NMPA published 18 voluntary recall notices submitted by foreign manufacturers in January 2023. Big names are on the list, some of which recalled overseas submitted recall information to NMPA. Among them, Covidien had a Class I recall which is the most serious scenario.
Full List of the NMPA Recall
For the recall root cause of any device below, please contact us at info@ChinaMedDevice.com.
- Covidien: Non-absorbable suture
- Covidien: V-loc PBT Non-Absorbable Reload
- Siemens: Axiom Luminors Drf
- Siemens: Luminors Agile Max
- Siemens: Uroskop Omnia Max
- Abbott: ARCHITECT Anti-Tg Reagent Kit
- Abbott: Fast-Cath Guiding Introducer
- Medtronic: Clinician Programmer System for DBS Neurostimulator
- Medtronic: Deep brain stimulator
- DiaSorin: LIAISON® 25 OH Vitamin D TOTAL Assay
- DiaSorin: LIAISON® Progesterone II Gen
- J&J: VICRYL PLUS Polyglactin910 Synthetic Absorbable Suture
- MAQUET: anesthesia machine
- Maquet: Heat units
- Mazor Robotics: Mazor X Surgical Instruments
- Biomet Orthopedics: Vanguard Total Knee System
- CooperVision: Soft (hydrophilic) Contact Lens
- Integra: CODMAN Surgical Patties/Strips
Recall Regulation in China
“Administrative Measures for the Recall of Medical Devices” released in February 2017 stipulates that medical device manufacturers conduct recall defective products by warning, inspection, repair, re-labeling, modification, and improvement of IFU, software update, replacement, recovery, destruction, etc. Foreign manufacturer can designate an agent in China to conduct the recall.
The “defective” medical device products have the following scenarios:
- Products with unreasonable risks that may endanger human health/life under normal uses
- Products that do not meet the technical requirements or mandatory standards
- Products that do not meet the relevant production and qualify management regulations which may lead to unreasonable risks
- Other products that need to be recalled
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- Source: https://chinameddevice.com/eighteen-foreign-manufacturers-recall-in-january/
