SURGICEL 1951Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10705031003019), received between Aug 2, 2018 and Apr 22, 2025 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. THERE WERE TWO PRODUCTS, BOTH ABSORBABLE HEMOSTAT THAT SEEM TO HAVE BEEN MISLABELED AND WANTED TO BRING UP TO THE MANUFACTURER'S ATTENTION TO SEE IF IT'S A NEW OR OLDER ISSUE. THE PRODUCT IS LABELED FOR 2 IN X 14 IN, HOWEVER, THE PRODUCT SEEMS TO BE 2 IN X 4 INCH. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882744 ↗
• InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 50 YEAR OLD PATIENT WITH FIBROIDS AND ENDOMETRIOSIS UNDERWENT A LAPAROSCOPIC TOTAL HYSTERECTOMY (TLH) PROCEDURE ON AN UNKNOWN DATE WHERE ABSORBABLE HEMOSTAT WAS USED. THERE WERE BILATERAL OVARIAN ENDOMETRIOSIS CYSTS AND SIGNIFICANT ADHESIONS AROUND THE UTERUS. THE BILATERAL URETERS WERE SEPARATED, THE UTERUS WAS REMOVED, AND NO OBVIOUS URETERAL INJURY WAS OBSERVED DURING THE SURGERY. ON THE 18TH POSTOPERATIVE DAY, BILATERAL HYDRONEPHROSIS DEVELOPED FROM AN ABSCESS IN THE RENAL PELVIS, AND BILATERAL URETERAL STENTS WERE PLACED BECAUSE IT APPEARED THAT URETERAL PERISTALSIS HAD BEEN SUPPRESSED. FIVE MONTHS AFTER SURGERY, THE STENT WAS REMOVED. HER ENTIRE PELVIS WAS FUSED DUE TO ENDOMETRIOSIS. SMALL BLEEDING OCCURRED DURING THE ADHESIOLYSIS PROCESS, AND ABSORBABLE HEMOSTAT WAS USED TO STOP THE BLEEDING. BLOOD CONTINUED TO ACCUMULATE IN THE DOUGLAS FOSSA AFTER SURGERY, AND WE BELIEVE THAT SURGICEL AND BLOOD ACCUMULATION INCREASED THE RISK OF INFECTION. IN SUCH CASES, A DRAIN SHOULD BE LEFT IN PLACE AND ANTIBIOTICS ADMINISTERED FOR SEVERAL DAYS POSTOPERATIVELY, REDUCING THE RISK OF PELVIC INFECTION AND ABSCESS FORMATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 18539438 ↗
• InjuryJun 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RENAL TRANSPLANTATION PROCEDURE ON UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. URETERAL STENOSIS AND HYDRONEPHROSIS WERE FOUND POSTOPERATIVELY, AND A URETERAL STENT WAS PLACED. THE URETERAL STENOSIS DID NOT IMPROVE EVEN AFTER TRANSURETHRAL DILATATION OF THE URETER, AND ONE YEAR AFTER THE TRANSPLANTATION, A TRANSPLANTED URETER AND AN AUTOURETERAL ANASTOMOSIS WERE PERFORMED. THE SURGEON OPINES STRICTURE DUE TO URETERAL ISCHEMIA MAY BE CONSIDERED, WHEN OBSERVED BY NAKED EYES. BUT THE SIDE EFFECT OF THE PACKAGE INSERT ON THE ABSORBABLE HEMOSTAT IS DESCRIBED AS FOREIGN BODY REACTION SUCH AS URETERAL OBSTRUCTION, AND STRICTURE DUE TO THIS ABSORBABLE HEMOSTAT EFFECT WAS ALSO CONSIDERED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Injury; No Code Available; Not Applicable

