Chrysalis Intelligence · Sponsors · ETHICON, Inc.

ETHICON, Inc.

Raritan, NJ, US · 13 510(k) clearances · 97 PMAs · 26 recalls

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Total clearances
13
2020-03-25 → 2026-06-25
Last 12 months
6
Product codes
6
Most recent
2026-06-25
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid Class II General, Plastic Surgery 5 2026-06-25
NEW — — — 4 2026-05-18
GAW Suture, Nonabsorbable, Synthetic, Polypropylene Class II General, Plastic Surgery 1 2026-03-27
OMD Cutaneous Tissue Adhesive With Mesh Class II General, Plastic Surgery 1 2021-12-07
OTN — — — 1 2020-09-17
FTL Mesh, Surgical, Polymeric Class II General, Plastic Surgery 1 2020-08-06
Class III

PMA approvals (97)

Total PMA records
97
Originals + supplements
Distinct product codes
4
First decision
2020-01-30
Most recent
2026-07-28
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-07-28 N12159-S129 SURGICELTM POWDER Absorbable Hemostatic Powder Normal 180 Day Track LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2026-06-25 P880047-S070 GYNECARE INTERCEED™ Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2026-06-25 P240035-S002 ETHIZIA Hemostatic Patch Panel Track SGV — —
2026-06-25 N12159-S130 SURGICEL® Absorbable Hemostats 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2026-02-26 P240035-S005 ETHIZIA Hemostatic Patch 30-Day Notice SGV — —
2026-02-24 P240035-S006 ETHIZIA™ Hemostatic Patch 30-Day Notice SGV — —
2026-01-28 P240035-S003 ETHIZIA™ Hemostatic Patch Normal 180 Day Track No User Fee SGV — —
2026-01-22 P240035-S001 ETHIZIA™ Hemostatic Patch 30-Day Notice SGV — —
2026-01-15 P880047-S069 GYNECARE INTERCEED™ Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2026-01-15 N12159-S128 SURGICEL® Absorbable Hemostats 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2025-12-15 P240035 ETHIZIA Original SGV — —
2025-12-12 P880047-S068 INTERCEED™ Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2025-12-12 N12159-S127 SURGICEL® Absorbable Hemostats 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2025-11-04 N12159-S122 SURGICEL® Absorbable Hemostats Real-Time Process LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2025-10-09 P880047-S067 GYNECARE INTERCEED 3INX4IN(7.6CMX10.2CM); GYNECARE INTERCEED 5INX6IN(12.7CMX15.2CM); GYNECARE INTERCEED 3INX2IN(7.6CMX5. 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2025-10-09 N12159-S126 SURGICEL ORIGINAL 2INX14IN (5.1CMX35.6CM); SURGICEL ORIGINAL 4INX8IN (10.2CMX20.3CM); SURGICEL ORIGINAL 2INX3IN(5.1CMX7. 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2025-09-24 P880047-S066 GYNECARE INTERCEED™ Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2025-09-24 N12159-S125 SURGICEL® Absorbable Hemostats; SURGICEL® POWDER Absorbable Hemostatic Powder 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2025-09-09 N12159-S123 SURGICEL BRAND ABSORBABLE HEMOSTAT 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2025-09-04 P880047-S065 GYNECARE INTERCEED™ Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2025-09-04 N12159-S124 SURGICEL® Absorbable Hemostats 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2025-03-21 N12159-S102 SURGICEL® Absorbable Hemostats and SURGICEL® POWDER Absorbable Hemostatic Powder 135 Review Track For 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2025-03-07 N12159-S120 SURGICEL SNoW Absorbable Hemostats; SURGICEL FIBRILLAR Absorbable Hemostats 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2025-03-05 N12159-S112 SURGICEL ORIGINAL Absorbable Hemostat, SURGICEL NU-KNIT Absorbable Hemostat, SURGICEL FIBRILLAR Absorbable Hemostat, SUR 135 Review Track For 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2025-01-30 P880047-S063 Gynecare Interceed™ Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2025-01-30 N12159-S119 SURGICEL® Absorbable Hemostats 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2024-12-19 P880047-S062 GYNECARE INTERCEED Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2024-12-19 N12159-S118 SURGICEL Absorbable Hemostats 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2024-12-13 N12159-S116 SURGICEL Powder Absorbable Hemostats Real-Time Process LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2024-12-05 N12159-S117 