SURGUARD3Recalls & reported problems across all models
Terumo (Philippines) Corporation · 19 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 144
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 0
We found 19 models of SURGUARD3 by Terumo (Philippines) Corporation in the FDA's device registry (GUDID). Together they are named in 144 adverse event reports in the FDA's MAUDE database, received between Nov 29, 2017 and Sep 28, 2026 — classified as 11 injuries, 133 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (46 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
Reports received per month, all models
Most reported SURGUARD3 problems
Device problems
- Malposition of Device46
- Activation Problem24
- Adverse Event Without Identified Device or Use Problem20
- Break17
- Activation Failure15
- Connection Problem9
- Use of Device Problem9
- Positioning Failure5
Patient problems
- Needle Stick/Puncture48
- No Clinical Signs, Symptoms or Conditions46
- Administration Site Reaction15
- Insufficient Information15
- No Consequences Or Impact To Patient14
- Cellulitis6
- No Patient Involvement4
- Abscess3
SURGUARD3 models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SURGUARD3 SG3-2525Needle, hypodermic, single lumen71 reports
- SURGUARD3 SG3+1916Needle, hypodermic, single lumen21 reports
- SURGUARD3 SG3+2213Needle, hypodermic, single lumen10 reports
- SURGUARD3 SG3+2713Needle, hypodermic, single lumen9 reports
- SURGUARD3 SG3+2051Needle, hypodermic, single lumen6 reports
- SURGUARD3 SG3+2125Needle, hypodermic, single lumen5 reports
- SURGUARD3 SG3+1816Needle, hypodermic, single lumen4 reports
- SURGUARD3 SG3+2038Needle, hypodermic, single lumen3 reports
- SURGUARD3 SG3+2525Needle, hypodermic, single lumen2 reports
- SURGUARD3 SG3-2238Needle, hypodermic, single lumen2 reports
- SURGUARD3 SG3-2516Needle, hypodermic, single lumen2 reports
- SURGUARD3 SG3-03L2525SYRINGE, ANTISTICK2 reports
- SURGUARD3 SG3+2325Needle, hypodermic, single lumen1 report
- SURGUARD3 SG3+03L2138SYRINGE, ANTISTICK1 report
- SURGUARD3 SG3+2025Needle, hypodermic, single lumen1 report
- SURGUARD3 SG3+2238Needle, hypodermic, single lumen1 report
- SURGUARD3 SG3-1825Needle, hypodermic, single lumen1 report
- SURGUARD3 SG3-1838Needle, hypodermic, single lumen1 report
- SURGUARD3 SG3-01T2516SYRINGE, ANTISTICK1 report
Recent SURGUARD3 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Terumo received the following information: It was reported that a healthcare professional in the United States reported that after administration of YEZTUGO, the patient developed cellulitis at the injection site on the right mid-thigh, measuring 9 cm. The reporter stated that the needles and syringes were utilized from the Gilead box. The reporter stated that "Patient was injected per prescribing orders. The left thigh was not affected.Additional Information Received 17-Sept-2026: The patient was treated for cellulitis with Keflex (cephalexin) 500 mg orally four times daily for 7 days.
Patient problems: Administration Site Reaction; Cellulitis
MAUDE report 50919150 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Terumo received the following information: It was reported that a healthcare professional in the United States reported that after administration of YEZTUGO, the patient developed cellulitis at the injection site on the right mid-thigh, measuring 9 cm. The reporter stated that the needles and syringes were utilized from the Gilead box. The reporter stated that "Patient was injected per prescribing orders. The left thigh was not affected.Additional Information Received 17-Sept-2026: The patient was treated for cellulitis with Keflex (cephalexin) 500 mg orally four times daily for 7 days.
Patient problems: Administration Site Reaction; Cellulitis
MAUDE report 50919140 ↗InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem
Terumo received the following information: It was reported that on (b)(6) 2026, Gilead was notified by a healthcare professional in the United States that a patient developed injection site reactions after administration of YEZTUGO. The patient developed a quarter-sized lesion on the left side and a pea-sized nodule on the right. The right-side reaction resolved; however, the left progressed to a red circular lesion with a yellow center and a visible puncture site. The patient was treated with antibiotics, with additional treatment planned. The patient's condition and treatment was not reported.
Patient problems: Administration Site Reaction; Localized Skin Lesion; Nodule
MAUDE report 50541707 ↗InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Administration Site Reaction; Localized Skin Lesion; Nodule
MAUDE report 50541706 ↗MalfunctionAug 28, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50497499 ↗MalfunctionAug 28, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50497498 ↗MalfunctionAug 28, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50497496 ↗MalfunctionAug 28, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50497416 ↗MalfunctionAug 27, 2026Connection Problem
Terumo received the following information: It was reported that the needle detached from the cartridge when slight pressure was applied to the safety cap. The needle fell off the cartridge and onto the floor before the safety cap could fully enclose the needle.Additional information was received on (b)(6) 2025: The reporter screwed the needle onto the barrel, pinched the patient's skin, and administered the medication as intended. After the injection, while attempting to engage the safety cap by pressing it against a bench with minimal force, the needle detached from the device and fell to the floor. The needle did not detach during administration; it detached during activation of the safety cap. There was no patient harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50479180 ↗MalfunctionAug 26, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50452125 ↗InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem
Terumo received the following information: It was reported that on (b)(6) 2026, Gilead was notified by a healthcare professional (HCP) in the United States regarding an injection site reaction for YEZTUGO. The healthcare provider assessed the bruised injection site as infected and prescribed doxycycline. The patient condition following the treatment was not reported.Additional information received on 29-Jul-2026: The patient was injected on Friday, (b)(6) 2026, and on Monday the patient required an emergency appointment due to bruise at one injection site.
