SURGICELRecalls & reported problems across all models
Ethicon Sàrl · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 114
- Deaths reported
- 1
- Injuries reported
- 42
- Recalls
- 0
We found 6 models of SURGICEL by Ethicon Sàrl in the FDA's device registry (GUDID). Together they are named in 114 adverse event reports in the FDA's MAUDE database, received between Aug 2, 2018 and Sep 30, 2026 — classified as 1 death, 42 injuries, 71 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (49 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. 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
Reports received per month, all models
Most reported SURGICEL problems
Device problems
- Device Markings/Labelling Problem49
- Adverse Event Without Identified Device or Use Problem39
- Delivered as Unsterile Product8
- Appropriate Device Problem Term/Code Not Available6
- Material Integrity Problem5
- Device Contaminated During Manufacture or Shipping4
- Structural Problem2
- Unsealed Device Packaging2
Patient problems
- No Clinical Signs, Symptoms or Conditions55
- Hypersensitivity/Allergic reaction14
- Hypoxia14
- No Consequences Or Impact To Patient14
- Asthma13
- Dyspnea13
- Not Applicable9
- Swelling/ Edema5
SURGICEL models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SURGICEL 1953Agent, absorbable hemostatic, non-collagen based56 reports
- SURGICEL 1952Agent, absorbable hemostatic, non-collagen based1 death41 reports
- SURGICEL 1951Agent, absorbable hemostatic, non-collagen based11 reports
- SURGICEL 1955Agent, absorbable hemostatic, non-collagen based3 reports
- SURGICEL 1951SAgent, absorbable hemostatic, non-collagen based2 reports
- SURGICEL 1952SAgent, absorbable hemostatic, non-collagen based1 report
Recent SURGICEL adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Device Markings/Labelling Problem
It was reported that the complaint handling unit received feedback from an employee about suspected counterfeit products from online sources. No adverse patient consequences were reported. Additional information was requested
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945983 ↗MalfunctionSep 23, 2026Device Contaminated During Manufacture or Shipping
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873409 ↗MalfunctionApr 29, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROTOMY PROCEDURE ON (B)(6) 2026 AND ABSORBABLE HEMOSTAT WAS USED. DURING SURGERY, HEMOSTATIC GAUZE WAS USED AND IT WAS FOUND THAT THE UNOPENED HEMOSTATIC GAUZE WAS NOT TIGHTLY SEALED. THE TOURING NURSE PROVIDED HEMOSTATIC GAUZE AGAIN, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25035620 ↗InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A SMALL BOWEL RESECTION WITH LATERAL DUODENOJEJUNOSTOMY WITH CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. THIS IS A SERIOUS ADVERSE EVENTS (SAE) FROM AN INVESTIGATOR REGARDING A SUBJECT, WHO WAS ENROLLED IN CORZA STUDY CM-TS01: PHASE III STUDY TO COMPARE THE EFFICACY AND SAFETY OF TACHOSIL AND SURGICEL ORIGINAL AS AN ADJUNCT TO CONTROL MILD TO MODERATE SOFT TISSUE BLEEDING DURING SURGERY, AND EXPERIENCED EMESIS, DELAYED GASTRIC EMPTYING, NAUSEA , MULTIFOCAL/ASPIRATION PNEUMONIA, ACUTE RESPIRATORY FAILURE AND DELIRIUM EPISODE WHILE ADMINISTERED WITH SURGICEL ORIGINAL (OXIDIZED REGENERATED CELLULOSE) AT RIGHT RETROPERITONEUM DUE TO BLEEDING DURING SMALL BOWEL RESECTION WITH LATERAL DUODENOJEJUNOSTOMY WITH CHOLECYSTECTOMY SURGERY. ON (B)(6) 2025, THE SUBJECT SIGNED THE INFORMED CONSENT FORM. ON (B)(6) 2025, THE SUBJECT WAS RANDOMIZED TO SURGICEL ORIGINAL (OXIDIZED REGENERATED CELLULOSE) WITH 1 SURGICEL ORIGINAL 2 IN X 3 IN. THE SUBJECT UNDERWENT SMALL BOWEL RESECTION WITH LATERAL DUODENOJEJUNOSTOMY WITH CHOLECYSTECTOMY WHEN SURGICEL ORIGINAL (OXIDIZED REGENERATED CELLULOSE) WAS ADMINISTERED FOR BLEEDING AT RIGHT RE
Patient problems: Abdominal Distention; Confusion/ Disorientation; Dysphagia/ Odynophagia; Hypoxia; Insufficient Information; Nausea; Pneumonia; Respiratory Failure; Vomiting
MAUDE report 24611524 ↗MalfunctionDec 3, 2025Structural Problem; Appropriate Device Problem Term/Code Not Available; Structural Problem; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. WHILE OPENING THE PACK, THE PRODUCT WAS BROKEN INTO THE PIECES. THE ABSORBABLE HEMOSTAT WAS ABSORBED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23709153 ↗MalfunctionDec 2, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
