Official product recall notices and clearly labeled enforcement reference records.
Reference notice · device
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.
Waukegan, IL, US · Updated 9/25/2026, 12:00:00 AM UTC
Source: FDA — device enforcement referenceReference notice · device
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.
Waukegan, IL, US · Updated 9/25/2026, 12:00:00 AM UTC
Source: FDA — device enforcement referenceReference notice · device
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.
Waukegan, IL, US · Updated 9/25/2026, 12:00:00 AM UTC
Source: FDA — device enforcement referenceReference notice · device
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.
Waukegan, IL, US · Updated 9/25/2026, 12:00:00 AM UTC
Source: FDA — device enforcement reference