CLASS II ONGOING Device recall · Reported 12 Jun 2024 · FDA Enforcement Report
Leica HistoCore Pegasus Tissue Processor recalled
Leica Biosystems Nussloch is recalling Leica HistoCore Pegasus Tissue Processor, distributed nationwide in the US. The recall was initiated on 10 Apr 2024 and the FDA has classified it as Class II.
Check your package
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-1947-2024
- FDA event ID
- 94470
- Recalling firm
- Leica Biosystems Nussloch, Nussloch, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Apr 2024
- FDA classified
- 4 Jun 2024
- Reported
- 12 Jun 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 10 Apr 2024 | Recall initiated by company | |
| 4 Jun 2024 | Classified by FDA | +55 days |
| 12 Jun 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximum fill level marks on reagent bottles or in the paraffin tanks.
Product as listed by the FDA
Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
Where it was distributed
Worldwide - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NJ, NV, NY, OH, TN, TX, UT, VA, WA, and WI. There was also government distribution but no military distribution. The country of Canada.
Nationwide AlaskaAlabamaArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaHawaiiIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesota
Questions about this recall
Why was it recalled?
Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximum fill level marks on reagent bottles or in the paraffin tanks.
Which lots are affected?
All devices with serial numbers: G0061 - G0154, G0156 - G0530, G0532 - G0779, G0781, G0782; UDI-DI 04049188216397.
Where was it sold?
Worldwide - US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NJ, NV, NY, OH, TN, TX, UT, VA, WA, and WI. There was also government distribution but no military distribution. The country of Canada.
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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