Modification to Olympus Bronchoscopes Bf-40 Series, Bf-240 Series, and Bf-160 Series

• 9 recalls, same reason

  • Ongoing Z-0067-2026 FDA Class I ·initiated 11 Sep 2025
  • Ongoing Z-0058-2026 FDA Class I ·initiated 11 Sep 2025
  • Ongoing Z-0064-2026 FDA Class I ·initiated 11 Sep 2025
  • Ongoing Z-0055-2026 FDA Class I ·initiated 11 Sep 2025
  • Ongoing Z-0059-2026 FDA Class I ·initiated 11 Sep 2025
  • Ongoing Z-0065-2026 FDA Class I ·initiated 11 Sep 2025
  • Ongoing Z-0045-2026 FDA Class I ·initiated 11 Sep 2025
  • Ongoing Z-0054-2026 FDA Class I ·initiated 11 Sep 2025
  • Ongoing Z-0047-2026 FDA Class I ·initiated 11 Sep 2025

  Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

• • Ongoing Z-0189-2024 FDA Class I ·initiated 12 Oct 2023

  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.

• • Ongoing Z-0327-2024 FDA Class II ·initiated 25 Sep 2023

  Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

• • Ongoing Z-2490-2023 FDA Class II ·initiated 27 Jul 2023

  Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

• 4 recalls, same reason

  • Ongoing Z-2014-2023 FDA Class I ·initiated 8 Jun 2023
  • Ongoing Z-2012-2023 FDA Class I ·initiated 8 Jun 2023
  • Ongoing Z-2011-2023 FDA Class I ·initiated 8 Jun 2023
  • Ongoing Z-2013-2023 FDA Class I ·initiated 8 Jun 2023

  There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

• 2 recalls, same reason

  • Ongoing Z-1047-2022 FDA Class II ·initiated 8 Mar 2022
  • Ongoing Z-1046-2022 FDA Class II ·initiated 8 Mar 2022

  Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization

• • Terminated Z-2497-2021 FDA Class II ·initiated 17 Aug 2021

  A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.

• 5 recalls, same reason

  • Terminated Z-2565-2021 FDA Class II ·initiated 16 Aug 2021
  • Terminated Z-2567-2021 FDA Class II ·initiated 16 Aug 2021
  • Terminated Z-2568-2021 FDA Class II ·initiated 16 Aug 2021
  • Terminated Z-2570-2021 FDA Class II ·initiated 16 Aug 2021
  • Terminated Z-2566-2021 FDA Class II ·initiated 16 Aug 2021 ·on shared 510(k) K023984

  The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

• 21 recalls, same reason

  • Terminated Z-3307-2018 FDA Class II ·initiated 8 Aug 2018
  • Terminated Z-3291-2018 FDA Class II ·initiated 8 Aug 2018
  • Terminated Z-3312-2018 FDA Class II ·initiated 8 Aug 2018
  • Terminated Z-3308-2018 FDA Class II ·initiated 8 Aug 2018
  • Terminated Z-3283-2018 FDA Class II ·initiated 8 Aug 2018
  • Terminated Z-3286-2018 FDA Class II ·initiated 8 Aug 2018
  • Terminated Z-3289-2018 FDA Class II ·initiated 8 Aug 2018
  • Terminated Z-3292-2018 FDA Class II ·initiated 8 Aug 2018
  • Terminated Z-3284-2018 FDA Class II ·initiated 8 Aug 2018
  • Terminated Z-3290-2018 FDA Class II ·initiated 8 Aug 2018
  • Terminated Z-3309-2018 FDA Class II ·initiated 8 Aug 2018
  • Terminated Z-3300-2018 FDA Class II ·initiated 8 Aug 2018
  • Terminated Z-3299-2018 FDA Class II ·initiated 8 Aug 2018
  • Terminated Z-3287-2018 FDA Class II ·initiated 8 Aug 2018
  • Terminated Z-3294-2018 FDA Class II ·initiated 8 Aug 2018
  • Terminated Z-3293-2018 FDA Class II ·initiated 8 Aug 2018
  • Terminated Z-3296-2018 FDA Class II ·initiated 8 Aug 2018
  • Terminated Z-3298-2018 FDA Class II ·initiated 8 Aug 2018
  • Terminated Z-3306-2018 FDA Class II ·initiated 8 Aug 2018
  • Terminated Z-3295-2018 FDA Class II ·initiated 8 Aug 2018
  • Terminated Z-3305-2018 FDA Class II ·initiated 8 Aug 2018

  The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K023984 ↗

FDA Product Code

EOQ

Device Class

Class II

Regulation

21 CFR Part 874.4680

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Disposable Bending Cannula Pr-233Q

  Class II

  FDA 510(k) K011149 Active Cleared 15 May 2001

• XBO1-824-18/19/20 Biopsy Forceps

  Class II

  FDA 510(k) K012074 Active Cleared 25 Sep 2001

• Disposable Aspiration Needle Na-200H

  Class II

  FDA 510(k) K023272 Active Cleared 23 Dec 2002

• Endoscope Contour Detection Device, Model 3DX45 and Colonoscope, Model Xcf-Q140L/13D

  Class II

  FDA 510(k) K002749 Active Cleared 4 Dec 2000

• Olympus Um 2R/3R Ultrasonic Probe and Associated Ancillary Equipment for Female Reproductive Tract

  Class II

  FDA 510(k) K001203 Active Cleared 26 May 2000

• Xenf-Dp Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment

  Class II

  FDA 510(k) K011869 Active Cleared 25 Jul 2001

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