SURGIFLO Hemostatic Matrix Kit with ThrombinRecalls & reported problems across all models

We found 2 models of SURGIFLO Hemostatic Matrix Kit with Thrombin by Ferrosan Medical Devices A/S in the FDA's device registry (GUDID). Together they are named in 46 adverse event reports in the FDA's MAUDE database, received between Mar 5, 2021 and Sep 14, 2026 — classified as 43 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (12 reports).

1 FDA recall record name at least one of these models by its device 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. 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

SURGIFLO Hemostatic Matrix Kit with Thrombin 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. May 25, 2022Open, Classified

   Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

   Z-1584-2022 · Root cause: Environmental control · Recall details · FDA record ↗

Most reported SURGIFLO Hemostatic Matrix Kit with Thrombin problems

SURGIFLO Hemostatic Matrix Kit with Thrombin models

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

• SURGIFLO® Hemostatic Matrix Kit with Thrombin 2994

  Agent, Absorbable Hemostatic, Collagen Based
  1 recall42 reports
• SURGIFLO™ Hemostatic Matrix Kit with Thrombin SF2995

  Agent, Absorbable Hemostatic, Collagen Based
  4 reports

Recent SURGIFLO Hemostatic Matrix Kit with Thrombin adverse event reports

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

• InjurySep 14, 2026Device Handling Problem

  It was reported by the account contact to sales rep that during a crania procedure, an expired device was used during the case. No additional information.No product is available for evaluation. Additional information was received 31.08.2026 stating:Was the use of expired product intentionally? No.Was the expiry date clear readable on the device? Unknown.Why was a expired product used? I was told it was a complete accident by the OR staff.What is the lot number? Unknown.What was the date of the procedure? Unknown.What was the indication for using the product? I was previously told it was for Hemostasis.Was there any patient consequence? Unknown.Can specific patient demographics Initials / ID; Age or date of birth; BMI; gender; patient pre-existing medical conditions (i.e. Allergies, history of reactions), all concomitant medications, past medical history, any treatment required for events, dose, frequency, and therapy dates of study drugs be provided? Unknown.What is the current condition of the patient? Unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50750158 ↗
• InjuryAug 25, 2026No Apparent Adverse Event

  It was reported to the Sales Rep that during a Craniotomy procedure, the surgeon was using Surgiflo when the product became very hard after application. The surgeon stated that the product would normally have a soft, mashed potato-like consistency. No patient consequences were reported. The device is returning.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50427389 ↗
• InjuryAug 7, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50174071 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  Case 1 of 3:It was reported to the Sales Rep that following a sling procedure, the surgeon used surgical flow intravaginally, and within one week, three patients returned with abscesses. The issue was reported to have occurred in three instances involving three different patients however, no additional information is available for the other patients. No further information was provided. The device is not being returned.

  Patient problems: Swelling/ Edema

  MAUDE report 50080892 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  Case 2 of 3:It was reported to the Sales Rep that following a sling procedure, the surgeon used surgical flow intravaginally, and within one week, three patients returned with abscesses. The issue was reported to have occurred in three instances involving three different patients however, no additional information is available for the other patients. No further information was provided. The device is not being returned.

