Chrysalis Intelligence · Sponsors · Ethicon Endo-Surgery, LLC

Ethicon Endo-Surgery, LLC

Guaynabo, PR, US · 21 510(k) clearances · 6 recalls (1 Class I)

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Total clearances
21
2020-02-28 → 2026-05-11
Last 12 months
3
Product codes
5
Most recent
2026-05-11
Name variants in FDA filings: Ethicon Endo-Surgery, LLC / Ethicon Endo-Surgery
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
GDW Staple, Implantable Class II General, Plastic Surgery 9 2026-05-11
GEI Electrosurgical, Cutting & Coagulation & Accessories Class II General, Plastic Surgery 5 2023-04-13
LFL Instrument, Ultrasonic Surgical Unclassified Unknown 3 2023-02-28
OXC — — — 2 2026-01-09
GAG — — — 2 2024-07-03
Safety

Recalls (6)

Class I (serious)
1
Risk of injury / death
Total recalls
6
Currently ongoing
5
Most recent
2025-09-11
DateSeverityStatusRecall # ProductCodeReason
2025-09-11 Class II Ongoing Z-0147-2026 ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product N… — The devices were shipped unsterilized.
2025-04-22 Class I Ongoing Z-1746-2025 Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35 — Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device…
2023-12-11 Class II Ongoing Z-0834-2024 ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutte… — There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue appos…
2021-07-20 Class II Ongoing Z-2356-2021 HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal therma… — An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burn…
2021-07-20 Class II Ongoing Z-2355-2021 HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal therm… — An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burn…
2021-06-03 Class II Terminated Z-2326-2021 ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomoses. The instruments h… — Mislabeled: Labeled on the package as 60mm contains 45mm devices
Filings

All 510(k) clearances (21)

Date K-number Device Code Class Specialty
2026-05-11 K260196 ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm) GDW Class II General, Plastic Surgery
2026-01-09 K252906 ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) OXC — —
2025-12-17 K252739 ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T) GDW Class II General, Plastic Surgery
2025-05-14 K250835 ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T) GDW Class II General, Plastic Surgery
2025-02-25 K243276 ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G) GDW Class II General, Plastic Surgery
2024-10-28 K241630 ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T) GDW Class II General, Plastic Surgery
2024-07-03 K241629 ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L) GAG — —
2023-04-13 K230387 ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 cm shaft length (NSLX137C); ENSEAL X1 Curved Tissue Sealers, 45 cm shaft ength (NSLX137C); ENSEAL X1 Straight Tissue Sealers, 25 cm shaft length (NSLX125S); ENSEAL X1 Straight Tissue Sealers, 37 cm shaft length (NSLX137S) GEI Class II General, Plastic Surgery
2023-03-15 K223760 ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G);ECHELON LINEAR™ Cutters 80mm Blue Reload (GLCR80B);ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G) GDW Class II General, Plastic Surgery
2023-02-28 K221790 HARMONIC 700 Shears LFL Unclassified Unknown
2022-09-16 K221343 ECHELON ENDOPATH Staple Line Reinforcement OXC — —
2022-04-08 K213633 ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler GAG — —
2021-05-21 K211273 Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray LFL Unclassified Unknown
2021-01-22 K201696 ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length GEI Class II General, Plastic Surgery
2021-01-22 K201066 ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length GEI Class II General, Plastic Surgery
2020-10-15 K202665 Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm GDW Class II General, Plastic Surgery
2020-07-27 K201280 Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed GDW Class II General, Plastic Surgery
2020-06-29 K200420 Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green GDW Class II General, Plastic Surgery
2020-05-27 K200253 Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector GEI Class II General, Plastic Surgery
2020-05-11 K200841 Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 GEI Class II General, Plastic Surgery
2020-02-28 K191555 HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length LFL Unclassified Unknown
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence