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https://www.medtechdive.com/news/bd-fda-warning-letter-pyxis-safety/736124/ BD receives FDA warning letter over quality system violations | MedTech Dive Inspectors found 111 open tickets for software defects categorized as catastrophic or severe patient harm. Several safety complaints were also listed that BD... fda warning quality system medtech dive bd receives https://thecapitolforum.com/dexcom-fda-warning-letter/ Dexcom: FDA Warning Letter States Company Made Changes to Continuous Glucose Monitors Without... Mar 25, 2025 - The FDA has published a warning letter it sent to Dexcom (DXCM) earlier this month... continuous glucose monitors fda warning letter states https://www.amlpa.org/ FDA warning Reglan Tardive Dyskinesia FDA warning Reglan Tardive Dyskinesia fda warning tardive dyskinesia reglan https://www.medtechdive.com/news/whoop-fda-warning-letter-blood-pressure-wellness/753489/ Whoop’s FDA warning letter sparks debate over blood pressure as a wellness metric | MedTech Dive Whoop pushed back on the warning letter, claiming its blood pressure feature for a wearable wristband is for “wellness” and should not be regulated as a... fda warning https://www.medtechdive.com/news/medline-recalls-angiographic-syringes-receives-fda-warning-letter/817433/ Medline recalls angiographic syringes, receives FDA warning letter | MedTech Dive The company removed the devices from the market in February following complaints of the syringes disconnecting from manifolds. fda warning medtech dive medline recalls angiographic https://www.buzzfeednews.com/article/katiecamero/breast-implants-health-risks Breast Implants And Cancer: FDA Warning A Reminder Of Health Risks Breast implants don’t last a lifetime, and often have to be replaced or removed due to complications or, in very rare cases, cancer. We spoke to experts to... breast implants and cancer fda warning https://www.medtechdive.com/news/cook-resolves-fda-warning-letter-that-slammed-quality-processes/532140/ Cook resolves FDA warning letter that slammed quality processes | MedTech Dive The close-out letter follows four years of work to improve quality management. fda warning quality processes medtech dive cook resolves https://www.pharmanow.live/regulatory-landscape/fda-warning-letters-2025-lab-compliance-patterns 470 FDA Warning Letters In 2025 Lab Compliance Patterns May 4, 2026 - FDA issued 470 warning letters in 2025, revealing repeated lab failures. Learn the patterns, data breakdown, and how to avoid enforcement action. fda warning letters lab compliance patterns https://www.medtechdive.com/news/manufacturer-modifies-wheelchair-for-off-roading-draws-fda-warning/563147/ Manufacturer modifies wheelchair for off-roading, draws FDA warning | MedTech Dive The agency warned power wheelchair maker 21st Century Scientific over offering seat modification packages with lifting, reclining and other functions not... off roading fda warning medtech dive manufacturer wheelchair https://www.morganlewis.com/blogs/asprescribed/2026/04/fdas-warning-letter-suggests-growing-scrutiny-of-ai-overreliance FDA AI Compliance: Warning Letter Signals New Scrutiny of AI Use FDA’s warning letter shows expanding scrutiny of artificial intelligence use in regulated operations, emphasizing that companies remain responsible for... ai compliance warning letter signals new of use fda https://www.fda.gov/consumers/health-fraud-scams/warning-letters-health-fraud Warning Letters - Health Fraud | FDA Warning Letters - Health Fraud warning letters health fraud fda https://www.frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2019.00294/full Frontiers | The FDA “Black Box” Warning on Antidepressant Suicide Risk in Young Adults: More Harm... Apr 24, 2026 - The U.S. Food and Drug Administration (FDA) “, black box” warning on antidepressant suicide in young people grounds on industry-sponsored trials, often carri... the fda suicide risk young adults frontiers warning https://apnews.com/article/hoeg-urato-fda-drugs-antidepressants-pregnancy-warnings-a2a48cd2285f5b33aef2d390b5b60d0c Top FDA official seeks to hire friend pushing new antidepressants warning | AP News Mar 13, 2026 - The Food and Drug Administration is reviewing a request for new warnings on antidepressant drugs, and that's presenting an unusual conflict of interest at the... https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters Warning Letters | FDA Main FDA Warning Letter Page warning letters fda https://www.medtechdive.com/news/fda-recommends-tissue-containment-for-power-morcellators/572990/ FDA advises boxed warning for surgical devices half-decade after flagging cancer risk to women |... In 2014, FDA warned against the use of laparoscopic power morcellators for hysterectomy or fibroid removal for most women, after determining through its own... https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/about-warning-and-close-out-letters About Warning and Close-Out Letters | FDA Information about warning letters and close-out letters posted on the FDA website close out warning letters fda https://www.medtechdive.com/news/Illumina-FDA-recall-cybersecurity-ILMN/648869/ Illumina gets