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
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 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
Mobius Imaging, LLC Detachable 10in Pend FRU-1 Pend 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
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 medical procedure convenience kits labeled as: 1) Lavh 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
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
Philips Azurion Systems R3.0. Includes the following label descriptions recall: Nine (9) identified software issues which may result in the following: loss
Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live…
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Class II · 9 months ago
Philips Medical Systems Nederland B.v. Product Name: Allura Xper FD10C 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 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
Medicrea, IB3D PL Instruments Set 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
Medtronic Neuromodulation A71200 Vanta" Clinician Programmer Application version recall: Complaints received that Vanta A71200 CP App does not function as intended
Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical…
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Class II · 9 months ago
Heraeus Medical GmbH Brand Name: Palacos Product Name: Palacos R+G 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
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 FD10F 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
Hangzhou Bever Medical Devices Co., Ltd. BD Ready-to-Use Hydrophilic Catheter 14 Fr recall: Labeling error, Incorrect expiration date
Labeling error, Incorrect expiration date
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Class II · 9 months ago
Intuitive Surgical, Inc. da Vinci SP, SP recall: Access Port System tray may develop cracks potentially resulting
Access Port System tray may develop cracks potentially resulting in a sterility breach.
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Class II · 9 months ago
Medline medical procedure convenience kits labeled as: KIT Robotics 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
Canon Medical System, USA, INC. Vantage Galan 3T Model MRT-3020/Mexl-3020 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
Elekta, Inc. Mosaiq Oncology Information System with Particle Therapy License recall: Using oncology information system that manages workflow may result
Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II…
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Elevated risk · 10 months ago
Olympus ViziShot 2 Flex Ebus -Tbna needles recall: Device & Drug Safety - Defect
Device & Drug Safety - Defect
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Class II · 10 months ago
Securitas Healthcare LLC Arial 900 MHz Call Station recall: Securitas Healthcare has become aware of a firmware issue in the Call
Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots…
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Class II · 10 months ago
Integra LifeSciences Corp. Codman CereLink ICP Sensor Basic Kit recall: Potential corrosion stains on the surface of the 14-gauge Tuohy Needle
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.