SURGICEL SNoW 2082Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10705031063594), received between Nov 21, 2018 and Mar 20, 2026 — classified as 9 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (8 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Delivered 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 BEFORE USING ON PATIENT DURING 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 24654530 ↗
• MalfunctionMar 20, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND 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 24654322 ↗
• MalfunctionMar 20, 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. AFTER OPENING THE STERILE PACKAGING, FOREIGN OBJECT WAS FOUND ATTACHED TO THE GAUZE. 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 24654096 ↗
• MalfunctionDec 17, 2025Material Discolored; Device Contaminated During Manufacture or Shipping; Material Discolored; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A THYROID AND PARATHYROID RESECTION PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. WHEN THE DOCTOR WAS UNPACKING AND PREPARING TO USE THE PRODUCT DURING THE OPERATION, DOCTOR FOUND BLACK SPOTS ON THE GAUZE AND COLOR DIFFERENCE, WITH THE GAUZE TURNING YELLOW IN COLOR. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829161 ↗
• MalfunctionOct 20, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATECTOMY PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. THE DEVICE PACKAGE WAS FOUND UNSEALED WHEN UNPACKING AND COUNTING. ONE END OF THE PACKAGE IS NOT SEALED. 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 23335528 ↗
• MalfunctionApr 11, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TUMOR RESECTION PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. IT WAS FOUND THAT THERE WAS HAIR FOREIGN OBJECT INSIDE THE PRODUCT, WHEN PREPARING FOR 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 21829769 ↗
• MalfunctionApr 3, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LOBECTOMY PROCEDURE ON AN UNKNOWN DATE, AND ABSORBABLE HEMOSTAT WAS USED. THE DEVICE PACKAGE WAS FOUND UNSEALED WHEN UNPACKING AND COUNTING. ONE END OF THE PACKAGE IS NOT SEALED. 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 21762557 ↗
• InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HEPATECTOMY ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. WHEN THE SURGEON USED THE ABSORBABLE HEMOSTAT, THEY FELT THAT THE PATIENT'S FIBRINOGEN LEVELS ARE LOWER THAN WHEN THEY USE REGULAR GAUZE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18902715 ↗
• MalfunctionFeb 26, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIAL REPAIR PROCEDURE ON (B)(6) 2024 AND ABSORBABLE HEMOSTAT WAS USED. WHEN OPENING IT, IT WAS FOUND THAT THE SEAL WAS NOT TIGHT. 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 18784161 ↗
• MalfunctionFeb 26, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND ABSORBABLE HEMOSTAT WAS USED. AFTER OPENING THE PACKAGE AND BEFORE USE, IT WAS FOUND THAT THERE WAS A HAIR INSIDE THE STERILE PACKAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777027 ↗
• MalfunctionDec 21, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RADICAL GASTRECTOMY PROCEDURE FOR GASTRIC CANCER ON AN UNKNOWN DATE AND AN ABSORBABLE HEMOSTAT WAS USED. THERE WAS A HAIR FOREIGN OBJECT INSIDE THE PRODUCT WHEN PREPARING FOR SURGERY. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. 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 18378279 ↗
• MalfunctionDec 20, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RADICAL GASTRECTOMY PROCEDURE FOR GASTRIC CANCER ON AN UNKNOWN DATE AND AN ABSORBABLE HEMOSTAT WAS USED. THERE WAS A HAIR FOREIGN OBJECT INSIDE THE PRODUCT WHEN PREPARING FOR SURGERY. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. 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 18367368 ↗
• MalfunctionNov 15, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATECTOMY PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. THERE WAS A HAIR FOREIGN MATTER THAT WAS FOUND IN THE PRODUCT BEFORE USE ON THE PATIENT DURING SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144915 ↗
• MalfunctionOct 11, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE HAD BEEN HAIR FOREIGN MATTER FOUND INSIDE THE PACKAGE, WHEN UNPACKING. 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 17916065 ↗
• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOTOMY PROCEDURE ON (B)(6) 2023 AND ABSORBABLE HEMOSTAT WAS USED. POST-OP THE PATIENTS RETURNED WITH CHEMICAL MENINGITIS. THEY WERE TREATED WITH ANTIBIOTICS AND ARE DOING FINE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Meningitis

  MAUDE report 17498307 ↗
• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOTOMY PROCEDURE ON (B)(6) 2023 AND ABSORBABLE HEMOSTAT WAS USED. POST-OP THE PATIENTS RETURNED WITH CHEMICAL MENINGITIS. THEY WERE TREATED WITH ANTIBIOTICS AND ARE DOING FINE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Meningitis

