SURGICEL FIBRILLAR 1961Recalls & reported problems

Summary

The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 10705031003118), received between Dec 16, 2018 and Aug 19, 2026 — classified as 2 deaths, 33 injuries, 85 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (32 reports).

1 FDA recall record name this device's identifier, 1 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, 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.

Recalls naming this device

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

Most reported problems

Recent adverse event reports

The 25 most recent of 120 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50325195 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 23, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. WHEN OPENING THE SINGLE PACKAGE OF THE PRODUCT, THE USER FOUND A SMALL BLACK DOT STAIN INSIDE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882477 ↗
• MalfunctionDec 17, 2025Structural Problem; Device Contaminated During Manufacture or Shipping; Structural Problem; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A NEUROSURGERY PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. DURING SURGERY, THE PRODUCT COULD NOT BE SPLIT WELL, AND THERE HAD BEEN NU-KNIT-LIKE MATERIAL MIXED IN. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832007 ↗
• MalfunctionNov 3, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. DURING SURGERY, A BROWN FOREIGN MATTER WAS ATTACHED TO THE ABSORBABLE HEMOSTAT. 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 23450125 ↗
• MalfunctionOct 16, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOOTH EXTRACTION PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. DURING A TOOTH EXTRACTION AT THE OUTPATIENT/TREATMENT ROOM, WHEN OPENING THE PACKAGE, IT WAS NOT IN THE EXPECTED CONDITION, SO THE PRODUCT WAS NOT USED, AND ANOTHER PACKAGE WAS OPENED AND USED INSTEAD. THERE WERE NO ABNORMALITIES IN THE PACKAGE FROM THE SAME LOT (THE PACKAGE IN THE SAME BOX) USED AS A REPLACEMENT FOR THE PRODUCT INVOLVED. ON (B)(6), THE PRODUCT WAS RETRIEVED AFTER THE CUSTOMER REQUESTED A RETURN/EXCHANGE DUE TO SOLID MATTER THAT IS NOT COTTON. THE CONDITION OF THE PRODUCT FROM THE PREVIOUS DAY, THE PRODUCT HAD BEEN TORN INTO PIECES FOR EASIER USE AFTER OPENING THE PACKAGE. 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 23316519 ↗
• MalfunctionAug 7, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A ABSORBABLE HEMOSTAT WAS USED. ON THE AFTERNOON, THE NURSE OPENED THE PACKAGING WITHOUT ANY RESISTANCE AND GENTLY PULLED IT OPEN. CONSIDERING THAT THE SEAL WAS NOT TIGHT AND THE STERILE BARRIER HAD BEEN DAMAGED, THE PRODUCT WAS IMMEDIATELY REPLACED AND COMMUNICATION WITH THE SURGEON WAS DONE TO EXPLAIN THE SITUATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22740287 ↗
• MalfunctionJul 31, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  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 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 22679467 ↗
• MalfunctionJul 31, 2025Device Contaminated During Manufacture or Shipping; Device 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, A HAIR WAS FOUND. 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 22674402 ↗
• MalfunctionJun 12, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NEUROSURGERY PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. DURING THE PROCEDURE, IT WAS FOUND THAT THERE WAS A HAIR IN THE PACKAGE. 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 22196490 ↗
• MalfunctionMay 28, 2025Device Contaminated During Manufacture or Shipping; Device 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 HAIR ABOUT 1 CM ON THE SURFACE OF THE ABSORBABLE HEMOSTAT WHEN THE PACKAGE WAS OPENED AND CHECKED INSIDE. THIS EVENT WAS FOUND BEFORE USE. IT WAS NOT USED. 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 22100535 ↗
• MalfunctionMay 16, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. HEALTH PROFESSIONAL FEEDBACK A PROJECT WAS CARRIED OUT IN THE HOSPITAL. THE SUBJECT DEVELOPED PELVIC ABSCESS AFTER SURGERY, WHICH WAS NOT COMPLETELY ABSORBED AFTER 30 DAYS OF USE, AND THE ABSORPTION DATA CANNOT RULE OUT THE OCCURRENCE OF ABSCESS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abscess

  MAUDE report 22039641 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND COMPLETED RELEVANT EXAMINATIONS. AFTER EXCLUDING SURGICAL CONTRAINDICATIONS, THE SURGERY WAS PERFORMED FROM 9:15 TO 10:24, AND HEMOSTATIC GAUZE WAS USED DURING THE SURGERY. NO ABNORMALITIES WERE FOUND DURING THE USE PROCESS, THE PLACEMENT WAS SMOOTH, AND THE PATIENT WAS DISCHARGED AFTER THE SURGERY AND FOLLOWED UP REGULARLY. 307 DAYS AFTER THE SURGERY, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR POSTOPERATIVE WOUND INFECTION OF THE KNEE JOINT. THE PATIENT'S LEFT KNEE JOINT HAD GOOD RANGE OF MOTION, BUT THERE WAS STILL INTERMITTENT PAIN. AFTER THE PATIENT WAS ADMITTED TO THE HOSPITAL, RELEVANT EXAMINATIONS WERE COMPLETED, AND THE LEFT KNEE JOINT WAS PUNCTURED AND FLUID WAS DRAWN FOR BACTERIAL CULTURE AND IDENTIFICATION, INDICATING DYSGALACTIAE STREPTOCOCCUS INFECTION. THE PATIENT'S IMAGING EXAMINATION SHOWED THE FORMATION OF A TRANSLUCENT ZONE AROUND THE PROSTHESIS, WHICH WAS CONSISTENT WITH SIGNS OF INFECTIOUS LOOSENING OF THE PROSTHESIS, AND SURGERY WAS PERFORMED. POSTOPERATIVE SEQUENTIAL ANTI-INFECTION, LO

  Patient problems: Pain; Unspecified Infection

  MAUDE report 22038632 ↗
• MalfunctionApr 30, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT PROCEDURE ON AN UNKNOWN DATE, AND ABSORBABLE HEMOSTAT WAS USED. DURING SURGERY THERE WERE PARTS OF LUMP IN THE COTTON. 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 21937034 ↗
• MalfunctionMar 26, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DAY AND ABSORBABLE HEMOSTAT WAS USED. THE PACKS WERE OPEN AND A DIFFERENT PRODUCT WAS FOUND INSIDE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698130 ↗
• MalfunctionJan 22, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND AN ABSORBABLE HEMOSTAT WAS USED. THE DEVICE PACKAGE WAS FOUND UNSEALED WHEN UNPACKING AND COUNTING. ONE END OF THE PACKAGE IS NOT SEALED. CHANGED 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 21213535 ↗
• MalfunctionJan 14, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2025 AND AN ABSORBABLE HEMOSTAT WAS USED. DURING SURGERY, WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THERE WAS HAIR IN THE PRODUCT. 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 21151478 ↗
• MalfunctionJan 10, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BASED ON FEEDBACK RECEIVED FROM GLOBAL BAND PROTECTION APAC TEAM THAT THERE ARE 8 BOXES AND 58 PACKAGES SUSPECTED ABSORBABLE HEMOSTAT PRODUCTS FROM OFFLINE LAW ENFORCEMENT. PRODUCTS WERE HOLD BY LAW ENFORCEMENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21130349 ↗
• MalfunctionJan 10, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BASED ON FEEDBACK RECEIVED FROM GLOBAL BAND PROTECTION APAC TEAM THAT THERE ARE 8 BOXES AND 58 PACKAGES SUSPECTED ABSORBABLE HEMOSTAT PRODUCTS FROM OFFLINE LAW ENFORCEMENT. PRODUCTS WERE HOLD BY LAW ENFORCEMENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21130149 ↗