Olympus Ultrasound Endoscope Recall: Infection Risk from Cleaning Steps
Olympus recalls GF-UCT140P-AL5 ultrasound endoscopes due to updated cleaning instructions that may increase infection risk during use. All units are affected.
Lower-risk recall
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
Contact the company
What happened, in plain English
Olymp: Olympus is recalling ultrasound endoscopes (model GF-UCT140P-AL5) because their cleaning instructions could lead to patient infections if not followed correctly. This affects all units sold for gastrointestinal procedures. Read more at govinfonow.com/recall/64079-olympus-ultrasound-endoscope-recall-infection-risk-from-cleaning-steps.
Source Summary by GovInfoNow · govinfonow.com/recall/64079-olympus-ultrasound-endoscope-recall-infection-risk-from-cleaning-steps · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0498-2021
Cite this page
“Olympus Ultrasound Endoscope Recall: Infection Risk from Cleaning Steps.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64079-olympus-ultrasound-endoscope-recall-infection-risk-from-cleaning-steps. Based on FDA recall #Z-0498-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0498-2021%22&limit=1).
Why it’s dangerous
The device requires specific cleaning steps to prevent infections. If the cleaning instructions are not followed correctly, it could lead to patient infections during medical procedures.
Who’s affected
Healthcare professionals using these endoscopes for gastrointestinal procedures are affected. Patients undergoing procedures with this equipment face the lowest risk of infection.
How to tell if you have this one
Check for the model number GF-UCT140P-AL5 on the device. All units sold for endoscopic ultrasound imaging and surgery in the gastrointestinal tract are affected.
- Brand
Olympus- Category
Medical device
All 10 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide distribution - US Nationwide distribution. Model Name ------------ Quantity distributed in U.S. GF-UC140P-AL5 ------------- 1,297 devices GF-UCT150-AL5 ------------- 564 devices GF-UCT180 -------------------- 3,145 devices GF-UM20 ----------------------- 31 devices GF-UM130 --------------------- 27 devices GF-UMQ130 ------------------- 373 devices GF-UM160 --------------------- 299 devices GF-UC160P-OL5 ------------- 46 devices GF-UCT160-OL5 ------------- 49 devices GF-UE160-AL5 -------------- 2,691 devices
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0498-2021 | Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.; All Serial/Lot Numbers | 1,297 devices |
| Z-0499-2021 | Olympus Ultrasound Endoscope, Model Number: GF-UCT140-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.; All Serial/Lot Numbers | 564 |
| Z-0500-2021 | Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used with an Olympus universal endoscopic ultrasound center or a diagnostic system (ALOKA CO. LTD), video system center, light source, documentation equipment, monitor, EndoTherapy accessories and other ancillary equipment.; All Serial/Lot Numbers | 3,145 devices |
| Z-0501-2021 | Olympus Ultrasound Endoscope, Model number :GF-UM20 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.; All Serial/Lot Numbers | 27 devices |
| Z-0502-2021 | Olympus Ultrasound Endoscope, Model number: GF-UM130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasound imaging of the gastrointestinal wall, biliary and pancreatic duct, and surrounding organs.; All Serial/Lot Numbers | 373 devices |
| Z-0503-2021 | Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasound imaging of the gastrointestinal wall, biliary and pancreatic duct, and surrounding organs.; All Serial/Lot Numbers | 31 devices |
| Z-0504-2021 | Olympus Ultrasound Endoscope, Model number: GF-UM160 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.; All Serial/Lot Numbers | 299 devices |
| Z-0505-2021 | Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.; All Serial/Lot Numbers | 46 devices |
| Z-0506-2021 | Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.; All Serial/Lot Numbers | 49 |
| Z-0507-2021 | Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: used for endoscopic ultrasonic imaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs.; All Serial/Lot Numbers | 2,691 |
What to do — step by step
Review Cleaning Instructions
Check the device's Instructions For Use for the updated cleaning steps to ensure proper infection control.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide distribution. Model Name ------------ Quantity distributed in U.S. GF-UC140P-AL5 ------------- 1,297 devices GF-UCT150-AL5 ------------- 564 devices GF-UCT180 -------------------- 3,145 devices…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0498-2021 (October 16, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0498-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.