FDA Medical devices recall ·
ThinPrep¿ CytoLyt¿ Solution recall
- Recall number
- Z-1093-2026
- Date
- (initiated December 12, 2025)
- Company / brand
- Hologic, Inc
250 Campus Dr, Marlborough, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3,728 units
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Why was it recalled?
Fungal contamination of affected lot with Parengyodontium album.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog number: 0236004; UDI: (01)25420045508405(17)270303(10)5062EC; UDI-DI: 25420045508405; Lot number: 5062EC.
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1093-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.