Use cautionMedical device recall · FDA · Published January 28, 2021
Olymp: Duodenoscope Recalls Due to Mucosal Injury Risk
Olympus recalls TJF-Q190V duodenoscopes after reports of mucosal injuries from forceps elevator regions. Affected units include specific models used with Olympus video systems.
Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated with the forceps elevator region of the TJF-Q190V duodenoscope, including the distal cover (model MAJ- 2315).
Take action
Contact the company
📍Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy, PO Box 610 · Center Valley, PA 18034-0610
“Olymp: Duodenoscope Recalls Due to Mucosal Injury Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63336-olymp-duodenoscope-recalls-due-to-mucosal-injury-risk. Based on FDA recall #Z-1292-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1292-2021%22&limit=1).
The FDA announced on Jan. 28, 2021, that Olympus Corporation of the Americas is recalling Duodenoscopes and accessories due to potential mucosal injury hazards. The recall affects model TJF-Q190V devices distributed worldwide.
How to tell if you have it
Brand: Olympus
Model: TJF-Q190V
Product: Duodenoscope and accessories, flexible/rigid
The hazard
Olympus Medical Systems Corporation has received complaints of mucosal injury associated with the forceps elevator region of the TJF-Q190V duodenoscope, including the distal cover (model MAJ-2315).
Context
GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since Aug. 18, 2017. Other recent recalls include an Olympus Tripp-Lite P580-025 DisplayPort Cable (Aug. 27, 2026), an Olympus M3 Gold Autoclavable Lateral Telescope (Aug. 24, 2026), and a BiCOAG Hemostasis Probe (Aug. 19, 2026). Other recent recalls of similar products include Katalyst Surgical DEX Ophthalmic Tissue Forceps (March 25, 2026), Medline Olympus Biopsy Kits (Feb. 16, 2026), and Wilson-Cook Instinct Plus Endoscopic Clipping Device (March 3, 2026).
How to tell if you have this one
Check if your duodenoscope has the model number TJF-Q190V. It was sold with Olympus video systems, light sources, and endoscopic equipment for procedures within the duodenum.
Brand
Olympus
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check for Mucosal Injury Symptoms
Look for signs of mucosal injury in the forceps elevator region after use. Contact your healthcare provider if you notice symptoms.
Contact Olympus Support
Reach out to Olympus Corporation of the Americas for guidance on next steps and potential remedies.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 42 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 3.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1292-2021 (January 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1292-2021 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.