Medical Device and Pharmaceutical News
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Allergy Alert: Silver Moon LP dba Loard’s Ice Cream
Loard’s Ice Cream Recalls Products Due to Undeclared Allergens and Missing Ingredient Labeling Silver Moon LP, doing business as Loard’s Ice Cream of San Leandro, California, has voluntarily recalled all retail-packaged ice cream products due to missing ingredient...
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...
Merit Medical Dialysis Catheter Recall – Risk of Serious Injury
Merit Medical Removes 16F Dual-Valved Splittable Sheath Introducer Design Defect May Lead to Hemorrhage, Embolization, and Loss of Vascular Access The U.S. Food and Drug Administration (FDA) has identified a Class I recall involving Merit Medical’s 16F Dual-Valved...
Blaine Labs Recalls Wound Care Gels for Microbial Contamination
Blaine Labs, Inc Issues Voluntary Nationwide Recall of Wound Care Gel Products Due to Microbial Contamination Potential infection risk for vulnerable patients highlights critical quality system considerations Recall Overview Blaine Labs, Inc. has issued a voluntary...
The Abbott NEC Case and Food Risk in Vulnerable Populations
What the Abbott NEC Case Reveals About Food Risk in Vulnerable PopulationsA companion analysis on how microbiological hazards, supplements, and clinical nutrition are reshaping regulatory expectations The recent $70 million verdict against Abbott Laboratories...
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...
Early Alert: Cook Medical Sizing Catheters
Cook Medical Sizing Catheters Removed Due to Risk of Device Breakage The U.S. Food and Drug Administration (FDA) has issued an early alert regarding a potentially serious device issue involving certain sizing catheters manufactured by Cook Medical. Cook Medical has...
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...