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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 201–220 of 1,000 recalls

BRONCHOVIDEOSCOPE OLYMPUS BF-Q170

Olympus Corporation of the Americas

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

September 11, 2025 · DeviceView details →

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter

Abbott

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

September 10, 2025 · DeviceView details →

Class IOngoing

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter

Abbott

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

September 10, 2025 · DeviceView details →

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter

Abbott

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

September 10, 2025 · DeviceView details →

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter

Abbott

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

September 10, 2025 · DeviceView details →

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter

Abbott

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

September 10, 2025 · DeviceView details →

NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

NOXBOX LTD

Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum device requirement of 0.5 LPM. In addition, dose fluctuations have been observed when Bunnel LifePulse HFJV system or conventional ventilators have the following device settings: low service pressures generally less than 3.0 PSI, a pressure difference greater than 5.0cm H2O; or at breath per minute rates of 300 (5 Hz).

September 9, 2025 · DeviceView details →

Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions Component: Not applicable

Draeger, Inc.

The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

September 9, 2025 · DeviceView details →

Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions Component: Not applicable

Draeger, Inc.

The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

September 9, 2025 · DeviceView details →

NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

NOXBOX LTD

The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.

September 9, 2025 · DeviceView details →

MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →

Biograph mMR. Model Number: 10433372.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →

MAGNETOM Verio. Model Number: 10276755.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →

MAGNETOM Lumina (DE). Model Number: 11344916.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →

MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →

MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →

MAGNETOM Vida Fit. Model Number: 11410481.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →

MAGNETOM Skyra fit. Model Number: 10849580.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →

MAGNETOM Cima.X (DE). Model Number: 11647158.

Siemens Medical Solutions USA, Inc

There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

August 28, 2025 · DeviceView details →

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