Ethicon Endo-Surgery Inc
Summary
- Total Recalls
- 54 (19 Class I)
- 510(k) Clearances
- 182
- Inspections
- 8
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0147-2026 | Class II | ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of an | September 11, 2025 |
| Z-1746-2025 | Class I | Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR | April 22, 2025 |
| Z-0834-2024 | Class II | ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, End | December 11, 2023 |
| Z-2355-2021 | Class II | HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding contr | July 20, 2021 |
| Z-2356-2021 | Class II | HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding contro | July 20, 2021 |
| Z-2326-2021 | Class II | ECHELON FLEX Powered Plus Stapler-intended for transection, resection, and/or creation of anastomose | June 3, 2021 |
| Z-0656-2020 | Class II | Ligamax 5 mm Endoscopic Multiple Clip Applier | November 7, 2019 |
| Z-0202-2020 | Class I | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A | October 3, 2019 |
| Z-0201-2020 | Class I | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A | October 3, 2019 |
| Z-0200-2020 | Class I | ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A | October 3, 2019 |
| Z-0203-2020 | Class I | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A | October 3, 2019 |
| Z-1888-2019 | Class II | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C | May 15, 2019 |
| Z-1889-2019 | Class II | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C | May 15, 2019 |
| Z-1890-2019 | Class II | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C | May 15, 2019 |
| Z-1270-2019 | Class I | Curved Intraluminal Staplers, 33 mm diameter, Model CDH33A The Ethicon Endo-Surgery Intraluminal | April 11, 2019 |
| Z-1268-2019 | Class I | Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon Endo-Surgery Intraluminal | April 11, 2019 |
| Z-1275-2019 | Class I | Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon Endo-Surgery Intralumina | April 11, 2019 |
| Z-1271-2019 | Class I | Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The Ethicon Endo-Surgery Int | April 11, 2019 |
| Z-1273-2019 | Class I | Endoscopic Curved Intraluminal Stapler, 29 mm diameter, Model ECS29A The Ethicon Endo-Surgery Int | April 11, 2019 |
| Z-1267-2019 | Class I | Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon Endo-Surgery Intraluminal | April 11, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K252906 | ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) | January 9, 2026 |
| K252739 | ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler (EC3DT45S); ETHIC | December 17, 2025 |
| K250835 | ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4 | May 14, 2025 |
| K243276 | ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler (GTX60); ECHELON | February 25, 2025 |
| K241630 | ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4 | October 28, 2024 |
| K241629 | ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 30 | July 3, 2024 |
| K230387 | ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved Tissue Sealers, 37 | April 13, 2023 |
| K223760 | ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR 100 mm Cut | March 15, 2023 |
| K221790 | HARMONIC 700 Shears | February 28, 2023 |
| K221343 | ECHELON ENDOPATH Staple Line Reinforcement | September 16, 2022 |
| K213633 | ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler | April 8, 2022 |
| K211273 | Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray | May 21, 2021 |
| K201696 | ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 | January 22, 2021 |
| K201066 | ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm | January 22, 2021 |
| K202665 | Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plu | October 15, 2020 |
| K201280 | Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed | July 27, 2020 |
| K200420 | Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Ech | June 29, 2020 |
| K200253 | Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pe | May 27, 2020 |
| K200841 | Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 | May 11, 2020 |
| K191555 | HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length | February 28, 2020 |