FDA Device recall Z-0879-2025
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296 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-0879-2025 |
| 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 SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
Reason
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Identifiers
| code_info | Model Number: 471296 Part Number: 471296-07 UDI-DI code: 00886874121504 Batch Numbers: K10221111 K10221113 K10230112 K1…Model Number: 471296 Part Number: 471296-07 UDI-DI code: 00886874121504 Batch Numbers: K10221111 K10221113 K10230112 K10230205 K10230212 K10230217 K10230824 K10240808 K10240822 K11221115 K11230112 K11230217 K12230217 Model Number: 471296 Part Number: 471296-08 UDI-DI code: 00886874121504 Batch Numbers: K10230302 K10230310 K10230316 K10230323 K10230504 K10230511 K10230601 K10230615 K10230622 K10230706 K10230713 K10230727 K10230803 K10230810 K10230817 K10230824 K10230831 K10231005 K10231012 K10231019 K10231027 K10231102 K10231109 K10231123 K10231207 K10231218 K10240104 K10240111 K10240118 K10240125 K10240208 K10240222 K10240229 K10240307 K10240314 K10240327 K10240404 K10240411 K10240418 K10240425 K10240516 K10240606 K10240613 K10240620 K10240627 K10240702 K10240711 K10240725 K11230302 K11230310 K11230323 K11230713 K11230831 K11231005 K11231102 K11231116 K11231207 K11240111 K11240208 K11240307 K11240411 K11240418 K11240606 K11240620 K11240711 K12231005 K12240307 K12240620 |
|---|
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-0879-2025%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.