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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 841–860 of 39,430 recalls

Class IIOngoing

Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; Product/UPN No.: H787107140405 (Box), H787107140400 (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 FD10C; System Code: 722001;

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 B12; System Code: (1)722067, (2)722225, (3)722235;

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 FD10; System Code: (1) 722003, (2)722010, (3)722026;

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

eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152

Civco Medical Instruments Co. Inc.

There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

March 2, 2026 · DeviceView details →
Class IOngoing

Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

March 2, 2026 · DeviceView details →
Class IOngoing

Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

March 2, 2026 · DeviceView details →
Class IIOngoing

eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159

Civco Medical Instruments Co. Inc.

There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

March 2, 2026 · DeviceView details →
Class IIOngoing

eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151

Civco Medical Instruments Co. Inc.

There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

March 2, 2026 · DeviceView details →
Class IIOngoing

eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157

Civco Medical Instruments Co. Inc.

There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

March 2, 2026 · DeviceView details →
Class IIOngoing

eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150

Civco Medical Instruments Co. Inc.

There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

March 2, 2026 · DeviceView details →
Class IOngoing

Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

March 2, 2026 · DeviceView details →
Class IIOngoing

eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156

Civco Medical Instruments Co. Inc.

There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

March 2, 2026 · DeviceView details →
Class IOngoing

Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

March 2, 2026 · DeviceView details →
Class IOngoing

Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

March 2, 2026 · DeviceView details →
Class IIOngoing

eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158

Civco Medical Instruments Co. Inc.

There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

March 2, 2026 · DeviceView details →
Class IOngoing

Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

March 2, 2026 · DeviceView details →
Class IIOngoing

eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149

Civco Medical Instruments Co. Inc.

There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.

March 2, 2026 · DeviceView details →
Class IOngoing

Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.

March 2, 2026 · DeviceView details →
Class IOngoing

Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.

Philips Respironics, Inc.

Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

March 2, 2026 · DeviceView details →
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