ETHICON 3013SPRecalls & reported problems

Summary

The FDA's MAUDE database contains 392 adverse event reports that list this exact device (DI 10705031237506), received between Jan 11, 2018 and Sep 30, 2026 — classified as 3 deaths, 375 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (7 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 392 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent a Total Knee Arthroplasty: TKA procedure on (b)(6) 2026 and absorbable hemostat was used. About one week to ten days after the procedure a rash appeared extending from the knee to the ankle. Regarding the application site, it was used only on the posterior joint capsule and not on the soft tissue. Irrigation was also performed. The patient went to a dermatologist. Additional information was requested.

  Patient problems: Inflammation; Rash

  MAUDE report 50946655 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent an Orthopedic procedure on (b)(6) 2026 and absorbable hemostat was used. The powder was sprayed around the posterolateral joint capsule prior to insert placement during surgery. After that, pulse cleaning was performed to thoroughly wash away any excess powder. Postoperatively, the patient exhibited significant knee swelling and frequently bleeding from the surgical wound. While persistent postoperative wound bleeding does occur occasionally, it typically resolves spontaneously within one to two weeks, and cases requiring additional sutures are extremely rare. In this case, no dehiscence of the wound was observed, and it was thought that bleeding occurred through a small gap in the wound when the knee joint was flexed or when local internal pressure increased. A blood test was performed on (b)(6), two weeks after the surgery, and a CRP level of 0.2 was confirmed, indicating a negative result. On the other hand, since there was persistent mild bleeding from the upper edge of the wound, additional sutures were performed under local anesthesia. Around (b)(6), the swelling in the knee worsened again. At this point, it was thought that suturing t

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema

  MAUDE report 50853866 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient underwent an spine procedure on (b)(6) 2026 and suture was used. After surgery, a postoperative hematoma developed, and symptoms of paralysis appeared on the patient. The details are unknown, and conservative treatment was performed. No adverse patient consequences were reported. Additional information was requested

  Patient problems: Fatigue; Hematoma; Paralysis

  MAUDE report 50853422 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Rash

  MAUDE report 50828881 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REP THAT POST OP OF THYROIDECTOMY PROCEDURE THAT THREE PATIENTS EXPERIENCED PARALYSIS OF THE LARYNGEAL NERVES AND INCREASED NEURO TOXICITY. UNKNOWN AS TO HOW THE PATIENTS WERE TREATED AND NO FURTHER COMMUNICATION HAS BEEN RECEIVED YET BY THE SALES REP ON THIS ISSUE.

  Patient problems: Paralysis

  MAUDE report 24912430 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROIDECTOMY PROCEDURE ON (B)(6) 2021 AND ABSORBABLE HEMOSTAT WAS USED. POST OP TO A THYROIDECTOMY, THE PATIENT EXPERIENCED PARALYSIS OF THE LARYNGEAL NERVES AND INCREASED NEURO TOXICITY. IT IS UNKNOWN AS TO HOW THE PATIENT WAS TREATED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Paralysis

  MAUDE report 24912381 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THYROIDECTOMY PROCEDURE ON (B)(6) 2021 AND ABSORBABLE HEMOSTAT WAS USED. POST OP TO A THYROIDECTOMY, THE PATIENT EXPERIENCED PARALYSIS OF THE LARYNGEAL NERVES AND INCREASED NEURO TOXICITY. IT IS UNKNOWN AS TO HOW THE PATIENT WAS TREATED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Paralysis

  MAUDE report 24912154 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FEM POP PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. IT WAS REPORTED BY THE DOCTOR THAT HE HAD ENCOUNTERED "4 OR 5" INFECTIONS IN HIS PATIENTS OVER THE PAST 6 MONTHS. NO EXACT DATES WERE SHARED. ALL OF THESE INFECTIONS OCCURRED IN THE GROIN REGION OF HIS FEM POP PROCEDURES. THE ABSORBABLE HEMOSTAT WAS USED IN THIS SITE. THE WOUNDS HEALED WELL INITIALLY, BUT INFECTIONS PRESENTED ABOUT 1 MONTH POST-OP. ADDITIONAL CARE/TREATMENT REQUIRED AFTER THESE INFECTIONS PRESENTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 24904933 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FEM POP PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. IT WAS REPORTED BY THE DOCTOR THAT HE HAD ENCOUNTERED "4 OR 5" INFECTIONS IN HIS PATIENTS OVER THE PAST 6 MONTHS. NO EXACT DATES WERE SHARED. ALL OF THESE INFECTIONS OCCURRED IN THE GROIN REGION OF HIS FEM POP PROCEDURES. THE ABSORBABLE HEMOSTAT WAS USED IN THIS SITE. THE WOUNDS HEALED WELL INITIALLY, BUT INFECTIONS PRESENTED ABOUT 1 MONTH POST-OP. ADDITIONAL CARE/TREATMENT REQUIRED AFTER THESE INFECTIONS PRESENTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 24904901 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FEM POP PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. IT WAS REPORTED BY THE DOCTOR THAT HE HAD ENCOUNTERED "4 OR 5" INFECTIONS IN HIS PATIENTS OVER THE PAST 6 MONTHS. NO EXACT DATES WERE SHARED. ALL OF THESE INFECTIONS OCCURRED IN THE GROIN REGION OF HIS FEM POP PROCEDURES. THE ABSORBABLE HEMOSTAT WAS USED IN THIS SITE. THE WOUNDS HEALED WELL INITIALLY, BUT INFECTIONS PRESENTED ABOUT 1 MONTH POST-OP. ADDITIONAL CARE/TREATMENT REQUIRED AFTER THESE INFECTIONS PRESENTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 24899113 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LUMBAR PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. DURING SURGERY, THE PATIENT HAD A DISABILITY IN CASE OF LUMBER SURGERY ABOUT 2 MONTHS AGO AFTER THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Paralysis

