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Medical Device Recalls | FDA

    https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls
    The FDA posts summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health...

FDA warns Lifescan recall letter is misleading - Medtech Insight

    https://medtech.pharmaintelligence.informa.com/MT083123/FDA-warns-Lifescan-recall-letter-is-misleading
    VDOMDHTML html>. The US FDA says it is concerned that the product replacement programme, which the Johnson & Johnson subsidiary, Lifescan, …

Class 2 Device Recall LifeScan OneTouch Ultra Control …

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=116222
    LifeScan sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 25, 2013 to all affected customers. The letter identified the product, problem, …

LifeScan Announces Voluntary Recall of All OneTouch® …

    https://www.jnj.com/media-center/press-releases/lifescan-announces-voluntary-recall-of-all-onetouch-verioiq-blood-glucose-meters
    LifeScan is recalling and replacing all OneTouch ® Verio ® IQ Meters because at extremely high blood glucose levels of 1024 mg/dL and above, the meter will not provide a warning …

Class 1 Device Recall Lifescan OneTouch Ultra Meter

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=38552
    Recall Number: Z-1596-05: Recall Event ID: 31815: 510(K)Number: K024194 Product Classification: System, Test, Blood Glucose, Over The Counter - Product Code …

Class 1 Device Recall LifeScan - Food and Drug …

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=38282
    Recall Number: Z-0822-05: Recall Event ID: 31640: 510(K)Number: K024194 Product Classification: System, Test, Blood Glucose, Over The Counter - Product Code …

U.S. FDA classifies recall of Philips' respiratory devices as most ...

    https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-classifies-recall-philips-respiratory-devices-most-serious-2023-02-16/
    2 days ago · Follow. Feb 16 (Reuters) - The U.S. Food and Drug Administration (FDA) on Thursday classified the recall of Dutch medical devices maker Philips' (PHG.AS) …

GE HealthCare Recalls Nuclear Medicine Systems for …

    https://www.fda.gov/medical-devices/medical-device-recalls/ge-healthcare-recalls-nuclear-medicine-600800-series-systems-risk-detector-fall-may-injure-patients
    See Medical Device Recall Database entry for more information. Distribution Dates: April 1, 2018 to December 16, 2022; Devices Recalled in the U.S.: 688; Date …

Class 2 Device Recall Lifescan OneTouch SureStep Meter

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=41344
    Recall Status 1: Terminated 3 on December 18, 2006: Recall Number: Z-0101-06: Recall Event ID: 33121: 510(K)Number: K023832 Product Classification: Glucose …

Class 2 Device Recall LifeScan - Food and Drug …

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=39361
    Recall Status 1: Terminated 3 on September 20, 2005: Recall Number: Z-0887-05: Recall Event ID: 32200: 510(K)Number: K024194 Product Classification: …



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