Device recall: Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers…
Class II FDA enforcement event 93222. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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
Class II, in the words of FDA
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
Aizu Olympus Co., Ltd. started this device recall on 25 Sep 2023. The firm address in the FDA record is in Aizuwakamatsu. FDA put the recall in Class II. FDA event 93222 has 22 product records. The first FDA enforcement report date is 29 Nov 2023. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide - US Nationwide distribution.
Recalling firm
Aizu Olympus Co., Ltd., Aizuwakamatsu, N/A, Japan.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
22 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0327-2024 | 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, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033,… | 1123 units | Class II | Ongoing | 29 Nov 2023 |
| Z-0328-2024 | 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 Numbers: BF-UC180F, BF-UC190F. | 823 units | Class II | Ongoing | 29 Nov 2023 |
| Z-0329-2024 | Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L,… | 3344 units | Class II | Ongoing | 29 Nov 2023 |
| Z-0330-2024 | Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60. | 3 units | Class III | Ongoing | 29 Nov 2023 |
| Z-0331-2024 | Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR. | 1243 units | Class II | Ongoing | 29 Nov 2023 |
| Z-0332-2024 | 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. | 46 units | Class II | Ongoing | 29 Nov 2023 |
| Z-0333-2024 | 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. | 680 units | Class II | Ongoing | 29 Nov 2023 |
| Z-0334-2024 | Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N,… | 3627 units | Class II | Ongoing | 29 Nov 2023 |
| Z-0335-2024 | Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T. | 0 units | Class II | Ongoing | 29 Nov 2023 |
| Z-0336-2024 | Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V. | 27 units | Class II | Ongoing | 29 Nov 2023 |
| Z-0337-2024 | Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP. | 16 units | Class II | Ongoing | 29 Nov 2023 |
| Z-0338-2024 | Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: LF-DP, LF-GP, LF-TP. | 65 units | Class II | Ongoing | 29 Nov 2023 |
| Z-0339-2024 | Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Number: LF-V. | 61 units | Class II | Ongoing | 29 Nov 2023 |
| Z-0340-2024 | Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: MAF-DM2, MAF-GM, MAF-GM2, MAF-TM, MAF-TM2. | 33 units | Class II | Ongoing | 29 Nov 2023 |
| Z-0341-2024 | 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, PCF-H190TI, PCF-H190TL, PCF-HQ190I, PCF-HQ190L, PCF-PH190I, PCF-PH190L, PCF-Q180AI, PCF-Q180AL,… | 3101 units | Class II | Ongoing | 29 Nov 2023 |
| Z-0342-2024 | Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Number: PCF-S. | 8 units | Class II | Ongoing | 29 Nov 2023 |
| Z-0343-2024 | Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, duodenum, and small intestine) by oral insertion or the lower digestive tract (including the anus, rectum, sigmoid colon, colon, ileocecal valve, and small intestine) by anal insertion.… | 32 units | Class II | Ongoing | 29 Nov 2023 |
| Z-0344-2024 | Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF-V. | 25 units | Class II | Ongoing | 29 Nov 2023 |
| Z-0345-2024 | Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs Model Number: TGF-UC180J. | 5 units | Class II | Ongoing | 29 Nov 2023 |
| Z-0346-2024 | Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery Model Numbers: TJF-145, TJF-150, TJF-Q180V, TJF-Q190V. | 0 units | Class II | Ongoing | 29 Nov 2023 |
| Z-0347-2024 | Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct). Model Numbers: URF-P6, URF-P6R. | 1577 units | Class II | Ongoing | 29 Nov 2023 |
| Z-0348-2024 | Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney. Model Numbers: URF-P7, URF-P7R, URF-V2, URF-V2R, URF-V3, URF-V3R. | N/A | Class II | Ongoing | 29 Nov 2023 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class II
- 88%
- Product records in this event
- 22Median of the firm: 5
- Events of the firm on the register
- 4
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 31 Oct 2025 | Olympus OER-Elite | Device | Class II | 3 |
| 16 Oct 2023 | CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE | Device | Class II | 5 |
| 20 Jul 2022 | EVIS EXERA III Bronchovideoscope | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0327-2024The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 93222. https://recallregister.com/fda/ii/93222/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide - US Nationwide distribution.
- What quantity of product is in FDA event 93222?
- The event has 22 product records. The first record gives this quantity:
1123 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 88% of the 917 device events that started in 2023 are in Class II.