Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 9 months ago
Instrumentation Laboratory The product is used for the evaluation of the intrinsic recall: Potential for microbial contamination
Potential for microbial contamination.
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Class II · 9 months ago
Heraeus Medical GmbH Brand Name: Palacos Product Name: Palacos MV pro 40 recall: increase of complaints regarding the breakage of the ampoules within
increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors…
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Class II · 9 months ago
Philips Medical Systems Nederland B.v. Allura Xper FD20 Biplane recall: Philips has identified that in a limited number of impacted systems the drip
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field…
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Class II · 9 months ago
Medline Kits containing B. Braun IV Administration Sets and Pump recall: Medline kits contain B. Braun IV Administration Sets and Pump Administration
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the…
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Class II · 9 months ago
Medline Kits containing B. Braun IV Administration Sets and Pump recall: Medline kits contain B. Braun IV Administration Sets and Pump Administration
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the…
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Class II · 9 months ago
Medicrea, IB3D Universal Implant Inserter recall: Due to complaints, orthopedic rotation tool handle may untread from the shaft
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
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Class II · 9 months ago
ICU Medical Inc. Portex Spinal Tray recall: Affected lots of syringes may have a crack on the syringe collar
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may…
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Class II · 9 months ago
Philips Medical Systems Nederland B.v. Allura Xper FD10 recall: Philips has identified that in a limited number of impacted systems the drip
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field…
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Class II · 9 months ago
Mobius Imaging, LLC Detachable 10in Pendant Upgrade component for the AIRO Computed recall: AIRO pendant replacement kits and upgrade do not possess the "Safe Hand
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
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Class II · 9 months ago
Fresenius Kabi USA, LLC Ivenix Infusion System , LVP Software: LVP-SW-0005 recall: Emphasizing instructions for LVP duration programming located in the IFU
Emphasizing instructions for LVP duration programming located in the IFU.
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Class II · 9 months ago
Philips Azurion Systems with software versions R2.1.10 and R2.2.10 recall: Six (6) identified software issues which may result in the following: system
Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out…
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Class II · 9 months ago
Ge Medical Systems Israel, Functional Imaging SMV DSI, System, Tomography recall: GE HealthCare has become aware that certain Nuclear Medicine systems
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted…
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Class II · 9 months ago
Medline Kits containing B. Braun IV Administration Sets and Pump recall: Medline kits contain B. Braun IV Administration Sets and Pump Administration
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the…
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Class II · 9 months ago
Philips Medical Systems Nederland B.v. Allura Xper FD20/10 recall: Philips has identified that in a limited number of impacted systems the drip
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field…
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Class II · 9 months ago
Canon Medical System, USA, INC. Vantage Titan 3T Model MRT-3010/Mexl-3010 recall: There is a potential for formation of ice occurring in the venting system
There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in…
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Class II · 9 months ago
Hologic, Inc ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution recall: Fungal contamination of affected lot with Parengyodontium album
Fungal contamination of affected lot with Parengyodontium album.
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Class II · 9 months ago
Diagnostica Stago, Inc. Asserachrom HPIA. Model/ recall: Potential for defect for Asserachrom HPIA lot 271288
Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
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Class II · 9 months ago
Medline medical procedure convenience kits labeled as: 1) Laparoscopy recall: Medline kits containing Stryker's Strykeflow 2 Suction Irrigators
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the…
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Class II · 9 months ago
ICU Medical Inc. Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 recall: Affected lots of syringes may have a crack on the syringe collar
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may…
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Class II · 9 months ago
Philips Medical Systems Nederland B.v. Allura Xper FD20 recall: Philips has identified that in a limited number of impacted systems the drip
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field…
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Class II · 9 months ago
Philips Medical Systems Nederland B.v. Allura Xper FD10/10 recall: Philips has identified that in a limited number of impacted systems the drip
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field…
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Class II · 9 months ago
Medline Kits containing B. Braun IV Administration Sets and Pump recall: Medline kits contain B. Braun IV Administration Sets and Pump Administration
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the…
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Class II · 9 months ago
Philips Medical Systems Nederland B.v. Allura Xper FD20/20 recall: Philips has identified that in a limited number of impacted systems the drip
Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field…
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Class II · 9 months ago
Repligen Corporation Maverick¿ Measurement Module Spectrometer PN 820-01367 Finished recall: Potential Elevated Laser Output A disconnected cable or a poorly crimped
Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical bending stress can cause loss of electrical contact…