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Megadyne issued a Class 1 Medical Device Correction to hospitals to limit the use of MEGA SOFT Universal and Universal Plus Reusable Patient Return Electrodes to patients aged 12 years or older after receiving reports of adult and pediatric patient burns following surgical procedures in which MEGA S
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FDA, Industry Actions End Sales of PFAS Used in US Food Packaging
FDA, Industry Actions End Sales of PFAS Used in US Food Packaging
http://www.fda.gov/news-events/press-announcements/fda-industry-actions-end-sales-pfas-used-us-food-packaging
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2023 Medical Device Recalls
2023 Medical Device Recalls
http://www.fda.gov/medical-devices/medical-device-recalls/2023-medical-device-recalls
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Olympus Corporation of the Americas Recalls Bronchofiberscopes and Bronchovideoscopes Because They Can Lead to Burns and Fire
Olympus bronchoscopes, used to examine or treat a person’s airways, are being recalled because they can lead to burns and fire.
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FDA Roundup: February 27, 2024
FDA Roundup: February 27, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-february-27-2024
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BioZorb Markers and Potential Risks with Use in Breast Tissue: FDA Safety Communication
FDA is informing the public of adverse events reported with the use of BioZorb Marker including pain, migration, erosion, and others.
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Avanos Medical, Inc. Announces Voluntary Recall in Response to Nurse Assist, LLC Sterile Water Medical Products Recall
In direct response to the Nurse Assist, LLC voluntary recall of pre-filled syringes and other sterile water products, Avanos Medical, Inc. (NYSE: AVNS) voluntarily recalled specific lots of MIC* Gastric – Jejunal Feeding Tube Kits on Jan. 16, 2024. These kits include Nurse Assist supplied syringes,
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Brassica Pharma Pvt. Ltd. Issues Voluntary Nationwide Recall of Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment, Lubricant PM Ointment Due to Potential Lack of Sterility
Brassica Pharma Pvt. Ltd. is voluntarily recalling Eye Ointment products listed in the table below with expiration date ranging from February 2024 to September 2025. The products are being recalled due to lack of sterility assurance at the facility noted during an inspection conducted by the Food an
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FDA Roundup: February 23, 2024
FDA Roundup: February 23, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-february-23-2024
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Update: Recommendations for Certain Medtronic Electromyogram Endotracheal Tubes and Risk of Airway Obstruction – Letter to Health Care Providers
Medtronic initiates recall for silicone-based EMG endotracheal tubes due to the risk of airway obstruction and ventilation failure.