FDA regulations

Linkbio Corp. recalls 5 LinkBio CORE Workstation units (Class II) due to incorrect "Planning Date" display on case menu screens; distributed in Alabama, Florida, and Kansas.

Beta Bionics iLet Ace Pump Kit Class II recall affects versions 1.3.7, 1.4.2, and 1.4.3 due to status bar icons enabling unauthorized device access bypass when in Limited Access Mode.

FDA Class II recall of MGC Health menthol cough drops distributed nationwide due to manufacturing facility quality observations identified during an August 15, 2025 inspection.

Philips Spectral CT on Rails (Model 728334) is subject to a Class II recall due to three software issues affecting gantry positioning, display messaging, and brain scan planning functionality.

Medline Industries recalls 640 CENTURION Circumcision Kits (SKU CIT7050F) distributed in South Carolina due to lack of required sterilization process, posing temporary health risks.

Booey's Gourmet LLC recalls 870 bottles of Dragon's Breath sauce (UPC 7 01936 29222 3) due to undeclared fish and sesame allergens; Class II recall affecting Washington distribution.

3B Medical, Inc. recalls 2 React Health PHOENIX 5L Oxygen Concentrators distributed in New York due to quality specification failures that may cause temporary health problems.

Apotex Corp. recalls desmopressin nasal spray due to defective bottle caps with dislodged or missing liners that may affect product integrity across U.S. distribution.

Harvard Drug Group recalls Memantine Hydrochloride Extended-Release 7 mg capsules nationwide due to failed dissolution specifications that may cause temporary or reversible health problems.

Wilson-Cook Medical Inc. issued a Class II recall of 713,702 Instinct Plus Endoscopic Clipping Devices nationwide due to potential malfunction risk.

Nephron SC recalls 146,280 units of Albuterol Sulfate inhalation solution nationwide due to illegible labeling that may cause temporary health issues.

Arjo Tenor mobile passive patient lift models KHA1000 US and KHA1010 US are subject to a Class II recall affecting 119 units nationwide due to actuator components that may fail suddenly, causing uncontrolled descent of the lifting arm.

FDA classifies Alzheimer's disease pathology assessment tests as Class II medical devices subject to special controls to ensure safety and effectiveness while reducing regulatory burden for manufacturers.

Avantor Performance Materials recalls 36 bottles of subpotent magnesium chloride hexahydrate API distributed nationwide in the USA, Belgium, and France in a Class III recall unlikely to cause health problems.

Clariance-SAS recalls 511 Elegance cervical plates nationwide due to burrs that may cause temporary health problems; affected states include California, Illinois, New York, and Texas.