  MAUDE report 10169874 ↗
• InjuryJun 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A JOURNAL ARTICLE: A (B)(6)-YEAR-OLD WOMAN WAS REFERRED TO OUR INSTITUTION BECAUSE OF SUSPECTED OF LUNG CANCER DUE TO A PART- SOLID-NODULE IN HER RIGHT LOWER LOBE, AND RECEIVED THORACOSCOPIC WEDGE RESECTION. AN OXIDIZED CELLULOSE ABSORBABLE HEMOSTATIC AGENT WAS ATTACHED TO THE WOUND SURFACE. FURTHERMORE, FIBRIN GLUE WAS APPLIED FOR REINFORCEMENT. POSTOPERATIVE ORAL INTAKE WAS STARTED ON THE FIRST POSTOPERATIVE DAY (POD) ; HOWEVER, THE DRAINAGE TURNED WHITE ON THE 2ND POD. WE DIAGNOSED THIS AS POSTOPERATIVE CHYLOTHORAX, AND OCTREOTIDE AND A LOW-FAT-DIET THERAPY WERE STARTED. A CHEST COMPUTED TOMOGRAPHY (CT) SHOWED PLEURAL EFFUSION ON THE LEFT SIDE ON THE 6TH POD, SO THORACENTESIS OF THE LEFT SIDE WAS PERFORMED AND DIAGNOSED AS BILATERAL CHYLOTHORAX. CONSERVATIVE MANAGEMENT DECREASED THE CHYLOUS LEAKAGE, AND CHYLOTHORAX DID NOT RECUR AFTER EVALUATION OF THE CHEST DRAIN. THE PATHOLOGICAL DIAGNOSIS WAS ADENOCARCINOMA (PTISN0M0 STAGE 0), AND THE PATIENT HAS BEEN RECURRENCE-FREE FOR 3 YEARS POSTOPERATIVELY. CHYLOTHORAX FOLLOWING THORACOSCOPIC WEDGE RESECTION IS AN EXTREMELY RARE OCCURRENCE. SHINSHU MED J 68 : 49 53, 2020 (RECEIVED FOR PUBLICATION JULY 4, 2019 ; ACCEPT

  Patient problems: No Code Available; Not Applicable; Pleural Effusion

  MAUDE report 10113782 ↗
• InjuryMay 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A JOURNAL ARTICLE: THE FOLLOWING INFORMATION IS FROM THE JOURNAL ARTICLE ATTACHED. ITO H, ONISHI H, SHOIN K, ET AL. GRANULOMA CAUSED BY OXIDIZED CELLULOSE FOLLOWING CRANIOTOMY. ACTA NEUROCHIR (WIEN). 1989;100(1-2):70-3. A PATIENT ((B)(6) YO) RECEIVED A FOLLOW UP CT SCAN 540 DAYS FOLLOWING REMOVAL OF A MENINGIOMA, WHICH APPEARED AS A SPACE-OCCUPYING LESION, SUSPECTED TO BE A LARGE GRANULOMA. THE PATIENTS FOLLOW UP CT SCAN WAS INTERPRETED AS A POSSIBLE RECURRENCE OF THE EXCISED MENINGIOMA IN THE FORM OF A MASS IN FRONTO-POLAR REGION. A SECOND PROCEDURE WAS PERFORMED, AND THE REMOVED TISSUE REVEALED A GRANULOMA WITH REMNANTS OF OXIDIZED CELLULOSE. SURGICEL WAS LEFT AT THE SURGICAL SITE DURING INITIAL PROCEDURE.

