SURGICEL FIBRILLARRecalls & reported problems across all models

We found 3 models of SURGICEL FIBRILLAR by Ethicon Sàrl in the FDA's device registry (GUDID). Together they are named in 199 adverse event reports in the FDA's MAUDE database, received between Dec 26, 2017 and Sep 25, 2026 — classified as 2 deaths, 75 injuries, 122 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (43 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

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

SURGICEL FIBRILLAR recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 11, 2024Class IIOpen, Classified

   Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.

   Z-2407-2024 · Root cause: Process control · Recall details · FDA record ↗

2. Jun 11, 2024Class IIOpen, Classified

   Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.

   Z-2406-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported SURGICEL FIBRILLAR problems

SURGICEL FIBRILLAR models

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

• SURGICEL FIBRILLAR 1961

  Agent, absorbable hemostatic, non-collagen based
  1 recall2 deaths120 reports
• SURGICEL FIBRILLAR 1963

  Agent, absorbable hemostatic, non-collagen based
  1 recall44 reports
• SURGICEL FIBRILLAR 1962

  Agent, absorbable hemostatic, non-collagen based
  35 reports

Recent SURGICEL FIBRILLAR adverse event reports

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

• MalfunctionSep 25, 2026Packaging Problem

  It was reported that a patient underwent an unknown procedure on an unknown date and absorbable hemostat was used. The primary package of the product was found damaged prior to use. Changed to another one to complete the surgery. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903474 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a Tibial osteotomy procedure on (b)(6) 2026 and absorbable hemostat was used. Hemostatic gauze were used for local hemostasis during surgery. More than 40 days after surgery, there was pain and discomfort in the surgical area, but symptomatic treatment did not improve. The patient was admitted to the hospital with cellulitis of the right calf. After admission, symptomatic treatments such as anti infection, anti-inflammatory, and wound drainage were given, and purulent secretions from the wound were cleared in stages until the inflammatory indicators and symptoms of the affected limb gradually improved. During hospitalization, the patient's condition remained stable and the infection was completely controlled. Prior to discharge, a dressing change was made at the incision site, and the patient's condition recovered. The patient was discharged. Additional information was requested

  Patient problems: Cellulitis; Discomfort; Inflammation; Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 50802257 ↗
• MalfunctionAug 19, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50325195 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  POST-OP INFECTION. THIS CASE IS FROM HEALTH AUTHORITY. AFTER THE PATIENT WAS ADMITTED, RELEVANT EXAMINATIONS WERE COMPLETED AND SURGICAL CONTRAINDICATIONS WERE RULED OUT. THE SURGERY WAS PERFORMED FROM 10:55 TO 12:15. DURING THE SURGERY, KNEE JOINT COMPONENTS SUCH AS FEMORAL IMPLANTS, HEMOSTATIC GAUZE, AND HEMOSTATIC FLUID GELATIN WERE USED. NO ABNORMALITIES WERE FOUND DURING THE USE, AND THE PLACEMENT WAS SMOOTH. THE PATIENT HAD GOOD POSTOPERATIVE RECOVERY AND WAS DISCHARGED. REGULAR FOLLOW-UP WAS CONDUCTED, AND THE PATIENT'S RIGHT KNEE JOINT MOBILITY WAS GOOD. 317 DAYS AFTER SURGERY, THE PATIENT EXPERIENCED PAIN IN THE RIGHT KNEE JOINT. THE RIGHT KNEE JOINT WAS PUNCTURED AND FLUID WAS DRAWN FOR EXAMINATION, INDICATING STREPTOCOCCAL INFECTION. THE PATIENT'S IMAGING EXAMINATION SHOWED THE FORMATION OF A TRANSLUCENT BAND AROUND THE PROSTHESIS, WHICH IS CONSISTENT WITH THE SIGN OF LOOSENING CAUSED BY PROSTHESIS INFECTION. AFTER ADMISSION, THE PATIENT COMPLETED RELEVANT EXAMINATIONS, UNDERWENT JOINT CAVITY PUNCTURE AND FLUID EXTRACTION FOR BACTERIAL CULTURE AND IDENTIFICATION, AND IDENTIFIED THE PATHOGENIC BACTERIA. 334 DAYS AFTER SURGERY, THE PATIENT WAS ADMITTED FOR SURGERY DUE TO P

