Ethicon Sarl
FDA adverse event reports naming Ethicon Sarl as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ETHICON SARL.
- Total reports
- 1,741
- Deaths
- 0
- Injuries
- 1,715
- Malfunctions
- 26
Reports per year
Source: FDA adverse event reports by year received, 2012–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or TransobturatorOTN1,488
- Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally PlacedOTP153
- Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-SlingPAH92
- Agent, Absorbable Hemostatic, Collagen BasedLMF6
- Mesh, Surgical, PolymericFTL1
- Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally PlacedOTO1
Recent recalls
- 2024-07-17Open, ClassifiedProcess control
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961
Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.
- 2024-07-17Open, ClassifiedProcess control
SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963
Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.
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