SURGICEL Absorbable Hemostats (SURGICEL Endoscopic Applicator) 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2024-08-28 N12159-S115 SURGICEL® Absorbable Hemostats (SURGICEL® SNOW™) 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2024-08-27 P880047-S061 GYNECARE INTERCEED™ Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2024-08-27 N12159-S114 SURGICEL® Absorbable Hemostats 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2024-06-13 P880047-S060 GYNECARE INTERCEED ™ Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2024-06-13 N12159-S113 SURGICEL® Absorbable Hemostats 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2024-05-16 P880047-S059 GYNECARE INTERCEED™ Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2024-05-16 N12159-S110 SURGICEL® ORIGINAL, SURGICEL® NU-KNIT™, SURGICEL® FIBRILLAR™, SURGICEL® SNOW™ 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2024-05-14 N12159-S111 SURGICEL® Absorbable Hemostats (SURGICEL POWDER™) 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2024-05-01 N12159-S109 SURGICEL® Absorbable Hemostats 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2024-03-25 P880047-S058 GYNECARE INTERCEED™ Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2023-12-14 N12159-S108 SURGICEL® Absorbable Hemostats (SURGICEL® POWDER™) 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2023-12-11 P880047-S057 GYNECARE INTERCEED™ Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2023-11-14 P880047-S055 GYNECARE INTERCEED Absorbable Adhesion Barrier Real-Time Process MCN Barrier, Absorbable, Adhesion Unknown
2023-11-14 N12159-S106 SURGICEL® Absorbable Hemostats Real-Time Process LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2023-11-01 P880047-S056 GYNECARE INTERCEED™ Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2023-11-01 N12159-S107 SURGICEL® Absorbable Hemostats 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2023-09-13 N12159-S105 SURGICEL® Absorbable Hemostats 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2023-07-11 N12159-S104 SURGICEL® ORIGINAL Absorbable Hemostat, SURGICEL® NU-KNIT™ Absorbable Hemostat, SURGICEL® SNOW™ Absorbable Hemostat 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2023-06-26 N12159-S103 SURGICEL® Absorbable Hemostats (SURGICEL® POWDER™) 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2023-04-04 N12159-S101 SURGICEL® Absorbable Hemostats (SURGICEL® POWDER™) 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2023-02-28 P880047-S054 GYNECARE INTERCEED™ Absorbable Adhesion Barrier 30-Day Notice — — —
2023-02-28 N12159-S100 SURGICEL® Absorbable Hemostats (SURGICEL® ORIGINAL, SURGICEL® NU-KNIT™, SURGICEL® POWDER™) 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2023-02-16 N12159-S099 SURGICEL® SNOW™ Absorbable Hemostat 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2023-02-16 N12159-S098 SURGICEL Absorbable Hemostats, SURGICEL Powder Special (Immediate Track) LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2022-12-20 P880047-S052 GYNECARE INTERCEED™ Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2022-12-20 N12159-S096 SURGICEL® Absorbable Hemostats 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2022-07-26 N12159-S086 SURGICEL™ Original Absorbable Hemostat, SURGICEL™ NU-KNIT Absorbable Hemostat, SURGICEL™ Fibrillar Absorbable Hemostat, Real-Time Process LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2022-07-08 P880047-S050 Gynecare Interceed Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2022-07-08 N12159-S094 SURGICELTM Family of Absorbable Hemostats 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2022-06-15 P880047-S046 GYNECARE INTERCEED™ Absorbable Adhesion Barrier Normal 180 Day Track MCN Barrier, Absorbable, Adhesion Unknown
2022-05-25 N12159-S092 Surgicel Nu-Knit Absorbable Hemostat 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2022-05-18 N12159-S089 SURGICEL® Absorbable Hemostats (SURGICEL® FIBRILLAR™, SURGICEL® SNOW) 135 Review Track For 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2022-03-15 N12159-S088 SURGICEL™ Fibrillar Absorbable Hemostat, SURGICEL SNoW™ Absorbable Hemostat 135 Review Track For 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2022-03-07 P880047-S047 GYNECARE INTERCEED™ Absorbable Adhesion Barrier Real-Time Process MCN Barrier, Absorbable, Adhesion Unknown