  Patient problems: Granuloma; Not Applicable

  MAUDE report 10063297 ↗
• InjuryMay 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A JOURNAL ARTICLE: THE FOLLOWING INFORMATION IS FROM THE JOURNAL ARTICLE. ITO H, ONISHI H, SHOIN K, ET AL. GRANULOMA CAUSED BY OXIDIZED CELLULOSE FOLLOWING CRANIOTOMY. ACTA NEUROCHIR (WIEN). 1989;100(1-2):70-3. A PATIENT ((B)(6) YO) PRESENTED WITH VISUAL IMPAIRMENT 730 DAYS FOLLOWING PRIMARY SURGERY FOR A RUPTURED ANTERIOR COMMUNICATING ANEURYSM, RESULTING IN SUBARACHNOID HEMORRHAGE. THE CT SCAN SHOWED A LARGE GRANULOMATOUS MASS, WHICH WAS ENHANCED BY CONTRAST MEDIUM, AND WAS SUSPECTED TO BE RELATED TO THE PREVIOUS ANEURYSM REPAIR. SURGICAL REMOVAL OF THE MASS SHOWED A GRANULOMA WITH REMNANTS OF OXIDIZED CELLULOSE. DURING THE PRIMARY SURGERY MULTIPLE PIECES OF SURGICEL WERE PLACED AT THE SURGICAL SITE AND LEFT IN THE PATIENT. IN THIS CASE THE INITIAL SURGERY WAS FURTHER COMPLICATED BY CONTAMINATION, SECONDARY TO THE RUPTURED ANEURYSM, REQUIRING ANTIBIOTICS.

  Patient problems: Granuloma; Not Applicable; Visual Impairment

  MAUDE report 10063296 ↗
• InjuryMay 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A JOURNAL ARTICLE: THE FOLLOWING INFORMATION IS FROM THE JOURNAL ARTICLE. ITO H, ONISHI H, SHOIN K, ET AL. GRANULOMA CAUSED BY OXIDIZED CELLULOSE FOLLOWING CRANIOTOMY. ACTA NEUROCHIR (WIEN). 1989;100(1-2):70-3 A PATIENT (65 YO) THAT PRESENTED WITH WORSENING VISION 630 DAYS FOLLOWING SURGERY FOR A TUBERCULUM SELLAE MENINGIOMA, ADJACENT TO THE OPTIC CHIASM. THE CT SCAN SHOWED A MASS THAT WAS SUSPECTED TO BE A RECURRENCE OF THE MENINGIOMA. A SECOND SURGERY WAS PERFORMED TO REMOVE THE MASS WHICH INCLUDED REMNANTS OF OXIDIZED CELLULOSE. VISUAL DISTURBANCES CONTINUED FOLLOWING THE SECOND SURGERY. DURING THE PRIMARY SURGERY MULTIPLE PIECES OF SURGICEL WERE PLACED AT THE SURGICAL SITE AND LEFT IN THE PATIENT FOLLOWING THE INITIAL SURGERY.

  Patient problems: Granuloma; Not Applicable; Visual Impairment

  MAUDE report 10063237 ↗
• InjuryMay 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A JOURNAL ARTICLE: IWABUCHI S, KOIKE K, OKABE T, ET AL. IATROGENIC PARAPLEGIA CAUSED BY SURGICEL USED FOR HEMOSTASIS DURING A THORACOTOMY: REPORT OF A CASE. SURG TODAY. 1997;27(10):969¿70.IWABUCHI ET AL. REPORTS A CASE OF A PATIENT ((B)(6) YO) THAT PRESENTS WITH PARAPLEGIA, 1 DAY AFTER A RIGHT LOWER LOBECTOMY. DURING THE SURGERY THE SURGEON PLACED SURGICEL AND BONE WAX TO CONTROL BLEEDING FROM THE 5TH INTERCOSTAL ARTERY. THE SURGEON CUT THE SURGICEL INTO SMALL PIECES AND PACKED THE HEMOSTATE INTO THE INTERCOSTAL SPACE. BONE WAX WAS THEN IMPACTED ON TOP OF THE SURGICEL TO PREVENT THE SURGICEL FROM BECOMING DISLODGED. FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED PARAPLEGIA BELOW T-5. MRI ON POD 1 REVEALED A SHADOW MASS COMPRESSING THE SPINAL CORD, INITIALLY THOUGHT TO BE A HEMATOMA. THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR AN EMERGENCY LAMINECTOMY WHERE A PIECE OF SURGICEL POSTERIOR TO THE SPINAL CORD WAS REMOVED. THE PATIENT HAS SINCE REGAINED MUCH OF THEIR MOTOR FUNCTION LOST AND CAN AMBULATE WITH THE ASSISTANCE OF CRUTCHES.

