This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.
Similar Posts
Fulijaya Manufacturing SDN. BHD. – 719172 – 01/14/2026
CGMP/Finished Pharmaceuticals/AdulteratedEarly Alert: Heart Pump Issue from Abiomed
The differential pressure sensor in certain Impella devices may malfunction and cause sensor values to drift.FDA In Brief: FDA issues 57 product-specific guidances, including 19 laying out path for developing generics to hard-to-copy “complex” medicines
FDA is posting 57 product-specific guidances to help industry generate evidence needed to support approval of generic drug applicationsEndoscopic Aspiration Needle Recall: Olympus Removes Certain ViziShot 2 FLEX (19G) Needles Due to Potentially Deformed A-traumatic Tips
Certain lots of ViziShot 2 FLEX (19G) aspiration needles may have deformed a-traumatic tips that pose a risk to patient safety if they are used.FDA Advances Drug Development Innovation by Establishing ISTAND as Permanent Qualification Program
ISTAND supports innovative, science-driven approaches that improve drug development and regulatory decision-making, ultimately helping to make therapies available to address patients’ unmet needs.Early Alert: Anesthesia System Issue from GE HealthCare
GE HealthCare issues updated use instructions for certain Carestation 600 and 700 series Anesthesia Systems
