January 21, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20; Model Number: 722028;
Hazard: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
January 21, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10/10; Model Number: 722027;
Hazard: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
January 21, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10; Model Number: 722026;
Hazard: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
January 21, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20 OR Table; Model Number: 722023;
Hazard: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
January 21, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20 Biplane; Model Number: 722013;
Hazard: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
January 21, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20; Model Number: 722012;
Hazard: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
January 21, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10/10; Model Number: 722011;
Hazard: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
January 21, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10; Model Number: 722010;
Hazard: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
January 21, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20 Biplane; Model Number: 722008;
Hazard: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
January 21, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD20; Model Number: 722006;
Hazard: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
January 21, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10/10; Model Number: 722005;
Hazard: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
January 21, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10; Model Number: 722003;
Hazard: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
January 21, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Allura Xper FD10F; Model Number: 722002;
Hazard: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
January 21, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Product Name: Allura Xper FD10C; Model number: 722001;
Hazard: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
January 21, 2026Medical DevicesFDA
HANGZHOU BEVER MEDICAL DEVICES CO., LTD. recalls BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
Hazard: Labeling error, Incorrect expiration date
January 21, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-PLASTIC CRANIO
Hazard: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
January 21, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: NEURO ANGIO PACK, M
Hazard: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
January 21, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medl
Hazard: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
January 21, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medl
Hazard: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
January 21, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) IV START KIT NS,
Hazard: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
January 21, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPP
Hazard: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
January 21, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL P
Hazard: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
January 21, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: RR-LAP DONOR NEP AC
Hazard: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
January 21, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-LE FORT MANDI
Hazard: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
January 21, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KI
Hazard: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
January 21, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) OPEN HEART ACCES
Hazard: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
January 21, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH K
Hazard: Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
January 21, 2026Medical DevicesFDA
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Hazard: Emphasizing instructions for LVP duration programming located in the IFU.
January 21, 2026Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls MAXXUS, System, Tomography, Computed, Emission
Hazard: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
January 21, 2026Medical DevicesFDA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls SMV BodyTrack, System, Tomography, Computed, Emission
Hazard: GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.