  Patient problems: Swelling/ Edema

  MAUDE report 50080890 ↗
• InjuryJun 16, 2026Off-Label Use

  CASE 1 OF 3: IT WAS REPORTED THAT GYN SURGEON USES SURGIFLO ON THE VAGINAL CUFF. HE HAS HAD 3 SSIS SINCE CONVERTING FROM FLOSEAL TO SURGIFLO IN (B)(6). HE THINKS SURGIFLO MIGHT BE GIVING HIS PATIENT'S SSIS. NO SURGICAL DELAY WAS REPORTED. PROCEDURE: (B)(6) 2025, EVENT: 11/03/2025 PROCEDURE: GYN. ADDITIONAL INFORMATION WAS RECEIVED ON 28.05.2026 STATING: WHAT IS THE NAME OF EACH PROCEDURE? ALL 3 REPORTS WERE FROM TOTAL HYSTERECTOMIES WHAT WAS THE DATE OF EACH PROCEDURE? PATIENT 1: (B)(6) 2025 PATIENT 2: (B)(6) 2025 PATIENT 3: (B)(6) 2025. ON WHAT DATE DID EACH INFECTION OCCUR? PATIENT 1: (B)(6) 2025 PATIENT 2: (B)(6) 2025 PATIENT 3: (B)(6) 2025. HOW MUCH SURGIFLO WAS USED DURING EACH PROCEDURE? ONE UNIT OF 2994 WAS USED PER PATIENT/CASE. WAS SURGIFLO REMOVED AFTER HEMOSTASIS WAS ACHIEVED? SURGIFLO WAS NOT REMOVED AFTER HEMOSTASIS ON ANY OF THE 3 PATIENTS. WHAT WAS THE INDICATION FOR THE USE OF SURGIFLO? HEMOSTASIS AFTER THE VAGINAL CUFF WAS CLOSED. WHAT WAS THE INDICATION FOR SURGERY? REMOVAL OF THE UTERUS AND CERVIX FOR ALL 3 PATIENTS. WHAT WAS THE MEDICAL HISTORY OF EACH PATIENT? PATIENT 1: UTERINE FIBROIDS PATIENT 2: ENDOMETRIOSIS PATIENT 3: ADENOMYOSIS. WHAT WAS THE TREATMENT FO

  Patient problems: Post Operative Wound Infection

  MAUDE report 25515426 ↗
• InjuryDec 15, 2025Device Handling Problem; Device Handling Problem

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT A SURGIFLO WITH AN EXPIRATION DATE OF NOVEMBER 30, 2025, WAS USED ON A PATIENT, DURING A CAROTID ENDARTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2025. NO FURTHER INFORMATION PROVIDED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DEVICE IS NOT AVAILABLE FOR RETURN. NO PRODUCT IS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23800684 ↗
• InjuryNov 24, 2025Device Handling Problem; Device Handling Problem

  EVENT DESCRIPTION: THE SALES REPRESENTATIVE REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE SURGIFLO WAS USED, SOME OF THE PATIENT'S BLOOD WAS SALVAGED AND PROCESSED THROUGH A CELL SAVER, AND THE PROCESSED BLOOD WAS RETURNED TO THE PATIENT. THE DEVICE IS NOT AVAILABLE FOR RETURN. NOTE IN FILE: AS PER REP: "THE SURGICAL TEAM WAS CONCERNED THAT THE BLOOD MAY BE CONTAMINATED WITH THE PARTICLES OF SURGIFLO CELL SAVER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630787 ↗
• InjuryJun 4, 2025Device Handling Problem; Device Handling Problem

