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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 3321–3340 of 39,430 recalls

Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

Edwards Lifesciences, LLC

due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.

May 14, 2025 · DeviceView details →

Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

Edwards Lifesciences, LLC

due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.

May 14, 2025 · Device

View details →

Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

Edwards Lifesciences, LLC

due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.

May 14, 2025 · DeviceView details →

Class IIOngoing

Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;

Philips North America Llc

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

May 13, 2025 · DeviceView details →

Class IIOngoing

Product Name: Ingenia 3.0T CX; Model Number: 781271;

Philips North America Llc

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

May 13, 2025 · DeviceView details →

Class IIOngoing

Product Name: Ingenia 1.5T CX; Model Number: 781262;

Philips North America Llc

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

May 13, 2025 · DeviceView details →

Class IIOngoing

Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;

Philips North America Llc

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

May 13, 2025 · DeviceView details →

Class IIOngoing

Ami HTX.

Spectral Instruments Inc

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.

May 13, 2025 · DeviceView details →

Class IICompleted

SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller

Cardinal Health 200, LLC

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

May 13, 2025 · DeviceView details →

Class IIOngoing

Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;

Philips North America Llc

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

May 13, 2025 · DeviceView details →

Class IIOngoing

Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;

Philips North America Llc

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

May 13, 2025 · DeviceView details →

Class IIOngoing

Product Name: Ingenia 1.5T S; Model Number: 781347;

Philips North America Llc

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

May 13, 2025 · DeviceView details →

Class IIOngoing

Product Name: SmartPath to dStream for 3.0T; Model Number: 782145

Philips North America Llc

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

May 13, 2025 · DeviceView details →

Class IIOngoing

Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;

Philips North America Llc

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

May 13, 2025 · DeviceView details →

Class IIOngoing

Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;

Philips North America Llc

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

May 13, 2025 · DeviceView details →

Class IIOngoing

Lago X

Spectral Instruments Inc

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.

May 13, 2025 · DeviceView details →

Class IIOngoing

Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;

Philips North America Llc

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

May 13, 2025 · DeviceView details →

Class IICompleted

Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 84021B Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller

Cardinal Health 200, LLC

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

May 13, 2025 · DeviceView details →

Class IIOngoing

Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;

Philips North America Llc

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

May 13, 2025 · DeviceView details →

Class IICompleted

Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SKU 84021P Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller

Cardinal Health 200, LLC

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

May 13, 2025 · DeviceView details →

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