China NMPA Product Recall - Disposable endoscopic injection needles for single use, disposable biopsy forceps, transparent mucosal suction sleeves, contrast tubes, fiberoptic bronchoscopes, flexible bronchoscopes.

The National Medical Products Administration (NMPA) announced a Level III recall on December 19, 2025, initiated by Olympus Medical Systems Co., Ltd. and its subsidiary, Olympus Trading (Shanghai) Co., Ltd. The recall addresses multiple single-use endoscopic devices, including various injection needles, biopsy forceps, transparent mucosal suction sheaths, imaging tubes, and flexible bronchoscopes. The primary violation involved the incorrect distribution of expired products, specifically those designated for "non-clinical use," to medical users. This issue highlights significant concerns regarding product lifecycle management and adherence to labeling protocols. Affected products include disposable biopsy forceps (models 183141519 and 20142025633), a flexible bronchoscope (model 20182062197), a transparent mucosal suction sleeve (model 20172060327), and a contrast tube (model 20162142790). The required action for Olympus is a voluntary recall to retrieve these specified medical devices, thereby mitigating potential patient safety risks arising from the use of expired or mislabeled equipment. Further details on specific models and batches are available in the attached "Medical Device Recall Event Report Form."