SURGICEL 1952SRecalls & reported problems
Ethicon Sàrl · Absorbable Hemostat (oxidized regenerated cellulose) · Class 3 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705031468115), received between Apr 30, 2025 and Apr 30, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Device Markings/Labelling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2025Device Markings/Labelling Problem; Appropriate Device Problem Term/Code Not Available; Device Markings/Labelling Problem; Appropriate Device Problem Term/Code Not Available
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 21938338 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.