FDA Device recall Z-2529-2024

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

FDA Device
Class II
ongoing
Published 2024-08-14

On 2024-08-14 the FDA classified a Class II recall of Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station by Leica Biosystems Nussloch, citing 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.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2529-2024
Classification	Class II
Status	ongoing
Initiated	2024-05-10
Published	2024-08-14
Last updated	2026-09-13 11:57 UTC
Company	Leica Biosystems Nussloch
Distribution	US

Product

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

Reason

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.

Identifiers

code_info	Model/Catalog Number: 14039354100; UDI-DI: 04049188194763, Serial numbers: 58, 62, 98, 99, 101, 117,120, 121, 122, 123… 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 128

code_info

Model/Catalog Number: 14039354100; UDI-DI: 04049188194763, Serial numbers: 58, 62, 98, 99, 101, 117,120, 121, 122, 123…

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 128

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2529-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.