2022-01-21 P880047-S043 GYNECARE INTERCEED™ Absorbable Adhesion Barrier 135 Review Track For 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2022-01-21 N12159-S085 SURGICEL® Absorbable Hemostats (SURGICEL® ORIGINAL, SURGICEL® NU-KNIT™ , SURGICEL® FIBRILLAR™, SURGICEL® SNOW™) 135 Review Track For 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2022-01-20 P880047-S049 GYNECARE INTERCEED™ Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2022-01-20 N12159-S090 SURGICEL™ ORIGINAL Absorbable Hemostat, SURGICEL™ Nu-Knit Absorbable Hemostat, SURGICEL™ Fibrillar Absorbable Hemostat, 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2022-01-19 N12159-S091 SURGICEL SNoW™ Absorbable Hemostat 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2021-10-29 P880047-S045 GYNECARE INTERCEED™ Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2021-10-21 P880047-S044 GYNECARE INTERCEED™ Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2021-10-21 N12159-S087 SURGICEL™ ORIGINAL Absorbable Hemostat, SURGICEL™ Nu-Knit Absorbable Hemostat , SURGICEL™ Fibrillar Absorbable Hemostat, 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2021-09-30 N12159-S084 SURGICEL® SNoW™ Absorbable Hemostat 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2021-09-10 P880047-S042 GYNECARE INTERCEED™ Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2021-09-10 N12159-S083 SURGICEL™ ORIGINAL Absorbable Hemostat, SURGICEL™ Nu-Knit Absorbable Hemostat, SURGICEL™ Fibrillar Absorbable Hemostat, 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2021-08-31 P880047-S041 GYNECARE INTERCEED™ Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2021-08-31 N12159-S082 SURGICEL ORIGINAL Absorbable Hemostat, SURGICEL Nu-Knit Absorbable Hemostat, SURGICEL Fibrillar Absorbable Hemostat, SUR 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2021-08-16 N12159-S081 SURGICEL Absorbable Hemostats 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2021-07-30 N12159-S080 SURGICEL NU-KNIT Absorbable Hemostat 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2021-04-21 P880047-S040 GYNECARE INTERCEED Absorbable Adhesion Barrier Special (Immediate Track) MCN Barrier, Absorbable, Adhesion Unknown
2021-04-01 P880047-S039 GYNECARE INTECEED Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2021-04-01 N12159-S079 SURGICEL Family of Absorbable Hemostats 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2021-03-31 N12159-S078 SURGICEL FIBRILLAR Absorbable Hemostat and SURGICEL NU-KNIT Absorbable Hemostat 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2020-12-22 N12159-S077 SURGICEL Absorbable Hemostat 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2020-11-12 N12159-S076 SURGICEL Absorbable Hemostats 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2020-11-04 P880047-S038 GYNECARE INTERCEED Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2020-11-03 N12159-S075 SURGICEL Absorbable Hemostats 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2020-09-24 N12159-S073 SURGICEL FIBRILLAR Absorbable Hemostat Real-Time Process LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2020-09-21 N12159-S069 SURGICEL Powder Absorbable Hemostatic Powder 135 Review Track For 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2020-08-14 N12159-S074 SURGICEL Absorbable Hemostat 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2020-07-15 P880047-S037 GYNECARE INTERCEED Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2020-07-15 N12159-S072 SURGICEL Family of Absorbable Hemostats 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2020-05-21 P880047-S036 GYNECARE INTERCEED Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2020-05-20 P880047-S035 GYNECARE INTERCEED Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
2020-04-13 N12159-S070 SURGICEL SNoW Absorbable Hemostat 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2020-03-04 N12159-S068 Surgicel Powder Absorbable Hemostatic Powder 30-Day Notice LMG Agent, Absorbable Hemostatic, Non-Collagen Based General, Plastic Surgery
2020-01-30 P880047-S034 Gynecare Interceed Absorbable Adhesion Barrier 30-Day Notice MCN Barrier, Absorbable, Adhesion Unknown
Safety

