Ion Flexison Biopsy Needle — Class II medical device recall Z-0106-2022
Terminated recall by Intuitive Surgical, Inc., reported 2021-10-20, distributed in AR, AZ, CA, CO, DC, FL, GA, IL…. Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.
| Recall number | Z-0106-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intuitive Surgical, Inc., Sunnyvale, CA, United States |
| Recall initiated | 2021-08-06 |
| Classified | 2021-10-13 |
| Reported by FDA | 2021-10-20 |
| Terminated | 2024-05-17 |
| Distributed | AR, AZ, CA, CO, DC, FL, GA, IL, IN, MA, MD, MI, MN, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, WA |
| Countries outside the US | CN |
| Quantity | 1,625 units |
| UPC / GTIN / UDI-DI | 00886874115978 |
| Lot numbers | S90200303, S90200622, S90200727, S90200811, S90200820, S90200831, S90200909, S90201008, S90201015, S90201103, S90201107, S90201125, S90201202, S90201204, S90210114, S90210211, S90210225, S90210310, S90210318, S90210408, S90210414 |
| Model numbers | 49004-10, 490104-09, 5-PACK |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0106-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.