  MAUDE report 17498255 ↗
• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOTOMY PROCEDURE ON (B)(6) 2023 AND ABSORBABLE HEMOSTAT WAS USED. POST-OP THE PATIENTS RETURNED WITH CHEMICAL MENINGITIS. THEY WERE TREATED WITH ANTIBIOTICS AND ARE DOING FINE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Meningitis

  MAUDE report 17498176 ↗
• InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POST-OP INFLAMMATION. THIS CASE IS FROM HEALTH AUTHORITY. AT 9:00, AFTER THE SURGERY , THE PRODUCT WAS PLACED IN THE ANUS ACCORDING TO THE REGULAR POSITION OF THE PATIENT TO FILL THE ANAL WOUND. LATER, DUE TO THE LARGE AMOUNT OF ANAL MUCUS AND INCISION SEEPAGE OF THE PATIENT, THE GAUZE COULD NOT BE SMOOTHLY REMOVED, AND BECAUSE OF THE ROUGH TEXTURE, IT STIMULATED THE ANAL MUCOSA AND WOUND OF THE PATIENT, RESULTING IN SEVERE SWELLING AND PAIN OF THE PATIENT. AFTER THE EVENT, THE PATIENT WAS GIVEN ENHANCED ANALGESIA AND HEMOSTASIS TREATMENT, AND THE PATIENT WAS INSTRUCTED TO WASH THE ANUS AND PROLONG THE HOSPITALIZATION TIME.

  Patient problems: Inflammation; Pain; Swelling/ Edema

  MAUDE report 15478113 ↗
• MalfunctionJul 12, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE ABSORBABLE HEMOSTAT DEVICE PACKAGE WAS FOUND UNSEALED DURING NORMAL CHECKING, NOT INVOLVED IN ANY SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14987185 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2020 AND ABSORBABLE HEMOSTAT WAS USED. POST-SURGERY INFECTION WAS REPORTED ALONG WITH AN OPEN WOUND UPON INCISION SITE INSPECTION, FOUR DAYS AFTER SURGERY. THE EVENT REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT DAMAGE. THE PATIENT ALSO EXPERIENCED PAIN AND A HIGH FEVER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Abdominal Pain; Fever; Fluid Discharge; Foreign Body In Patient; Wound Dehiscence

  MAUDE report 11017067 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION ON (B)(6) 2020 AND ABSORBABLE HEMOSTAT WAS USED. POST-SURGERY INFECTION WAS REPORTED ALONG WITH AN OPEN WOUND UPON INCISION SITE INSPECTION, FOUR DAYS AFTER SURGERY. THE EVENT REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT DAMAGE. THE PATIENT ALSO EXPERIENCED PAIN AND A HIGH FEVER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fever; Fluid Discharge; Foreign Body In Patient; Not Applicable; Pain; Unspecified Infection; Wound Dehiscence

  MAUDE report 10718200 ↗
• InjuryJun 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RADICAL TOTAL GASTRECTOMY PROCEDURE ON (B)(6) 2020 AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT SUFFERED FROM FEVER 7 DAYS AFTER USING THE PRODUCT. CHEST CT SHOWED THAT THERE WAS PNEUMONITIS. ANTI-INFECTION AND ANTIPYRETIC SYMPTOMATIC TREATMENT WERE GIVEN. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Fever; Pneumonia

  MAUDE report 10140475 ↗
• MalfunctionMar 4, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT A BREAST MASTECTOMY PROCEDURE ON AN UNKNOWN DATE ABSORBABLE HEMOSTAT DEVICE WAS USED TO CONTROL BLEEDING. EIGHT WEEKS, POST OP, THE PATIENT RETURNED TO THE DOCTOR, COMPLAINING OF A LOW GRADE FEVER AND RAISED SWELLING AT THE INCISION SITE. THE DOCTOR REOPERATED AND FOUND BLACK PIECES OF THE ABSORBABLE HEMOSTAT IN THE WOUND THAT HAD NOT REABSORBED. THE DOCTOR REMOVED THE PRODUCT, IRRIGATED AND CLOSED THE WOUND. THE PATIENT WAS RELEASED AND IS FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Fever; No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 8388047 ↗
• InjuryNov 21, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE FACILITY CONDUCTING A CLINICAL TRIAL STUDY THAT ABSORBABLE HEMOSTAT DEVICE WAS USED ON A PATIENT DURING A HAND SEWN ESOPHAGOGASTRIC ANASTOMOSIS PROCEDURE. THE PATIENT EXPIRED ON (B)(6) 2016 DUE TO RESPIRATORY FAILURE WITH HYPOXIA. THE RESPIRATORY FAILURE WITH HYPOXIA WAS RELATED TO THE PATIENT¿S CONDITION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Respiratory Failure

  MAUDE report 8096492 ↗