Quick Facts at a Glance
- Recall Date
- December 12, 2025
- Hazard Level
- HIGH
- Brand
- Hologic
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Hologic
- Product type
- Buffered Cell Wash Solution
- Model numbers
- Catalog number: 0236004, UDI: (01)25420045508405(17)270303(10)5062EC, UDI-DI: 25420045508405, Lot number: 5062EC.
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 12, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
January 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Fungal contamination of affected lot with Parengyodontium album.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Hologic, Inc or your healthcare provider for instructions. Notification method: Letter
About This Product
ThinPrep CytoLyt Solution is a buffered cell wash solution used in medical procedures for the preparation of specimens. Healthcare providers rely on this product for accurate cytological analysis.
Why This Is Dangerous
The presence of Parengyodontium album in the solution can lead to contamination, posing a risk of infection to patients during medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall impacts healthcare operations, potentially delaying procedures and requiring the immediate stoppage of use of the affected solution.
Practical Guidance
How to identify if yours is affected
- Check the catalog number and lot number on the product.
- Verify if the lot number is 5062EC to confirm if affected.
- Consult with your healthcare provider about your product.
Where to find product info
The catalog number and lot number can typically be found on the product label or packaging.
What timeline to expect
Expect a processing time of 4-6 weeks for refunds or replacements after contacting the manufacturer.
If the manufacturer is unresponsive
- Follow up with Hologic, Inc. if you do not receive a response within a reasonable timeframe.
- Document all communications to keep records of your interactions.
How to prevent similar issues
- Always check recall databases before using medical devices.
- Ensure that the products used are from reputable sources with clear labeling.
- Stay informed about safety alerts in the medical device industry.
Documentation advice
Keep copies of any correspondence, receipts, and photographs of the product as evidence.
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Product Details
The recalled product is ThinPrep CytoLyt Solution, catalog number 0236004, with lot number 5062EC. It is distributed nationwide across the United States. Specific identifiers include UDI: (01)25420045508405(17)270303(10)5062EC.
Key Facts
- Recall date: December 12, 2025
- Distribution: US Nationwide
- Quantity recalled: 3,728 units
- Fungal contamination with Parengyodontium album
- Follow instructions from healthcare providers for next steps
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Safety Guide
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