Ethicon Inc
FDA adverse event reports naming Ethicon Inc as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ETHICON INC.
- Total reports
- 1,759
- Deaths
- 5
- Injuries
- 1,658
- Malfunctions
- 84
Reports per year
Source: FDA adverse event reports by year received, 2006–2025. 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 TransobturatorOTN619
- Mesh, Surgical, PolymericFTL605
- Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally PlacedOTP255
- Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-SlingPAH100
- Suture, Absorbable, Synthetic, Polyglycolic AcidGAM61
- Laparoscope, Gynecologic (And Accessories)HET20
- Cutaneous Tissue Adhesive With MeshOMD13
- Suture, Nonabsorbable, Synthetic, PolypropyleneGAW9
- Tissue Adhesive For The Topical Approximation Of SkinMPN9
- Suture, Absorbable, NaturalGAL8
Recent recalls
- 2024-11-19Open, ClassifiedProcess control
MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery.
Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
- 2024-11-07Open, ClassifiedUnder Investigation by firm
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.
- 2024-06-14Open, ClassifiedUnder Investigation by firm
VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues. PRODUCT CODE: J214H J218H J258H J268H J269H J327H J344H J345H J370H J416H J417H J426H J427H J458H J493H J603H J699H J936H J978H
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- 2024-06-14Open, ClassifiedUnder Investigation by firm
VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, except for ophthalmic, cardiovascular and neurological tissues. PRODUCT CODE: VCP196H VCP417H VCP602H VCP603H VCP662H VCPB259H VCPB946H
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- 2024-06-14Open, ClassifiedUnder Investigation by firm
PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: D6261 Z117H Z149H Z259H Z305H Z320H
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- 2024-06-14Open, ClassifiedUnder Investigation by firm
PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: PDP304H PDP316H PDP341H
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- 2024-06-14Open, ClassifiedUnder Investigation by firm
MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- 2024-06-14Open, ClassifiedUnder Investigation by firm
MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CODE: MCP266H13 MCP3200H16 MCP3212H16 MCP3213H16 MCP340H13 MCP345H13 MCP416H14 MCP417H14 MCP426H13 MCP427H13 MCP4423H16 MCP4424H14 MCP442H14 MCP496H16 MCP497H16 MCP604H13 MCP936H13 MCP945H14 MCPB346H13
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
- 2024-05-22Open, ClassifiedUnder Investigation by firm
SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Some applicator tips from these lots had open seals.
- 2024-04-12Open, ClassifiedUnder Investigation by firm
STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product Code: SXMP2B412
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
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