SURGICEL FIBRILLAR 411962Recalls & reported problems
Ethicon, LLC · Surgicel Fibrillar Absorbable Hemostat · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031005204), received between Aug 12, 2022 and Aug 24, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping1
- Device Markings/Labelling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2026Device Contaminated During Manufacture or Shipping
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50417964 ↗MalfunctionAug 12, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE OPME OBSERVED IN THE BOX OF ABSORBABLE HEMOSTAT IT IS WRITTEN "USE IN HUMANS PROHIBITED", CONSIGNMENT FOR DEMONSTRATION, PROHIBITED SALE, THE MATERIAL WAS SEALED WITH A JOHNSON AND JOHNSON LABEL. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15217514 ↗
Other Agent, absorbable hemostatic, non-collagen based devices
- ETHICON 3013SPEthicon, LLC · Agent, absorbable hemostatic, non-collagen based3 deaths392 reports
- SURGICEL FIBRILLAR 1961Ethicon Sàrl · Agent, absorbable hemostatic, non-collagen based1 recall2 deaths120 reports
- SURGICEL FIBRILLAR 1963Ethicon Sàrl · Agent, absorbable hemostatic, non-collagen based1 recall44 reports
- SURGICEL 1953Ethicon Sàrl · Agent, absorbable hemostatic, non-collagen based56 reports
- SURGICEL 1952Ethicon Sàrl · Agent, absorbable hemostatic, non-collagen based1 death41 reports
- SURGICEL FIBRILLAR 1962Ethicon Sàrl · Agent, absorbable hemostatic, non-collagen based35 reports
- Veriset HP0510ECovidien LP · Agent, Absorbable Hemostatic, Non-Collagen Based1 death33 reports
- SURGICEL SNoW 2082Ethicon, LLC · Agent, absorbable hemostatic, non-collagen based24 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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