Categories
The FDA is alerting consumers, tattoo artists, and retailers of the potential for serious injury from use of tattoo inks that are contaminated with bacteria, including Pseudomonas aeruginosa.
Categories
EnShiShiXiangNiShangMaoYouXianGongSi Issues Voluntary Nationwide Recall of ENDURANCE BOOST WITH HORNY GOAT WEED Capsules Due To Presence of Undeclared Propoxyphenylsildenafil and Sildenafil
EnShiShiXiangNiShangMaoYouXianGongSi is voluntarily recalling one lot of ENDURANCE BOOST WITH HORNY GOAT WEED (20 Count)
Categories
FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities
FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities
http://www.fda.gov/news-events/press-announcements/fda-announces-expanded-use-unannounced-inspections-foreign-manufacturing-facilities
Categories
Heart Pump Accessory Removal: Abbott Removes HeartMate Mobile Power Unit due to Instances of Sudden Power Loss
Heart Pump Accessory Removal: Abbott Removes HeartMate Mobile Power Unit due to Instances of Sudden Power Loss
Categories
Risk of False Positive Results with Certain Capillary Blood Collection Tubes Used with Magellan Diagnostics LeadCare Testing Systems – FDA Safety Communication
FDA is alerting health care providers and lab staff of reports of false positives when using certain Micro Capillary Blood Collection tubes with the LeadCare Testing Systems.
Categories
HHS, FDA to Phase Out Petroleum-Based Synthetic Dyes in Nation’s Food Supply
HHS, FDA to Phase Out Petroleum-Based Synthetic Dyes in Nation’s Food Supply
http://www.fda.gov/news-events/press-announcements/hhs-fda-phase-out-petroleum-based-synthetic-dyes-nations-food-supply
Categories
Early Alert: Intravascular PICC Catheter Issue from BD
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Categories
Early Alert: Diagnostic Intravascular Catheter Issue from Conavi
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
Categories
FDA Classifies Q’Apel Medical Inc.’s Worldwide Medical Device Recall and Discontinuation of its 072 Aspiration System (Hippo) as Class I
On April 7, 2025, the U.S. Food and Drug Administration (“FDA” or “the agency”), classified Q’Apel Medical, Inc.’s (“Q’Apel” or “the company”) voluntary recall of 1,617 units of its 072 Aspiration System (also known under the product name “Hippo”, which includes “Cheetah”; collectively, the “product
Categories
FDA Commissioner Makary Announces New Policy on Individuals Serving on FDA Advisory Committees
FDA Commissioner Makary Announces New Policy on Individuals Serving on FDA Advisory Committees
http://www.fda.gov/news-events/press-announcements/fda-commissioner-makary-announces-new-policy-individuals-serving-fda-advisory-committees