FDA Device recall Z-0849-2025
8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006 by Intuitive Surgical, citing due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0849-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-19 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Intuitive Surgical |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
Product
8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006
Reason
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Identifiers
| code_info | Model Number: 470006 Part Number: 470006-12 UDI-DI code: 00886874112151 Batch Numbers: K10230120 K10230118 K12230119 K1…Model Number: 470006 Part Number: 470006-12 UDI-DI code: 00886874112151 Batch Numbers: K10230120 K10230118 K12230119 K11230118 K10230217 Part Number: 470006-13 UDI-DI code: 00886874112151 Batch Numbers: K10230623 K10240506 K10240815 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0849-2025%22
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