Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

RSS Feed

Home
/
Brands
/
Smith & Nephew, Inc.

Smith & Nephew, Inc. Recalls

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

Get alerts for this brand

Recall Summary

Total Recalls

559

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 1–20 of 559 recalls

BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fix... (Smith & Nephew, Inc.) – removal of affected lot of screws due... (2025)

Removal of affected lot of screws due to labeling error.

Low

FDANov 24, 2025Nationwide• Smith & Nephew, Inc.

CADD-Solis VIP Pump (Smiths Medical) – Occlusion Alarm (2025)

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

FDAApr 10, 2025Nationwide• Smiths Medical ASD, Inc.

CADD Solis VIP Pump (Smiths Medical) – Thermal Damage (2025)

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

FDAApr 10, 2025

12 3...28

Page 1 of 28Next

Nationwide

• Smiths Medical ASD, Inc.

CADD Solis Pump (Smiths Medical) – Wireless Connection (2025)

Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

FDAApr 10, 2025Nationwide• Smiths Medical ASD, Inc.

CADD-Solis Infusion Pump (Smiths Medical) – Thermal Damage (2025)

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

FDAApr 10, 2025Nationwide• Smiths Medical ASD, Inc.

CADD-Solis HPCA Pump (Smiths Medical) – Occlusion Alarm (2025)

FDAApr 10, 2025Nationwide• Smiths Medical ASD, Inc.

META-TAN Screw Kit (Smith & Nephew) – compression screw issue (2025)

Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.

FDAMar 18, 2025Nationwide• Smith & Nephew, Inc.

CAPNOCHECK Airway Adapter (Smiths Medical) – Breakage Risk (2025)

Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.

FDAFeb 14, 2025Nationwide• Smiths Medical ASD, Inc.

ProPort Venous Access System (Smiths Medical) – Port Housing Separation (2025)

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

FDAFeb 13, 2025Nationwide• Smiths Medical ASD, Inc.

ProPort Plastic Venous System (Smiths Medical) – port housing separation (2025)

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

FDAFeb 13, 2025Nationwide• Smiths Medical ASD, Inc.

Portex Endotracheal Tube (Smiths Medical) – Diameter Inconsistency (2025)

Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.

FDAFeb 13, 2025Nationwide• Smiths Medical ASD, Inc.

BIORAPTOR Suture Anchors (Smith & Nephew) – packaging sterility breach (2024)

Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.

FDAOct 29, 2024Nationwide• Smith & Nephew Inc.

PORTEX Tracheal Tube Exchange Guide (Smiths Medical) – fluid ingress risk (2024)

Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.

FDAOct 28, 2024Nationwide• Smiths Medical ASD, Inc.

PORTEX Venn Tracheal Tube Introducer (Smiths Medical) – fluid ingress risk (2024)

FDAOct 28, 2024Nationwide• Smiths Medical ASD, Inc.

Tandem Bipolar Shell (Smith & Nephew) – Retaining Ring Size (2024)

The Bipolar assembly contains an oversized Retainer Ring.

FDAOct 15, 2024Nationwide• Smith & Nephew, Inc.

RENASYS EDGE Pump (Smith & Nephew) – Battery Maintenance Issue (2024)

Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.

FDAOct 2, 2024AL, CA, CO +10 more• Smith & Nephew Medical, Ltd.

Legion Oxinium Constrained Femoral Component (Smith & Nephew) – Implant Mislabeling (2024)

Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.

FDAOct 2, 2024TX• Smith & Nephew Inc

Genesis II Posterior Stabilized Femoral Component (Smith & Nephew) – Implant Mislabeling (2024)

Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.

FDAOct 2, 2024AL, CA, DE +4 more• Smith & Nephew Inc

Legion Oxinium Posterior Stabilized Component (Smith & Nephew) – Implant Mislabeling (2024)

Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.

FDAOct 2, 2024AL, CA, DE +4 more• Smith & Nephew Inc

Medex TranStar DPT Stopcocks (Smiths Medical) – Pressure Monitoring (2024)

Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

FDASep 24, 2024Nationwide• Smiths Medical ASD, Inc.