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
Northeast Scientific Inc. NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy recall: Potential for breaches in the sterile barrier packaging
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
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Class II · 1+ years ago
North American Rescue LLC. Junctional Emergency Treatment Tool , REF: 30-0088 recall: Device used for unilateral or bilateral occlusion of blood flow to the lower
Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the…
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Class I · 1+ years ago
Siemens Medical Solutions USA, Inc Biograph mMR recall: There is a potential for an ice blockage to form or currently exist within
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be…
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Class I · 1+ years ago
Siemens Medical Solutions USA, Inc Magnetom Skyra recall: There is a potential for an ice blockage to form or currently exist within
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be…
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Class II · 1+ years ago
Medtronic, Simplera Sensor, REF: MMT-5100JD1 recall: The device cap label may not adhere to the sensor
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
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Class II · 1+ years ago
True Metrix Blood Glucose Meters recall: Potential for defective LCD displays that can affect product performance
Potential for defective LCD displays that can affect product performance
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Class II · 1+ years ago
Philips Medical Systems Nederland B.v. Allura Xper FD20/10 recall: Systems may not perform as intended due to the deterioration of certain
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply…
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Class II · 1+ years ago
Philips CT systems labeled as the following: 1. Brilliance iCT SP recall: The patient support table (couch) may descend unexpectedly to the lowermost
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
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Class II · 1+ years ago
Philips Medical Systems Nederland B.v. Allura Xper FD20/20 recall: Systems may not perform as intended due to the deterioration of certain
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply…
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Class II · 1+ years ago
Philips Medical Systems Nederland B.v. Allura Xper FD20 Product Codes: 722012 recall: Systems may not perform as intended due to the deterioration of certain
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply…
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Class II · 1+ years ago
Philips CT systems labeled as the following: 1. Ingenuity Core128 / recall: The patient support table (couch) may descend unexpectedly to the lowermost
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
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Class II · 1+ years ago
Ethicon, LLC Stratafix Spiral PDS Plus Bidirectional Knotless Tissue Control Device recall: Potential for barb non-engagement
Potential for barb non-engagement.
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Class II · 1+ years ago
CooperVision, Inc. Sofmed Breathables, contact lens recall: One lot manufactured with an invalid sterilization cycle
One lot manufactured with an invalid sterilization cycle.
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Class I · 1+ years ago
Medline medical convenience kits labeled as: 1. Newborn Resuscitation recall: Medline Industries, LP is issuing a recall for specific item(s) and lot(s)
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic…
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Class II · 1+ years ago
Boston Scientific Corporation Extractor Pro RX Retrieval Balloon Catheter recall: The product in incorrectly labeled. The label indicates that the skive hole
The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and…
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Class II · 1+ years ago
Philips CT systems labeled as the following: 1. Ingenuity CT 728326 recall: The patient support table (couch) may descend unexpectedly to the lowermost
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
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Class II · 1+ years ago
CooperVision, Inc. Voyant 1-Day Premium Toric, contact lens recall: One lot manufactured with an invalid sterilization cycle
One lot manufactured with an invalid sterilization cycle.
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Class II · 1+ years ago
Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel recall: The patient support table (couch) may descend unexpectedly to the lowermost
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
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Class II · 1+ years ago
Mindray North America BeneVision N1 Patient Monitor . Part Numbers: 6660E-PA00017 recall: Potential for activation of an abnormal alarm pause
Potential for activation of an abnormal alarm pause.
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Class II · 1+ years ago
Philips Medical Systems Nederland B.v. Allura Xper FD20 Biplane OR Table Product recall: Systems may not perform as intended due to the deterioration of certain
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply…
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Class II · 1+ years ago
Biofire Defense FilmArray Ngds Warrior Panel Ngds-Asy-0007 is a qualitative recall: FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk
FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead…
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Class II · 1+ years ago
Biomet, Inc. Juggerknot Mini Soft Anchors, Model/ recall: The outer carton box label is for the JuggerKnot 1.0mm Mini products
The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.
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Class II · 1+ years ago
Philips CT systems labeled as the following: 1. Brilliance 16 Power recall: The patient support table (couch) may descend unexpectedly to the lowermost
The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.
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Class II · 1+ years ago
Philips Medical Systems Nederland B.v. Allura Xper FD20/20 OR Table recall: Systems may not perform as intended due to the deterioration of certain
Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply…