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Showing 1941–1960 of 3039 results

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Hand Sanitizer (Consumer Product Partners) - Subpotent Alcohol (2025)

Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl Alcohol

Class IIModerate

FDAMay 23, 2025Nationwide• Consumer Product Partners, LLC

Apex Knee System (Corin Medical) – Packaging Integrity Issue (2025)

Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.

FDAMay 23, 2025Nationwide• CORIN MEDICAL, LTD. Unit 1-57-8 Corinium Centre Cirencester United Kingdom

SIGNA Architect (GE Medical) – Gradient Coil Safety Problem (2025)

GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.

Moderate

FDAMay 23, 2025Nationwide• GE Medical Systems, LLC

MicroMyst Applicator (Integra) – Sterility Concern (2025)

Lack of sterility assurance.

FDAMay 23, 2025Nationwide• Integra LifeSciences Corp. (NeuroSciences)

Extended Tip Applicator 8CM (Integra) – Endotoxin Concern (2025)

Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.

FDAMay 22, 2025Nationwide• Integra LifeSciences Corp. (NeuroSciences)

Femoral Nail T2 GTN (Stryker) – Incorrect Nail Version (2025)

Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.

FDAMay 22, 2025Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

Change Healthcare Cardiology Software (Change Healthcare) – Unexpected Shutdown (2025)

Due to complaints, software update may cause software to unexpectedly shutdown.

FDAMay 22, 2025Nationwide• CHANGE HEALTHCARE CANADA COMPANY

Acetaminophen Tablets (Aurobindo) - Tablet Discoloration (2025)

cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).

Class IIModerate

FDAMay 22, 2025Nationwide• Aurobindo Pharma USA Inc

Jewel Precision Sterilization Container (Jewel Precision) – Use Instructions Mismatch (2025)

The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.

FDAMay 22, 2025Nationwide• Jewel Precision Sheet Metal & Machining Co, Inc.

Extended Tip Applicator 15CM (Integra) – Endotoxin Concern (2025)

Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.

FDAMay 22, 2025Nationwide• Integra LifeSciences Corp. (NeuroSciences)

IontoPatch 80 (LTS Therapy) – Absorption Problem (2025)

The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.

FDAMay 22, 2025Nationwide• LTS Therapy Systems, LLC

IontoPatch STAT (LTS Therapy) – Absorption Problem (2025)

The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.

FDAMay 22, 2025Nationwide• LTS Therapy Systems, LLC

Atellica CH Diluent (Siemens) – Contamination Risk (2025)

Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.

FDAMay 22, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

Femoral Nail T2 GTN (Stryker) – Incorrect Nail Version (2025)

Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail.

FDAMay 22, 2025Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

BD Insyte Autoguard IV Catheter (Becton Dickinson) – Needle Retraction Issue (2025)

Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.

FDAMay 21, 2025Nationwide• Becton Dickinson Infusion Therapy Systems, Inc.

Authentic Greek Salad (Sysco) – Salmonella potential (2025)

Cucumbers have the potential to be contaminated with Salmonella

FDAMay 21, 2025CT, DE, FL +15 more• Sysco Corporation

Tirzepatide Injections (Thrive) - Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 21, 2025Nationwide• Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

CJC-1295 Injectable (Thrive) - Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 21, 2025Nationwide• Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

Newport HT70 Ventilator (Covidien) – Circuit Board Failure (2025)

Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, thus necessitating use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during shut down, which may result in respiratory failure, hypoventilation, low oxygen saturation, hypoxia, treatment delay.

FDAMay 21, 2025Nationwide• Covidien

LX Bioboost Plus (Thrive) - Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 21, 2025Nationwide• Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)

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