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  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 461–480 of 1,000 recalls

Class IOngoing

Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Allura Xper FD20/15; Catalog numbers: 722058

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Allura Xper FD20/10; Catalog numbers: 722029

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Allura Xper FD10C; Catalog number: 722001

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Allura Xper FD20/20; Catalog numbers: 722038

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Possibility of the patient falling from the table related to the mattress used on the patient table.

January 13, 2025 · DeviceView details →
Class IOngoing

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.

Fresenius Kabi USA, LLC

Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.

January 10, 2025 · DeviceView details →
Class IOngoing

Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 154150041; Tack, 4F Gen 1.5, 150cm CE, REF: 154150042; Tack, 4F Gen 1.5, 90cm CE, REF: 154090042 (6F, 3.5 - 6.0mm), 135cm, REF: 156135061; (6F, 4.0 - 8.0mm), 135cm, REF: 206135061; Tack, 6F Gen 2.0, 135cm CE, REF: 206135062; Tack, 6F Gen 1.5, 135cm CE, REF: 156135062; Tack, 6F Gen 2.0, 80cm CE, REF: 206080062; Tack, 6F Gen 1.5, 80cm CE, REF: 156080062

Spectranetics Corporation

Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface, could result in problems with deployment and stability of device in vessel after deployment, which may cause failure to resolve dissection, migration of implant, bailout stenting, reintervention, unintended removal of tack devices, and ischemia.

January 10, 2025 · DeviceView details →
Class IOngoing

VARIPULSE Bi-Directional Ablation Catheter REF D141201. The Field Catheter is indicated for use in catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used for TRUPULSE Generator, for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The catheter provides location information when used with the CARTO 3 System.

Biosense Webster, Inc.

Due to an observed trend of neurovascular events

January 5, 2025 · DeviceView details →
Class IOngoing

Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690

MEDLINE INDUSTRIES, LP - Northfield

The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.

December 31, 2024 · DeviceView details →
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