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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 361–380 of 1,000 recalls

Class IIOngoing

Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

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 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; Catalog No.: 13709005; Product/UPN No.: H787137090055 (Box), H787137090050 (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

Azurion 5 M12; System Code: (1)722227, (2)722231;

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, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); Box Quantity: 10 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

OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem

Oxoid Australia Pty Limited

Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells.

March 3, 2026 · DeviceView details →

Class IIOngoing

ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;

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 FD10F; System Code: 722002;

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, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (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 038 NB 6SH; Catalog No.: 10714001; Product/UPN No.: H787107140015 (Box), H787107140010 (Pouch); Box Quantity: 10 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 FD20/10; System Code: 722029;

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, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (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 (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; Product/UPN No.: H787107140175 (Box), H787107140170 (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 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 →

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