  Patient problems: Pain; Unspecified Infection

  MAUDE report 25058902 ↗
• MalfunctionApr 29, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND ABSORBABLE HEMOSTAT WAS USED. DURING SURGERY, IT WAS FOUND THAT THERE WAS A FOREIGN MATTER LIKE A GAUZE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035480 ↗
• MalfunctionApr 29, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND ABSORBABLE HEMOSTAT WAS USED. DURING SURGERY, IT WAS FOUND THAT THERE WAS A FOREIGN MATTER LIKE A GAUZE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035332 ↗
• MalfunctionApr 13, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. DURING SURGERY, IT WAS FOUND THAT THERE WAS A FOREIGN MATTER LIKE A HAIR WHEN THE PACKAGE WAS OPENED TO USE. THE PRODUCT WAS NOT USED. THIS EVENT WAS FOUND BEFORE USE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24863119 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A OPEN REDUCTION AND INTERNAL FIXATION PROCEDURE ON (B)(6) 2026 AND ABSORBABLE HEMOSTAT WAS USED. THE SUTURE BROKE ON THE FIRST USE. THE PATIENT UNDERWENT SURGERY DUE TO A THORACIC SPINE FRACTURE, DURING WHICH HEMOSTATIC GAUZE WAS USED. DISCHARGE AFTER 6 DAYS. AFTER DISCHARGE, POOR BLOOD SUGAR CONTROL AND POOR NUTRITIONAL STATUS LED TO POOR WOUND HEALING. THE PATIENT WAS READMITTED ON THE EIGHTH DAY AFTER SURGERY. AFTER ADMISSION, COMPLETE PATHOGEN EXAMINATION INDICATES A HIGH POSSIBILITY OF INCISION INFECTION. AFTER ADMISSION, SYMPTOMATIC TREATMENT WAS GIVEN WITH ANTI INFECTION AND NUTRITIONAL SUPPORT. 16 DAYS AFTER THE FIRST SURGERY, ON (B)(6) /2026 ANOTHER SURGERY, A POSTERIOR THORACIC RESECTION DEBRIDEMENT WAS PERFORMED. THE PATIENT CONTINUED TO RECEIVE SYMPTOMATIC TREATMENT WITH ANTI-INFECTION AND NUTRITIONAL SUPPORT AFTER SURGERY (VANCOMYCIN+AZTREONAM, NEGATIVE PRESSURE DRAINAGE DEVICE). THE INFECTION INDICATORS TEND TO IMPROVE. THE PATIENT WAS DISCHARGED 53 DAYS AFTER THE SECOND SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Impaired Healing; Unspecified Infection

  MAUDE report 24857376 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A POSTERIOR LUMBAR DISCECTOMY, DECOMPRESSION, BONE GRAFT FUSION, AND INTERNAL FIXATION PROCEDURE ON (B)(6) 2026 AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT ACTIVELY COMPLETED RELEVANT EXAMINATIONS AFTER ADMISSION AND UNDERWENT SURGERY AFTER RULING OUT SURGICAL CONTRAINDICATIONS. THE DOCTOR USED ABSORBABLE HEMOSTATIC GAUZE DURING THE SURGERY, AND THE SURGERY WENT SMOOTHLY. AFTER THE SURGERY, ANTI-INFLAMMATORY TREATMENT (100ML OF 0.9% SODIUM CHLORIDE INJECTION+INTRAVENOUS INFUSION OF CEFAZOLIN SODIUM 4+72G BID), PAIN RELIEF, SWELLING REDUCTION, AND STOMACH PROTECTION WERE GIVEN. THE PATIENT'S SKIN WAS DELICATE, AND THE WOUND HEALING WAS POOR AFTER SURGERY. THERE WAS FAT LIQUEFACTION AT THE LOWER END OF THE INCISION. RE EXAMINATION OF BLOOD ROUTINE+FULL CYCLE C-RP (WHOLE BLOOD): RED BLOOD CELL COUNT 3.62 10 ^ 12/L , HEMOGLOBIN 109.00G/L ; SERUM ALBUMIN MEASUREMENT (SERUM (VENOUS BLOOD COLLECTION): ALBUMIN 36.6G/L . ON THE 17TH DAY AFTER SURGERY, THE PATIENT'S SKIN WAS DELICATE AND THE WOUND HEALING WAS POOR. THERE WAS FAT LIQUEFACTION AT THE LOWER END OF THE INCISION. THE PATIENT UNDERWENT LUMBAR DEBRIDEMENT AND NEGATIVE PRESSURE DRAINAGE AGA

