SURGICEL SNoWRecalls & reported problems across all models
Ethicon, LLC · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls
- 0
We found 5 models of SURGICEL SNoW by Ethicon, LLC in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Jan 24, 2018 and Mar 20, 2026 — classified as 16 injuries, 21 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (9 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 SNoW problems
Device problems
- Adverse Event Without Identified Device or Use Problem14
- Delivered as Unsterile Product9
- Device Contaminated During Manufacture or Shipping9
- Appropriate Device Problem Term/Code Not Available2
- Material Integrity Problem2
- Device Markings/Labelling Problem1
- Material Discolored1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Fever7
- Foreign Body In Patient3
- Meningitis3
- Not Applicable3
- Pain3
- Unspecified Infection3
- Fluid Discharge2
SURGICEL SNoW models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SURGICEL SNoW 2082Agent, absorbable hemostatic, non-collagen based24 reports
- SURGICEL SNoW 2081Agent, absorbable hemostatic, non-collagen based5 reports
- SURGICEL SNoW 2083Agent, absorbable hemostatic, non-collagen based4 reports
- SURGICEL SNoW 2093Agent, absorbable hemostatic, non-collagen based3 reports
- SURGICEL SNoW 2092Agent, absorbable hemostatic, non-collagen based1 report
Recent SURGICEL SNoW adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. THE PRIMARY PACKAGE OF THE PRODUCT WAS FOUND DAMAGED BEFORE USING ON PATIENT DURING SURGERY. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24654530 ↗MalfunctionMar 20, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. THE DEVICE PACKAGE WAS FOUND UNSEALED WHEN UNPACKING AND COUNTING. ONE END OF THE PACKAGE IS NOT SEALED . CHANGED ANOTHER ONE TO COMPLETE THE SURGERY.. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24654322 ↗MalfunctionMar 20, 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. AFTER OPENING THE STERILE PACKAGING, FOREIGN OBJECT WAS FOUND ATTACHED TO THE GAUZE. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24654096 ↗MalfunctionDec 17, 2025Material Discolored; Device Contaminated During Manufacture or Shipping; Material Discolored; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE PATIENT UNDERWENT A THYROID AND PARATHYROID RESECTION PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. WHEN THE DOCTOR WAS UNPACKING AND PREPARING TO USE THE PRODUCT DURING THE OPERATION, DOCTOR FOUND BLACK SPOTS ON THE GAUZE AND COLOR DIFFERENCE, WITH THE GAUZE TURNING YELLOW IN COLOR. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23829161 ↗MalfunctionOct 20, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT A HEPATECTOMY PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. THE DEVICE PACKAGE WAS FOUND UNSEALED WHEN UNPACKING AND COUNTING. ONE END OF THE PACKAGE IS NOT SEALED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23335528 ↗MalfunctionApr 11, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT A TUMOR RESECTION PROCEDURE ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. IT WAS FOUND THAT THERE WAS HAIR FOREIGN OBJECT INSIDE THE PRODUCT, WHEN PREPARING FOR SURGERY. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21829769 ↗MalfunctionApr 3, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT A LOBECTOMY PROCEDURE ON AN UNKNOWN DATE, AND ABSORBABLE HEMOSTAT WAS USED. THE DEVICE PACKAGE WAS FOUND UNSEALED WHEN UNPACKING AND COUNTING. ONE END OF THE PACKAGE IS NOT SEALED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21762557 ↗InjuryNov 14, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN EMERGENCY LAPAROSCOPIC OVARIAN CYSTECTOMY PROCEDURE ON AN UNKNOWN DATE AND AN ABSORBABLE HEMOSTAT WAS USED. A YOUNG GIRL CAME FROM THE PROCEDURE, WHICH WENT WELL. THE ABSORBABLE HEMOSTAT WAS LAPAROSCOPICALLY PUT IN THE DEFECT WHERE THE CYST WAS, INTO THE BED OF THE OVARY. IT WASN¿T A LARGE CYST, LESS THAN 5CM. SIX MONTHS LATER SHE PRESENTED WITH PAIN AND SCAN SHOWED THAT A COMPLEX CYST HAD RE-FORMED. HOWEVER ON RE-LAPAROSCOPING HER IT WAS FOUND THAT ALL THE ABSORBABLE HEMOSTAT WAS STILL PRESENT WITHIN THE OVARY AND HAD NOT DISSOLVED AT ALL. IT HAD FORMED A DARK BROWN CRUST AND LOOKED LIKE NONE AT ALL HAD BEEN ABSORBED. IT WAS PARTICULARLY TRICKY BECAUSE IT DID NOT GO UP THE SUCTION WELL ONCE IRRIGATED, SO THE SURGEON PICKED IT ALL OUT WITH GRASPERS, WHICH TOOK A WHILE. