China NMPA Product Recall - 25# glass cutter

The National Medical Products Administration (NMPA) issued a notice regarding a voluntary Class II recall initiated by Johnson & Johnson Surgical Vision, Inc., for its 25-gauge vitrectomy blade (Registration Certificate No.: 20173236671). The recall was reported by Allergan (Shanghai) Medical Device Trading Co., Ltd., and publicly announced on November 7, 2018. The primary issue stems from a packaging error where a 20-gauge vitrectomy blade might be present inside a package labeled for a 25-gauge blade. This discrepancy, while carrying a potential for patient injury, is generally considered avoidable. The product, model NGP0025, is a single-use tool intended for vitreous humor removal in conjunction with the WHITESTAR SIGNATURE system. The global recall impacts regions such as the USA, Australia, and Japan. Crucially, Johnson & Johnson Surgical Vision, Inc. confirmed that the specific affected product batches were not distributed within the Chinese market. Therefore, no corrective actions are required for medical device users or distributors in China, as the local market is unaffected by this particular packaging issue.