FDA Device recall Z-0869-2025
8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of 8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347 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-0869-2025 |
| 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,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347
Reason
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Identifiers
| code_info | Model Number: 470347 Part Number: 470347-11 UDI-DI code: 00886874112496 Batch Numbers: K10230122 K10230129 K10230227 K1…Model Number: 470347 Part Number: 470347-11 UDI-DI code: 00886874112496 Batch Numbers: K10230122 K10230129 K10230227 K10230302 K10230313 K10230316 K10230323 K10230330 K10230405 K10230413 K10230420 K10230427 K10230428 K10230504 K10230511 K10230516 K10230518 K10230525 K10230601 K10230602 K10230608 K10230615 K10230622 K10230629 K10230706 K10230710 K10230713 K10230719 K10230720 K10230727 K10230801 K10230803 K10230810 K10230817 K10230824 K10230831 K10230907 K10230913 K10230914 K10230921 K10230928 K10231005 K10231019 K10231027 K10231102 K10231123 K10231130 K10231218 K10240104 K10240111 K10240116 K10240118 K10240124 K10240125 K10240208 K10240215 K10240218 K10240222 K10240229 K10240303 K10240307 K10240315 K10240322 K10240326 K10240418 K10240425 K10240502 K10240515 K10240516 K10240523 K10240530 K10240606 K10240618 K10240718 K10240725 K10240801 K10240805 K10240808 K10240815 K11230122 K11230313 K11230316 K11230323 K11230330 K11230405 K11230413 K11230420 K11230427 K11230504 K11230511 K11230518 K11 |
|---|
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-0869-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.