EXPOSURE TO THE HEALTH CARE PROVIDER (HCP). THE EVENT OCCURRED POST-OPERATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18549229 ↗
• 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 ↗
• MalfunctionOct 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY NURSE REPORTED A PRODUCT SAFETY CONCERN THAT WAS EXPERIENCED WITH THE INVOLVED TERUMO SURGUARD 2 SAFETY HYPODERMIC NEEDLE. THE SYRINGES COME PREFILLED WITH THE DEPO PROVERA CONTRACEPTIVE INJECTION. THE NEEDLE SAFETY CLASP FALLS COMPLETELY OFF THE DEVICE. THE PATIENT ADMINISTRATING THE INJECTION AND THE PATIENT RECEIVED THE INJECTION WERE NOT INJURED DURING THE EVENT AND MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 19 OCT 2023: THERE WAS NO VISIBLE DAMAGE TO THE DEVICE. THE PLASTIC PIECE ATTACHED TO THE NEEDLE ITSELF DID NOT COME OFF. IT WAS JUST THE OUTER CLASP THAT DETACHED FROM WHERE THE SAFETY CAP AND NEEDLE MEET AT THE BASE. THE INCIDENT HAPPENED WHEN TRIED TO ACTIVATE THE SAFETY AND INSTEAD IT FELL ONTO THE FLOOR. OVERUSE OF FORCE WAS NOT APPLIED WHEN THE SAFETY WAS ACTIVATED OR WHEN THE NEEDLE WAS ATTACHED TO THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18036226 ↗
• MalfunctionNov 14, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT TWO (2) TERUMO SURGUARD2 NEEDLES HAD A PERFORATION IN A BLISTER ON THE PRINTER SIDE WERE FOUND AFTER VISUALLY CHECKING (B)(4) NEEDLE POUCHES. THE FIRST PERFORATED BLISTER WAS INITIALLY FOUND DURING AN IN-PROCESS CONTROL (IPC) OF THE PACKED PRODUCT. THE SECOND PERFORATED BLISTER WAS FOUND DURING A SAMPLE TEST OF (B)(4) UNPROCESSED NEEDLE POUCHES. THE SAMPLE WAS RECEIVED ON (B)(6) 2022. BASED ON THE ACTUAL SAMPLE EVALUATION THE HOLE ON BLISTER AFFECTING STERILITY IS NOT VISIBLE TO THE USER HENCE, PROBABILITY OF USING UNSTERILE PRODUCT IS HIGH. THIS EVENT OCCURRED PRE-TREATMENT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15794248 ↗
• MalfunctionNov 14, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT ONE PERFORATED BLISTER WAS FOUND DURING MANUAL INSERTION OF THE POUCHES INSIDE THE BLISTERS. THE SAMPLE WAS RECEIVED ON OCTOBER 24, 2022. BASED ON THE ACTUAL SAMPLE EVALUATION, THE HOLE ON THE BLISTER AFFECTING STERILITY WAS NOT VISIBLE TO THE USER THEREFORE THE PROBABILITY OF USING THIS UNSTERILIZED PRODUCT WAS HIGH. THIS EVENT OCCURRED PRE-TREATMENT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15794162 ↗

Other Terumo (Philippines) Corporation products

• SURGUARD319 models · 144 reports