Major Medtech Firms Including Johnson & Johnson, Philips, and Fujifilm Issue Recalls for Defective Devices

Philips Medical Systems Nederland B.V. Initiates Voluntary Recall of Mobile C-Arm X-Ray Systems in China

Philips (China) Investment Co., Ltd. reported that due to manufacturing issues in some products, the manufacturer, Philips Medical Systems Nederland B.V.,Philips Medical Systems Nederland B.V. voluntarily recalls its Mobile C-arm X-Ray Equipment (Registration No.: 20203060470) with a Level II recall. The products involved in this recall were not imported into China. For detailed information such as specific models, specifications, and batches, please refer to the "Medical Device Recall Report."

Fujifilm Corporation (Fujifilm Holdings Corporation) Voluntarily Recalls Dual-Energy X-ray Bone Densitometers

Fujifilm (China) Investment Co., Ltd. reported that due to printing errors in the Unique Device Identification (UDI) of the product, the manufacturer Fujifilm Corporation (Fujifilm Holdings Corporation) voluntarily recalled its Dual-Energy X-ray Bone Densitometer (Registration No.: GuoXieZhuJin 20212060266). The recall level is classified as a Level III recall. The products involved in this recall were not imported into China. For specific model, specifications, batch numbers, and other detailed information, please refer to the Medical Device Recall Report Form.

W.L. Gore & Associates, Inc. Initiates Voluntary Recall of Non-Absorbable Sutures

Gore Industrial Products Trading (Shanghai) Co., Ltd. reported that due to labeling errors on the outer packaging of specific product models, the manufacturer W.L. Gore & Associates, Inc. voluntarily recalled its non-absorbable sutures GORE-TEX® Suture (Registration No.: 20172021669). The recall is classified as a Level Three recall. The products involved in this recall were not imported into China. For detailed information regarding specific models, specifications, and batches, please refer to the Medical Device Recall Report.

ConvaTec Inc. Initiates Voluntary Recall of Ostomy Bags

ConvaTec (China) Medical Supplies Co., Ltd. reported that due to holes at the bottom of specific batch products, which led to leakage, the manufacturer ConvaTec Inc. voluntarily recalled its ostomy pouch Natura+ Two Piece Drainable Pouch /Skin Barrier (Record No. 20210159). The recall level is classified as a Level Three recall. The products involved in this recall were not imported into China. For specific model, specifications, and batch details, please refer to the "Medical Device Recall Event Report."

Ethicon LLC, a subsidiary of Johnson & Johnson, voluntarily recalls absorbable surgical sutures.

Johnson & Johnson Medical (Shanghai) Ltd. reported that due to some products in specific batch models of absorbable surgical sutures not meeting Johnson & Johnson's quality requirements, the manufacturer, Ethicon LLC, is voluntarily recalling its STRATAFIX Spiral PDS Plus Knotless Tissue Control Device (Registration No. 20213020210). The recall level is a Class II recall. The products involved in this recall were not imported into China. For detailed information such as specific models, specifications, and batches, please refer to the "Medical Device Recall Event Report Form."