Johnson & Johnson, Medtronic, and Others Issue Multiple Medical Device Recalls Amid Regulatory Scrutiny

Since July 2023, the National Medical Products Administration has announced multiple medical device recall notices, including two Class I recalls, one of which was upgraded to a Class I recall, and several other products involved in Class II recalls. Specific information is as follows:

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. reported that due to unexpected skin thermal injuries in patients using the product, Megadyne Medical Products Inc., the manufacturer, has initiated a Level 2 recall of the Reusable Patient Return Electrode (Registration No. 20232010220).

Medtronic (Shanghai) Management Co., Ltd. reported that due to the potential for separation or welding failure in trackers used to fix and guide neurosurgical instruments, Medtronic Navigation, Inc. initiated a voluntary recall of navigation positioning system tools (Record No. 20230078) and cranial neurosurgery positioning devices (Registration No. 20223010631). The recall is classified as a Level II recall.

Medtronic (Shanghai) Management Co., Ltd. reported that due to the use of incorrect materials for accessories, the manufacturer Medtronic Sofamor Danek Manufacturing initiated a Level 2 recall of the spinal internal fixation system (China Medical Device Registration No. 20203130312).

AMO (SHANGHAI) MEDICAL Devices Trading Co., Ltd. reported that Johnson & Johnson Surgical Vision, Inc., the manufacturer of TECNIS intraocular lenses, initiated a Level 2 recall of the non-toric correction type intraocular lenses (China Registration No. 20233160195) due to the presence of toric correction reference marks during production.

Ortho-Clinical Diagnostics Trading (China) Co., Ltd. reported that due to potential negative bias in troponin results, the manufacturer Quidel Cardiovascular Inc. has initiated a voluntary recall of the Quidel Triage Cardiac Panel (fluorescent immunoassay) (Registration No. 20172402180). The recall is classified as a Level 1 recall.

Covidien LLC, reported by Coviden Medical Devices International Trade (Shanghai) Co., Ltd., is voluntarily recalling central venous catheter kits for hemodialysis (Registration No.: National Medical Device Import Registration 20143106176, National Medical Device Import Registration 20143666176) due to an incorrect mixture ratio of the silicone-based lubricant coated on the catheter tip during production. This resulted in a thicker coating that blocked the catheter tip. The recall level is Class I.

Teleflex Medical Trading (Shanghai) Co., Ltd. reported that due to the disconnection of the 15mm connector of the affected products from the endotracheal tube (ET tube), there is a possibility of decreased oxygen saturation. The manufacturer, Teleflex Medical Sdn. Bhd., has initiated a voluntary recall of the disposable sterile tracheal tube (Tracheal Tube, registration numbers: G20192081715 and SFDA (Import) 2014 No. 2664102). Relevant product recall information was released on May 25, 2023, with an initial recall level of Level 2, which has now been changed to Level 1.

Ortho-Clinical Diagnostics Trading (China) Co., Ltd. reported that due to incorrect regional configuration settings, Ortho-Clinical Diagnostics (UK) Limited, the manufacturer, has voluntarily recalled the fully automatic blood type analyzer (Registration No.: 20173222376, 20173222355). The recall level is classified as a Level 2 recall.

Maquet (Shanghai) Medical Equipment Co., Ltd. reported that due to the potential breakage of the base of the guidewire dilator in the intra-aortic balloon catheter and accessories during sheath puncture, the manufacturer Datascope Corp. has initiated a voluntary recall of the Sensation Plus Intra-Aortic Balloon Catheters (Registration No. 20223030475). The recall is classified as a Level II recall. (Economic Daily Online Han Lu)