Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 1+ years ago
AVID Medical, Inc. Halyard, ENT PACK recall: Potential for open header bag seals, compromising sterility
Potential for open header bag seals, compromising sterility.
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Class II · 1+ years ago
Orthofix U.S. LLC Pillar SA Ti, Sterile, 37mm x 28mm x 18mm , 20-degrees recall: A 37 mm implant width intervertebral body fusion device has a labeling
A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap…
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Class I · 1+ years ago
Olympus Corporation of the Americas ViziShot 2FLEX. Single Use Aspiration Needle recall: Potential for undetected, deformed a-traumatic tips
Potential for undetected, deformed a-traumatic tips.
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Class II · 1+ years ago
Quidel Corporation QuickVue recall: Dipstick strep A test has potential for false positive results
Dipstick strep A test has potential for false positive results.
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Class II · 1+ years ago
Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked recall: Measles IgM Test Kit lacks premarket approval or clearance
Measles IgM Test Kit lacks premarket approval or clearance.
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Class II · 1+ years ago
Philips Medical Systems Nederland B.V. IntelliSpace Cardiovascular, Software 8.0.0.4 recall: Software issue that results in the display of outdated information
Software issue that results in the display of outdated information.
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Class II · 1+ years ago
Siemens Medical Solutions USA, Inc Artis Pheno. Image-Intensified Flouroscopic X-Ray recall: Limited system movements after startup
Limited system movements after startup .
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Class II · 1+ years ago
Boston Scientific Corporation ICEfx Cryoablation System recall: Certain desiccant tube subassemblies were built with end caps
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
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Class II · 1+ years ago
Encore Medical, LP Brand Name: DJO Surgical Product Name: Altivate Reverse Wedge recall: Their is a potential that the reamer may kick or bind up during
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
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Class II · 1+ years ago
Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers recall: Two new potential laser safety failure modes have been identified
Two new potential laser safety failure modes have been identified in the product design. Overcurrent of laser diode, and a fail-unsafe mode. The…
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Class II · 1+ years ago
Boston Scientific NephroMax Kit, Material Numbers : 1. M0062101180 recall: The Encore 26 Inflation Device is used with balloon dilation catheters
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An…
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Highest risk · 1+ years ago
BD Alaris BD Alaris Pump Module model 8100 used with a subset of compatible pump recall: Pump performance variations compared to the performance described in the user
Pump performance variations compared to the performance described in the user manual could impact infusion delivery
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Class II · 1+ years ago
Raysearch Laboratories Ab RayStation with the following product descriptions: 1 recall: DICOM SOP Instance UID and Series Instance UID from RayGateway
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
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Class II · 1+ years ago
Raysearch Laboratories Ab RayStation with the following product descriptions: 1 recall: DICOM SOP Instance UID and Series Instance UID from RayGateway
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
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Class I · 1+ years ago
Medtronic Perfusion Systems DLP Left Heart Vent Catheter Malleable body and vented recall: The catheters may not retain their shape
The catheters may not retain their shape.
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Class II · 1+ years ago
ICU Medical Inc. Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow recall: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic…
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Class I · 1+ years ago
Boston Scientific Corporation Watchman TruSeal Access System ANT, OUS recall: Boston Scientific has identified a higher likelihood of air embolism events
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled…
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Class II · 1+ years ago
Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series recall: Potential that a component (air baffle) may be missing in some Nehalem
Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.
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Class I · 1+ years ago
mo-Vis BVBA Multi Joystick R-net. Electrical wheelchair component recall: Devices with firmware versions 2.3 and lower may experience timing variations
Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary…
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Class II · 1+ years ago
O&m Halyard Inc Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack recall: Surgical drape packs may have open seals, which may compromise the sterility
Surgical drape packs may have open seals, which may compromise the sterility of the product.
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Class I · 1+ years ago
Boston Scientific Corporation Watchman TruSeal Access System ANT, US recall: Boston Scientific has identified a higher likelihood of air embolism events
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled…
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Class I · 1+ years ago
Boston Scientific Corporation Watchman FXD Curve Access System Sgl, US recall: Boston Scientific has identified a higher likelihood of air embolism events
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled…
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Class I · 1+ years ago
Boston Scientific Corporation Watchman TruSeal Access System SGL, OUS recall: Boston Scientific has identified a higher likelihood of air embolism events
Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled…
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Class II · 1+ years ago
Integra LifeSciences Corp. Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel recall: Packaging failures were identified which could lead to a breach
Packaging failures were identified which could lead to a breach in the sterile barrier.