“Hologic ThinPrep CytoLyt Solution Recall: Fungal Contamination Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50473-hologic-thinprep-cytolyt-solution-recall-fungal-contamination-risk. Based on FDA recall #Z-1093-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1093-2026%22&limit=1).
Hologic, Inc. recalled ThinPrep CytoLyt Solution due to fungal contamination with Parengyodontium album, the FDA announced on Dec. 12, 2025. The agency classified the Class II recall as voluntary.
The affected lots contain Parengyodontium album fungal contamination. The recall involves 3,728 units distributed nationwide.
Context
GovInfoNow's records show Hologic, Inc. has issued 30 other recalls since June 27, 2017. Recent Hologic recalls include the April 8, 2026 SELENIA Dimensions Mammography Systems Recall for loose bolts and the March 23, 2026 Genius Review Station Display Recall regarding user modifications. Other recent recalls of similar products include the Aug. 11, 2026 Medline Convenience Kits Recall for fungal contamination risk and the June 12, 2026 Medline Convenience Kits Recall for microbial contamination risk from packaging wrinkles.
How to tell if you have this one
Check the lot number on the product label, which should be 5062EC for affected units. The product is sold under catalog number 0236004 and has a unique identifier starting with 25420045508405.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1093-2026 (December 12, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1093-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.