Agency classClass IIOur severity:High FDA (Devices)·Z-2529-2024·Announced 2024-08-14

Paraffin Embedding Station Recalled for Internal Fire and Toxic Smoke Risk

The FDA is recalling 180 Leica HistoCore Arcadia H paraffin embedding stations due to a sealing defect in the paraffin tank that can cause toxic smoke and internal fire.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a medical device with an actual hazard (toxic smoke and internal fire from sealing defect). Although no illnesses or injuries have been reported, the device poses a clear risk of harm to laboratory personnel. Per the rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported,' resulting in a High severity score.

Plain-English summary

Leica Biosystems Nussloch GmbH is recalling the Leica HistoCore Arcadia H paraffin embedding station. This device is used in laboratory histology settings for embedding tissue samples in paraffin. Two model numbers are affected: 14039354100 and 14039357258. Approximately 180 devices are included in this recall.

A defect has been identified in the paraffin tank sealing mechanism. This defect can cause toxic smoke generation and internal fire to develop within the device, creating a hazard for laboratory personnel who operate or work near the equipment.

The recalled devices have been distributed nationwide, including to government facilities. Anyone with an affected device should review the FDA recall notice for contact information and instructions from the manufacturer regarding remediation options.

The recalled product

Product: Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
Manufacturer: LEICA BIOSYSTEMS NUSSLOCH GMBH
Category: Medical Device — Histology Equipment
Hazard: fire
toxic-smoke
Affected units: 180

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed nationwide across the United States.

Same manufacturer · LEICA BIOSYSTEMS NUSSLOCH GMBH

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