Aizuwakamatsu, N/A, Japan

Aizu Olympus Co., Ltd. recalls

4 recalls recorded since 2018, most recently on 31 October 2025. 3 are listed as ongoing. Status and classification are as published by the FDA.

Recalls4

Ongoing (FDA)3

Terminated or completed1

Class I (FDA)0

Recall started: 31 October 2025
Reason: Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
Distribution: US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0872-2026, Z-0873-2026, Z-0874-2026

Recall started: 16 October 2023
Reason: Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
Distribution: Domestic distribution to FL, KY, MA, NJ, NY, and PA
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0419-2024, Z-0418-2024, Z-0415-2024, Z-0416-2024, Z-0417-2024

Recall started: 25 September 2023
Reason: 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
Distribution: Worldwide - US Nationwide distribution.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0342-2024, Z-0338-2024, Z-0333-2024, Z-0330-2024, Z-0327-2024, Z-0332-2024, Z-0341-2024, Z-0328-2024, Z-0347-2024, Z-0344-2024, Z-0331-2024, Z-0339-2024 and 10 more

Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Number: PCF-S.
Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: LF-DP, LF-GP, LF-TP.
Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numbers: GF-UC140P-AL5, GF-UCT180, GF-UE160-AL5.
Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190,
Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea). Model Numbers: ENF-T3, ENF-VT2, ENF-VT3.
Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Numbers: PCF-H180AI, PCF-H180AL, PCF-H190DI, PCF-H190DL, PCF-H190I, PCF-H190L
Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the airways, trancheobronchial tree, esophagus and surrounding organs Model
and 14 more product lines

Recall started: 20 July 2022
Terminated: 22 January 2025
Reason: The recalled unit was utilized in a veterinary endoscopy procedure in advance of being assigned to healthcare facilities as a loaner.
Distribution: US Nationwide distribution in the states of FL, IL, NC, PA & TX.
Initiated: Voluntary: Firm initiated
Recall number: Z-1559-2022

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.