  IT WAS REPORTED BY THE SALES REP THAT THE PRODUCT WAS EXPIRED BY ONE DAY AND WAS STILL USED. IT WAS USED MAY 1 BUT EXPIRED ON APRIL 30. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22140243 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON HAS STOPPED USING SURGIFLO DUE TO TWO PATIENTS NEEDING TO BE BROUGHT BACK TO THE OR TO CLEAN AND WASHOUT THE INCISION SITE. PATIENTS CURRENTLY DOING FINE. SURGEON HAS SEEN NO MORE ISSUES SINCE STOPPING THE USE OF SURGIFLO ON EVERY PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21354605 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON HAS STOPPED USING SURGIFLO DUE TO TWO PATIENTS NEEDING TO BE BROUGHT BACK TO THE OR TO CLEAN AND WASHOUT THE INCISION SITE. PATIENTS CURRENTLY DOING FINE. SURGEON HAS SEEN NO MORE ISSUES SINCE STOPPING THE USE OF SURGIFLO ON EVERY PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 21354492 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROIDECTOMY PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. THE SURGEON HAS STOPPED USING THE DEVICE DUE TO TWO PATIENTS NEEDING TO BE BROUGHT BACK TO THE OPERATING ROOM TO CLEAN AND WASHOUT THE INCISION SITE. THE PATIENTS ARE CURRENTLY DOING FINE. SURGEON HAS SEEN NO MORE ISSUES SINCE STOPPING THE USE OF SURGIFLO ON EVERY PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21240158 ↗
• InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND AN ABSORBABLE HEMOSTAT WAS USED. THE SURGEON HAS STOPPED USING ABSORBABLE HEMOSTAT DUE TO TWO PATIENTS NEEDING TO BE BROUGHT BACK TO THE OPERATING ROOM TO CLEAN AND WASHOUT THE INCISION SITE. PATIENTS CURRENTLY DOING FINE. SURGEON HAS SEEN NO MORE ISSUES SINCE STOPPING THE USE OF ABSORBABLE HEMOSTAT ON EVERY PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21223843 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO THE SALES REP BY THE OPERATING ROOM MANAGER REPORTED ON BEHALF OF THE SURGEON AND HIS PA (B)(6). THAT THEY ARE FRUSTRATED WITH SURGIFLO. THEY PREFER FLOSEAL OVER SURGIFLO. THEY BELIEVE FLOSEAL IS MUCH MORE GRANULAR AND STICKS/ADHERES TO THE TISSUES OF THE BLEEDING SITE. WHERE THEY HAVE NOTICED THAT SURGIFLO ISN'T ADHERING AS WELL AS FLOSEAL EVEN AFTER THEY WAIT 3 MINUTES. THEY ARE STILL NOTICING BLEEDING AT THE BLEEDING SITE. THERE HAVE BEEN TWO PATIENTS THAT HAVE COME BACK WITH HEMATOMAS WHICH WERE ABLE TO BE TREATED WITH MEDICATION BUT (B)(6) THE PA BELIEVES THIS IS DUE TO THE CHANGE TO SURGIFLO OVER FLOSEAL. NO PATIENT CONSEQUENCE WAS REPORTED. NO DEVICE IS AVAILABLE FOR EVALUATION. FOLLOW-UP INFORMATION WAS RECEIVED STATING: WAS SURGIFLO REMOVED AFTER HEMOSTASIS WAS ACHIEVED OR LEFT: "YES, SURGIFLO WAS REMOVED". HOW MUCH SURGIFLO WAS USED?: "1 EACH OF 2994 (8ML)". HOW WAS THE HEMATOMA/S TREATED?: "MEDICATION - NO ADDITIONAL INFORMATION PROVIDED."

  Patient problems: Hematoma

  MAUDE report 20705987 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO THE SALES REP BY THE OR MANAGER REPORTED ON BEHALF OF THE SURGEON AND HIS PA IGOR. THAT THEY ARE FRUSTRATED WITH SURGIFLO. THEY PREFER FLOSEAL OVER SURGIFLO. THEY BELIEVE FLOSEAL IS MUCH MORE GRANULAR AND STICKS/ADHERES TO THE TISSUES OF THE BLEEDING SITE. WHERE THEY HAVE NOTICED THAT SURGIFLO ISN'T ADHEREING AS WELL AS FLOSEAL EVEN AFTER THEY WAIT 3 MINUTES. THEY ARE STILL NOTICING BLEEDING AT THE BLEEDING SITE. THERE HAVE BEEN TWO PATIENTS THAT HAVE COME BACK WITH HEMATOMAS WHICH WERE ABLE TO BE TREATED WITH MEDICATION BUT IGOR THE PA BELIEVES THIS IS DUE TO THE CHANGE TO SURGIFLO OVER FLOSEAL. NO PATIENT CONSEQUENCE WAS REPORTED. NO DEVICE IS AVAILABLE FOR EVALUATION. FOLLOW-UP INFORMATION WAS RECEIVED STATING: - WAS SURGIFLO REMOVED AFTER HEMOSTASIS WAS ACHIEVED OR LEFT: "YES, SURGIFLO WAS REMOVED" - HOW MUCH SURGIFLO WAS USED? "1 EACH OF 2994 (8ML)" - HOW WAS THE HEMATOMA/S TREATED? "MEDICATION - NO ADDITIONAL INFORMATION PROVIDED."

  Patient problems: Hematoma

  MAUDE report 20705818 ↗

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