Olympus Corporation of the Americas: Medical Device Recalls in 2021

According to to data from the FDA, there were 17 medical device recalls made by Olympus Corporation of the Americas in 2021. See the details of the recalls below.

You can see similar recalls for other firms.

• EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
• Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC
• Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 ENDOCUFF-V S PURPLE PK8, Part Number: E0420502; ARV140 ENDOCUFF-V XL ORANGE PK8 ARV110, Part Number: E0420503 Intended to be attached to the distal end of the endoscope to facilitate endoscopic therapy
• EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
• Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological surgery
• BF-XP60 OES Bronchofiberscope, Model No. BF-XP60
• BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F
• BF-P180 EVIS EXERA II Bronchovideoscope, Model No. BF-P180
• BF-N20 OES Bronchofiberscope, Model No. BF-N20
• BF-Q180-AC EVIS EXERA II Bronchovideoscope, Model No. BF-Q180-AC
• BF-3C40 OES Bronchofiberscope, Model No. BF-3C40
• BF-1T60 OES Bronchofiberscope, Model No. BF-1T60
• BF-P60 OES Bronchofiberscope, Model No. BF-P60
• Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
• BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180
• BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160
• ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue, considered benign, resected during single-port or multi- site laparoscopic surgery during power morcellation and removal.