Patient problems: Administration Site Reaction; Bruise/Contusion
MAUDE report 50350600 ↗InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem
Terumo received the following information: It was reported that on (b)(6)2026, Gilead was notified by a healthcare professional (HCP) in the United States regarding an injection site leakage and subsequent cellulitis in a 26-year-old male patient receiving YEZTUGO. The patient received his maintenance (second) YEZTUGO injection in the thigh on (b)(6)2026. The patient subsequently reported experiencing "significant leakage" from the right injection site. The reporting healthcare professional (HCP) did not directly observe the leakage and was not initially concerned. Six days after administration, on (b)(6)2026, the patient presented to the emergency room with pronounced right-sided cellulitis at the injection site. The cellulitis was described as very warm, tender and red to the touch. The injection nodule remained unchanged in size. There was no reported skin breakage, ulceration, or other injection site complications beyond cellulitis. The patient started on doxycycline on (b)(6)2026 for treatment of cellulitis. Despite the event, the reporting healthcare professional (HCP) continued YEZTUGO therapy. The outcome of cellulitis was not reported.
Patient problems: Administration Site Reaction; Cellulitis; Nodule; Skin Infection
MAUDE report 50201334 ↗InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem
Terumo received the following information: It was reported that a patient was presented on (b)(6) 2026 for a second dose of YEZTUGO. The medication was administered in the clinic without complications. On (b)(6) 2026, the patient contacted the healthcare provider and reported swelling, redness, pain, and purulent drainage ("pus") at the left abdominal injection site. The patient was referred to urgent care and was diagnosed with cellulitis and treated with antibiotics. Following antibiotic treatment, the patient's symptoms improved.
Patient problems: Abscess; Administration Site Reaction; Cellulitis; Pain; Swelling/ Edema
MAUDE report 50155682 ↗InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE PATIENT RECEIVED YEZTUGO INJECTIONS ABOUT ONE WEEK AGO, APPROXIMATELY EARLY (B)(6) 2026. NURSE PRACTITIONER STATED THAT THE LPN (NURSE) AT THE OFFICE ADMINISTERED THE INJECTIONS. NURSE PRACTITIONER WAS UNAWARE OF ANY ISSUES DURING THE INJECTIONS. ON (B)(6) 2026, THE PATIENT RETURNED TO OFFICE PRESENTING WITH AN INJECTION SITE REACTION (ISR) AND ABSCESS. THE NURSE PRACTITIONER REPORTED THAT THE YEZTUGO WAS ADMINISTERED ON THE ABDOMEN AND THE INJECTION SITE REACTION WAS PRESENT AT ONE OF THE INJECTION SITES. THE NURSE PRACTITIONER REPORTED THAT SHE BEGAN A COURSE OF ANTIBIOTICS FOR THE ABSCESS, BACTRIM DS X 10 DAYS. AS OF (B)(6) 2026, THE PATIENT IS STILL BEING TREATED FOR THE INJECTION SITE REACTION.
Patient problems: Abscess; Administration Site Reaction
MAUDE report 25074826 ↗InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem
TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT THE PATIENT RECEIVED YEZTUGO INJECTIONS ABOUT ONE WEEK AGO, APPROXIMATELY EARLY (B)(6) 2026. NURSE PRACTITIONER STATED THAT THE LPN (NURSE) AT THE OFFICE ADMINISTERED THE INJECTIONS. NURSE PRACTITIONER WAS UNAWARE OF ANY ISSUES DURING THE INJECTIONS. ON (B)(6) 2026, THE PATIENT RETURNED TO OFFICE PRESENTING WITH AN INJECTION SITE REACTION (ISR) AND ABSCESS. THE NURSE PRACTITIONER REPORTED THAT THE YEZTUGO WAS ADMINISTERED ON THE ABDOMEN AND THE INJECTION SITE REACTION WAS PRESENT AT ONE OF THE INJECTION SITES. THE NURSE PRACTITIONER REPORTED THAT SHE BEGAN A COURSE OF ANTIBIOTICS FOR THE ABSCESS, BACTRIM DS X 10 DAYS. AS OF (B)(6) 2026, THE PATIENT IS STILL BEING TREATED FOR THE INJECTION SITE REACTION.
Patient problems: Abscess; Administration Site Reaction
MAUDE report 25074825 ↗
Other Terumo (Philippines) Corporation products
All Terumo (Philippines) Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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