Medical Devices and Pharma
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FDA Class I Recall for Abiomed Impella Gen 1 Purge Cassettes
Medical Device Alert: Abiomed Impella Purge Cassette Recall (Class I) Abiomed has initiated a Class I recall, the most serious classification issued by the U.S. Food and Drug Administration, for certain Impella purge cassettes and associated pump sets due to a...
Class I Correction for Abiomed Impella Inaccurate Flow Readings
Abiomed Impella RP: FDA Class I Correction for Inaccurate Flow Readings Abiomed has issued an Urgent Medical Device Correction for its Impella RP with SmartAssist and Impella RP Flex with SmartAssist systems due to potential inaccuracies in displayed pump performance...
Class I Correction for Homecare Bed Fire and Entrapment Risks
Medline Homecare Beds: FDA Class I Correction for Fire and Entrapment Risks Medline Industries has issued a critical safety correction involving multiple models of homecare beds following reports of overheating components, electrical hazards, and patient entrapment...
FDA Flags High-Risk Issue with Erbe Flexible Cryoprobes
FDA Flags High-Risk Issue with Erbe Flexible Cryoprobes The FDA’s Center for Devices and Radiological Health (CDRH) has issued an Early Alert regarding a potentially high-risk issue involving certain flexible cryoprobes manufactured by Erbe USA. Issue Overview Erbe...
Medline Recalls Angiographic RA Control Syringes
Angiographic Syringe Recall: Medline Removes RA Control Syringes Due to Risk of Disconnection and Air Embolism The U.S. Food and Drug Administration (FDA) has announced that Medline Industries has issued an Urgent Medical Device Recall involving certain Namic...
FDA Class I Recall for Abiomed Impella Gen 1 Purge Cassettes
Medical Device Alert: Abiomed Impella Purge Cassette Recall (Class I) Abiomed has initiated a Class I recall, the most serious classification issued by the U.S. Food and Drug Administration, for certain Impella purge cassettes and associated pump sets due to a...
Class I Correction for Abiomed Impella Inaccurate Flow Readings
Abiomed Impella RP: FDA Class I Correction for Inaccurate Flow Readings Abiomed has issued an Urgent Medical Device Correction for its Impella RP with SmartAssist and Impella RP Flex with SmartAssist systems due to potential inaccuracies in displayed pump performance...
Class I Correction for Homecare Bed Fire and Entrapment Risks
Medline Homecare Beds: FDA Class I Correction for Fire and Entrapment Risks Medline Industries has issued a critical safety correction involving multiple models of homecare beds following reports of overheating components, electrical hazards, and patient entrapment...
FDA Cites Data Integrity and OOS Failures at Intas Pharma
FDA Warning Letter: Data Integrity and OOS Failures at Intas Pharmaceuticals Limited The U.S. Food and Drug Administration issued a Warning Letter to Intas Pharmaceuticals Limited citing significant violations of Current Good Manufacturing Practice (CGMP) at its...
Major Eye Drop Recall Shows Manufacturing and Inspection Issues
Kian Pee Wan Capsules Recalled for Undeclared Drug Ingredients
Kian Pee Wan Capsules Recalled Due to Undeclared Drug Ingredients Aphreseller (Buy-herbal.com), an online seller based in Flushing, New York, has voluntarily recalled all lots of Kian Pee Wan capsules after testing identified the presence of undeclared drug...
How to Know if Internet GLP-1 Ads Are Safe to Purchase Online
Ads for GLP‑1 drugs are flooding the internet – here’s how to know if it’s safe to buy them online Websites that sell compounded versions of GLP-1 drugs are not allowed to sell them under the brand names. Michael Siluk/UCG, Universal Images Group via Getty Images...
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Abbott Hit with $70 Million Verdict from Infant Formula Litigation
Neonatal nutritional product litigationJury findings raise new questions about risk communication, labeling, and regulatory expectations for neonatal nutrition products A Chicago jury has ordered Abbott Laboratories to pay $70 million in damages after finding that its...
Class I Correction for Homecare Bed Fire and Entrapment Risks
Medline Homecare Beds: FDA Class I Correction for Fire and Entrapment Risks Medline Industries has issued a critical safety correction involving multiple models of homecare beds following reports of overheating components, electrical hazards, and patient entrapment...
Adulterated Supplements and the Limits of Post-Market Oversight
FDA Recall of Adulterated Supplements Raises Questions About DSHEA Oversight Lessons from the “Boner Bear” Recall The FDA’s recent recall of several honey-based “sexual enhancement” supplements illustrates a recurring problem in the dietary supplement marketplace:...
Tippy Toes Apple Pear Banana Baby Food Recalled
Baby Food Recalled for Elevated Patulin Levels Recall Date: February 13, 2026Company: IF Copack LLC d.b.a. Initiative FoodsBrand: Tippy ToesProduct Type: Baby Food Fruit PuréeHazard: Elevated levels of patulin (a mycotoxin) Initiative Foods has issued a voluntary...
FDA Warns Amazon for Unapproved Drugs Sold On Its Website
FDA Issues Warning Letter to Amazon for Unapproved Drug Products FDA issued a warning letter to Amazon.com, Inc. after...
FDA Warns Leading Edge Health Over Unapproved New Drugs
FDA Warning Letter Targets Erectin Stimulating Gel and VigRX Delay Wipes FDA issued a warning letter to Leading Edge Health...
FDA Targets Online Marketing of Unapproved Drugs
FDA Issues 14 Warning Letters Targeting Online Unapproved Drug Sales The U.S. Food and Drug Administration (FDA) has issued...
FDA Approves First Treatment to Reduce Risk of Acute Pancreatitis
FDA Approves First Treatment Proven to Reduce Acute Pancreatitis Risk in Severe HypertriglyceridemiaAn important example of...
One Contaminated Alcohol Pad, Multiple Recalls
A Lesson in Medical Device Supply Chain Quality At first glance, Cardinal Health's recent recall of Webcol™ Alcohol Prep...
Early Alert: Windstone Medical Recall for Convenience Kits
FDA Warns of Convenience Kits Containing Recalled Cardinal Health Alcohol Pads The FDA has issued an Early Alert regarding...
Welcome to Medical Devices and Pharma, a website dedicated to providing timely and relevant medical device and pharma information to the regulated medical device and pharmaceutical industries, and consumers of those products.
Our goal is to provide organized, clearly written information from regulatory affairs and consumer perspectives.
- Key information from the Food and Drug Administration (FDA), the federal regulatory agency responsible for providing oversight over the industries and assuring the safety and efficacy of their products.
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Perhaps most importantly, we will strive to maintain vigilance over product issues and their impacts. Check back here for consumer news, product alerts, and current litigation.
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