The U.S. Department of Health and Human Services (HHS) has taken a pivotal step forward in…
Category: US
US / FDA updates on medical device regulation and quality.
Fresenius Kabi Recalls Famotidine Injection Due to Elevated Endotoxin Levels in Reserve Samples
On November 6, 2025, Fresenius Kabi announced a voluntary nationwide recall of three lots of Famotidine…
FDA Cracks Down on Illegal Marketing of Unapproved Botulinum Toxin Products
The U.S. Food and Drug Administration (FDA) has issued formal warnings to 18 website owners found…
FDA Expands National Priority Voucher Program With Six New Awardees
The U.S. Food and Drug Administration (FDA) has announced six additional recipients of the Commissioner’s National…
Olympus Updates Laser Bronchoscope Instructions Following Safety Concerns
Olympus Corporation has announced an important voluntary labeling update for bronchoscopes used with laser therapy, argon…
Nationwide Recall of Mislabelled Potassium Chloride Injection – Critical FDA Update
Clinical professionals, regulatory teams, and healthcare providers should note the recent voluntary nationwide recall of a…
FDA Moves to Halt Sale of Unapproved Fluoride Prescription Drugs for Children
The FDA has taken a significant step to protect children from unapproved ingestible fluoride prescription products.…
Nationwide Recall Issued for Mislabelled Potassium Chloride Injection by Otsuka ICU Medical LLC
Otsuka ICU Medical LLC has announced a voluntary nationwide recall of a specific lot of potassium…
Critical Labeling Update Issued for Olympus Bronchoscopes Used in Laser Therapy Procedures
Olympus Corporation has announced a voluntary corrective action involving bronchoscopes used in conjunction with certain high-risk…
FDA Restricts Sale of Unapproved Fluoride Prescription Drugs for Children’s Safety
The U.S. Food and Drug Administration (FDA) has announced significant regulatory steps to enhance child safety,…