Covidien Issues Class I Recall of SpO2 Patient Monitoring System in China

Jul 14, 2025 17:31 CST Updated 17:31

Covidien Healthcare

Medical Product Manufacturer

The National Medical Products Administration (NMPA) has recently released recall information for 6 medical device companies, includingCovidien HealthcareLevel 1 Recall, 4 Level 2 Recalls。

1、CovidienLevel 1 RecallPulse Oximeter

Covidien Healthcare International Trading(Shanghai)Co.,Ltd. reported,Due to the possibility of device alarms not being recognized during product use, which may result in patient injury., the manufacturer Covidien LLC has voluntarily recalled its Sp02 Patient Monitoring System (Registration No. 20152072123 for Imported Medical Devices in China). The recall is classified as a Level 1 recall.

2、Siemens Medical Diagnostics Inc., USALevel 2 RecallCleaning Solution

Siemens Medical Diagnostics Products (Shanghai) Co., Ltd. reported,Due to some batches of products may contain incorrect flushing packsThe manufacturer, Siemens Healthcare Diagnostics Inc., USA, voluntarily recalled its Wash/Waste Cartridge (4) (Record No. 20220668 of Medical Devices in China). The recall level is Class II.

3、Abbott Medical DevicesLevel 2 RecallRecall of Implantable Left Ventricular Assist System

Abbott Medical Products (Shanghai) Co., Ltd. reported,Since the AC power cord of the portable power supply device is not fully locked in place when plugged in for some productsAbbott Medical, the manufacturer, voluntarily recalled its Left Ventricular Assist System (Registration No. 20243120384 in China). The recall level is classified as a Level 2 recall.

4、Philips Medical Systems Netherlands B.V.Level 2 RecallMedical Vascular Angiography X-ray System

Philips (China) Investment Co., Ltd. reported,Due to the possibility that the bolts connecting the product's gearbox to the C-arm rolling motor mounting flange may not have received sufficient torquePhilips Medical Systems Nederland B.V., the manufacturer, voluntarily recalled its Medical Angiography X-ray System (Registration No. 20193060317) in China. The recall level is classified as a Level 2 recall.

5、Anshengxin Diabetes Health Care Co., Ltd.Level 2 RecallBlood Glucose Meter

Shanghai Jianzhen Medical Technology Co., Ltd. reported,Due to the incorrect setting of the reading display unit, the manufacturer Ascensia Diabetes Care Holdings AG voluntarily recalled its blood glucose meter, CONTOUR NEXT GEN meter. The recall level is Class II.

6、Olympus Medical Corporation Recalls Ultrasonic Electronic Upper Gastrointestinal Endoscope

Olympus Trading (Shanghai) Co., Ltd. reported,Due to the incorrect inclusion of other products in the packaging of some batches of ultrasound electronic upper gastrointestinal endoscope accessoriesThe manufacturer, Olympus Medical Systems Corporation, voluntarily recalled its ultrasound electronic upper gastrointestinal endoscope (Registration No. 20163063147) in China. The recall level is classified as a Level Three recall.

▲ Article Source: Medical Device R&D - Jiayu Testing Network, compiled from NMPA

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