SURGICEL NU-KNIT 1946Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705031002999), received between Jan 11, 2018 and Feb 2, 2026 — classified as 11 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (4 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• 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. IT WAS FOUND THAT THERE HAD BEEN BLUE COTTON-LIKE FOREIGN MATTER IN THE STERILE 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 24241955 ↗
• MalfunctionSep 15, 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, WHEN OPENING THE PACKAGE TO TRY TO USE, IT WAS FOUND THAT THERE WAS A FOREIGN MATTER LIKE A BLACK DOT ON THE PRODUCT, SO THE PRODUCT DID NOT GET USED AND KEPT. WHEN OPENING ANOTHER PRODUCT OF THE SAME TYPE AND CHECKING IT, THERE WERE NO PROBLEMS, SO THAT ONE WAS USED AND THE SURGERY WAS COMPLETED. 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 23058365 ↗
• MalfunctionMar 17, 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. IT WAS FOUND THAT THE BOX WAS PARTIALLY OPENED AT THE PERFORATION LINE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619191 ↗
• MalfunctionMar 3, 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. WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THERE WAS COLORED LIKE A LIGHT BLUE INK ON THE PRODUCT, SO THE USE WAS STOPPED. 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 21509869 ↗
• MalfunctionJul 9, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. WHEN OPENING THE PACKAGE, IT WAS CONFIRMED THAT THERE WAS A STAIN, SO A NEW PRODUCT WAS OPENED JUST TO BE SURE. THE INVOLVED PRODUCT WAS NOT USED. THE OPERATION TIME WAS NOT EXTENDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19700000 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON AN UNKNOWN DATE THREE YEARS AGO AND ABSORBABLE HEMOSTAT WAS USED. AN INFECTION OCCURRED AND RE-OPERATING WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 18188490 ↗
• MalfunctionApr 19, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT BEFORE OPENING THE PACKAGE OF ABSORBABLE HEMOSTAT ON AN UNKNOWN DATE, IT WAS THAT THE PERFORATION OF THE BOX WAS TORN, AND THE STERILE PACKAGE WAS OPENED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16768684 ↗
• InjuryJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN OVARIAN CANCER PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. THE PATIENT¿S BLOOD PRESSURE DECREASED GREATLY. DESPITE VARIOUS TREATMENTS, THE SYMPTOMS DID NOT HEAL. AFTER THE ABSORBABLE HEMOSTAT WAS REMOVED, BLOOD PRESSURE RETURNED TO NORMAL WITHIN 30 SECONDS. THE SURGEON THINKS IT WAS ANAPHYLACTIC SHOCK CAUSED BY THE ABSORBABLE HEMOSTAT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THERE WAS NO PROBLEM WITH THE PATIENT. THE PATIENT WAS NOT TESTED FOR ALLERGIES. THERE WERE NO OTHER ALLERGIC REACTIONS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Anaphylactic Shock; Low Blood Pressure/ Hypotension

  MAUDE report 14684612 ↗
• InjuryAug 5, 2021Adverse 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 ABSORBABLE HEMOSTAT WAS USED. DURING THE SURGERY BLEEDING DID NOT STOP, AND ABSORBABLE HEMOSTAT WAS PLACED. THE PATIENT WAS DISCHARGED A FEW DAYS AGO. THREE WEEKS AFTER THE SURGERY, IT WAS OBSERVED THAT ABSORBABLE HEMOSTAT REMAINED VIA CT SCAN, AND ASCITES HAD ACCUMULATED. DRAINAGE WAS PERFORMED, BUT THERE WAS A SUBSTANCE LIKE FRAGMENT OF THE ABSORBABLE HEMOSTAT LEFT, AND ALTHOUGH IT DID NOT BECOME INFECTION, THERE WAS SOME DRAINAGE LEFT. THE SURGEON COMMENTED THAT IT MAY BE A POSSIBLE SOURCE OF INFECTION IN THE FUTURE. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12285424 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN ATTORNEY THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. THE ABSORBABLE HEMOSTAT WAS USED TO STOP BLEEDING DURING THE SURGERY. THE ABSORBABLE HEMOSTAT WAS LEFT IN THE BODY AND CLOSED, RESULTING IN NERVE DAMAGE. A SUBSTANCE THOUGHT TO BE THE ABSORBABLE HEMOSTAT HAS BEEN REMOVED FROM THE BODY AND STORED. IT HAS BEEN CONSIDERED WITH THE PLAINTIFF, THE DEFENDANTS, AND THE COURT WHETHER THE REMOVED SUBSTANCE IS REALLY THE ABSORBABLE HEMOSTAT OR NOT. INQUIRIES WERE MADE TO SEVERAL LABORATORIES AND FACILITIES, HOWEVER ALL OF THEM HAVE REPLIED IT IS HARD TO MAKE A DETERMINATION. NO FURTHER INFORMATION WILL BE PROVIDED.

