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Showing 1961–1980 of 3039 results

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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.

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.

East Coast Fresh Salsa Cup (Sysco) – Salmonella risk (2025)

Salmonella

Cucumbers have the potential to be contaminated with Salmonella

Class IHigh

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

NAD+ 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)

Tirzepatide/Cyanocobalamin (Thrive) - Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

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

Semaglutide/Cyanocobalamin Injectable (Thrive Health Solutions) – Sterility Risk (2025)

Lack of Assurance of Sterility

Class IIModerate

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

Southwest Breakfast Bowl (Sysco) – Salmonella potential (2025)

Cucumbers have the potential to be contaminated with Salmonella

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

Semaglutide (Thrive) - Sterility Concern (2025)

Lack of Assurance of Sterility

Class IIModerate

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

Methylcobalamin 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)

LL Bioboost Injectable (Thrive Health Solutions) – Sterility Risk (2025)

Lack of Assurance of Sterility

Class IIModerate

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

LUCAS Chest Compression System (Jolife) – Demonstration Unit Risk (2025)

Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.

FDAMay 21, 2025Nationwide• Jolife AB Scheelevagen 17 Ideon Science Park Lund Sweden

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.

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.

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.

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.

Bigfoot Unity Diabetes System (Bigfoot) – Insulin Pen Error (2025)

Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function. This error may pose a potential health risk for people living with diabetes as they may not have all information necessary to make a timely treatment decision.

FDAMay 21, 2025Nationwide• BIGFOOT BIOMEDICAL

Acido Hialuronico (Umary-USA) - Undeclared Ingredients (2025)

Undeclared Allergen

Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone, Diclofenac and Omeprazole.

FDAMay 21, 2025Nationwide• Umary-USA.com

STA-Owren Koller (Diagnostica Stago) – Clotting Time Inaccuracy (2025)

Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%

FDAMay 21, 2025IN, PR• Diagnostica Stago, Inc.

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.

Imperial Fresh Diced Cucumber (Sysco) – Salmonella risk (2025)

Cucumbers have the potential to be contaminated with Salmonella

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

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