cybersecurity warning from FDA over sequencing software | MedTech Dive Apr 28, 2023 - The vulnerability could result in an attacker gaining control of an instrument remotely and altering genomic data results, the agency said. medtech dive illumina gets cybersecurity warning https://lifehacker.com/health/fda-warning-against-some-wearable-baby-monitors Why the FDA Is Warning Against Some Wearable Baby Monitors | Lifehacker Sep 18, 2025 - The FDA warned consumers away from unauthorized baby monitors that claim to measure breathing or other vital signs, saying that they may be inaccurate, and... the fda is warning baby monitors https://www.foxnews.com/video/6393228039112 FDA's hormone therapy warning rollback sparks estrogen patch shortage | Fox News Video Apr 16, 2026 - FDA's hormone therapy warning rollback sparks estrogen patch shortage hormone therapy fox news https://www.fda.gov/cosmetics/cosmetics-compliance-enforcement/warning-letters-related-cosmetics Warning Letters Related to Cosmetics | FDA Warning Letters to Industry on Cosmetic-Related Issues warning letters related cosmetics fda https://www.benzoinfo.com/2020-fda-warning/ FDA 2020 Benzodiazepine Boxed Warning - Benzodiazepine Information Coalition Mar 30, 2024 - We encourage those who have not reported their harm to file a MedWatch report so that the FDA is aware of the many problems that remain unaddressed. Learn How... boxed warning information coalition fda benzodiazepine https://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-requiring-boxed-warning-updated-improve-safe-use-benzodiazepine-drug-class FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class | FDA Listen to an audio podcast of the September 23, 2020, FDA Drug Safety communication to address the serious risks of abuse, addiction, physical dependence, and... boxed warning safe use https://www.medtechdive.com/news/olympus-warning-letter-endoscope-caps/645398/ Olympus accused of ‘troubling disregard for patient safety’ by FDA after flurry of warning letters... The agency’s investigation included a complaint that cracked endoscope caps caused a patient to suffer esophageal trauma. for patient warning letters olympus accused disregard https://www.medtechdive.com/news/FDA-iRhythm-second-510k-response-warning-letter/731769/ FDA clears iRhythm’s second 510(k) in response to warning letter | MedTech Dive However, the company said it will delay a submission for its next-generation Zio cardiac monitoring system until remediation efforts are further along. in response warning letter medtech dive fda clears https://www.self.com/story/fda-removes-safety-warning-hormone-therapy-menopause The FDA Will Strip the Misleading Safety Warning From Hormone Therapy. Here’s What This Means for... Nov 10, 2025 - The FDA will remove the black box warning from hormone therapy for menopause. Doctors explain why this is long overdue and how to decide if HRT is right for... what this means the fda safety warning hormone therapy https://desertharvest.com/blogs/blog/fda-removes-black-box-warning-menopause-hormone-therapy FDA Removes Black Box Warning on Menopause Hormone Therapy – Desert Harvest Nov 10, 2025 - Breaking: FDA removes controversial black box warning on HRT for menopause, ending 20+ years of women being denied treatment. What this means for your options. menopause hormone therapy black box fda removes warning https://www.lifeandstylemag.com/posts/tiktoks-frozen-egg-trend-gets-fda-and-usda-warning/ TikTok’s Frozen Egg Trend Gets FDA and USDA Warning Apr 24, 2026 - Experts say the viral frozen egg TikTok hack can crack shells and increase salmonella risk, making it unsafe to try at home frozen egg trend gets fda https://www.fda.gov/news-events/public-health-focus/warning-letters-cannabis-derived-products?mod=article_inline Warning Letters for Cannabis-Derived Products | FDA Warning Letters for Cannabis-Derived Products warning letters for cannabis derived products fda https://www.ladybirdpt.com/post/black-box-warning-removed-on-estrogen-therapy Big News in Women’s Health: The FDA Removes the “Black Box” Warning from Estrogen Therapy — Lady... big news the fda estrogen therapy health removes https://www.fda.gov/drugs/enforcement-activities-fda/warning-letters-and-notice-violation-letters-pharmaceutical-companies Warning Letters and Notice of Violation Letters to Pharmaceutical Companies | FDA CDER Warning Letters notify manufacturers of significant violations of FDA regulations. CDER works with the company to ensure correction. warning letters pharmaceutical companies notice violation fda https://consumer.ftc.gov/consumer-alerts/2019/02/ftc-fda-issue-warning-letters-supplement-sellers FTC & FDA issue warning letters to supplement sellers | Consumer Advice Ads abound for products that claim to treat or prevent serious health conditions. Unfortunately, these products often are unproven and useless. warning letters consumer advice ftc fda issue https://www.newsweek.com/warning-issued-as-xanax-recalled-nationwide-fda-announces-11836625 Warning Issued As Xanax Recalled Nationwide, FDA Announces - Newsweek Apr 16, 2026 - The FDA has designated it a class II recall. warning issued xanax recalled nationwide