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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

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 181–200 of 559 recalls

Smith & Nephew, Inc.: TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture...

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture ...

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

FDASep 9, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture...

Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

1...8 91011 12...28

Page 10 of 28Next

FDA

Sep 9, 2020

Nationwide

• Smith & Nephew, Inc.

Smiths Medical ASD Inc.: Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This t...

Label has the incorrect size for the tracheotomy tube.

FDAAug 28, 2020CT• Smiths Medical ASD Inc.

Smith & Nephew, Inc.: EVOS Screws - Product Usage: is a part of the EVOS MINI p...

Multiple or incorrect expiration dates were provided on the affected designation labels.

FDAAug 24, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: Single RIKKI Retractor, Catalog #71934609 - Product Usage...

The products were improperly heat treated.

FDAAug 3, 2020CA, CO, CT +15 more• Smith & Nephew, Inc.

Chocolate Non-Dairy Dessert (Smith Foods) – Undeclared cashews (2020)

Undeclared Allergen

Undeclared cashews in the product.

Class IHigh

FDAJul 29, 2020AL, AR, CA +33 more• Smith Foods Inc.

Vanilla Non-Dairy Dessert (Smith Foods) – Undeclared cashews (2020)

Undeclared Allergen

Undeclared cashews in the product.

Class IHigh

FDAJul 29, 2020AL, AR, CA +33 more• Smith Foods Inc.

Mocha Fudge Non-Dairy Dessert (Smith Foods) – Undeclared cashews (2020)

Undeclared Allergen

Undeclared cashews in the product.

Class IHigh

FDAJul 29, 2020AL, AR, CA +33 more• Smith Foods Inc.

Smith & Nephew Orthopaedics AG Schachenallee 29 Aarau Switzerland: POLARSTEM COLLAR Reamer Guide, Catalog Number: 75102205, ...

Multiple lots being recalled due to a product design issue

FDAJul 22, 2020Nationwide• Smith & Nephew Orthopaedics AG Schachenallee 29 Aarau Switzerland

Smith & Nephew, Inc.: Tibial knee prosthesis

Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.

FDAJul 16, 2020AL, AZ, AR +22 more• Smith & Nephew, Inc.

Smiths Medical ASD Inc.: CADD Administration Sets, Model #21-7346-24

Product may have been manufactured with an air filter assembled in an incorrect orientation.

FDAJul 14, 2020Nationwide• Smiths Medical ASD Inc.

Smith & Nephew, Inc.: PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-S...

The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part.

FDAJun 29, 2020Nationwide• Smith & Nephew, Inc.

Smiths Medical ASD Inc.: Medfusion Syringe Pump Model 4000; Software Versions V1.5...

Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.

FDAJun 26, 2020Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: Medfusion Syringe Pump Model 3500, Software Version V6.0....

Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.

FDAJun 26, 2020Nationwide• Smiths Medical ASD Inc.

Smith & Nephew, Inc.: SUTUREFIX ULTRA Suture, Product number 72203855

A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill.

FDAJun 24, 2020AL, AZ, AR +20 more• Smith & Nephew, Inc.

Smith & Nephew, Inc.: Smith & Nephew T-F1X0 RCG Drill Pac, 2 mm Drill & (2) Sle...

The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve

FDAJun 24, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: TRIGEN, Intramedullary nail - Product Usage: is intended ...

A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.

FDAJun 24, 2020IN• Smith & Nephew, Inc.

Childrens Robitussin Honey Cough (Glaxosmithkline) – Defective Dosing Cup (2020)

Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.

Class IIModerate

FDAJun 16, 2020Nationwide• Glaxosmithkline Consumer Healthcare Holdings

Childrens Dimetapp Cold & Cough (Glaxosmithkline) – Defective Dosing Cup (2020)

Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.

Class IIModerate

FDAJun 16, 2020Nationwide• Glaxosmithkline Consumer Healthcare Holdings