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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

573

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 241–260 of 573 recalls

Smith & Nephew, Inc.: LEGION PS High Flex XLPE size 5-6 9mm Articular Insert

LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part

FDADec 19, 2019CA, IL, LA +8 more• Smith & Nephew, Inc.

Smith & Nephew, Inc.: LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP ...

Laceration Risk

Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications.

FDADec 16, 2019DE, IA, NC +2 more• Smith & Nephew, Inc.

Smith & Nephew, Inc.: smith&nephew PROFIX Mallet, 750 GRAMS, REF 71512452 - Pro...

There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. If the potential failure mode occurs, particles generated in the poly thread potentially could enter the surgical field or a delay in surgery could occur if the tip disengages during the use of the mallet.

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FDANov 11, 2019Nationwide• Smith & Nephew, Inc.

Smiths Medical ASD Inc.: Medfusion Syringe Pump, Model 4000. The Model 4000 pump ...

There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm functionality, and interruption of therapy.

FDAOct 28, 2019CO, MD, NY• Smiths Medical ASD Inc.

Smith & Nephew, Inc.: LAG SCREW 3.2MM GUIDE PIN SLEEVE, REF 71674032 - Product ...

LAG SCREW 3.2 GUIDE PIN SLEEVE are being recalled due to a manufacturing error. The detent balls in the guide pin sleeve were not drilled to the correct depth, which will cause them to not fully compress.

FDAOct 7, 2019Nationwide• Smith & Nephew, Inc.

Bexarotene Capsules (Upsher Smith) – Dissolution Failure (2019)

Failed Dissolution Specifications

Class IIModerate

FDAJul 29, 2019KY, LA, NJ +1 more• Upsher Smith Laboratories, Inc.

Smiths Medical ASD Inc.: GRIPPER Needles sold individually. Labeled as the follow...

Potential for certain GRIPPER Needles to contain an occluded or blocked needle.

FDAJul 8, 2019Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUM...

Potential for certain GRIPPER Needles to contain an occluded or blocked needle.

FDAJul 8, 2019Nationwide• Smiths Medical ASD Inc.

30-Gallon Gas Water Heater (A.O. Smith) – fire hazard (2018)

Fire/Burn Risk

This recall includes A. O. Smith 30-gallon natural gas water heaters with model number G6-UT3030NV and serial numbers with the first four digits of 1805 through 1809. A. O. Smith, the model number and the serial number are printed on the data plate located next to the gas water heater's control valve/thermostat. A. O. Smith is printed near the top of the water heater.

CPSCNov 8, 2018Nationwide• A. O. Smith Corp., of Milwaukee, Wis.

Ultra-Low NOx Water Heaters (A.O. Smith) – fire risk (2018)

Fire/Burn Risk

This recall includes 30, 40 and 50 gallon natural or propane gas-fired Ultra-Low NOx emission gas water heaters. They are designed to comply with regulations in certain air quality districts in California, and were sold primarily in California. They were sold under the American, A. O. Smith, Kenmore, Reliance, State, U.S. Craftsmaster and Whirlpool brand names and manufactured from April 8, 2011 through August 1, 2016. Only water heaters with the first four digit serial numbers between 1115 and 1631, where the first four digits represent the year and week of production, are included in the recall. The brand name, model number and serial number can be found on the data plate on the product located next to the gas control valve/thermostat. The brand name is printed near the top of the water heater. Consumers can look up their water heater's serial number to see if it is affected by this recall at www.waterheaterrecall.com.

CPSCNov 8, 2018Nationwide• A. O. Smith Corp., of Milwaukee, Wis.

2017 SMITTYBILT SCOUT Recall: EQUIPMENT:OTHER:LABELS

TAP Worldwide, LLC (TAP) is recalling certain 2017-2018 Smittybilt SCOUT trailer kits, sold with tires and wheels included in the kit (SKU number 87400). These trailer kits were sold without the required labeling for the Gross Vehicle Weight Rating (GVWR), Gross Axle Weight Rating (GAWR), and cargo capacity statements. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 110, "Tire Selection and Rims."

NHTSAOct 10, 2018Nationwide• SMITTYBILT

Prevacid 24HR (GlaxoSmithKline) – CGMP Deviation (2018)

CGMP deviations

Class IIModerate

FDASep 26, 2018Nationwide• GLAXOSMITHKLINE NEBRASKA

Bumetanide 2mg (Upsher Smith) – Impurity Specification (2018)

Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.

Class IIModerate

FDASep 19, 2018Nationwide• Upsher Smith Laboratories, Inc.

Bumetanide 1mg (Upsher Smith) – Impurity Specification (2018)

Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.

Class IIModerate

FDASep 19, 2018Nationwide• Upsher Smith Laboratories, Inc.

Sterile Eyewash (Smiths Medical) – Sterility Risk (2017)

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Class IIModerate

FDASep 5, 2017IA, WI• Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Sterile Eyewash (Smiths Medical) – Sterility Risk (2017)

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Class IIModerate

FDASep 5, 2017IA, WI• Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Sterile Eyewash (Smiths Medical) – Sterility Risk (2017)

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Class IIModerate

FDASep 5, 2017IA, WI• Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Sterile Eyewash (Smiths Medical) – Sterility Risk (2017)

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Class IIModerate

FDASep 5, 2017IA, WI• Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Ventolin HFA Inhaler (GlaxoSmithKline) – Delivery System Defect (2017)

Defective Delivery System: Elevated number of units with out of specification results for leak rate

Class IIModerate

FDAMay 16, 2017Nationwide• GlaxoSmithKline, LLC

Ventolin HFA (GlaxoSmithKline) – Defective Delivery System (2017)

Defective Delivery System: Elevated number of units with out of specification results for leak rate.

Class IIModerate

FDAMar 22, 2017Nationwide• GlaxoSmithKline, LLC