SURGICEL 1953Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10705031003033), received between Jun 18, 2019 and Sep 30, 2026 — classified as 9 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (30 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Device Markings/Labelling Problem

  It was reported that the complaint handling unit received feedback from an employee about suspected counterfeit products from online sources. No adverse patient consequences were reported. Additional information was requested

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945983 ↗
• MalfunctionSep 23, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873409 ↗
• MalfunctionApr 29, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROTOMY PROCEDURE ON (B)(6) 2026 AND ABSORBABLE HEMOSTAT WAS USED. DURING SURGERY, HEMOSTATIC GAUZE WAS USED AND IT WAS FOUND THAT THE UNOPENED HEMOSTATIC GAUZE WAS NOT TIGHTLY SEALED. THE TOURING NURSE PROVIDED HEMOSTATIC GAUZE AGAIN, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25035620 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SMALL BOWEL RESECTION WITH LATERAL DUODENOJEJUNOSTOMY WITH CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. THIS IS A SERIOUS ADVERSE EVENTS (SAE) FROM AN INVESTIGATOR REGARDING A SUBJECT, WHO WAS ENROLLED IN CORZA STUDY CM-TS01: PHASE III STUDY TO COMPARE THE EFFICACY AND SAFETY OF TACHOSIL AND SURGICEL ORIGINAL AS AN ADJUNCT TO CONTROL MILD TO MODERATE SOFT TISSUE BLEEDING DURING SURGERY, AND EXPERIENCED EMESIS, DELAYED GASTRIC EMPTYING, NAUSEA , MULTIFOCAL/ASPIRATION PNEUMONIA, ACUTE RESPIRATORY FAILURE AND DELIRIUM EPISODE WHILE ADMINISTERED WITH SURGICEL ORIGINAL (OXIDIZED REGENERATED CELLULOSE) AT RIGHT RETROPERITONEUM DUE TO BLEEDING DURING SMALL BOWEL RESECTION WITH LATERAL DUODENOJEJUNOSTOMY WITH CHOLECYSTECTOMY SURGERY. ON (B)(6) 2025, THE SUBJECT SIGNED THE INFORMED CONSENT FORM. ON (B)(6) 2025, THE SUBJECT WAS RANDOMIZED TO SURGICEL ORIGINAL (OXIDIZED REGENERATED CELLULOSE) WITH 1 SURGICEL ORIGINAL 2 IN X 3 IN. THE SUBJECT UNDERWENT SMALL BOWEL RESECTION WITH LATERAL DUODENOJEJUNOSTOMY WITH CHOLECYSTECTOMY WHEN SURGICEL ORIGINAL (OXIDIZED REGENERATED CELLULOSE) WAS ADMINISTERED FOR BLEEDING AT RIGHT RE

  Patient problems: Abdominal Distention; Confusion/ Disorientation; Dysphagia/ Odynophagia; Hypoxia; Insufficient Information; Nausea; Pneumonia; Respiratory Failure; Vomiting

