Ethicon Endo-Surgery recalls

Ethicon Endo-Surgery has 58 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 22 Oct 2025. 9 are still ongoing. 1 was reported in the last 12 months. The most frequent reason is device malfunction.

Total recalls58since 2012

Last 12 months1reported

Class I1933% of total

Ongoing9latest 22 Oct 2025

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 4 1May 0 0 0Aug 0 1 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 19 33%Class II 39 67%Class III 0 0%

Why ethicon endo-surgery is recalled

Product types

By year

2025610%
202412%
202135%
20192238%
2018814%
201712%
201623%
201535%
201412%
20131017%

Ongoing ethicon endo-surgery recalls

9 active

Reported	Class	Recall	Company	Reason	Where
22 Oct 2025Device	CLASS II	Echelon Linear Cutters Reload Blue, intended recalled	Ethicon Endo-Surgery	Other	OH
28 May 2025Device	CLASS I	Endopath Echelon Vascular White Reload recalled by Ethicon Endo-Surgery	Ethicon Endo-Surgery	Other	Nationwide
9 Apr 2025Device	CLASS II	Pdsii¿vio¿¿usp6-0(m0.7)¿d/a¿c recalled by Ethicon Endo Surgery	Ethicon Endo Surgery	Other	Nationwide
9 Apr 2025Device	CLASS II	Ethibond Excel Grn Usp2-0(m3) D/a Mh recalled by Ethicon Endo Surgery	Ethicon Endo Surgery	Other	Nationwide
9 Apr 2025Device	CLASS II	Prolene Blu Usp6-0(m0.7) S/a P-1 Prm recalled by Ethicon Endo Surgery	Ethicon Endo Surgery	Other	Nationwide
9 Apr 2025Device	CLASS II	Pds¿plus¿vio¿¿usp6-0(m0.7)¿d/a¿c-1¿mp recalled	Ethicon Endo Surgery	Other	Nationwide

All ethicon endo-surgery recalls, newest first

58 total

Reported	Class	Recall	Company	Reason	Where
22 Oct 2025Device	CLASS II	Echelon Linear Cutters Reload Blue, intended recalled	Ethicon Endo-Surgery	Other	OH
28 May 2025Device	CLASS I	Endopath Echelon Vascular White Reload recalled by Ethicon Endo-Surgery	Ethicon Endo-Surgery	Other	Nationwide
9 Apr 2025Device	CLASS II	Pdsii¿vio¿¿usp6-0(m0.7)¿d/a¿c recalled by Ethicon Endo Surgery	Ethicon Endo Surgery	Other	Nationwide
9 Apr 2025Device	CLASS II	Ethibond Excel Grn Usp2-0(m3) D/a Mh recalled by Ethicon Endo Surgery	Ethicon Endo Surgery	Other	Nationwide
9 Apr 2025Device	CLASS II	Prolene Blu Usp6-0(m0.7) S/a P-1 Prm recalled by Ethicon Endo Surgery	Ethicon Endo Surgery	Other	Nationwide
9 Apr 2025Device	CLASS II	Pds¿plus¿vio¿¿usp6-0(m0.7)¿d/a¿c-1¿mp recalled	Ethicon Endo Surgery	Other	Nationwide
7 Feb 2024Device	CLASS II	Endopath Echelon Reloads With Gripping Surface Technology recalled	Ethicon Endo-Surgery	Other	Nationwide
1 Sep 2021Device	CLASS II	Harmonic HD 1000i Shears Shaft Length)-indicated recalled	Ethicon Endo-Surgery	Device Malfunction	Nationwide
1 Sep 2021Device	CLASS II	Harmonichd 1000i Shears Shaft Length)-indicated recalled	Ethicon Endo-Surgery	Device Malfunction	Nationwide
25 Aug 2021Device	CLASS II	Echelon Flex Powered Plus Stapler-intended for transection recalled	Ethicon Endo-Surgery	Labeling Errors	Nationwide
18 Dec 2019Device	CLASS II	Ligamax Endoscopic Multiple Clip Applier recalled	Ethicon Endo-Surgery	Sterility	Nationwide
6 Nov 2019Device	CLASS I	Echelon Flex Powered Plus Endopath Stapler - shaft, Product recalled	Ethicon Endo-Surgery	Potency & Assay	Nationwide
6 Nov 2019Device	CLASS I	Echelon Flex Powered Plus Endopath Stapler - shaft, Product recalled	Ethicon Endo-Surgery	Potency & Assay	Nationwide
6 Nov 2019Device	CLASS I	Echelon Flex Powered Plus Endopath Stapler - shaft, Product recalled	Ethicon Endo-Surgery	Potency & Assay	Nationwide
6 Nov 2019Device	CLASS I	Echelon Flex Endopath Stapler - shaft, Product recalled	Ethicon Endo-Surgery	Potency & Assay	Nationwide
3 Jul 2019Device	CLASS II	Ethicon Enseal X1 Curved Jaw Tissue Sealer Shaft Product recalled	Ethicon Endo-Surgery	Packaging Defects	Nationwide
3 Jul 2019Device	CLASS II	Ethicon Enseal X1 Curved Jaw Tissue Sealer Shaft Product recalled	Ethicon Endo-Surgery	Packaging Defects	Nationwide
3 Jul 2019Device	CLASS II	Ethicon Enseal X1 Curved Jaw Tissue Sealer Shaft Product recalled	Ethicon Endo-Surgery	Packaging Defects	Nationwide
22 May 2019Device	CLASS I	Curved Intraluminal Staplers diameter recalled by Ethicon Endo-Surgery	Ethicon Endo-Surgery	Device Malfunction	Nationwide
22 May 2019Device	CLASS I	Endoscopic Curved Intraluminal Stapler diameter recalled	Ethicon Endo-Surgery	Device Malfunction	Nationwide
22 May 2019Device	CLASS I	Curved Intraluminal Staplers diameter recalled by Ethicon Endo-Surgery	Ethicon Endo-Surgery	Device Malfunction	Nationwide
22 May 2019Device	CLASS I	Curved Intraluminal Staplers diameter recalled by Ethicon Endo-Surgery	Ethicon Endo-Surgery	Device Malfunction	Nationwide
22 May 2019Device	CLASS I	Straight Intraluminal Staplers diameter recalled by Ethicon Endo-Surgery	Ethicon Endo-Surgery	Device Malfunction	Nationwide
22 May 2019Device	CLASS I	Endoscopic Curved Intraluminal Stapler diameter recalled	Ethicon Endo-Surgery	Device Malfunction	Nationwide
22 May 2019Device	CLASS I	Curved Intraluminal Staplers diameter recalled by Ethicon Endo-Surgery	Ethicon Endo-Surgery	Device Malfunction	Nationwide
22 May 2019Device	CLASS I	Straight Intraluminal Staplers diameter recalled by Ethicon Endo-Surgery	Ethicon Endo-Surgery	Device Malfunction	Nationwide
22 May 2019Device	CLASS I	Endoscopic Curved Intraluminal Stapler diameter recalled	Ethicon Endo-Surgery	Device Malfunction	Nationwide
22 May 2019Device	CLASS I	Endoscopic Curved Intraluminal Stapler diameter recalled	Ethicon Endo-Surgery	Device Malfunction	Nationwide
22 May 2019Device	CLASS I	Straight Intraluminal Staplers diameter recalled by Ethicon Endo-Surgery	Ethicon Endo-Surgery	Device Malfunction	Nationwide
22 May 2019Device	CLASS I	Straight Intraluminal Staplers diameter recalled by Ethicon Endo-Surgery	Ethicon Endo-Surgery	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.