CLASS II ONGOING Device recall · Reported 21 Jan 2026 · FDA Enforcement Report

ThinPrep¿ CytoLyt¿ Solution recalled by Hologic

Hologic is recalling ThinPrep¿ CytoLyt¿ Solution, distributed nationwide in the US. The recall was initiated on 12 Dec 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog number: 0236004; UDI: (01)25420045508405(17)270303(10)5062EC; UDI-DI: 25420045508405; Lot number: 5062EC.

Quantity recalled3,728 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1093-2026
FDA event ID: 98058
Recalling firm: Hologic, Marlborough, MA
Classification: Class II
Status: Ongoing
Recall initiated: 12 Dec 2025
FDA classified: 15 Jan 2026
Reported: 21 Jan 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

12 Dec 2025	Recall initiated by company
15 Jan 2026	Classified by FDA	+34 days
21 Jan 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Fungal contamination of affected lot with Parengyodontium album.

Product as listed by the FDA

ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Fungal contamination of affected lot with Parengyodontium album.

Which lots are affected?

Catalog number: 0236004; UDI: (01)25420045508405(17)270303(10)5062EC; UDI-DI: 25420045508405; Lot number: 5062EC.

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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