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Foreign Body In Patient; Pain
MAUDE report 20684888 ↗MalfunctionApr 9, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT PRIOR TO AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE THE HOSPITAL WAREHOUSE STAFF FOUND THE ABSORBABLE HEMOSTAT FIRST BARCODE NUMBER AFTER (01) FOR OUTER PACKAGE WAS ¿2¿, BUT THE FIRST BARCODE NUMBER AFTER (01) FOR INNER PACKAGE WAS¿1¿, THEY ARE DIFFERENT. NO PRODUCT ISSUE OR PATIENT CONSEQUENCE WAS FOUND. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19075925 ↗MalfunctionApr 1, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND ABSORBABLE HEMOSTAT WAS USED. THE PACKAGE WAS OPENED ONTO THE FIELD AND BEGAN TO BE PLACED IN PATIENT TISSUE WHEN A TINY HOLE WAS DISCOVERED IN PACKAGING. THE SURGEON WAS MADE AWARE IMMEDIATELY. THE ABSORBABLE HEMOSTAT AND ALL CONTAMINATED ITEMS WERE REMOVED FROM THE FIELD, AND ALL SCRUBBED INDIVIDUALS CHANGED GLOVES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19014485 ↗InjuryMar 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HEPATECTOMY ON AN UNKNOWN DATE AND ABSORBABLE HEMOSTAT WAS USED. WHEN THE SURGEON USED THE ABSORBABLE HEMOSTAT, THEY FELT THAT THE PATIENT'S FIBRINOGEN LEVELS ARE LOWER THAN WHEN THEY USE REGULAR GAUZE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18902715 ↗MalfunctionFeb 26, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIAL REPAIR PROCEDURE ON (B)(6) 2024 AND ABSORBABLE HEMOSTAT WAS USED. WHEN OPENING IT, IT WAS FOUND THAT THE SEAL WAS NOT TIGHT. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18784161 ↗MalfunctionFeb 26, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND ABSORBABLE HEMOSTAT WAS USED. AFTER OPENING THE PACKAGE AND BEFORE USE, IT WAS FOUND THAT THERE WAS A HAIR INSIDE THE STERILE PACKAGE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18777027 ↗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 UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHERE ABSORBABLE HEMOSTAT WAS USED. AFTER INTRAOPERATIVE HEMOSTASIS, THE SURGICAL WOUND WAS COVERED WITH, AND A RAPID INCREASE IN HEART RATE OCCURRED, WITH A MAXIMUM OF 155 BEATS PER MINUTE. BLOOD PRESSURE DROPPED TO 60/40, AND THE PATIENT'S ARMS AND FACE WERE FOUND TO HAVE PAPULES AND REDNESS. IT WAS SUSPECTED THAT THE ABSORBABLE HEMOSTAT TRIGGERED AN ALLERGIC REACTION. IMMEDIATELY, THE ABSORBABLE HEMOSTAT MATERIAL WAS REMOVED THROUGH LAPAROTOMY AND STERILIZED WITH WATER. AFTER WASHING WITH WATER, THE HEART RATE AND BLOOD PRESSURE RETURNED TO NORMAL. AFTER SURGERY, THE PATIENT WAS SENT TO THE ICU FOR OBSERVATION. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: High Blood Pressure/ Hypertension; Hypersensitivity/Allergic reaction; Inflammation; Low Blood Pressure/ Hypotension; Skin Inflammation/ Irritation
MAUDE report 18539744 ↗MalfunctionDec 21, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A PATIENT UNDERWENT A RADICAL GASTRECTOMY PROCEDURE FOR GASTRIC CANCER ON AN UNKNOWN DATE AND AN ABSORBABLE HEMOSTAT WAS USED. THERE WAS A HAIR FOREIGN OBJECT INSIDE THE PRODUCT WHEN PREPARING FOR SURGERY. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED. CHANGED TO ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18378279 ↗
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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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