THE COMPLAINT HANDLING UNIT RECEIVED EMPLOYEE'S FEEDBACK ABOUT ABSORBABLE HEMOSTAT SUSPECTED COUNTERFEIT PRODUCTS FROM ONLINE SOURCES. CHINA SUPPLY CHAIN AND RDC CHECKED PRODUCT TRACEABILITY INFORMATION BUT THERE'S NO RECORD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23692394 ↗MalfunctionDec 2, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
THE COMPLAINT HANDLING UNIT RECEIVED EMPLOYEE'S FEEDBACK ABOUT ABSORBABLE HEMOSTAT SUSPECTED COUNTERFEIT PRODUCTS. CHINA SUPPLY CHAIN AND RDC CHECKED PRODUCT TRACEABILITY INFORMATION BUT THERE'S NO RECORD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23692273 ↗MalfunctionDec 1, 2025Structural Problem; Structural Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. WHILE OPENING THE PACK, THE PRODUCT WAS BROKEN INTO THE PIECES. THE ABSORBABLE HEMOSTAT WAS ABSORBED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23687711 ↗MalfunctionOct 16, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOTOMY FOR REMOVAL OF INTRACRANIAL HEMATOMA PROCEDURE ON (B)(6) 2025 AND ABSORBABLE HEMOSTAT WAS USED. DOCTOR NEEDED TO USE ABSORBABLE HEMOSTATIC GAUZE DURING SURGERY FOR PATIENTS. DURING THE PACKAGING PROCESS, THE TRAVELING NURSE FOUND THAT THE SEALING OF THE PRODUCT PACKAGING WAS NOT FIRM AND THE ADHESION WAS NOT STRONG. NURSE IMMEDIATELY REPORTED TO THE HEAD NURSE AND REPLACED IT WITH A NEW HEMOSTATIC GAUZE, WHICH DID NOT AFFECT THE SURGICAL USE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23316198 ↗MalfunctionAug 19, 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. IN THE MORNING, DURING THE SURGERY, ABSORBABLE HEMOSTATIC GAUZE WAS REQUIRED. WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THE EDGE SEALING WAS NOT QUALIFIED, AND THE DOCTOR IMMEDIATELY REPLACED IT. THE SURGERY SUCCESSFULLY COMPLETED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22841794 ↗InjuryJul 3, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A CERVICAL BIOPSY PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. DURING THE PROCEDURE THEY PLACED THE ABSORBABLE HEMOSTAT ON THE BIOPSY SITE. THE PATIENT CAME BACK WITH A CERVICAL FLUSH INFECTION. THEY ARE SAYING THAT THE ABSORBABLE HEMOSTAT IS NOT DISSOLVED LIKE TYPICALLY HAD IN THE PAST. THEY HAD TO TAKE BACK IN THE OFFICE AND PHYSICALLY REMOVED THE ABSORBABLE HEMOSTAT. BOTH OF THE PATIENT WERE HOSPITALIZED AFTER THE FACT DUE TO INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Unspecified Infection
MAUDE report 22394861 ↗InjuryJul 3, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A CERVICAL BIOPSY PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. DURING THE PROCEDURE THEY PLACED THE ABSORBABLE HEMOSTAT ON THE BIOPSY SITE. THE PATIENT CAME BACK WITH A CERVICAL FLUSH INFECTION. THEY ARE SAYING THAT THE ABSORBABLE HEMOSTAT IS NOT DISSOLVED LIKE TYPICALLY HAD IN THE PAST. THEY HAD TO TAKE BACK IN THE OFFICE AND PHYSICALLY REMOVED THE ABSORBABLE HEMOSTAT. BOTH OF THE PATIENT WERE HOSPITALIZED AFTER THE FACT DUE TO INFECTION. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Unspecified Infection
MAUDE report 22394682 ↗MalfunctionJun 25, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT FEEDBACK WAS RECEIVED ABOUT SUSPECTED COUNTERFEIT PRODUCTS FROM ONLINE SOURCES. CHINA SUPPLY CHAIN CHECKED PRODUCT TRACEABILITY INFORMATION BUT THERE'S NO RECORD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22331882 ↗MalfunctionJun 25, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT FEEDBACK WAS RECEIVED ABOUT SUSPECTED COUNTERFEIT PRODUCTS FROM ONLINE SOURCES. CHINA SUPPLY CHAIN CHECKED PRODUCT TRACEABILITY INFORMATION BUT THERE'S NO RECORD. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22331607 ↗MalfunctionApr 30, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT UNAUTHORIZED DISTRIBUTORS SELLING ABSORBABLE HEMOSTAT IN MINAS GERAIS. ONE BATCH WAS NOT DISTRIBUTED IN BRAZIL, IT HAS A LABEL THAT IS NOT FROM J&J ¿ DEVIATION CONFIRMED WITH THE POSSIBILITY OF BEING FAKE. TWO OTHER BATCHES WERE SOLD IN BRAZIL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21938453 ↗
Other Ethicon Sàrl products
All Ethicon Sàrl devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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