# FDA recall Z-0106-2022

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2021-08-06.

## Product

Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978

## Reason for recall

Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.

## Distribution

US: AZ, AR, CA, CO, DC, FL, GA, IL, IN, IO, MD, MA, MI, MN, MO, NV, NJ, NY, NC, OH, OK, PA, TN, TX, UT, VA, WA OUS: China

## Key facts

- **Recall number:** Z-0106-2022
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-06
- **Report date:** 2021-10-20
- **Termination date:** 2024-05-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sunnyvale, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0106-2022

## Citation

> AI Analytics. FDA recall Z-0106-2022. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-0106-2022. Source: US FDA. Licensed CC0.

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