Reported Aug 14, 2024 · Ongoing

Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.

Leica Biosystems Nussloch GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: LEICA BIOSYSTEMS NUSSLOCH GMBH · Heidelberger Str. 17-19 · Nussloch · N/A

Is this the product you have?

  • Leica HistoCore Arcadia H
  • REF14039354100 and 14039357258, Paraffin Embedding Station
Lot codes and dates
  • Model/Catalog Number14039354100
  • UDI-DI04049188194763
  • Serial numbers

    179 of 179 codes

    • 58
    • 62
    • 98
    • 99
    • 101
    • 117
    • 120
    • 121
    • 122
    • 123
    • 124
    • 125
    • 127
    • 128
    • 129
    • 177
    • 178
    • 179
    • 180
    • 181
    • 185
    • 186
    • 218
    • 222
    • 223
    • 279
    • 282
    • 284
    • 286
    • 287
    • 288
    • 289
    • 290
    • 291
    • 292
    • 314
    • 315
    • 317
    • 318
    • 319
    • 321
    • 322
    • 353
    • 354
    • 355
    • 356
    • 357
    • 358
    • 360
    • 363
    • 365
    • 366
    • 371
    • 478
    • 480
    • 483
    • 484
    • 487
    • 488
    • 489
  • Model/Catalog Number14039357258
  • UDI-DI
    • 04049188205971
    • serial number 5033
Amount recalled
180 devices

Where it was sold

  • Nationwide

Why it was recalled

An issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resulting from a problem associated with the sealing of the paraffin tank.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:36 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.