# FDA recall Z-1292-2021

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2021-01-28.

## Product

Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

## Reason for recall

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).

## 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, WV, WY  and the countries of Japan, Europe, Australia.

## Key facts

- **Recall number:** Z-1292-2021
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-28
- **Report date:** 2021-03-31
- **Termination date:** 2024-03-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1292-2021

## Citation

> AI Analytics. FDA recall Z-1292-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1292-2021. Source: US FDA. Licensed CC0.

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