  Patient problems: Injury; Not Applicable

  MAUDE report 10058062 ↗
• InjuryNov 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN VASCULAR PROCEDURE ON (B)(6) 2019 AND AFTER THE PROCEDURE, THE PATIENT NEEDED A PICC LINE INSTALLED. THE NURSE WAS INSERTING THE PICC LINE AND THERE WAS BLEEDING. THE NURSE COULDN'T STOP THE BLEEDING AND USED AN ABSORBABLE HEMOSTAT TO STOP THE BLEEDING BY PACKING/WADDING UP THE ABSORBABLE HEMOSTAT UNDER THE SKIN. THE PATIENT WAS STILL IN THE HOSPITAL FOR TWO DAYS AND IT WAS NOTICED THAT THE ABSORBABLE HEMOSTAT WAS WADDED UP UNDER THE PATIENT'S SKIN AND COULDN'T EASILY BE REMOVED. A HOSPITAL DOCTOR SURGICALLY REMOVED THE ABSORBABLE HEMOSTAT AND CLOSED THE INCISION. THE PATIENT CONTINUED TO STAY IN THE HOSPITAL FOR OBSERVATION AND EXPIRED DUE TO OTHER COMPLICATIONS NOT RELATED TO THE ABSORBABLE HEMOSTAT, ACCORDING TO THE HOSPITAL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Code Available

  MAUDE report 9354934 ↗
• MalfunctionOct 22, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHEN THE BOX ARRIVED AT THE ACCOUNT, THERE WERE PACKAGES MARKED WITH LABELS STATING "SAMPLES NOT INTENDED FOR HUMAN USE". NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7991896 ↗
• InjuryAug 2, 2018Defective Device; Patient-Device Incompatibility

  IT WAS REPORTED THAT A (B)(6) MULTIPARA FEMALE PATIENT UNDERWENT A SUPERSELECTIVE MICROCOIL EMBOLIZATION OF THE VASA RECTA OF SIGMOID ARTERY FOR HEMORRHAGING AFTER LAPAROSCOPIC ADNEXECTOMY FOR CORPUS LUTEUM HEMATOMA WITH SEVERE ADHESION AND ABSORBABLE HEMOSTAT DEVICE WAS USED. THE PATIENT HAD SUDDEN ONSET OF LEFT LOWER ABDOMINAL PAIN. CORPUS LUTEUM HEMATOMA WAS SUSPECTED AND CONSERVATIVELY MANAGED. TWO DAYS LATER, DUE TO WORSENING OF ABDOMINAL SYMPTOMS, EMERGENCY LAPAROSCOPIC SURGERY WAS PERFORMED. SEVERE PELVIC ADHESION AROUND THE LEFT OVARY FORMING CORPUS LUTEUM HEMATOMA WAS IDENTIFIED. AFTER ADHESIOLYSIS, WHICH WAS COMPLICATED BY MASSIVE BLEEDING, LEFT ADNEXECTOMY WAS PERFORMED. HEMOSTASIS WAS ACHIEVED BY THE COAGULATION OF BLEEDING VESSELS, FOLLOWED BY SPRAYING FIBRIN GLUE WITH THE PLACEMENT OF OXIDIZED CELLULOSE COTTON FOR BLEEDING OOZING FROM DISSECTED SURFACE. TWO HOURS AFTER SURGERY, EMERGENCY COMPUTED TOMOGRAPHY PERFORMED DUE TO THE DEVELOPMENT OF HEMODYNAMIC INSTABILITY DEMONSTRATED EXTRAVASATION FROM THE VERSA RECTA OF THE SIGMOID ARTERY. AFTER THE CONFIRMATION OF HEMORRHAGING, SUPERSELECTIVE CATHETERIZATION TO THE BLEEDING VESSEL FOLLOWED BY EMBOLIZATION BY PLATINUM MIC

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Not Applicable

  MAUDE report 7742130 ↗