CLASS II ONGOING Device recall · Reported 14 Aug 2024 · FDA Enforcement Report
Leica HistoCore Arcadia H recalled by Leica Biosystems Nussloch
Leica Biosystems Nussloch is recalling Leica HistoCore Arcadia H, distributed nationwide in the US. The recall was initiated on 10 May 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-2529-2024
- FDA event ID
- 94776
- Recalling firm
- Leica Biosystems Nussloch, Nussloch
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 May 2024
- FDA classified
- 7 Aug 2024
- Reported
- 14 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 10 May 2024 | Recall initiated by company | |
| 7 Aug 2024 | Classified by FDA | +89 days |
| 14 Aug 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
Where it was distributed
US Nationwide, including government distribution.
Questions about this recall
Is Leica HistoCore Arcadia H recalled?
Yes. Leica Biosystems Nussloch recalled Leica HistoCore Arcadia H on 10 May 2024. The recall is Class II and its status is Ongoing. Recall number Z-2529-2024.
Why was it 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.
Which lots are affected?
Model/Catalog Number: 14039354100; UDI-DI: 04049188194763, Serial numbers: 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, 490, 491, 492, 553, 560, 561, 562, 584, 586, 588, 589, 590, 593, 597, 643, 644, 647, 649, 650, 651, 652, 653, 656, 658, 659, 697, 698, 705, 710, 714, 715, 716, 717, 739, 740, 741, 742, 743, 757, 819, 820, 821, 822, 825, 826, 827, 828, 829, 830, 831, 832, 878, 879, 880, 881, 882, 883, 884, 885, 886, 887, 888, 889, 890, 891, 892, 893, 894, 896, 897, 898, 900, 901, 904, 906, 907, 909, 911, 919, 921, 922, 923, 924, 927, 928, 930, 1113, 1114, 1115, 1116, 1117, 1118, 1123, 1124, 1198, 1199, 1200, 1201, 1202, 1203, 1204, 1205, 1206, 1207, 1212, 1216, 1217, 1266, 1267, 1268, 1271, 1273, 1274, 1277, 1278, 1279, 1280, 1283, and 1285. Model/Catalog Number: 14039357258; UDI-DI: 04049188205971, serial number 5033.
Where was it sold?
US Nationwide, including government distribution.
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 21 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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