Food, drugs, devices › Aizu Olympus Co., Ltd.
Device recall: CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
Aizu Olympus Co., Ltd. (Aizuwakamatsu) initiated this device recall on 16 Oct 2023; FDA lists 5 product records under event 93335, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Aizu Olympus Co., Ltd. has 4 enforcement events on this register, with a median of 5 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Aizu Olympus Co., Ltd., Aizuwakamatsu, Japan.
Reason for recall
"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…"
Distribution
"Domestic distribution to FL, KY, MA, NJ, NY, and PA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0415-2024 | CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE | 24 incorrectly repaired units | Class II | Ongoing | 6 Dec 2023 |
| Z-0416-2024 | GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE | 24 incorrectly repaired units | Class II | Ongoing | 6 Dec 2023 |
| Z-0417-2024 | GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE | 24 incorrectly repaired units | Class II | Ongoing | 6 Dec 2023 |
| Z-0418-2024 | PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE | 24 incorrectly repaired units | Class II | Ongoing | 6 Dec 2023 |
| Z-0419-2024 | PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE | 24 incorrectly repaired units | Class II | Ongoing | 6 Dec 2023 |
Context
Other enforcement events for Aizu Olympus Co., Ltd.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 31 Oct 2025 | Olympus OER-Elite | Device | Class II | 3 |
| 25 Sep 2023 | Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, | Device | Class II | 22 |
| 20 Jul 2022 | EVIS EXERA III Bronchovideoscope | Device | Class II | 1 |
All 4 events for Aizu Olympus Co., Ltd.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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…"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Domestic distribution to FL, KY, MA, NJ, NY, and PA"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.