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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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High RiskFDA Device
Medical Devices/Diagnostic Equipment

LEICA BIOSYSTEMS NUSSLOCH GMBH: HistoCore Arcadia H Paraffin Embedding Stations Recalled for Fire Risk

Agency Publication Date: August 7, 2024
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Summary

Leica Biosystems has recalled approximately 180 units of the HistoCore Arcadia H Paraffin Embedding Station. This recall was initiated after it was discovered that a sealing problem in the paraffin tank can lead to internal fires and the development of toxic smoke. Consumers should identify if their laboratory equipment is part of the affected batch by checking the model and serial numbers and contact the manufacturer or their healthcare provider for further instructions.

Risk

A faulty seal in the paraffin tank can cause the device to catch fire internally. This poses a significant fire hazard and risk of respiratory injury from the release of toxic smoke within a laboratory environment.

What You Should Do

  1. Identify if your device is a Leica HistoCore Arcadia H Paraffin Embedding Station with reference number 14039354100 or 14039357258.
  2. Check the serial number on the back or side of your device. For model 14039354100, the affected serial numbers are: 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.
  3. For model 14039357258, check for serial number 5033.
  4. Contact Leica Biosystems Nussloch GMBH directly or your local authorized distributor for technical assistance and a remedy plan.
  5. Contact your healthcare provider or facility safety officer to discuss potential safety concerns and report any incidents.
  6. For further questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer correction/instruction following identified safety issue.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Leica HistoCore Arcadia H Paraffin Embedding Station (REF 14039354100)
Model / REF:
14039354100
UPC Codes:
04049188194763
Lot Numbers (179):
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
Product: Leica HistoCore Arcadia H Paraffin Embedding Station (REF 14039357258)
Model / REF:
14039357258
UPC Codes:
04049188205971
Lot Numbers:
5033

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94776
Status: Active
Manufacturer: LEICA BIOSYSTEMS NUSSLOCH GMBH
Sold By: Government distribution; Authorized medical device distributors
Manufactured In: Germany
Units Affected: 180 devices
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.