  MAUDE report 24781982 ↗
• InjuryFeb 17, 2026Adverse 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. IT WAS REPORTED BY THE SURGEON THAT THE ABSORBABLE HEMOSTAT HAS CLOGGED SEVERAL DRAINS IN THE PAST SEVERAL MONTHS POST OP. REMOVAL OF DRAIN HAS BEEN PERFORMED. SURGICAL DELAY WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Seroma

  MAUDE report 24363885 ↗
• InjuryJan 29, 2026Adverse 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. IT WAS REPORTED BY THE SURGEON THAT THE ABSORBABLE HEMOSTAT HAS CLOGGED SEVERAL DRAINS IN THE PAST SEVERAL MONTHS POST OP. REMOVAL OF DRAIN HAS BEEN PERFORMED. SURGICAL DELAY WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; Seroma

  MAUDE report 24210046 ↗
• InjuryJan 29, 2026Adverse 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. IT WAS REPORTED BY THE SURGEON THAT THE ABSORBABLE HEMOSTAT HAS CLOGGED SEVERAL DRAINS IN THE PAST SEVERAL MONTHS POST OP. REMOVAL OF DRAIN HAS BEEN PERFORMED. SURGICAL DELAY WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Insufficient Information; Seroma

  MAUDE report 24209994 ↗
• InjuryNov 20, 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. DURING A POST-OPERATIVE THYROIDECTOMY PROCEDURE, THE SURGEON STATED THAT HER PATIENT DEVELOPED AN UNEXPLAINED SEVERE SKIN RASH POST-OP. THE PATIENT REQUIRED AN URGENT CARE VISIT AND REPORTED INABILITY TO SLEEP DUE TO SEVERE ITCHING. THE RASH COVERS THE UPPER PART OF THE PATIENT¿S BODY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypersensitivity/Allergic reaction; Insufficient Information; Itching Sensation; Rash

  MAUDE report 23605667 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC CYSTECTOMY PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. DURING THE PROCEDURE, AFTER USING ABSORBABLE HEMOSTAT ON (B)(6) 2025, AN INFECTION OCCURRED IN THE PATIENT. THE CAUSAL RELATIONSHIP IS UNKNOWN, BUT THE PATIENT IS CURRENTLY UNDERGOING TREATMENT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 23451682 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PACEMAKER SURGERY PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. POST OPERATIVELY THE PATIENT EXPERIENCED SEROMA AND DEHISCENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypervolemia; Insufficient Information; Seroma; Wound Dehiscence

  MAUDE report 23075969 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PACEMAKER SURGERY PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. POST OPERATIVELY THE PATIENT EXPERIENCED SEROMA AND DEHISCENCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Hypervolemia; Insufficient Information; Seroma; Wound Dehiscence

  MAUDE report 23075744 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. THE PRODUCT WAS USED IN THE WARDS/ICU, AND THE DAY AFTER THE SURGERY, URTICARIA DEVELOPED ALL OVER THE BODY. STEROIDS WERE ADMINISTERED AND THE PATIENT'S CONDITION IMPROVED 3 WEEKS LATER. THE DOCTOR THOUGHT THAT THE POWDER WAS THE CAUSE, AS HE HAD PREVIOUSLY TREATED ONE OF THE FEET AND THE ONLY CHANGE FROM THEN WAS THE USE OF POWDER. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Urticaria

  MAUDE report 23073940 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL KNEE ARTHROPLASTY (TKA) PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. THE PRODUCT WAS USED IN THE WARDS/ICU, AND URTICARIA DEVELOPED AROUND THE KNEE 1 TO 2 WEEKS AFTER THE SURGERY. STEROIDS WERE ADMINISTERED AND THE PATIENT'S CONDITION IMPROVED 1 WEEK LATER. THIS OCCURRED AT A SURGERY IN WHICH THE CLEANING METHOD WAS CHANGED FROM JET CLEANING TO SYRINGE CLEANING. THE DOCTOR THOUGHT THAT THE POWDER WAS THE CAUSE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Urticaria

  MAUDE report 23073434 ↗
• MalfunctionSep 15, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. AFTER REMOVING THE PRODUCT'S OUTER PACKAGING AND INSPECTING IT, THE SEALING PART OF THE PACKAGING WAS FOUND TO BE LOOSE, WHICH IS DIFFERENT FROM NORMAL. IT WAS NOT USED. IT WAS REPLACED WITH A NEW ONE FOR USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058159 ↗
• InjuryAug 28, 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 ABSORBABLE HEMOSTAT WAS USED. THE PRODUCTS USED ARE CAUSING INFECTIONS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 22911960 ↗
• InjuryAug 28, 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 ABSORBABLE HEMOSTAT WAS USED. THE PRODUCTS USED ARE CAUSING INFECTIONS. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Unspecified Infection

  MAUDE report 22911869 ↗
• MalfunctionAug 27, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. DURING SURGERY, IT WAS FOUND THERE HAD BEEN A HAIR INSIDE 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 22907733 ↗
• InjuryAug 19, 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 A ABSORBABLE HEMOSTATIC POWDER WAS USED ON FOUR SEPARATE OCCASIONS, DOCTOR WAS UNCLOGGING THE DRAINS AND HAD TO BRING FOUR PATIENTS BACK AT LEAST ONCE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22844045 ↗