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
Medshape Universal Joints, REF: DNE-9000-UJ recall: Bone external fixation system may have the pin that can become dislodged
Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in…
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Class II · 1+ years ago
Integra LifeSciences Corp. Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste 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.
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Class I · 1+ years ago
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product recall: The affected devices are the Dexcom G7 Continuous Glucose Monitoring System
The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0…
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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
Boston Scientific Corporation Watchman TruSeal 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 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
Lumicell, Inc. Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly recall: The potential of the elastic bands included in the kit detaching
The potential of the elastic bands included in the kit detaching or fracturing during surgical procedures. As a result, these failures may pose a…
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Class II · 1+ years ago
Visgeneer, Inc. Blood Uric Acid Monitoring System Each kit contains 1 meter recall: Due to products distributed without premarket clearance or approvals
Due to products distributed without premarket clearance or approvals.
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Class II · 1+ years ago
ICU Medical Inc. Smiths Medical CADD Medication Cassette Reservoir with clamp 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
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 I · 1+ years ago
mo-Vis BVBA IDM-MICRO-R. 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 III · 1+ years ago
Philips Ultrasound, Inc X3-1 Transducer Probe recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class II · 1+ years ago
CareFusion 303, Inc. BD Pyxis Product Name / UDI-DI code / recall: Antivirus software was not consistently installed on impacted devices during
Antivirus software was not consistently installed on impacted devices during the implementation process.
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Class III · 1+ years ago
Philips Ultrasound, Inc S7-2t Transducer Probe recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class III · 1+ years ago
Philips Ultrasound, Inc S12-4 Transducer Probe recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class III · 1+ years ago
Philips Ultrasound, Inc S8-3 Transducer Probe recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class III · 1+ years ago
Philips Ultrasound, Inc C9-5ec Transducer Probe recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class II · 1+ years ago
Orascoptic Superior Visualization Phantom Essential kit recall: Due to complaints, loupe nose pads containing nickel may cause an allergic
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
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Class III · 1+ years ago
Philips Ultrasound, Inc C10-3v Transducer Probe recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class II · 1+ years ago
Vantive Us Healthcare LLC PrisMax V3 control Unit-US, Hemodialysis Delivery System recall: Unexpected PrisMax System alarm T0830: Blood Leak Detected
Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD)…
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Class III · 1+ years ago
Philips Ultrasound, Inc L17-5 Transducer Probe recall: To provide clarification and labelling to define the useful life
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
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Class II · 1+ years ago
American Contract Systems, Medical Procedure kits and trays labeled recall: During an internal investigation, ACS determined that the rationale
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some…
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Class II · 1+ years ago
Orascoptic Superior Visualization Custom loupes configured with Phantom recall: Due to complaints, loupe nose pads containing nickel may cause an allergic
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
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Class II · 1+ years ago
Onkos Surgical, Inc. Eleos Segmental Limb Salvage System recall: Unidentified substance of unknown impact was identified on devices during
Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.