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Olympus Corporation of the Americas Recalls
414 recalls on record · October 7, 2015 to July 29, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 15, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
Hazard: There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.
November 15, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model
Hazard: There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.
November 15, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180
Hazard: There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.
November 15, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC
Hazard: There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.
November 15, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYM
Hazard: There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.
October 25, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
Hazard: There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal cavity resulting from use of the UHI-4 during the procedures.
October 18, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including singl
Hazard: Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery
October 18, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including sing
Hazard: Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery
October 11, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19
Hazard: Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment
October 11, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Alw
Hazard: Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment
October 11, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend¿ 21ga, 1.8 OD, 5/Bx INS-5440
Hazard: Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment
October 11, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-56
Hazard: Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment
October 11, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Ac
Hazard: Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment
October 11, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN
Hazard: Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Bronchovideoscope, Models BF-3C160.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Bronchovideoscope, Models BF-P190 & BF-XP190.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Bronchovideoscope, Models BF-XT190.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Bronchovideoscope, Models BF-MP190F.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Airway Mobilescope, Models MAF-GM & MAF-TM.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Bronchovideoscope, Model BF-Q180-AC
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160.
Hazard: Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
September 6, 2023Medical DevicesFDA
Olympus Corporation of the Americas recalls Visera Hysterovideoscope Olympus HYF Type V
Hazard: IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.