Leica HistoCore PEGASUS Processor Recall: Incorrect Tissue Processing Risk

Take action

Contact the company & request your remedy

Recalling firmLEICA BIOSYSTEMS NUSSLOCH GMBHHeidelberger Str. 17-19, N/A · Nussloch, N/A N/A

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Leica is recalling HistoCore PEGASUS processors and tissue systems because they can cause damaged biopsy samples due to incorrect protocol settings. This affects lab equipment used for medical tissue analysis.

Why it’s dangerous

The processor may assign incorrect values to tissue samples during analysis, potentially damaging biopsy specimens. This happens when protocol settings are not properly configured for the tissue processing workflow.

Who’s affected

Pathologists and lab technicians using Leica HistoCore PEGASUS systems with serial numbers G0061-G0701 are most at risk. The recall impacts medical labs that process biopsy tissue.

How to tell if you have this one

Check if your Leica HistoCore PEGASUS processor has a serial number between G0061 and G0701. The product is sold as a tissue processing system for medical labs.

Brand
Leica
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Verify your processor's serial number falls within the range G0061-G0701.

✎ GovInfoNow

Questions people ask

What could happen if I use this processor?

The processor may cause damaged biopsy tissue samples due to incorrect protocol settings.

How do I know if my processor is affected?

Check if your Leica HistoCore PEGASUS processor has a serial number between G0061 and G0701.

Is there a fix for this issue?

The recall record does not specify a remedy or fix.

Take action

Contact Leica

We’ve drafted a message you can send Leica to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0590-2024 — Leica Leica

Hello,

I own a Leica that is covered by recall Z-0590-2024 from Leica.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

Where this comes from

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-0590-2024 (November 20, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0590-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.

LEICA BIOSYSTEMS NUSSLOCH GMBH recalls Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)

Lower-risk recall