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 · 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 · 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 · 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 · 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 · 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 · 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 reference