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Showing 2041–2060 of 3039 results

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Ingenia 1.5T CX (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

FDAMay 13, 2025Nationwide• Philips North America Llc

Ingenia 1.5T S (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

FDAMay 13, 2025Nationwide• Philips North America Llc

MR 7700 Upgrade (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

Low

FDAMay 13, 2025Nationwide• Philips North America Llc

Ingenia Elition X (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

FDAMay 13, 2025Nationwide• Philips North America Llc

Avarampoo Soup (NatureMills) – Undeclared Wheat (2025)

Undeclared Allergen

Undeclared wheat allergens

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

Esomeprazole Magnesium Suspension 20mg (Zydus) – Impurity Specification (2025)

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.

Class IIModerate

FDAMay 13, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Lago X (Spectral Instruments) – Label Mismatch (2025)

The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.

FDAMay 13, 2025Nationwide• Spectral Instruments Inc

SCD Comfort Sleeve (Cardinal Health) – Software Pressure Error (2025)

Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.

FDAMay 13, 2025AK, CA, FL +2 more• Cardinal Health 200, LLC

Kendall SCD Blended Comfort Sleeve (Cardinal Health) – Software Pressure Error (2025)

Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.

FDAMay 13, 2025AK, CA, FL +2 more• Cardinal Health 200, LLC

Ingenia 3.0T (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

FDAMay 13, 2025Nationwide• Philips North America Llc

Wonderberry Leaf Soup (NatureMills) – Undeclared Wheat (2025)

Undeclared Allergen

Undeclared wheat allergens

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

Horsegram Soup (NatureMills) – Undeclared Wheat (2025)

Undeclared Allergen

Undeclared wheat allergens

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

Moringa Rice Mix (NatureMills) – Undeclared Wheat (2025)

Undeclared Allergen

Undeclared wheat allergens

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

MR 5300 (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

FDAMay 13, 2025Nationwide• Philips North America Llc

Evolution Upgrade 1.5T (Philips) – Image Alignment Error (2025)

Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.

FDAMay 13, 2025Nationwide• Philips North America Llc

Tomato Vadam (NatureMills) – Undeclared Wheat (2025)

Undeclared Allergen

Undeclared wheat allergens

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

Garlic Vadam (NatureMills) – Undeclared Wheat (2025)

Undeclared Allergen

Undeclared wheat allergens

Class IIModerate

FDAMay 13, 2025Nationwide• NatureMills US Incorporated

Celecoxib Capsules (AvKARE) – Foreign Tablet Contamination (2025)

Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules

Class IIModerate

FDAMay 13, 2025Nationwide• AvKARE

Ami HTX (Spectral Instruments) – Label Mismatch (2025)

The X-ray safety and manufacturing date labels affixed to the Lago X/ AMI HTX instrument do not correspond exactly to the labeling stipulated by the FDA / CDRH.

FDAMay 13, 2025Nationwide• Spectral Instruments Inc

Esomeprazole Magnesium Suspension 40mg (Zydus) – Impurity Specification (2025)

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.

Class IIModerate

FDAMay 13, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

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