# RecallRisk-BERT: A Multi-Task Framework for Post-Report Medical Device Recall Triage

arXiv: https://arxiv.org/abs/2606.27174 · HTML: https://mlsanity.com/paper/2606.27174/

## Key facts

- No citing papers in the map yet (data through 14 Oct 2026).
- Builds on 10 of its 54 references that are in the map.
- First posted on arXiv 25 Jun 2026.

## Builds on (most cited first, 10 of 10)

- [BERT: Pre-training of Deep Bidirectional Transformers for Language Understanding](https://mlsanity.com/paper/1810.04805/) (2018)
- [Adam: A Method for Stochastic Optimization](https://mlsanity.com/paper/1412.6980/) (2014)
- [XGBoost: A Scalable Tree Boosting System](https://mlsanity.com/paper/1603.02754/) (2016)
- [BioBERT: a pre-trained biomedical language representation model for biomedical text mining](https://mlsanity.com/paper/1901.08746/) (2019)
- [Domain-Specific Language Model Pretraining for Biomedical Natural Language Processing](https://mlsanity.com/paper/2007.15779/) (2020)
- [ClinicalBERT: Modeling Clinical Notes and Predicting Hospital Readmission](https://mlsanity.com/paper/1904.05342/) (2019)
- [Multimodal Deep Learning](https://mlsanity.com/paper/2301.04856/) (2023)
- [Stopwords in Technical Language Processing](https://mlsanity.com/paper/2006.02633/) (2020)
- [In-depth analysis of recall initiators of medical devices with a Machine Learning-Natural language Processing workflow](https://mlsanity.com/paper/2406.10312/) (2024)
- [Harmonizing Safety and Speed: A Human-Algorithm Approach to Enhance the FDA's Medical Device Clearance Policy](https://mlsanity.com/paper/2407.11823/) (2024)

## Abstract (arXiv)

Medical device recalls are a critical regulatory mechanism for protecting patient safety. The growing volume of FDA recall records presents challenges in post-report recall triage, severity assessment, and root-cause interpretation. Existing studies mostly address recall occurrence prediction or root-cause analysis separately, while joint modeling of recall severity and root-cause categories has received limited attention. We develop an automated recall triage framework using 54,165 FDA medical device recall records from openFDA, covering the period from 2002 to October 2025. We first evaluate classical machine learning and boosting-based models for recall severity and root-cause category prediction. We then develop RecallRisk-BERT, a multi-task model that combines PubMedBERT-based textual representations of recall narratives with embedding-based representations of structured categorical features, including product code, regulation number, and medical specialty. The model simultaneously predicts recall severity (Class I/II/III) and a consolidated root-cause category (9 classes). Performance was evaluated using accuracy, macro-averaged precision, recall, F1-score, and ROC-AUC. In single-task severity prediction, our LightGBM-based text--tabular configuration achieved the strongest performance, with an accuracy of 0.963, macro-F1 of 0.856, and ROC-AUC of 0.974. In the multi-task setting, RecallRisk-BERT substantially outperformed the single-task PubMedBERT baseline. Model-derived risk rankings were strongly consistent with observed root-cause severity patterns (rho = 0.983, p = 1.936e-6). These findings indicate that text--tabular learning can support scalable post-report recall triage, regulatory decision support, and model-based root-cause risk analysis.