[pending] HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The Hi
Pending LLM rewrite. Source: FDA_DEVICE Z-1683-2025.
What this means for you
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: Pending LLM scoring against the rubric.
Plain-English summary
There is a leakage issue associated with the tubing in the manifold of the instrument.
The recalled product
- Product
- HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.
- Manufacturer
- Leica Biosystems Melbourne Pty Ltd
- Category
- Medical Device — Devices
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)
- UDI-DI: 09349458004811
- Serial Numbers: 45111117
- 45111154
- 45111155
- 45111156
- 45111157
- 45111158
- 45111159
- 45111160
- 45111161
- 45111162
- 45111164
- 45111166
- 45111167
- 45111168
- 45111169
- 45111170
- 45111171
- 45111174
- 45111175
Distribution
Distributed in 14 states:
- AZ
- CA
- FL
- MN
- NC
- NJ
- NY
- OH
- PA
- TN
- TX
- UT
- VA
- WI
Related recalls
Same category
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27