FDA Device recall Z-0870-2025
8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of 8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401 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-0870-2025 |
| 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,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
Reason
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Identifiers
| code_info | Model Number: 470401 Part Number: 470401-07 UDI-DI code: 00886874112670 Batch Numbers: K10230129 K10230205 K10230212 K1…Model Number: 470401 Part Number: 470401-07 UDI-DI code: 00886874112670 Batch Numbers: K10230129 K10230205 K10230212 K10230226 K10230323 K10230405 K10230413 K10230420 K10230504 K10230608 K10230630 K10230706 K10230713 K10230803 K10230810 K10230817 K10230928 K10231005 K10231019 K10231027 K10231102 K10230112 K10240125 K10240208 K10240222 K10240327 K10240411 K10240523 K10240606 K10240620 K10240627 K10240702 K10240711 K10240725 K11240112 Model Number: 470401 Part Number: 470401-08 UDI-DI code: 00886874112670 Batch Numbers: K10230914 K10231012 K10240327 K10240509 K10240523 K10240530 |
|---|
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-0870-2025%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.