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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 821–840 of 39,430 recalls

Class IIOngoing

ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026 · DeviceView details →

Class IIOngoing

Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026 · DeviceView details →

Class IIOngoing

Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026 · DeviceView details →

Class IIOngoing

AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM; Catalog No.: 13709804; Product/UPN No.: H787137098045 (Box), H787137098040 (Pouch); Box Quantity: 5 pouches;

Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

March 3, 2026 · DeviceView details →

Class IIOngoing

Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch); Box Quantity: 10 units;

Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

March 3, 2026 · DeviceView details →

Class IIOngoing

Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch); Box Quantity: 10;

Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

March 3, 2026 · DeviceView details →

Class IIOngoing

Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026 · DeviceView details →

Class IIOngoing

Allura Xper FD20/20 OR Table; System Code: 722039;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026 · DeviceView details →

Class IIOngoing

Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401; Product/UPN No.: H787107314015 (Box), H787107314010 (Pouch); Box Quantity: 5 pouches;

Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

March 3, 2026 · DeviceView details →

Class IIOngoing

ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026 · DeviceView details →

Class IIOngoing

Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0SH; Catalog No.: 10714024; Product/UPN No.: H787107140245 (Box), H787107140240 (Pouch); Box Quantity: 5 pouches;

Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

March 3, 2026 · DeviceView details →

Class IIOngoing

Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch); Box Quantity: 5 pouches;

Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

March 3, 2026 · DeviceView details →

Class IIOngoing

ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026 · DeviceView details →

Class IIOngoing

AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM; Catalog No.: 13709704; Product/UPN No.: H787137097045 (Box), H787137097040 (Pouch); Box Quantity: 5 pouches;

Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

March 3, 2026 · DeviceView details →

Class IIOngoing

Allura Xper FD20/15; System Code: 722058;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026 · DeviceView details →

Class IIOngoing

Allura Xper FD20/20; System Code: 722038;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026 · DeviceView details →

Class IIOngoing

ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026 · DeviceView details →

Class IIOngoing

Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

March 3, 2026 · DeviceView details →

Class IIOngoing

Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); Box Quantity: 5 pouches;

Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

March 3, 2026 · DeviceView details →

Class IIOngoing

Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches;

Angiodynamics, Inc.

The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

March 3, 2026 · DeviceView details →

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