Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2026-01-21FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IICheck your Philips Allura Xper FD20 system
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.
- 2026-01-21FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IICheck your Philips Allura Xper FD10/10 system
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.
- 2026-01-21FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIAllura Xper FD10; Model Number: 722026;
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.
- 2026-01-21FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IICheck your Philips Allura Xper FD20 OR Table for drip tray
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.
- 2026-01-21FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IICheck your Philips Allura Xper FD20 system
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.
- 2026-01-21FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IICheck your Philips Allura Xper FD20 system
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.
- 2026-01-21FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IICheck your Philips Allura Xper FD10/10 system
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.
- 2026-01-21FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IICheck your Philips Allura Xper FD10 system
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.
- 2026-01-21FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IICheck your Philips Allura Xper FD20 system
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.
- 2026-01-21FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IICheck your Philips Allura Xper FD20 system
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.
- 2026-01-21FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IICheck your Philips Allura Xper FD10/10 system
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.
- 2026-01-21FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IICheck your Philips Allura Xper FD10 system
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.
- 2026-01-21FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IICheck your Philips Allura Xper FD10F system
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.
- 2026-01-21FDA-DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Class IIContact Philips about your Allura Xper FD10C system
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.
- 2026-01-21FDA-DeviceHANGZHOU BEVER MEDICAL DEVICES CO., LTD.Class IICheck your BD catheter expiration date
Labeling error, Incorrect expiration date
- 2026-01-21FDA-DeviceMedline Industries, LPClass IIStop using affected Medline surgical kits
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.
- 2026-01-21FDA-DeviceMedline Industries, LPClass IIStop using Medline Neuro Angio Pack IV kits
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.
- 2026-01-21FDA-DeviceMedline Industries, LPClass IIStop using Medline IV Administration Kits
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.
- 2026-01-21FDA-DeviceMedline Industries, LPClass IIStop using affected Medline pre-op kits
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.
- 2026-01-21FDA-DeviceMedline Industries, LPClass IIStop using recalled Medline IV kits
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.
- 2026-01-21FDA-DeviceMedline Industries, LPClass IIMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPPLIES, Medline kit SKU ACC010271B; 2) DRAWER 2 IV FLUIDS & TUBING, Medline kit SKU ACC010416B; 3) OXYGENATION & TUBING TRAY, Medline kit SKU ACC010525C; 4) TOP DRAWER #6, Medline kit SKU ACC010688; 5) RRMC CODE CART DRAWER 3, Medline kit SKU ACC010770; 6) SURGERY BAG, Medline kit SKU DYKM1279C; 7) ADMISSION KIT, Medline kit SKU DYKS1179; 8) PRE OP KIT, Medline kit
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.
- 2026-01-21FDA-DeviceMedline Industries, LPClass IIStop using Medline DR HOLCOMB FACIAL PACK kits
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.
- 2026-01-21FDA-DeviceMedline Industries, LPClass IIStop using Medline IV Administration Sets
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.
- 2026-01-21FDA-DeviceMedline Industries, LPClass IIStop using affected Medline surgical kits
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.
- 2026-01-21FDA-DeviceMedline Industries, LPClass IIStop using affected Medline Pre Op Kits
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.
- 2026-01-21FDA-DeviceMedline Industries, LPClass IIStop using affected Medline cardiac kits
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.
- 2026-01-21FDA-DeviceMedline Industries, LPClass IIStop using Medline AN01 carotid anesthesia kits
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.
- 2026-01-21FDA-DeviceFresenius Kabi USA, LLCClass IICheck Fresenius Kabi Ivenix Infusion System software
Emphasizing instructions for LVP duration programming located in the IFU.
- 2026-01-21FDA-DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGClass IICheck GE MAXXUS imaging system detector support
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.
- 2026-01-21FDA-DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGClass IICheck GE HealthCare nuclear medicine system detector support
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.
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