Leica recalls specific models of HistoCore Arcadia H Paraffin Embedding Stations due to toxic smoke and internal fire risks from paraffin tank sealing issues. Affected units have serial numbers listed in the recall notice.
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.
Leica is recalling certain HistoCore Arcadia H Paraffin Embedding Stations because a problem with the paraffin tank sealing can cause toxic smoke and internal fire. This poses a serious risk of injury or death if the device is used as intended.
The paraffin tank sealing issue can lead to toxic smoke and internal fire when the device is used normally. This hazard occurs during routine operation and can cause serious injury or death if not addressed.
Users of the Leica HistoCore Arcadia H Paraffin Embedding Station with the specific serial numbers listed in the recall notice are affected. Pathologists and lab technicians who use these devices are at the highest risk.
Check the serial numbers on the device: 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. The model numbers 14039354100 and 14039357258 are also affected.
Immediately stop using the Leica HistoCore Arcadia H Paraffin Embedding Station if it has the affected serial numbers listed in the recall notice.
The affected models are 14039354100 and 14039357258.
Check the serial numbers on your device; the affected units have the specific serial numbers listed in the recall notice.
The recall notice does not mention any remedy or replacement options.
We’ve drafted a message you can send Leica to request your refund or repair — edit it as you like.
Subject: Recall Z-2529-2024 — Leica Leica Hello, I own a Leica that is covered by recall Z-2529-2024 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.
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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.
