Official product recall notices and clearly labeled enforcement reference records.
Reference notice · device
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences…
Northfield, IL, US · Updated 9/14/2026, 12:00:00 AM UTC
Source: FDA — device enforcement referenceReference notice · drug
Presence of particulate matter: Particulates identified as fiberglass
Deerfield, IL, US · Updated 9/9/2026, 12:00:00 AM UTC
Source: FDA — drug enforcement referenceReference notice · drug
Cross Contamination with Other Products
Cary, IL, US · Updated 9/9/2026, 12:00:00 AM UTC
Source: FDA — drug enforcement referenceReference notice · drug
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Lake Zurich, IL, US · Updated 9/2/2026, 12:00:00 AM UTC
Source: FDA — drug enforcement referenceReference notice · device
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
Deerfield, IL, US · Updated 8/31/2026, 12:00:00 AM UTC
Source: FDA — device enforcement referenceReference notice · device
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
Deerfield, IL, US · Updated 8/31/2026, 12:00:00 AM UTC
Source: FDA — device enforcement reference