FDA Medical Device Recalls (openFDA)
LEICA BIOSYSTEMS NUSSLOCH GMBH: Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
- Recall number
- Z-2529-2024
- Recalling firm
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Product
- Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
- Status
- Open, Classified
- Initiated
- 2024-05-10
- Posted
- 2024-08-07
- Terminated
- not on file
- 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.
- 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
- 180 devices
- Distribution
- US Nationwide, including government distribution.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IDW
- Firm FEI
- 3002179321
- Firm city
- Nussloch
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28