FDA Device recall Z-0864-2025
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296
- 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 470296 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-0864-2025 |
| 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 470296
Reason
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Identifiers
| code_info | Model Number: 470296 Part Number: 470296-05 UDI-DI code: 00886874112410 Batch Numbers: K10230217 Model Number: 470296…Model Number: 470296 Part Number: 470296-05 UDI-DI code: 00886874112410 Batch Numbers: K10230217 Model Number: 470296 Part Number: 470296-08 UDI-DI code: 00886874112410 Batch Numbers: K10230302 K10230413 K10230420 K10230427 K10230824 K10231123 K10240229 K10240425 K10240627 K10240718 K16240613 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Intuitive Surgical
- da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
FDA Device · Class II · 2026-07-22 · Intuitive Surgical - Da Vinci ASSY, PSS, SP1098, Part Number: 380601
FDA Device · Class II · 2026-07-01 · Intuitive Surgical - Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface:…
FDA Device · Class II · 2026-06-10 · Intuitive Surgical - Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000
FDA Device · Class II · 2026-05-13 · Intuitive Surgical - Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
FDA Device · Class I · 2026-05-13 · Intuitive Surgical
All Intuitive Surgical recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0864-2025%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.