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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 781–800 of 1,000 recalls

Class IIOngoing

Philips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper FD10C; Model # 722002 for Allura Xper FD10F; Model # 722003 for Allura Xper FD10; Model # 722005 for Allura Xper FD10/10; Model # 722006 for Allura Xper FD20; Model # 722008 for Allura Xper FD20 Biplane; Model # 722010 for Allura Xper FD10; Model # 722011 for Allura Xper FD10/10; Model # 722012 for Allura Xper FD20; Model # 722013 for Allura Xper FD20 Biplane; Model # 722015 for Allura Xper FD20 OR Table; Model # 722019 for Allura Xper FD10/10 OR Table; Model # 722020 for Allura Xper FD20 Biplane OR Table; Model # 722022 for Allura Xper FD10 OR Table; Model # 722023 for Allura Xper FD20 OR Table; Model # 722025 for Allura Xper FD20 Biplane OR Table; Model # 722026 for Allura Xper FD10; Model # 722027 for Allura Xper FD10/10; Model # 722028 for Allura Xper FD20; Model # 722029 for Allura Xper FD20/10; Model #722033 for Allura Xper FD10 OR Table; Model #722035 for Allura Xper FD20 OR Table; Model #722038 for Allura Xper FD20/20; Model #722039 for Allura Xper FD20/20 OR Table; Model #722058 for Allura Xper FD20/15; Model #722059 for Allura Xper FD20/15 OR Table.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection

May 18, 2026 · DeviceView details →
Class II
Ongoing

HarmonyAIR A-Series Surgical Lighting System

Steris Corporation

The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.

May 15, 2026 · DeviceView details →
Class IIOngoing

HarmonyAIR A-Series Surgical Lighting System

Steris Corporation

There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.

May 15, 2026 · DeviceView details →
Class IIOngoing

ALYON Surgical Lighting System

Steris Corporation

The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.

May 15, 2026 · DeviceView details →
Class IIOngoing

ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-100. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

ConMed Corporation

Potential for overpressure alerts.

May 14, 2026 · DeviceView details →
Class IIOngoing

ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS5-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

ConMed Corporation

Potential for overpressure alerts.

May 14, 2026 · DeviceView details →
Class IIOngoing

ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS12-120LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

ConMed Corporation

Potential for overpressure alerts.

May 14, 2026 · DeviceView details →
Class IIOngoing

ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length. Catalog Number: iASB5-150. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy

ConMed Corporation

Potential for overpressure alerts.

May 14, 2026 · DeviceView details →
Class IIOngoing

ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS8-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

ConMed Corporation

Potential for overpressure alerts.

May 14, 2026 · DeviceView details →
Class IIOngoing

ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS8-120LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

ConMed Corporation

Potential for overpressure alerts.

May 14, 2026 · DeviceView details →
Class IIOngoing

ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150mm Length. Catalog Number: iAS12-150LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

ConMed Corporation

Potential for overpressure alerts.

May 14, 2026 · DeviceView details →
Class IIOngoing

ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS5-120LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

ConMed Corporation

Potential for overpressure alerts.

May 14, 2026 · DeviceView details →
Class IIOngoing

ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length. Catalog Number: iAS5-75LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

ConMed Corporation

Potential for overpressure alerts.

May 14, 2026 · DeviceView details →
Class IIOngoing

ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog Number: iASB12-120. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

ConMed Corporation

Potential for overpressure alerts.

May 14, 2026 · DeviceView details →
Class IIOngoing

ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS12-100LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

ConMed Corporation

Potential for overpressure alerts.

May 14, 2026 · DeviceView details →
Class IIOngoing

Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the Power Module, the Mobile Power Unit, Lithium-Ion Batteries, or its own integrated emergency backup supply, down to the LVAD via the Driveline. The HeartMate 3 System Controller constantly monitors system performance through communication with the implanted LVAD and Controller internal measurements and alerts the user to any alarm conditions by activating membrane panel LEDs and integrated audio annunciators. Further information on alarm conditions as well as system status can be attained by the user from the front panel LCD on the System Controller. When connected to a HeartMate Touch" Communication System, the System Controller sends information regarding the System Controller and Pump Status once per second to provide additional information to the user. This link also allows the clinician to set new patient operating parameters (e.g. pump speed) and provides a link for downloading trend and/or event recorder data. Component: Yes, HeartMate 3 Left Ventricular System (LVAS) Kits

Thoratec LLC

Due to 11 volt Backup Battery failures.

May 13, 2026 · DeviceView details →
Class IIOngoing

Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide therapeutic benefit to those affected with advanced heart failure. In service, the LVAS assumes some or all of the workload of the left ventricle, thereby restoring the patient's systemic perfusion while palliating the underlying pathology. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus all of the features, controls, attachments, interfaces, power sources, supporting equipment, labeling, and tools required to achieve the desired therapeutic benefit. Component: No

Thoratec LLC

Due to 11 volt Backup Battery failures.

May 13, 2026 · DeviceView details →
Class IIOngoing

SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System

Alphatec Spine, Inc.

Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change.

May 13, 2026 · DeviceView details →
Class IIOngoing

EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM RFG-EF100 ENDOFLIP 1 10884521808096 05391530810166 DL ENDOFLIP 1 10884521786684 Endoscopic measuring system, including catheter components.

Covidien, LLC

The system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures.

May 13, 2026 · DeviceView details →
Class IIOngoing

Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Description: The HeartMate 11 Volt Lithium Ion Standalone Backup Battery is a component of the HeartMate 3" System Controller and provides power to the System Controller. The HeartMate System Controller is an external device that manages the HeartMate Left Ventricular Assist System (LVAS), including alarms, system monitoring, and communication. It contains an internal 11V lithium-ion backup battery that provides at least 15 minutes of emergency power should the main system power source fail. The backup battery must be properly installed, charges automatically during normal use, and has a 36-month service life from date of manufacture. Component: Yes, HeartMate 3" System Controller

Thoratec LLC

Due to 11 volt Backup Battery failures.

May 13, 2026 · DeviceView details →
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