  Patient problems: Nerve Damage

  MAUDE report 11661064 ↗
• InjuryJan 14, 2021Adverse 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 (B)(6) 2020 AND ABSORBABLE HEMOSTAT WAS USED. IMMEDIATELY AFTER SURGERY, IT WAS CONFIRMED THAT A COFFEE-LIKE DRAINAGE WAS COMING OUT FROM THE DRAIN PLACED JUST UNDER THE ANASTOMOTIC SITE. ANASTOMOTIC LEAKAGE WAS SUSPECTED, AND RE-PNEUMOPERITONEUM WAS PERFORMED TO CONFIRM THE ANASTOMOTIC SITE. AN ENDOSCOPY WAS ADDITIONALLY PERFORMED AND A TRANSANAL DRAIN WAS PLACED WITHOUT A PROPHYLACTIC COLOSTOMY, AND THE OPERATION WAS COMPLETED. FOR HEMOSTASIS, THE ABSORBABLE HEMOSTAT WAS CUT INTO 2 CM SQUARES AND THEY WERE PLACED NEAR THE ANASTOMOTIC SITE, AND WITHIN A 5 CM AREA, 5 ~ 6 SHEETS WERE PLACED ON TOP OF EACH OTHER (SUPERIMPOSED ON SITES WHERE HEMOSTASIS COULD NOT BE CONFIRMED). AFTER HEMOSTASIS WAS ACHIEVED, THE ABSORBABLE HEMOSTAT WAS LEFT IN PLACE WITHOUT REMOVAL. THE SURGEON KNEW OF THE POSSIBILITY THAT THE DRAINAGE FLUID FROM THE DRAIN MAY BE DISCOLORED DUE TO THE MATERIAL BALANCE. THE SURGEON COMMENTED THAT ALTHOUGH THERE WERE NO SIGNS SUCH AS ODOR FROM THE DRAINAGE, THE COLOR WAS DEEP ENOUGH TO SUSPECT ANASTOMOTIC LEAKAGE. ADDITIONAL INFORMATION WAS REQUESTED. ON (B)(6) 2020, THE PATIENT WAS DISCHARGED FROM THE HOSP

