Z-2529-2024Class II

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

Name: Z-2529-2024 Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station
Creator: Leica Biosystems Nussloch Gmbh
Published: 2024-05-10
License: https://open.fda.gov/license/

Leica Biosystems Nussloch GmbH / initiated 2024-05-10 / Open, Classified / root cause: design

FDA source

LEICA BIOSYSTEMS NUSSLOCH GMBH began a recall of Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station on 2024-05-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2529-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-10
Posted: 2024-08-07
Recalling firm: Leica Biosystems Nussloch GmbH
Product: Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
Product code: IDW Dispensers, Paraffin
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.
Root cause tag: design
FDA root cause: Device Design
Action: The recalling firm issued letters dated 4/30/2024 via email on 5/10/2024. The letter provided the model and serial number of the devices involved, a description of the problem, and immediate actions to be taken. The consignee is to check to see if they have one of the affected instruments and determine whether the Arcadia H is in active use in the facility. If it is, the consignee is to discontinue the use of it immediately and disconnect it from main voltage. If it has not been decommissioned at the time of receipt of the letter, the consignee is to reach out to their sales representative. The sales representative will work with the consignee to determine the disposition of the device according to their local regulations. The consignee is requested to pass the notification letter to users of the device and to all within their organization who need to know. The consignee is to confirm receipt of the letter within 5 days by completing the attached acknowledgement form and returning a scanned copy via email.
Quantity in commerce: 180 devices
Distribution: US Nationwide, including government distribution.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2529-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2529-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-14	2024-08-07

Product code IDW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)