Critical Recall: Baxter Sigma Spectrum Infusion Pumps Removed Due to Software Risks
The FDA has issued a notice regarding the urgent recall of specific Baxter Sigma Spectrum Infusion Pumps due to software…
US
US / FDA updates on medical device regulation and quality.
168 articles
168 articles in US
Latest News
Latest News
Urgent FDA Recall: Serious Safety Risks Linked to Bard PowerPICC Catheters
The FDA has issued an urgent recall for specific Bard PowerPICC Intravascular Catheters. Healthcare providers and regulatory teams are alerted…
Latest News
Critical FDA Alert: AVID Medical Updates on Organ Recovery Kits to Address Safety Risks
The U.S. Food and Drug Administration (FDA) has issued a critical alert concerning Organ Recovery Packs and Medical Convenience Kits…
Latest News
Nationwide Recall of Silintan Capsules Due to Undeclared Meloxicam: Safety Risks Highlighted
An urgent recall has been issued for Silintan capsules by Anthony Trinh, 123Herbals LLC, following FDA confirmation that the product…
Latest News
Modern Warrior Ready Dietary Supplement Recalled for Undeclared and Unsafe Ingredients
On January 10, 2026, the U.S. Food and Drug Administration (FDA) announced an urgent recall of “Modern Warrior Ready,” a…
Latest News
FDA Alert: Nationwide Recall of Rheumacare Capsules Due to Dangerous Lead Levels
On January 10, 2026, Handelnine Global Limited, operating under the trade name Navafresh, announced a nationwide recall of their Rheumacare…
Latest News
Federal Alert: Gold Star Distribution Recalls FDA-Regulated Products Citing Severe Contamination Risks
On December 26, 2025, Gold Star Distribution, Inc. issued a recall of multiple FDA-regulated products in response to serious contamination…
Latest News
Primavera Nueva Inc. Expands Recall of Tamales Due to Potential Listeria Risk: Updated Details You Need to Know
Primavera Nueva Inc., a Sonoma, California-based company, has announced an expanded voluntary recall of selected lots of its 4-count tamales…
Latest News
Carrot Top Kitchens Recalls Hummus Over Undeclared Sesame Risk
On January 10, 2026, Carrot Top Kitchens LLC, operating in Bridgeport, Connecticut (formerly Redding), issued a Class II recall for…
Latest News
Modern Warrior’s “Ready” Supplement Recall: Undeclared 1,4-DMAA, Aniracetam, and Unapproved Tianeptine Identified by FDA
[Phoenix, Arizona] – On December 22, 2025, Modern Warrior voluntarily announced a nationwide recall of all lots of its dietary…
Latest News
Urgent Recall: Publix Maple Walnut Coffee Cake Labeling Error and Allergen Risk
The James Skinner LLC has issued a voluntary recall of Publix Maple Walnut Coffee Cake due to an incorrect labeling…
Latest News
FDA Broadens Use of Real-World Evidence for Drug and Medical Device Reviews
On December 15, 2025, the U.S. Food and Drug Administration (FDA) announced a major policy shift aimed at enhancing regulatory…
Loading more articles…