SURGUARD3 SG3+2213Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 14806017510746), received between Nov 12, 2025 and Sep 28, 2026 — classified as 9 injuries, 1 malfunction.

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 10 most recent of 10 reports, 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 ↗
• 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 ↗
• MalfunctionNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TERUMO MEDICAL CORPORATION RECEIVED THE REPORTED INFORMATION. THE PATIENT EXPERIENCED SIGNIFICANT LEAKAGE FROM THE INJECTION SITES. THE PATIENT THEN DEVELOPED ERYTHEMA, WARMTH, AND SOME SKIN EDEMA SURROUNDING THE SITES. THE AREAS WERE NOT FRANKLY TENDER; HOWEVER, THEY WERE UNCOMFORTABLE WITH WEARING PANTS THAT COVERED THE AREAS. ADDITIONAL INFORMATION WAS RECEIVED ON 23OCT2025: THERE WAS NO LEAKAGE IN/FROM THE NEEDLE. WE ARE REQUESTING AN INVESTIGATION INTO THE STERILITY OF THE NEEDLES. PER THE COMPLAINT REPORTER, THE PATIENT WAS TREATED FOR BACTERIAL CELLULITIS JUST IN CASE, SINCE SHE OFTEN COMES IN WITH SKIN ABSCESSES. THEY WANTED TO RULE OUT THAT THE NEEDLES MAY HAVE CAUSED POTENTIAL CELLULITIS.

  Patient problems: Administration Site Reaction; Erythema; Swelling/ Edema

  MAUDE report 23534139 ↗