  Patient problems: Failure to Anastomose

  MAUDE report 11174582 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PANCREATICODUODENECTOMY PROCEDURE ON AN UNKNOWN DATE AND AN ABSORBABLE HEMOSTAT WAS USED. THE PATIENT EXPERIENCED AND INFECTION. IT IS UNKNOWN HOW THE ABSORBABLE HEMOSTAT WAS USED. IT WAS LEFT IN THE ABDOMINAL CAVITY AS IT WAS FOR HEMOSTASIS DURING WOUND CLOSURE BECAUSE THE DEVICE WOULD BE ABSORBED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE EVENT WAS NOT SERIOUS. FURTHER DETAILS WERE NOT PROVIDED FROM THE HOSPITAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 8911253 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRANSVERSE COLECTOMY PROCEDURE ON AN UNKNOWN DATE AND AN ABSORBABLE HEMOSTAT WAS USED. THE PATIENT EXPERIENCED AND INFECTION. IT IS UNKNOWN HOW THE ABSORBABLE HEMOSTAT WAS USED. IT WAS LEFT IN THE ABDOMINAL CAVITY AS IT WAS FOR HEMOSTASIS DURING WOUND CLOSURE BECAUSE THE DEVICE WOULD BE ABSORBED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE EVENT WAS NOT SERIOUS. FURTHER DETAILS WERE NOT PROVIDED FROM THE HOSPITAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 8911192 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRANSVERSE COLECTOMY PROCEDURE ON AN UNKNOWN DATE AND AN ABSORBABLE HEMOSTAT WAS USED. THE PATIENT EXPERIENCED AND INFECTION. IT IS UNKNOWN HOW THE ABSORBABLE HEMOSTAT WAS USED. IT WAS LEFT IN THE ABDOMINAL CAVITY AS IT WAS FOR HEMOSTASIS DURING WOUND CLOSURE BECAUSE THE DEVICE WOULD BE ABSORBED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE EVENT WAS NOT SERIOUS. FURTHER DETAILS WERE NOT PROVIDED FROM THE HOSPITAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 8911186 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRANSVERSE COLECTOMY PROCEDURE ON AN UNKNOWN DATE AND AN ABSORBABLE HEMOSTAT WAS USED. THE PATIENT EXPERIENCED AND INFECTION. IT IS UNKNOWN HOW THE ABSORBABLE HEMOSTAT WAS USED. IT WAS LEFT IN THE ABDOMINAL CAVITY AS IT WAS FOR HEMOSTASIS DURING WOUND CLOSURE BECAUSE THE DEVICE WOULD BE ABSORBED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE EVENT WAS NOT SERIOUS. FURTHER DETAILS WERE NOT PROVIDED FROM THE HOSPITAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 8911176 ↗
• InjuryJul 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EMERGENCY HYSTERECTOMY PROCEDURE ON (B)(6) 2019 ((B)(6) GESTATION DAY 0) AFTER A VAGINAL DELIVERY AND AN ABSORBABLE HEMOSTAT WAS USED. AFTER THE VAGINAL DELIVERY, A LARGE AMOUNT OF UTERINE BLEEDING, DIC, CARDIOPULMONARY ARREST OCCURRED. RESUSCITATION TREATMENT AND BLOOD TRANSFUSION WERE CONDUCTED. AMNIOTIC FLUID EMBOLISM WAS CONSIDERED, AND IT WAS DETERMINED THAT REMOVAL OF THE UTERUS, WHICH WAS THE CAUSE OF BLEEDING, WOULD BE PERFORMED AS AN EMERGENCY SURGERY. ABDOMINAL SIMPLE TOTAL HYSTERECTOMY WAS PERFORMED. BLEEDING LASTS FROM THE WOUND IN THE ABDOMINAL CAVITY (CUTTING END, CUTTING END OF UTERINE SUPPORT TISSUE, ETC.) FOR EXTRACTION UNDER DIC. AFTER SUTURE HEMOSTASIS, PERITONEAL WASHING AND WIPING WERE CONDUCTED AND THE ABSORBABLE HEMOSTAT WAS APPLIED TO THE ABDOMINAL CAVITY (PELVIS) AND CLOSED. POSTOPERATIVE DIC TREATMENT SUCH AS BLOOD TRANSFUSION WAS PERFORMED AND GENERAL CONDITION IMPROVED GRADUALLY, BUT HEMATOMA WAS FREQUENTLY GENERATED AND REMAINED IN THE ABDOMINAL CAVITY, ABDOMINAL WALL, VAGINAL WALL AND SO ON. HEMATOMA WAS CONSIDERED TO BE A NATURAL ABSORPTION AND WAS FOLLOWED UP BECAUSE THERE WERE NO SIGNS OF INFECTION OR INFL

  Patient problems: Abscess; Inflammation; No Code Available; Pain

  MAUDE report 8748806 ↗
• InjuryJan 11, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A BOWEL SURGERY AND ABSORBABLE HEMOSTAT WAS USED. IT WAS REPORTED THAT JUST AFTER A SURGERY, REOPERATION WAS PERFORMED BECAUSE THE DRAINAGE SEEMED LIKE FECES FLOWED THROUGH THE DRAIN. THE SURGEON CONFIRMED IT WAS NOT FECES BUT PIECE OF THE ABSORBABLE HEMOSTAT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Not Applicable

  MAUDE report 7183180 ↗