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Showing 1021–1040 of 3039 results

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Dubai Style Chocolate (Rolling Pin) – Undeclared Wheat (2025)

Product does not declare wheat in the allergen statement.

Class IIModerate

FDAAug 29, 2025AL, AZ, CA +11 more• ROLLING PIN BAKING COMPANY LLC

NES Turbo Elite 1.4mm Catheter (Northeast Scientific) – Sterility Breach (2025)

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

FDAAug 29, 2025Nationwide• Northeast Scientific Inc.

UV Germicidal Wand (BigTree) – Radiation Risk (2025)

The subject product emits unsafe level of UVC radiation (i.e., the product reaches the exposure limit for Risk Group 3 (high risk) in about 2.2 minutes). The product has a radiation safety defect, in that these radiation emissions are unnecessary to the accomplishment of the product s primary purpose of disinfecting objects and surfaces, and create a risk of skin and/or eye injuries to user and nearby persons.

High

FDAAug 29, 2025Nationwide• BigTree Sales Inc.

NES 2.0mm RX Laser Atherectomy Catheter (Northeast Scientific) – Sterility Concern (2025)

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

FDAAug 29, 2025Nationwide• Northeast Scientific Inc.

MAGNETOM Skyra Fit (Siemens) – Magnet Venting Issue (2025)

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

FDAAug 28, 2025Nationwide• Siemens Medical Solutions USA, Inc

MAGNETOM Prisma (Siemens) – Magnet Venting Issue (2025)

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

FDAAug 28, 2025Nationwide• Siemens Medical Solutions USA, Inc

BIOGRAPH One (Siemens) – Magnet Venting Issue (2025)

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

FDAAug 28, 2025Nationwide• Siemens Medical Solutions USA, Inc

MAGNETOM Vida (Siemens) – Magnet Venting Issue (2025)

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

FDAAug 28, 2025Nationwide• Siemens Medical Solutions USA, Inc

Sharesource Connectivity Platform (Vantive) – Software Prescription Error (2025)

Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.

FDAAug 28, 2025Nationwide• Vantive US Healthcare LLC

Extractor Pro Retrieval Catheter (Boston Scientific) – Incorrect Labeling (2025)

The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.

FDAAug 28, 2025Nationwide• Boston Scientific Corporation

Dextroamphetamine Saccharate (Granules) – Impurity degradation risk (2025)

Failed Impurities/Degradation Specifications:

FDAAug 28, 2025Nationwide• Granules Pharmaceuticals Inc.

Dextroamphetamine Saccharate (Granules) – Impurity degradation risk (2025)

Failed Impurities/Degradation Specifications:

FDAAug 28, 2025Nationwide• Granules Pharmaceuticals Inc.

Exeter V40 Stem (Howmedica) – Product Mix Concern (2025)

a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.

FDAAug 28, 2025IN• Howmedica Osteonics Corp.

Dexcom G6 CGM System (Dexcom) – App Termination Risk (2025)

A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could result in the missed detection of a hyperglycemic or hypoglycemic event, protentional resulting in severe hyperglycemia, diabetic ketoacidosis (DKA), or hyperosmolar hyperglycemic state (HHS).

FDAAug 28, 2025Nationwide• Dexcom, Inc.

MAGNETOM Verio Dot Upgrade (Siemens) – Magnet Venting Issue (2025)

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

FDAAug 28, 2025Nationwide• Siemens Medical Solutions USA, Inc

MAGNETOM Lumina (Siemens) – Magnet Venting Issue (2025)

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

FDAAug 28, 2025Nationwide• Siemens Medical Solutions USA, Inc

Dextroamphetamine Saccharate (Granules) – Impurity degradation risk (2025)

Failed Impurities/Degradation Specifications:

FDAAug 28, 2025Nationwide• Granules Pharmaceuticals Inc.

MAGNETOM Connectom.X (Siemens) – Magnet Venting Issue (2025)

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

FDAAug 28, 2025Nationwide• Siemens Medical Solutions USA, Inc

MAGNETOM Verio (Siemens) – Magnet Venting Issue (2025)

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

FDAAug 28, 2025Nationwide• Siemens Medical Solutions USA, Inc

MAGNETOM Vida Fit (Siemens) – Magnet Venting Issue (2025)

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

FDAAug 28, 2025Nationwide• Siemens Medical Solutions USA, Inc

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