SURGUARD2 SG2+2525Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 14806017507128), received between Oct 23, 2020 and Jun 23, 2026 — classified as 15 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, 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

Recent adverse event reports

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

• 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 ↗
• MalfunctionSep 1, 2022Break; Break

  THE USER FACILITY REPORTED THAT THE INVOLVED INJECTION NEEDLE BROKE. THE PHARMACY DELIVERED A NEW BOX. THE PHARMACY THREW AWAY THE DEFECTIVE PRODUCT. THE EVENT OCCURRED PRE-TREATMENT. THERE WAS NO PATIENT INVOLVEMENT. BEFORE INJECTION THE NEEDLE WAS FOUND BROKE, AND THE TREATMENT WAS STOPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15333349 ↗
• MalfunctionMay 14, 2021Activation Failure; Activation Failure

  THE USER FACILITY REPORTED THAT AFTER THE INJECTION, THE SAFETY NEEDLE COULD NOT BE COMPLETELY CLOSED AND COVERED. CAUSING A NEEDLE STICK TO THE NURSE. ADDITIONAL INFORMATION WAS RECEIVED ON 23APRIL2021: THE NURSE WAS STUCK BY THE NEEDLE. HER INJURY WAS RECOVERED. SHE HAD A BLOOD TEST AND THE RESULTS SHOWED NO INFECTION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11825640 ↗
• MalfunctionApr 13, 2021Material Too Soft/Flexible; Material Too Soft/Flexible

  THE USER FACILITY REPORTED THE CUSTOMER STATED THAT THE SAFETY MECHANISM ON NEEDLE WAS VERY FLEXIBLE AND DANGEROUS, AND AFTER COVERING THE NEEDLE AFTER INJECTION, THE NEEDLE STUCK THE NURSE TRYING TO COVER IT COMPLETELY. THERE WAS NO REPORTED DAMAGE TO BOX OR PRODUCT. NEEDLE STICK WAS WITH THE USED NEEDLE. NO ADDITIONAL ACTIONS WERE TAKEN, EXCEPT BASIC FIRST AID. THERE WAS NO IMPACT ON THE PATIENT. THE PATIENT BEING TREATED RECEIVED THE DOSE ADMINISTERED AS INTENDED. THE NEEDLE STICK OCCURRED AFTER USE ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 30MARCH2021: THE INVOLVED PART OF THE DEVICE WAS THE SAFETY SHEATH INSTEAD OF THE PROTECTOR.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11654963 ↗
• MalfunctionFeb 18, 2021Positioning Failure; Improper or Incorrect Procedure or Method; Positioning Failure; Improper or Incorrect Procedure or Method

  THE USER FACILITY REPORTED THE NURSE COMPLAINED THAT AFTER INJECTING THE DOSE, THE SAFETY NEEDLE COVER WOULD NOT KEEP CLOSED, IT SWINGS AROUND THE NEEDLE. DUE TO THIS, THE NURSE INCURRED A NEEDLE STICK INJURY. THERE WAS NO PATIENT IMPACT. THE EVENT/INCIDENT OCCURRED POST TREATMENT. ADDITIONAL INFORMATION WAS RECEIVED ON 08FEBRUARY2021: THE TREATMENT THE MEDICAL DEVICE WAS BEING USED FOR WAS A FIRMAGON 80MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION. OTHER MEDICAL DEVICES USED IN COMBINATION WITH THE REPORTED DEVICE WERE A SYRINGE, DRUG VIAL, AND RUBBER STOPPER OF VIAL.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11345071 ↗
• MalfunctionOct 23, 2020Break; Use of Device Problem; Break; Use of Device Problem

  THE USER FACILITY REPORTED THAT AFTER THE NURSE RECONSTITUTED THE PRODUCT (HE/SHE) THEN TRIED TO ADMINISTER IT TO THE PATIENT, THE NEEDLE BROKE. THE USER TRIED TO INSERT THE NEEDLE INTO THE VIAL IS WHEN THE NEEDLE BROKE, AND THE LIQUID LEAKED OUT. THE PROCEDURE WAS NOT SUCCESSFUL. THE PATIENT WAS NOT ABLE TO GET THE DOSE. THE NEEDLE DID NOT BREAK IN PATIENT'S SKIN. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10725757 ↗