Recalls (26)

Class I (serious)
0
Risk of injury / death
Total recalls
26
Currently ongoing
22
Most recent
2025-08-15
DateSeverityStatusRecall # ProductCodeReason
2025-08-15 Class II Ongoing Z-2605-2025 STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/… — Potential for barb non-engagement.
2024-12-20 Class II Ongoing Z-1098-2025 ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US — Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in s…
2024-12-20 Class II Ongoing Z-1097-2025 PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tiss… — Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in s…
2024-12-20 Class II Ongoing Z-1096-2025 PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general so… — Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in s…
2024-10-08 Class II Ongoing Z-0487-2025 MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approxi… — Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
2024-09-25 Class II Ongoing Z-0319-2025 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 …
2024-05-10 Class II Ongoing Z-2149-2024 MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or li… — Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
2024-05-10 Class II Ongoing Z-2148-2024 MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an abs… — Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
2024-05-10 Class II Ongoing Z-2147-2024 PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in … — Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
2024-05-10 Class II Ongoing Z-2146-2024 PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardi… — Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
2024-05-10 Class II Ongoing Z-2145-2024 VICRYL Plus Antibacterial (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligat… — Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
2024-05-10 Class II Ongoing Z-2144-2024 VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use … — Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
2024-04-23 Class II Ongoing Z-1881-2024 SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979. — Some applicator tips from these lots had open seals.
2024-03-08 Class II Ongoing Z-1533-2024 STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12I… — Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
2023-08-10 Class II Ongoing Z-2617-2023 PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05, D6776-05, D6776-05, D9297-05, D9297-05, Z… — Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
2023-08-10 Class II Ongoing Z-2616-2023 PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PD… — Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
2023-03-31 Class II Ongoing Z-1571-2023 PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in… — Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or …
2022-11-16 Class II Ongoing Z-0480-2023 PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approx… — knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than p…
2022-09-20 Class II Ongoing Z-0150-2023 STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of … — Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point …
2022-08-08 Class II Ongoing Z-1773-2022 PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles — Product may contain the incorrect material which could impact treatment.
2022-03-24 Class II Ongoing Z-1053-2022 STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A P… — Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
2021-01-04 Class II Terminated Z-0953-2021 Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of … — Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach
2020-10-23 Class II Terminated Z-0533-2021 PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm — The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single …
2020-09-09 Class II Terminated Z-0116-2021 VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - Product Usage: Intended for ophthalmic soft… — Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. The correct VICRYL suture is size 10-0, 4 inches (10 cm) in leng…
2020-06-10 Class II Ongoing Z-2486-2020 PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W… — Lots of size 8-0 Blue twisted Silk Suture may not meet the stringent full shelf life of 5 years
2020-01-03 Class II Terminated Z-0989-2020 Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surg… — Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.
Filings

All 510(k) clearances (13)

Date K-number Device Code Class Specialty
2026-06-25 K253394 Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture GAM Class II General, Plastic Surgery
2026-05-18 K252047 STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices NEW — —
2026-03-27 K253572 STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device GAW Class II General, Plastic Surgery
2026-02-06 K253852 MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture GAM Class II General, Plastic Surgery
2025-12-22 K252743 STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device GAM Class II General, Plastic Surgery
2025-11-12 K243897 PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture NEW — —
2022-11-15 K221744 STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device GAM Class II General, Plastic Surgery
2022-02-22 K212380 PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture NEW — —
2021-12-07 K213512 DERMABOND PRINEO Skin Closure System OMD Class II General, Plastic Surgery
2020-12-21 K201996 Monocryl Plus Antibacterial Suture GAM Class II General, Plastic Surgery
2020-09-17 K201686 GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide OTN — —
2020-08-06 K201143 VICRYL Mesh FTL Class II General, Plastic Surgery
2020-03-25 K192144 STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device NEW — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence