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. The most frequent reason is sterility.

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

0Oct '24 5 1 0Jan '25 0 0 0Apr 1 0 0Jul 0 0 0Oct 0 1 0Jan '26 0 0 0Apr 0 1 0Jul 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	Lead & Heavy Metals	Nationwide
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	Sterility	Nationwide
6 Nov 2024Device	CLASS II	Leigon Oxinium Constrained Nonporous Femoral Component, Size 3 Left recalled	Smith & Nephew	Foreign Material	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	Lead & Heavy Metals	Nationwide
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	Sterility	Nationwide
6 Nov 2024Device	CLASS II	Leigon Oxinium Constrained Nonporous Femoral Component, Size 3 Left recalled	Smith & Nephew	Foreign Material	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	Foreign Material	TX
25 Sep 2024Device	CLASS II	Diamond Point, Both Ends K-wire recalled by Smith & Nephew	Smith & Nephew	Packaging Defects	TN

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.