Recent Food and Drug Administration regulations affecting small businesses

Siemens Medical Solutions recalls 73 ARTIS Pheno VE30A and VE40A imaging systems due to brightness variation during 3D acquisitions that may cause unintended low-dose radiation exposure to patients.

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.

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.

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.

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.

Remel Inc. issued a Class II recall for Yeastone Broth (2,819 units distributed worldwide) due to potential incorrect AST results during quality control that may delay antifungal treatment responses.

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.

Island Kinetics CoValence Laboratories recalls 28,163 bottles of Blemish Spot Treatment nationwide due to failed stability specifications that may cause temporary or reversible health problems.

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.

FDA classifies mandibular-movement-based sleep apnea testing devices as Class II medical devices subject to special controls to ensure safety and effectiveness while reducing regulatory burden.

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.

Gentuity LLC recalls 184 units of its HF-OCT Imaging System Model G10-01 (28 in US) due to potential repeated frames during pullback with certain software versions that may affect longitudinal measurement accuracy.

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

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.

Integra LifeSciences recalls 226 units of Cytal Burn Matrix and four related products nationwide due to out-of-specification endotoxin levels that may cause temporary or reversible health complications.