Smith & Nephew recalls

Smith & Nephew has 258 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 24 Jun 2026. 86 are still ongoing. 2 were reported in the last 12 months.

Total recalls258since 2012

Last 12 months2reported

Class I00% of total

Ongoing86latest 24 Jun 2026

Recalls per month, last 24 months

click a bar for that month

5Nov '24 1 0 0Feb 0 0 1May 0 0 0Aug 0 0 0Nov 1 0 0Feb 0 0 0May 1 0 0Aug 0 0

Severity split

Class I 0 0%Class II 258 100%Class III 0 0%

Why smith & nephew is recalled

Product types

By year

202610%
202521%
2024114%
2023104%
202242%
2021104%
20206324%
2019104%
2018229%
20174819%

Ongoing smith & nephew recalls

86 active

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	Trigen Proximal Straight Humeral Nail recalled by Smith & Nephew	Smith & Nephew	Other	DE
24 Dec 2025Device	CLASS II	Biosure HA Screw Threaded metallic bone fixation fastener recalled	Smith & Nephew	Labeling Errors	Nationwide
28 May 2025Device	CLASS II	Meta-tan Lag/compression Screw Kit recalled by Smith & Nephew	Smith & Nephew	Other	Nationwide
11 Dec 2024Device	CLASS II	Bioraptor Suture Anchors recalled by Smith & Nephew	Smith & Nephew	Sterility	Nationwide
13 Nov 2024Device	CLASS II	Tandem Intl Bipolar Cocr Shell/Uhmwpe Liner recalled by Smith & Nephew	Smith & Nephew	Other	TN
6 Nov 2024Device	CLASS II	Leigon Oxinium Constrained Nonporous Femoral Component, Size 3 Left recalled	Smith & Nephew	Packaging Defects	TX

All smith & nephew recalls, newest first

258 total

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	Trigen Proximal Straight Humeral Nail recalled by Smith & Nephew	Smith & Nephew	Other	DE
24 Dec 2025Device	CLASS II	Biosure HA Screw Threaded metallic bone fixation fastener recalled	Smith & Nephew	Labeling Errors	Nationwide
28 May 2025Device	CLASS II	Meta-tan Lag/compression Screw Kit recalled by Smith & Nephew	Smith & Nephew	Other	Nationwide
11 Dec 2024Device	CLASS II	Bioraptor Suture Anchors recalled by Smith & Nephew	Smith & Nephew	Sterility	Nationwide
13 Nov 2024Device	CLASS II	Tandem Intl Bipolar Cocr Shell/Uhmwpe Liner recalled by Smith & Nephew	Smith & Nephew	Other	TN
6 Nov 2024Device	CLASS II	Leigon Oxinium Constrained Nonporous Femoral Component, Size 3 Left recalled	Smith & Nephew	Packaging Defects	TX
6 Nov 2024Device	CLASS II	Genesis Ii Nonporous Posterior Stabilized Femoral Component recalled	Smith & Nephew	Packaging Defects	7 states
6 Nov 2024Device	CLASS II	Legion Oxinium Posterior Stabilized Nonporous Femoral recalled	Smith & Nephew	Packaging Defects	7 states
6 Nov 2024Device	CLASS II	Leigon Oxinium Constrained Nonporous Femoral Component, Size 4 Left recalled	Smith & Nephew	Packaging Defects	TX
25 Sep 2024Device	CLASS II	Diamond Point, Both Ends K-wire recalled by Smith & Nephew	Smith & Nephew	Packaging Defects	TN
25 Sep 2024Device	CLASS II	Diamond Point, Both Ends K-wire recalled by Smith & Nephew	Smith & Nephew	Packaging Defects	TN
18 Sep 2024Device	CLASS II	Rotation Medical Tendon Staples (broad recalled by Smith & Nephew	Smith & Nephew	Sterility	Nationwide
18 Sep 2024Device	CLASS II	Rotation Medical Tendon Staples (narrow recalled by Smith & Nephew	Smith & Nephew	Sterility	Nationwide
5 Jun 2024Device	CLASS II	Oxinium Femoral Head 12/14 Taper recalled by Smith & Nephew	Smith & Nephew	Packaging Defects	TN
1 Nov 2023Device	CLASS II	Journey Ii Bcs Articular Insert, Left Size recalled by Smith & Nephew	Smith & Nephew	Packaging Defects	Nationwide
1 Nov 2023Device	CLASS II	Journey II Bcs Constrained Articular Insert Size 5-6 Left recalled	Smith & Nephew	Packaging Defects	Nationwide
27 Sep 2023Device	CLASS II	Legion Oxinum Posterior Stabilized Nonporous Fermoal recalled	Smith & Nephew	Packaging Defects	7 states
30 Aug 2023Device	CLASS II	Trigen Trochanteric Antegrade Nail Lime 130 Degree Left recalled	Smith & Nephew	Packaging Defects	CA, DE, PA
30 Aug 2023Device	CLASS II	Trigen Trochanteric Antegrade Nail Lime 130 Degree Left recalled	Smith & Nephew	Packaging Defects	CA, DE, PA
7 Jun 2023Device	CLASS II	Engage Cementless Partial Knee System, Coated Tibial Insert recalled	Smith & Nephew	Other	Nationwide
7 Jun 2023Device	CLASS II	Engage Cementless Partial Knee System, Coated Tibial Tray recalled	Smith & Nephew	Other	Nationwide
7 Jun 2023Device	CLASS II	Engage Cementless Partial Knee System recalled by Smith & Nephew	Smith & Nephew	Other	Nationwide
7 Jun 2023Device	CLASS II	Engage Cementless Partial Knee System, Tibial Anchor Stem recalled	Smith & Nephew	Other	Nationwide
26 Apr 2023Device	CLASS II	Journey Ii Uni Xlpe Tibia Insert Medial Sz recalled by Smith & Nephew	Smith & Nephew	Packaging Defects	Nationwide
27 Jul 2022Device	CLASS II	Genesis II Non-Porous Tibial Baseplate Size 5 Right recalled	Smith & Nephew	Packaging Defects	Nationwide
25 May 2022Device	CLASS II	Legion Narrow PS Oxin SZ 6N RT and Jrny II Bcs Femoral Oxin LT SZ recalled	Smith & Nephew	Other	Nationwide
16 Feb 2022Device	CLASS II	Acufex Access Advanced Positioning Kit - indicated recalled	Smith & Nephew	Sterility	Nationwide
9 Feb 2022Device	CLASS II	Integra Surfix Alpha Screwdriver Torx recalled by Smith & Nephew	Smith & Nephew	Potency & Assay	Nationwide
22 Dec 2021Device	CLASS II	Evos Medial Distal Femur Plate, R, 5h recalled by Smith & Nephew	Smith & Nephew	Other	Nationwide
22 Dec 2021Device	CLASS II	Evos Condylar Medial Distal Femur Plate, R, 5h recalled	Smith & Nephew	Other	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.