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Smith & Nephew, Inc.

Smith & Nephew, Inc. Recalls

All product recalls associated with Smith & Nephew, Inc..

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Recall Summary

Total Recalls

232

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–40 of 232 recalls

Journey II BCS Insert (Smith & Nephew) – Labeling Mixup (2023)

The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.

Moderate

FDASep 27, 2023Nationwide• Smith & Nephew, Inc.

Legion Oxinum Posterior Stabilized Component (Smith & Nephew) – packaging mix-up (2023)

The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label.

Low

FDAAug 31, 2023CA, CT, NE +4 more• Smith & Nephew Inc

Bard Marquee Biopsy Kit (Bard) – Needle Diameter Mismatch (2023)

Laceration Risk

Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohibits the biopsy needle (cutting cannula) from properly fitting into the coaxial cannula and accessing target tissue, which may lead to repeated procedure, and procedural complications, such as pain/discomfort, pneumothorax, and bleeding.

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Moderate

FDAAug 10, 2023Nationwide• Bard Peripheral Vascular Inc

Trigen Trochanteric Nail (Smith & Nephew) – incorrect implant (2023)

A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.

Moderate

FDAJul 24, 2023CA, DE, PA• Smith & Nephew, Inc.

ENGAGE Knee System (Smith & Nephew) – High Revision Rate (2023)

Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.

Moderate

FDAMay 2, 2023Nationwide• Smith & Nephew, Inc.

Bard Mission Biopsy Instrument Kit (Bard) - Instrument Size Mismatch (2023)

Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle from properly fitting into the coaxial cannula and accessing the target tissue, which could lead to procedure delay, and insufficient sample acquisition requiring a repeat procedure.

High

FDAApr 11, 2023Nationwide• Bard Peripheral Vascular Inc

JOURNEY II UNI Tibia Insert (Smith & Nephew) – mispack error (2023)

A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.

Moderate

FDAMar 27, 2023Nationwide• Smith & Nephew, Inc.

Bard Mission Biopsy Instrument Kit (Bard) - Size Mismatch (2023)

The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirement of an additional device, 3), Needle tip breakage, if used despite incompatibility.

High

FDAFeb 28, 2023Nationwide• Bard Peripheral Vascular Inc

Broviac Catheter Repair Kit (Bard) – Adhesive Hardening (2023)

Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).

Moderate

FDAJan 4, 2023Nationwide• Bard Peripheral Vascular Inc

Covera Vascular Stent (Bard) – Deployment Problem (2022)

An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.

High

FDADec 22, 2022Nationwide• Bard Peripheral Vascular Inc

Genesis II Non-Porous Tibial Baseplate (Smith & Nephew) – Mispackaged Product (2022)

The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.

Moderate

FDAJun 27, 2022Nationwide• Smith & Nephew, Inc.

Safe-t-Centesis Catheter (Bard) – needle size mismatch (2022)

There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Universal extension set and drainage bag, vacuum bottle, and wall suction.

FDAApr 22, 2022Nationwide• Bard Peripheral Vascular Inc

Legion Narrow Knee Implant (Smith & Nephew) – mislabeling (2022)

It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.

FDAApr 19, 2022Nationwide• Smith & Nephew Inc