SURGICEL FIBRILLAR 1962Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10705031003125), received between Apr 3, 2018 and Sep 25, 2026 — classified as 3 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 25 most recent of 35 reports, 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 ↗
• MalfunctionJan 6, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MITRAL VALVE REPLACEMENT PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. UPON OPENING THE PRODUCT PACKAGING, HAIR FOREIGN OBJECT WAS FOUND ON THE PRODUCT. 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 23979242 ↗
• MalfunctionJan 6, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN RADICAL PROSTATECTOMY PROCEDURE FOR PROSTATE CANCER ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PACKAGE WAS FOUND CONTAMINATED. 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 23978247 ↗
• MalfunctionDec 1, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A ENDOSCOPIC INTRACRANIAL LESION BIOPSY, PREPARATION OF THIRD VENTRICULAR FLOOR FISTULA, TRANSPARENT SEPTUM FISTULA, AND VENTRICULOPERITONEAL SHUNT PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT UNDERWENT SURGERY AND RECEIVED HEMOSTATIC GAUZE TO STOP BLEEDING FROM THE WOUND. HOWEVER, WHEN OPENED FOR USE, THE FOREIGN OBJECT WAS FOUND, POSING A POTENTIAL RISK OF INFECTION TO THE PATIENT. THE DOCTOR IMMEDIATELY REPLACED THE SPARE HEMOSTATIC GAUZE FOR THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687929 ↗
• MalfunctionMay 28, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A FIBRIN SEALANT PREPARATION DEVICE 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 22100810 ↗
• MalfunctionMay 16, 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 ABSORBABLE HEMOSTAT WAS USED. TT WAS FOUND THAT THERE WERE THREE GREEN STRING-LIKE FOREIGN OBJECTS INSIDE A PACKAGE IN THE NEWLY DISPENSED SUTURE WHEN IT WAS OPENED TO PREPARE FOR SURGERY. 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 22040203 ↗
• MalfunctionDec 3, 2024Delivered 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 DEVICE WAS USED. DURING THE SURGERY, IT WAS NOTED THAT THERE WAS A HOLE ON THE STERILE PACKAGE. THE DEVICE WASN'T USED ON THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833365 ↗
• MalfunctionDec 3, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE COMPLAIN HANDLING UNIT RECEIVE EMPLOYEE FEEDBACK ABOUT SUSPECT ABSORBABLE HEMOSTAT PRODUCTS ON AN UNKNOWN DATE FROM AN ONLINE SOURCE, (B)(6). NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833131 ↗
• MalfunctionNov 1, 2024Device 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. IT WAS FOUND THAT THERE WAS A LINEAR FOREIGN OBJECT INSIDE THE PRODUCT WHEN PREPARING FOR SURGERY. 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 20591210 ↗
• MalfunctionSep 30, 2024Device 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. IT WAS FOUND THAT THERE HAD BEEN FILAMENTOUS FOREIGN MATTER ON THE PRODUCT BEFORE USING ON PATIENT DURING SURGERY. CHANGED TO ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20333562 ↗
• MalfunctionSep 30, 2024Device 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. IT WAS FOUND THAT THERE HAD BEEN FILAMENTOUS FOREIGN MATTER ON THE PRODUCT BEFORE USING ON PATIENT DURING SURGERY. CHANGED TO ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20333444 ↗
• MalfunctionSep 30, 2024Device 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. IT WAS FOUND THAT THERE HAD BEEN FILAMENTOUS FOREIGN MATTER ON THE PRODUCT BEFORE USING ON PATIENT DURING SURGERY. CHANGED TO ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20333301 ↗
• MalfunctionSep 30, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE ABSORBABLE HEMOSTAT PRIMARY PACKAGE OF THE PRODUCT WAS FOUND DAMAGED DURING NORMAL CHECKING. NOT INVOLVED IN ANY SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20333039 ↗
• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BABA THYROIDECTOMY PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. THE DOCTOR USED ABSORBABLE HEMOSTAT TO FILL THE CAVITY IN THE PATIENT'S BODY AFTER BABA THYROIDECTOMY. THE PATIENT KEPT COMPLAINING OF PAIN THE DAY AFTER THE OPERATION. LATER, HE WENT BACK TO OPEN THE WOUND AND REMOVE ABSORBABLE HEMOSTAT. THE DOCTOR DETERMINED THAT IT WAS ALLOGENEIC REJECTION. CURRENTLY, THE PATIENT HAS RETURNED TO NORMAL AFTER REMOVING ALLOGENEIC REJECTION, WITH NO OTHER SYMPTOMS OR REACTIONS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Foreign Body Reaction; Pain; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 19593166 ↗
• MalfunctionMay 21, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE LOCAL TEAM RECEIVED FEEDBACK ABOUT 16 BOXES OF SUSPECTED ABSORBABLE HEMOSTAT PRODUCTS FROM ONLINE SHOPS; WHICH CONTAINS (B)(4).; (B)(4); (B)(4); (B)(4).; (B)(4); (B)(4). NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19361746 ↗
• MalfunctionMay 14, 2024Device 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 THAT IT WAS FOUND THAT THERE HAD BEEN WHITE FOREIGN MATTER ON THE ABSORBABLE HEMOSTAT BEFORE USING ON PATIENT DURING SURGERY. 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 19310259 ↗
• MalfunctionApr 29, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RADICAL PANCREATICODUODENECTOMY PROCEDURE ON (B)(6) 2024 AND AN ABSORBABLE HEMOSTAT WAS USED. THE DOCTOR NEEDED TO USE HEMOSTATIC GAUZE FOR LOCAL TISSUE HEMOSTASIS DURING SURGERY. AFTER OPENING IT, IT WAS FOUND THAT THE HEMOSTATIC GAUZE WAS NOT COMPLETELY SEALED, SUSPECTED OF CONTAMINATION. 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 19210519 ↗
• MalfunctionJan 2, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  ON AN UNKNOWN DATE THE ABSORBABLE HEMOSTAT PRIMARY PACKAGE OF THE PRODUCT WAS FOUND DAMAGED DURING NORMAL CHECKING. CHANGED TO ANOTHER ONE, AND THE SAME PROBLEM HAPPENED. THIS DEVICE WAS NOT INVOLVED IN ANY SURGERY OR PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18429523 ↗
• MalfunctionJan 2, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  ON AN UNKNOWN DATE THE ABSORBABLE HEMOSTAT PRIMARY PACKAGE OF THE PRODUCT WAS FOUND DAMAGED DURING NORMAL CHECKING. CHANGED TO ANOTHER ONE, AND THE SAME PROBLEM HAPPENED. THIS DEVICE WAS NOT INVOLVED IN ANY SURGERY OR PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18429403 ↗
• InjuryOct 20, 2023Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN BREAST PROCEDURE ON AN UNKNOWN DATE IN (B)(6) AND ABSORBABLE HEMOSTAT WAS USED. HOWEVER AN ULTRASOUND SHOWED THE ABSORBABLE HEMOSTAT WAS NOT INCOMPLETELY ABSORBED AND SECOND OPERATION WAS PERFORMED (B)(6) 2023, TO REMOVE THE PRODUCT. NOW THE PATIENT IS IN NORMAL CONDITION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Failure of Implant; Hematoma; Insufficient Information; Swelling/ Edema

  MAUDE report 17975561 ↗
• MalfunctionAug 25, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THE SUSPECTED ABSORBABLE HEMOSTAT PRODUCTS WERE FROM SIX DIFFERENT ONLINE SOURCES ON AN UNKNOWN DATE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17623420 ↗
• MalfunctionAug 25, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THE SUSPECTED ABSORBABLE HEMOSTAT PRODUCTS WERE FROM SIX DIFFERENT ONLINE SOURCES ON AN UNKNOWN DATE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17623404 ↗
• MalfunctionAug 17, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A SUSPECTED PRODUCT INQUIRY OF (B)(6) SCIENCE TRADE CO.,LTD., DURING AN IPO INVESTIGATION. CHINA SUPPLY CHAIN CHECKED AND THERE WAS NO RECORD OF THE ABSORBABLE HEMOSTAT PRODUCTS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15242821 ↗
• MalfunctionJul 12, 2022Delivered 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 DEVICE WAS NOT WELL-SEALED. CHANGED A NEW ONE AND COMPLETED THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14989307 ↗
• MalfunctionApr 1, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A FIBRIN SEALANT PREPARATION DEVICE WAS USED. THE PACKAGE WAS NOT WELL-SEALED, THEY CHANGED A NEW ONE, AND COMPLETED THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13982702 ↗