# FDA recall Z-2269-2023

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2023-05-15.

## Product

Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga    Intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic brINS-0362onchoscopy are currently used for visualizing     Model: INS-5450

## Reason for recall

Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay

## Distribution

Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: CN, DE, HK, IT, KR, SG, TH & TW.

## Key facts

- **Recall number:** Z-2269-2023
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-15
- **Report date:** 2023-08-09

- **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-2269-2023

## Citation

> AI Analytics. FDA recall Z-2269-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-2269-2023. Source: US FDA. Licensed CC0.

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