RecallRisk-BERT: A Multi-Task Framework for Post-Report Medical Device Recall Triage
Authors: Ali Semih Atalay, Sevgi Yigit-Sert
Organizations: aDepartment of Computer Engineering, Faculty of Engineering, Ankara University, Ankara, 06830, Türkiye
Abstract
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.
Machine learning in high-stakes domains such as healthcare requires not only strong predictive performance but also reliable uncertainty quantification (UQ) to support human oversight. Multi-label text classification (MLTC) is a central task in this domain, yet remains challenging due to label imbalances, dependencies, and combinatorial complexity. Existing MLTC benchmarks are increasingly saturated and may be affected by training data contamination, making it difficult to distinguish genuine reasoning capabilities from memorization. We introduce MADE, a living MLTC benchmark derived from {m}edical device {ad}verse {e}vent reports and continuously updated with newly published reports to prevent contamination. MADE features a long-tailed distribution of hierarchical labels and enables reproducible evaluation with strict temporal splits. We establish baselines across more than 20 encoder- and decoder-only models under fine-tuning and few-shot settings (instruction-tuned/reasoning variants, local/API-accessible). We systematically assess entropy-/consistency-based and self-verbalized UQ methods. Results show clear trade-offs: smaller discriminatively fine-tuned decoders achieve the strongest head-to-tail accuracy while maintaining competitive UQ; generative fine-tuning delivers the most reliable UQ; large reasoning models improve performance on rare labels yet exhibit surprisingly weak UQ; and self-verbalized confidence is not a reliable proxy for uncertainty. Our work is publicly available at https://hhi.fraunhofer.de/aml-demonstrator/made-benchmark.
Many operational cases are documented more than once, at different workflow stages and for different purposes, yet model evaluations normally select one of these records before model comparison begins. We treat that selection as part of the evaluation and compare matched records of the same cases under fixed labels and splits in three systems: GE Aerospace repair events, NASA ASRS safety reports and NHTSA vehicle recalls. Across the three GE fields, for events whose label comes from parts transactions independently of the narratives, held-out macro-F1 ranged from 0.33 to 0.91. A difference of 0.46 separated the customer report, written before shop work, from the technician report, written after diagnosis but before the transaction that generates the label. That difference is substantially larger than the representation and architecture differences tested on the same events. The public systems showed different patterns: the NHTSA defect summary remained strongest under every model family tested, whereas the ASRS analyst synopsis outperformed the reporter narrative under learned sequence models but not under lexical baselines. Secondary analyses showed that some model comparisons were also record-dependent. Evaluations should be run on the information available at the intended decision point and should report how both the record and the label were produced.
Hisham Ihshaish, Peter Mayhew, Tasnim M. A. Zayet +1
Clinical early warning systems built on electronic health records, in which clinical observations are recorded as irregularly sampled medical time series (ISMTS), must deliver both calibrated risk scores for patient triage and interpretable rationales that clinicians can verify. Large Language Models (LLMs) have been explored for this task, yet they collapse graded clinical risk into overconfident binary predictions. This risk polarization undermines both calibration and cross-patient comparability. To address this, we propose TRIAGE, a framework that trains an LLM to generate dialectical reasoning over competing clinical outcomes by eliciting outcome-specific rationales. This dialectical formulation mitigates risk polarization, enabling a single LLM to yield continuous risk scores grounded in explicit clinical reasoning. Evaluated on three ISMTS benchmarks, TRIAGE achieves an average AUPRC improvement of 3.3% and reduces calibration error by 81% compared to the competitive baselines. An LLM-as-a-judge assessment further shows that our rationales surpass post-hoc explanations from the baseline by 20% in clinical reasoning quality. The source code is available at https://github.com/HyeongWon-Jang/TRIAGE .