ULTRASONIC GASTROVIDEOSCOPE recallZ-1034-2022 · Olympus Corporation of the Americas · initiated Mar 18, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients
FDA root cause category: Device Design
What the company is doing
Olympus issued URGENT: MEDICAL DEVICE CORRECTIVE ACTION on 3/18/22. Letter states reason for recall, health risk and action to take: 1. Inspect your inventory for the referenced devices and identify any device with the model number specified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. The model number can be found on the device as illustrated in the following picture. 2. If you are using the OER-Pro for high level disinfection of the GF-UC140P-AL5, please transition to an OER-Elite or another AER validated for GF-UC140P-AL5 reprocessing as soon as possible. 3. When manually cleaning the GF-UC140P-AL5 carefully follow the instructions in the IFU, vigilantly cleaning all channels and the forceps elevator. Ensure that you are inspecting the GFUC140P-AL5 prior to each use and after each use according to the instructions. 4. Ensure all personnel understand that the GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and further that such personal are completely knowledgeable and thoroughly trained on the Instructions for Use applicable to the GF-UC140P-AL5 device 5. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number 0406 and provide your contact information as indicated in the portal. If you require additional information about the GF-UC140P-AL5 reprocessing, you can obtain additional information as follows: You can contact our Technical Assistance Center (TAC) at 1-800-848-9024, option 1 and the TAC department can assist you in answering questions. OMSC requests you to report any patient injuries, including infections or persistent microbial colonization associated with any OMSC endoscope. Call our Technical Assistance Center (TAC) at 1- 800-848-9024, option 1 to report complaints.
Recall details
- Recall number
- Z-1034-2022
- Status
- Open, Classified
- Initiated by the company
- Mar 18, 2022
- Posted by the FDA
- May 5, 2022
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 731 units
- Product code
- ITX
- FDA submissions
- K011314
- Distribution
- Nationwide
Product description
Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
Code information (models, lots, serial numbers)
All serial numbers. GTIN: 04953170356322
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UC140P-AL5Olympus Medical Systems Corp. · Transducer, ultrasonic, diagnostic2 recalls114 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page