FDA Device recall Z-0865-2025
8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of 8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309 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-0865-2025 |
| 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,MEGA SUTURECUT ND,IS4000¿ REF 470309
Reason
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Identifiers
| code_info | Model Number: 470309 Part Number: 470309-15 UDI-DI code: 00886874112434 Batch Numbers: K10230217 Model Number: 470309…Model Number: 470309 Part Number: 470309-15 UDI-DI code: 00886874112434 Batch Numbers: K10230217 Model Number: 470309 Part Number: 470309-17 UDI-DI code: 00886874112410 Batch Numbers: K10230302 |
|---|
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-0865-2025%22
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