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Glaxosmithkline Consumer Healthcare Holdings

Glaxosmithkline Consumer Healthcare Holdings Recalls

All product recalls associated with Glaxosmithkline Consumer Healthcare Holdings.

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Recall Summary

Total Recalls

559

Past Year

11

Class I (Serious)

11

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 221–240 of 559 recalls

Advil Liqui-Gel Mini (GSK) – Incomplete Labeling (2020)

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

Class IIModerate

FDAMar 16, 2020Nationwide• Glaxosmithkline Consumer Healthcare Holdings

Advil Sinus Congestion (GSK) – Incomplete Labeling (2020)

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

Class IIModerate

FDAMar 16, 2020Nationwide• Glaxosmithkline Consumer Healthcare Holdings

Ibuprofen Combination Tablets (GSK) – Incomplete Labeling (2020)

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

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Class IIModerate

FDAMar 16, 2020Nationwide• Glaxosmithkline Consumer Healthcare Holdings

Ibuprofen Oral Suspension (GSK) – Incomplete Labeling (2020)

Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.

Class IIModerate

FDAMar 16, 2020Nationwide• Glaxosmithkline Consumer Healthcare Holdings

Smiths Medical ASD Inc.: smiths medical medex CBSS 2-fach Druckmesset mit Option, ...

Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.

FDAMar 10, 2020Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: medex LogiCal 5mL Closed Blood Sampling System, Model Num...

Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.

FDAMar 10, 2020Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: smiths medical medex CBSS 5 ml, Antishunt proximaler Entn...

Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.

FDAMar 10, 2020Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: smiths medical medex HemoDraw Plus Closed Blood Sampling ...

Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.

FDAMar 10, 2020Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: smiths medical medex CBSS-5ML Zweifach set, Model Number ...

Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.

FDAMar 10, 2020Nationwide• Smiths Medical ASD Inc.

Smiths Medical ASD Inc.: Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4...

Cases of Portex Lumbar Puncture Tray Child, SKU #4826PL-20 had been mislabeled with invalid information. The product was correct, but the inner trays were labeled as 4824PL-20 instead of 4826PL-20.

FDAFeb 28, 2020Nationwide• Smiths Medical ASD Inc.

Smith & Nephew, Inc.: NAVIO Soft Tissue Protector, included in instrument kits....

Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.

FDAFeb 27, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT L...

The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.

FDAJan 28, 2020Nationwide• Smith & Nephew, Inc.

Smiths Medical ASD, Inc.: Portex LineDraw Arterial Blood Sampling Syringe with Dry ...

Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.

FDAJan 7, 2020AL, AZ, AR +31 more• Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc.: Portex ProVent Arterial Blood Sampling Kit with Dry Lithi...

Lots of Smiths Medical Portex Pro-Vent and LineDraw Arterial Blood Sampling syringes may have broken luers.

FDAJan 7, 2020AL, AZ, AR +31 more• Smiths Medical ASD, Inc.

Smith & Nephew, Inc.: TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fix...

Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a breach of the sterile barrier, which could affect the sterility of the device.

FDADec 30, 2019Nationwide• Smith & Nephew, Inc.

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.

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.