Ethicon recalls

Ethicon has 76 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 1 Oct 2025. 23 are still ongoing. The most frequent reason is sterility.

Total recalls76since 2012

Last 12 months0reported

Class I23% of total

Ongoing23latest 1 Oct 2025

Recalls per month, last 24 months

click a bar for that month

2Nov '24 0 0 3Feb 0 0 0May 0 0 0Aug 0 1 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 2 3%Class II 74 97%Class III 0 0%

Why ethicon is recalled

Product types

By year

202545%
20241013%
202334%
202245%
202111%
202079%
2019811%
20182837%
201634%
201511%

Ongoing ethicon recalls

23 active

Reported	Class	Recall	Company	Reason	Where
1 Oct 2025Device	CLASS II	Stratafix Spiral PDS Plus Bidirectional Knotless Tissue recalled	Ethicon	Other	Nationwide
12 Feb 2025Device	CLASS II	Perma-hand Silk Suture recalled by Ethicon	Ethicon	Sterility	Nationwide
12 Feb 2025Device	CLASS II	Ethibond Excel Polyester Suture recalled by Ethicon	Ethicon	Sterility	Nationwide
12 Feb 2025Device	CLASS II	Prolene Polypropylene Suture recalled by Ethicon	Ethicon	Sterility	Nationwide
27 Nov 2024Device	CLASS II	Monocryl" (poliglecaprone Suture recalled by Ethicon	Ethicon	Packaging Defects	45 states
13 Nov 2024Device	CLASS II	Coated Vicryl Polyglactin 910 Suture VIO USP0(M3.5) S/A CT recalled	Ethicon	Potency & Assay	NJ

All ethicon recalls, newest first

76 total

Reported	Class	Recall	Company	Reason	Where
1 Oct 2025Device	CLASS II	Stratafix Spiral PDS Plus Bidirectional Knotless Tissue recalled	Ethicon	Other	Nationwide
12 Feb 2025Device	CLASS II	Perma-hand Silk Suture recalled by Ethicon	Ethicon	Sterility	Nationwide
12 Feb 2025Device	CLASS II	Ethibond Excel Polyester Suture recalled by Ethicon	Ethicon	Sterility	Nationwide
12 Feb 2025Device	CLASS II	Prolene Polypropylene Suture recalled by Ethicon	Ethicon	Sterility	Nationwide
27 Nov 2024Device	CLASS II	Monocryl" (poliglecaprone Suture recalled by Ethicon	Ethicon	Packaging Defects	45 states
13 Nov 2024Device	CLASS II	Coated Vicryl Polyglactin 910 Suture VIO USP0(M3.5) S/A CT recalled	Ethicon	Potency & Assay	NJ
26 Jun 2024Device	CLASS II	Monocryl Plus Antibacterial (poliglecaprone Suture recalled by Ethicon	Ethicon	Sterility	Nationwide
26 Jun 2024Device	CLASS II	Vicryl Plus Antibacterial (polyglactin 910) Suture recalled by Ethicon	Ethicon	Sterility	Nationwide
26 Jun 2024Device	CLASS II	PDS II (polydioxanone) Suture - Intended for use recalled by Ethicon	Ethicon	Sterility	Nationwide
26 Jun 2024Device	CLASS II	Vicryl (polyglactin 910) Suture - Indicated for use recalled by Ethicon	Ethicon	Sterility	Nationwide
26 Jun 2024Device	CLASS II	Monocryl (poliglecaprone Suture - Intended for use recalled by Ethicon	Ethicon	Sterility	Nationwide
26 Jun 2024Device	CLASS II	PDS Plus Antibacterial (polydioxanone) Suture - Intended recalled	Ethicon	Sterility	Nationwide
29 May 2024Device	CLASS II	Surgifoam" Absorbable Gelatin Powder Kit, Product recalled by Ethicon	Ethicon	Packaging Defects	Nationwide
24 Apr 2024Device	CLASS II	Stratafix Spiral Monocryl Plus BI UD 12+(30+ USP3-0(M2) D/A recalled	Ethicon	Sterility	9 states
27 Sep 2023Device	CLASS II	PDS II (polydioxanone) Suture, Product Numbers Z844G recalled by Ethicon	Ethicon	Other	Nationwide
27 Sep 2023Device	CLASS II	PDS Plus Antibacterial (polydioxanone) Suture recalled by Ethicon	Ethicon	Other	Nationwide
17 May 2023Device	CLASS II	Pds¿ Plus Antibacterial (polydioxanone) Suture recalled by Ethicon	Ethicon	Device Malfunction	NJ
21 Dec 2022Device	CLASS II	Pds II (polydioxanone) Suture- Violet Monofilament 0 S/A recalled	Ethicon	Device Malfunction	NJ
9 Nov 2022Device	CLASS II	Stratafix Spiral Pga-pcl Uni Ud Usp2-0(m3) S/a Sh recalled by Ethicon	Ethicon	Packaging Defects	NJ
28 Sep 2022Device	CLASS II	PDS II (polydioxanone) Suture, Product recalled by Ethicon	Ethicon	Other	NJ
18 May 2022Device	CLASS II	Stratafix Spiral Pga-pcl Uni UD sizes recalled by Ethicon	Ethicon	Packaging Defects	NJ
10 Feb 2021Device	CLASS II	Dermabond Advanced Topical Skin Adhesive-topical skin recalled	Ethicon	Sterility	Nationwide
9 Dec 2020Device	CLASS II	Proceed Surgical Mesh Hernia Mesh Oval recalled by Ethicon	Ethicon	Sterility	NJ
28 Oct 2020Device	CLASS II	Vicryl Monofilament Violet USP 10-0 (m0.2) Single-armed Cs140 recalled	Ethicon	Packaging Defects	NJ
8 Jul 2020Device	CLASS II	Perma-hand/Mersilk Silk Blu and Virgin Silk Blu recalled by Ethicon	Ethicon	Device Malfunction	NJ
26 Feb 2020Device	CLASS II	1 Stratafix" Spiral PDS Plus Violet 12" CT-1 Needle, SXPP1B429 recalled	Ethicon	Other	NJ
26 Feb 2020Device	CLASS II	1 Stratafix" Spiral PDS Plus Violet 36" CTX Needle, SXPP1B402 recalled	Ethicon	Other	NJ
26 Feb 2020Device	CLASS II	1 Stratafix Spiral PDS Plus Violet 18" OS-6 Needle, SXPP1B201 recalled	Ethicon	Other	NJ
12 Feb 2020Device	CLASS II	Coated Vicryl (Polyglactin 910) Suture, 18" Product recalled by Ethicon	Ethicon	Other	Nationwide
16 Oct 2019Device	CLASS II	Stratafix Spiral PDS Plus Violet 18 CT-1 Needle Product recalled	Ethicon	Device Malfunction	14 states

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.