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Showing 2901–2920 of 68218 results

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Falafel King Mediterranean Meal – unlisted sesame (2025)

Label declares tahini paste but does not declare sesame.

Class IIModerate

FDAMar 25, 2025CO, IN• Falafel King Enterprises, Inc.

MULTI-V Multivitamin (MTN OPS) – undeclared soy (2025)

Undeclared soy flour

Class IIModerate

FDAMar 25, 2025Nationwide• MTN OPS, LLC

IceSeed 1.5 CX S Needle OUS (Boston Scientific) – Demo Settings Issue (2025)

Laceration Risk

Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.

Low

FDAMar 24, 2025Nationwide• Boston Scientific Corporation

Intera 1.5T (Philips) – Coil Seal Adhesive Failure (2025)

Laceration Risk

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

FDAMar 24, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Intera 1.5T Omni/Stellar (Philips) – Coil Seal Adhesive Failure (2025)

Laceration Risk

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

FDAMar 24, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Intera 3.0T Quasar Dual (Philips) – Coil Seal Adhesive Failure (2025)

Laceration Risk

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

FDAMar 24, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

SmartPath to dStream (Philips) – Coil Seal Adhesive Failure (2025)

Laceration Risk

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

FDAMar 24, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

IceSeed 1.5 CX S Needle US (Boston Scientific) – Demo Settings Issue (2025)

Laceration Risk

Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.

FDAMar 24, 2025Nationwide• Boston Scientific Corporation

Intera 1.0T Omni/Stellar (Philips) – Coil Seal Adhesive Failure (2025)

Laceration Risk

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

FDAMar 24, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Intera 1.0T Power/Pulsar (Philips) – Coil Seal Adhesive Failure (2025)

Laceration Risk

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

FDAMar 24, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

IceSeed 1.5 CX Needle OUS (Boston Scientific) – Demo Settings Issue (2025)

Laceration Risk

Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.

FDAMar 24, 2025Nationwide• Boston Scientific Corporation

Intera CV (Philips) – Coil Seal Adhesive Failure (2025)

Laceration Risk

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

FDAMar 24, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Intera 1.5T Power/Pulsar (Philips) – Coil Seal Adhesive Failure (2025)

Laceration Risk

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

FDAMar 24, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Intera 0.5T Standard (Philips) – Coil Seal Adhesive Failure (2025)

Laceration Risk

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

FDAMar 24, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Intera 1.5T Master/Nova (Philips) – Coil Seal Adhesive Failure (2025)

Laceration Risk

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

FDAMar 24, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Zimmer Biomet Ceramic Head (Zimmer) – Compatibility Information Missing (2025)

The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.

FDAMar 24, 2025Nationwide• Zimmer, Inc.

Intera 1.5T Explorer/Nova Dual (Philips) – Coil Seal Adhesive Failure (2025)

Laceration Risk

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

FDAMar 24, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

IceSeed 1.5 CX Needle US (Boston Scientific) – Demo Settings Issue (2025)

Laceration Risk

Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX needle to the Cryoablation System, the user will be prompted to perform the Needle Integrity and Functionality Test (NIT) per standard protocols. The affected needles perform as intended unless they are disconnected and reconnected to any channel after testing. In this case, the Cryoablation System will prompt re-execution of the NIT.

FDAMar 24, 2025Nationwide• Boston Scientific Corporation

Enterprise 1.5T (Philips) – Coil Seal Adhesive Failure (2025)

Laceration Risk

The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

FDAMar 24, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Connex Vital Signs Monitor (Baxter) – Battery Fire Risk (2025)

There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter.

FDAMar 24, 2025Nationwide• Baxter Healthcare Corporation

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