Siemens Medical Recalls NAEOTOM Alpha CT Software Over FDA Clearance Issue
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
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To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
The supplier manufactured anatomical left plates with an incorrect thread orientation.
Due to products not having FDA Premarket authorization to be distributed within the United States.
Canon Medical Systems recalled 34 MRI systems due to a risk of helium gas release. The recall affects models MRT-3020 and MEXL-3020 distributed across 13 states. Healthcare providers should stop using these devices immediately and follow recall instructions.
The supplier manufactured anatomical left plates with an incorrect thread orientation.
Product not cleared by the FDA.
Siemens Medical Solutions USA recalled two units of its CT software applications on December 19, 2025. The software lacks FDA 510(k) clearance, posing potential risks to patients. Healthcare providers should stop using the affected software immediately.
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Siemens Medical Solutions recalled software applications for certain CT systems on December 19, 2025. The applications did not receive FDA 510(k) clearance. Five units distributed worldwide are affected by this recall.
ICU Medical recalled 64,290 Pulsator Arterial Blood Sampling Kits due to a potential crack in the syringe collar. This defect may cause blood leakage and delayed sampling. The recall affects models sold nationwide since December 2025.
Failed Disintegration Specifications: above the time expected.
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Presence of Particulate Matter: Hair was found in a prefilled syringe
Novo Nordisk recalled Wegovy (semaglutide) injections on December 19, 2025, after discovering hair in prefilled syringes. The contamination poses a serious hazard to consumers. The recall affects all units distributed nationwide.
Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.
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