FDA Device recall Z-0860-2025
8MM,TENACULUM FORCEPS,IS4000¿ REF 470207
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of 8MM,TENACULUM FORCEPS,IS4000¿ REF 470207 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-0860-2025 |
| 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,TENACULUM FORCEPS,IS4000¿ REF 470207
Reason
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Identifiers
| code_info | Model Number: 470207 Part Number: 470207-10 UDI-DI code: 00886874112366 Batch Numbers: K10221218 K10230108 K10230205 K1…Model Number: 470207 Part Number: 470207-10 UDI-DI code: 00886874112366 Batch Numbers: K10221218 K10230108 K10230205 K10230212 K10230226 K10230302 K10230310 K10230316 K10230323 K10230420 K10230427 K10230504 K10230511 K10230518 K10230525 K10230601 K10230608 K10230615 K10230706 K10230713 K10230803 K10230810 K10230928 K10231005 K10231109 K10231123 K10231130 K10240104 K10240111 K10240119 K10240208 K10240215 K10240222 K10240314 K10240321 K10240411 K10240417 K10240502 K10240509 K10240613 K10240620 K10240815 K10240822 K11230108 K11230817 K11230928 K11231116 K11231123 K11240119 K12231123 |
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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-0860-2025%22
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