  MAUDE report 24611524 ↗
• MalfunctionDec 3, 2025Structural Problem; Appropriate Device Problem Term/Code Not Available; Structural Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. WHILE OPENING THE PACK, THE PRODUCT WAS BROKEN INTO THE PIECES. THE ABSORBABLE HEMOSTAT WAS ABSORBED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23709153 ↗
• MalfunctionDec 2, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THE COMPLAINT HANDLING UNIT RECEIVED EMPLOYEE'S FEEDBACK ABOUT ABSORBABLE HEMOSTAT SUSPECTED COUNTERFEIT PRODUCTS FROM ONLINE SOURCES. CHINA SUPPLY CHAIN AND RDC CHECKED PRODUCT TRACEABILITY INFORMATION BUT THERE'S NO RECORD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692394 ↗
• MalfunctionDec 2, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THE COMPLAINT HANDLING UNIT RECEIVED EMPLOYEE'S FEEDBACK ABOUT ABSORBABLE HEMOSTAT SUSPECTED COUNTERFEIT PRODUCTS. CHINA SUPPLY CHAIN AND RDC CHECKED PRODUCT TRACEABILITY INFORMATION BUT THERE'S NO RECORD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23692273 ↗
• MalfunctionDec 1, 2025Structural Problem; Structural Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. WHILE OPENING THE PACK, THE PRODUCT WAS BROKEN INTO THE PIECES. THE ABSORBABLE HEMOSTAT WAS ABSORBED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687711 ↗
• MalfunctionOct 16, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOTOMY FOR REMOVAL OF INTRACRANIAL HEMATOMA PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. DOCTOR NEEDED TO USE ABSORBABLE HEMOSTATIC GAUZE DURING SURGERY FOR PATIENTS. DURING THE PACKAGING PROCESS, THE TRAVELING NURSE FOUND THAT THE SEALING OF THE PRODUCT PACKAGING WAS NOT FIRM AND THE ADHESION WAS NOT STRONG. NURSE IMMEDIATELY REPORTED TO THE HEAD NURSE AND REPLACED IT WITH A NEW HEMOSTATIC GAUZE, WHICH DID NOT AFFECT THE SURGICAL USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316198 ↗
• MalfunctionAug 19, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. IN THE MORNING, DURING THE SURGERY, ABSORBABLE HEMOSTATIC GAUZE WAS REQUIRED. WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THE EDGE SEALING WAS NOT QUALIFIED, AND THE DOCTOR IMMEDIATELY REPLACED IT. THE SURGERY SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841794 ↗
• MalfunctionJun 25, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT FEEDBACK WAS RECEIVED ABOUT SUSPECTED COUNTERFEIT PRODUCTS FROM ONLINE SOURCES. CHINA SUPPLY CHAIN CHECKED PRODUCT TRACEABILITY INFORMATION BUT THERE'S NO RECORD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331882 ↗
• MalfunctionJun 25, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT FEEDBACK WAS RECEIVED ABOUT SUSPECTED COUNTERFEIT PRODUCTS FROM ONLINE SOURCES. CHINA SUPPLY CHAIN CHECKED PRODUCT TRACEABILITY INFORMATION BUT THERE'S NO RECORD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331607 ↗
• MalfunctionFeb 20, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT'S REPORTED THAT 2 BOXES OF ABSORBABLE HEMOSTAT FROM HENAN JUSHENG MEDICAL EQUIPMENT CO., LTD. AND 2 BOXES OF ABSORBABLE HEMOSTAT FROM HENAN ZHUOJIAN MEDICAL EQUIPMENT CO., LTD. WITH COUNTERFEIT CHARACTERISTICS WHICH ARE BASICALLY FOUND ON THE INTERNAL PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21426800 ↗
• MalfunctionFeb 20, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT'S REPORTED THAT 2 BOXES OF ABSORBABLE HEMOSTAT FROM HENAN JUSHENG MEDICAL EQUIPMENT CO., LTD. AND 2 BOXES OF ABSORBABLE HEMOSTAT FROM HENAN ZHUOJIAN MEDICAL EQUIPMENT CO., LTD. WITH COUNTERFEIT CHARACTERISTICS WHICH ARE BASICALLY FOUND ON THE INTERNAL PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21426689 ↗
• MalfunctionJan 29, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT ONE BOX OF ABSORBABLE HEMOSTAT PRODUCT FROM(B)(6). AND ONE BOX OF ABSORBABLE HEMOSTAT PRODUCT FROM (B)(6) WITH COUNTERFEIT CHARACTERISTICS WHICH ARE BASICALLY FOUND ON THE INTERNAL PACKAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21268826 ↗
• MalfunctionJan 27, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT ONE BOX OF ABSORBABLE HEMOSTAT PRODUCT FROM HENAN HAIWOXI MEDICAL INSTRUMENT CO., LTD. AND ONE BOX OF ABSORBABLE HEMOSTAT PRODUCT FROM GUIZHOU YIHEKANG MEDICAL INSTRUMENT CO., LTD. WITH COUNTERFEIT CHARACTERISTICS WHICH ARE BASICALLY FOUND ON THE INTERNAL PACKAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21246129 ↗
• MalfunctionJan 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  A BLIND UNIT WAS RECEIVED FROM THE CUSTOMER FOR ANALYSIS AND A MALFUNCTION WAS IDENTIFIED. THE DEVICE WAS RECEIVED WITH NO COMPLAINT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21212513 ↗
• 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 ON HOLD BY LAW ENFORCEMENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21131372 ↗
• 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 21130907 ↗
• 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 21130647 ↗
• 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 21130402 ↗
• 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 21130365 ↗
• MalfunctionDec 10, 2024Device Markings/Labelling Problem; Appropriate Device Problem Term/Code Not Available; Device Markings/Labelling Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE LOCAL TEAM RECEIVED FEEDBACK THAT THERE ARE SUSPECTED ABSORBABLE HEMOSTAT PRODUCTS IN THE MARKET. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892852 ↗
• MalfunctionSep 10, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THE LATIN AMERICA GLOBAL BRAND PROTECTION TEAM HAS PERFORMED A TEST PURCHASE IN ARGENTINA DUE TO A SUSPICIOUS SELLER. THE SUTURE DEVICE WAS SUSPECTED OF BEING DIVERTED PRODUCT FROM BRAZIL, BECAUSE THIS PRODUCT IS NOT APPROVED IN ARGENTINA. THE ABSORBABLE HEMOSTAT WAS SUSPICIOUS OF BEING COUNTERFEIT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20186004 ↗
• MalfunctionSep 10, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THE LATIN AMERICA GLOBAL BRAND PROTECTION TEAM HAS PERFORMED A TEST PURCHASE IN ARGENTINA DUE TO A SUSPICIOUS SELLER. THE SUTURE DEVICE WAS SUSPECTED OF BEING DIVERTED PRODUCT FROM BRAZIL, BECAUSE THIS PRODUCT IS NOT APPROVED IN ARGENTINA. THE ABSORBABLE HEMOSTAT WAS SUSPICIOUS OF BEING COUNTERFEIT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185972 ↗