  Patient problems: Fluid Discharge; Impaired Healing; Insufficient Information; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 24835628 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THORACOSCOPIC RADICAL RESECTION FOR LUNG CANCER PROCEDURE ON (B)(6) /2026 AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT UNDERWENT SURGERY WITH A HISTORY OF OPEN CHEST SURGERY, SEVERE THORACIC ADHESIONS, AND BLEEDING FROM THE WOUND WAS STOPPED USING HEMOSTATIC GAUZE. AFTER THE SURGERY WAS COMPLETED AND A DRAINAGE TUBE WAS PLACED, THE BLEEDING POINT OF THE INCISION WAS SEEN, AND ELECTROCOAGULATION WAS USED TO STOP THE BLEEDING. AT THIS TIME, A SMALL AMOUNT OF HEMOSTATIC FIBERS STUCK ON THE INCISION CAUGHT FIRE, WHICH MELTED THE DRAINAGE TUBE AND IMMEDIATELY RINSE AND EXTINGUISH WITH STERILIZED WATER. THE FIRE BURNED PART OF THE DRAINAGE TUBE, BUT NO TRACES OF SKIN BURNS WERE FOUND IN THE PATIENT. THE INCISION WAS CLOSED AFTER THE ENDOSCOPIC RE-EXPLORATION OF THE CHEST CAVITY WAS NORMAL. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24638569 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOT ASSISTED LUMBAR POSTERIOR DISCECTOMY, DECOMPRESSION, BONE GRAFT FUSION, AND INTERNAL FIXATION PROCEDURE UNDER GENERAL ANESTHESIA ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT HAD COMPLEX UNDERLYING DISEASES SUCH AS ADVANCED AGE, POLYCYSTIC KIDNEY DISEASE, RENAL ANEMIA, RENAL INSUFFICIENCY, HYPERTENSION, PARKINSON'S SYNDROME, POOR GENERAL CONDITION, POOR HYGIENE HABITS, AND POOR COMPLIANCE. AFTER ADMISSION, RELEVANT EXAMINATIONS WERE COMPLETED, SURGICAL CONTRAINDICATIONS WERE RULED OUT, AND SURGERY WAS PERFORMED. THE DOCTOR USED ABSORBABLE HEMOSTATIC FLUID GELATIN AND ABSORBABLE HEMOSTATIC GAUZE DURING THE SURGERY. THE SURGERY WENT SMOOTHLY, WITH MINIMAL DRAINAGE AND EXTUBATION. THE POSTOPERATIVE RECOVERY WAS GOOD, AND SYMPTOMS IMPROVED COMPARED TO BEFORE SURGERY. GUIDANCE WAS GIVEN TO USE BRACES TO PROTECT THE PATIENT FROM GETTING OUT OF BED AND GRADUALLY EXERCISE THE FUNCTIONS OF THE FOUR LIMBS. POSTOPERATIVE IMAGING EXAMINATION SHOWED GOOD INTERNAL FIXATION AND FIXATION IN PLACE. ON THE 81ST DAY AFTER SURGERY, IT WAS FOUND THAT THE WOUND HAD POOR HEALING. UNDER THE GUIDANCE OF COLOR DOPPLER ULTRASOUND, PERCUTANEOUS P

  Patient problems: Impaired Healing; Inflammation

  MAUDE report 24503725 ↗
• MalfunctionFeb 2, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. DURING SURGERY, WHEN THE BAG WAS OPENED, IT WAS FOUND THAT THERE HAD BEEN A SESAME-LIKE FOREIGN MATTER. THE PRODUCT WAS NOT USED FOR THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241903 ↗
• MalfunctionJan 20, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORAL PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. DURING SURGERY, WHEN THIS PRODUCT WAS TO BE USED, IT WAS FOUND THAT THERE HAD BEEN A HUMAN HAIR-LIKE FOREIGN MATTER IN THE STERILE PACKAGE. THIS ISSUE OCCURRED 3 STERILE PACKAGES IN A ROW. THE PRODUCT WAS NOT USED FOR THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115868 ↗
• MalfunctionJan 20, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORAL PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. DURING SURGERY, WHEN THIS PRODUCT WAS TO BE USED, IT WAS FOUND THAT THERE HAD BEEN A HUMAN HAIR-LIKE FOREIGN MATTER IN THE STERILE PACKAGE. THIS ISSUE OCCURRED 3 STERILE PACKAGES IN A ROW. THE PRODUCT WAS NOT USED FOR THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115731 ↗
• MalfunctionJan 20, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORAL PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. DURING SURGERY, WHEN THIS PRODUCT WAS TO BE USED, IT WAS FOUND THAT THERE HAD BEEN A HUMAN HAIR-LIKE FOREIGN MATTER IN THE STERILE PACKAGE. THIS ISSUE OCCURRED 3 STERILE PACKAGES IN A ROW. THE PRODUCT WAS NOT USED FOR THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115723 ↗

Other Ethicon Sàrl products

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