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The Abbott Proclaim and Infinity neurostimulation systems deliver low-intensity electrical impulses to nerve structures. The device may be unable to exit MRI mode and resume therapy.
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Bone Matrix Product: FDA Safety Communication – Important Information for Human Cell, Tissue and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Tuberculosis Outbreaks
FDA is working closely with the CDC to investigate recent reports of a TB outbreak caused by Mycobacterium tuberculosis (Mtb) that appears to be linked to a bone matrix product.
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FDA Issues Warning Letters to Firms Marketing Unapproved Eye Products
FDA Issues Warning Letters to Firms Marketing Unapproved Eye Products
http://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-firms-marketing-unapproved-eye-products
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Mallinckrodt Manufacturing, LLC Recalls One-Way Valve, 22F x 22M for Not Opening Properly
The One-Way Valve, 22F x 22M is a single-use device accessory used to prevent backward flow of nitric oxide gas into the airways.
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FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants
FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants
http://www.fda.gov/news-events/press-announcements/fda-takes-action-updated-mrna-covid-19-vaccines-better-protect-against-currently-circulating
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Novartis Issues Voluntary Nationwide Recall of One Lot of Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL Due to Crystallization
Novartis is conducting a voluntary nationwide recall at the consumer level of one lot of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. No other Sandimmune for
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FDA Roundup: September 8 2023
FDA Roundup: September 8 2023
http://www.fda.gov/news-events/press-announcements/fda-roundup-september-8-2023
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Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication
Certain surgical respirators, surgical masks, and pediatric face masks by O&M Halyard do not meet quality and performance expectations.
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Church & Dwight Initiates Voluntary Recall of One Specific Lot of TheraBreath Kids Strawberry Splash 16oz Sold Exclusively on Amazon Between May 31 and September 02, 2023, Due to an Isolated Manufacturing Issue
FOR IMMEDIATE RELEASE – September 8, 2023 – EWING, N.J – Church & Dwight Co., Inc. (NYSE:CHD) today initiated a voluntary recall of one specific lot of TheraBreath Kids Strawberry Splash 16oz after the
Company identified a microbial contamination due to the presence of yeast (Candida Parapsilosis)
Company identified a microbial contamination due to the presence of yeast (Candida Parapsilosis)
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WEFUN Inc Issues Voluntary Nationwide Recall of WEFUN Capsules Due to Presence of Undeclared Sildenafil
Brooklyn, New York, WEFUN Inc is voluntarily recalling 300 Boxes of WEFUN Capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil. Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) inhibitor found in FDA-approved products for the trea