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Showing 2161–2180 of 68218 results

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Philips L9-3 Transducer (Philips) – Life Refurbishment Problem (2025)

Ultrasound transducer devices were refurbished beyond their useful life.

FDAMay 28, 2025Nationwide• Philips Ultrasound, Inc

Philips L8-4 Transducer (Philips) – Life Refurbishment Problem (2025)

Ultrasound transducer devices were refurbished beyond their useful life.

FDAMay 28, 2025Nationwide• Philips Ultrasound, Inc

Philips C9-5EC Transducer (Philips) – Life Refurbishment Problem (2025)

Ultrasound transducer devices were refurbished beyond their useful life.

Low

FDAMay 28, 2025Nationwide• Philips Ultrasound, Inc

Philips eL18-4 Transducer (Philips) – Life Refurbishment Problem (2025)

Ultrasound transducer devices were refurbished beyond their useful life.

FDAMay 28, 2025Nationwide• Philips Ultrasound, Inc

Gamma4 Right Long Nail (Stryker) – Incorrect Nail Geometry (2025)

Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.

FDAMay 28, 2025Nationwide• Stryker GmbH Bohnackerweg 1 Selzach Switzerland

Philips 3D9-3v Transducer (Philips) – Life Refurbishment Problem (2025)

Ultrasound transducer devices were refurbished beyond their useful life.

FDAMay 28, 2025Nationwide• Philips Ultrasound, Inc

Philips L12-4 Transducer (Philips) – Life Refurbishment Problem (2025)

Ultrasound transducer devices were refurbished beyond their useful life.

FDAMay 28, 2025Nationwide• Philips Ultrasound, Inc

Philips S8-3t Transducer (Philips) – Life Refurbishment Problem (2025)

Ultrasound transducer devices were refurbished beyond their useful life.

FDAMay 28, 2025Nationwide• Philips Ultrasound, Inc

Philips S5-1 Transducer (Philips) – Life Refurbishment Problem (2025)

Ultrasound transducer devices were refurbished beyond their useful life.

FDAMay 28, 2025Nationwide• Philips Ultrasound, Inc

Philips X8-2t Transducer (Philips) – Life Refurbishment Problem (2025)

Ultrasound transducer devices were refurbished beyond their useful life.

FDAMay 28, 2025Nationwide• Philips Ultrasound, Inc

Philips XL14-3 Transducer (Philips) – Life Refurbishment Problem (2025)

Ultrasound transducer devices were refurbished beyond their useful life.

FDAMay 28, 2025Nationwide• Philips Ultrasound, Inc

Philips S7-3t Transducer (Philips) – Life Refurbishment Problem (2025)

Ultrasound transducer devices were refurbished beyond their useful life.

FDAMay 28, 2025Nationwide• Philips Ultrasound, Inc

Philips C5-2 Transducer (Philips) – Life Refurbishment Problem (2025)

Ultrasound transducer devices were refurbished beyond their useful life.

FDAMay 28, 2025Nationwide• Philips Ultrasound, Inc

Philips V6-2 Transducer (Philips) – Life Refurbishment Problem (2025)

Ultrasound transducer devices were refurbished beyond their useful life.

FDAMay 28, 2025Nationwide• Philips Ultrasound, Inc

Philips L12-3 Transducer (Philips) – Life Refurbishment Problem (2025)

Ultrasound transducer devices were refurbished beyond their useful life.

FDAMay 28, 2025Nationwide• Philips Ultrasound, Inc

Philips X5-1 Transducer (Philips) – Life Refurbishment Problem (2025)

Ultrasound transducer devices were refurbished beyond their useful life.

FDAMay 28, 2025Nationwide• Philips Ultrasound, Inc

Philips X6-1 Transducer (Philips) – Life Refurbishment Problem (2025)

Ultrasound transducer devices were refurbished beyond their useful life.

FDAMay 28, 2025Nationwide• Philips Ultrasound, Inc

Casa Mamita Churro Bites (Camerican) – Undeclared Milk (2025)

Undeclared Allergen

Undeclared Allergen (Milk). Consumer found a breaded halloumi Cheese Stick in the bag of churro bites. The Halloumi Cheese contains milk which is not an allergen in the churros.

Class IIModerate

FDAMay 28, 2025AL, FL, GA +3 more• Camerican International Inc

Brimonidine/Timolol Ophthalmic Solution (Apotex) – Sterility Concerns (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 28, 2025Nationwide• Apotex Corp.

Ketorolac Ophthalmic Solution (Apotex) – Sterility Concerns (2025)

Lack of Assurance of Sterility

Class IIModerate

FDAMay 28, 2025Nationwide• Apotex Corp.

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