Hologic, Inc: Medical Device Recall in 2026 - (Recall #: Z-1093-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.

Product Classification:

Class II

Date Initiated: December 12, 2025

Date Posted: January 21, 2026

Recall Number: Z-1093-2026

Event ID: 98058

Reason for Recall:

Fungal contamination of affected lot with Parengyodontium album.

Status: Ongoing

Product Quantity: 3,728 units

Code Information:

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

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated