FDA Device recall Z-0854-2025
8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of 8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093 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-0854-2025 |
| 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,PROGRASP FORCEPS,IS4000 ¿ REF 470093
Reason
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Identifiers
| code_info | Model Number: 470093 Part Number: 470093-11 UDI-DI code: 00886874112267 Batch Numbers: K10221211 K10230302 K10230413 K1…Model Number: 470093 Part Number: 470093-11 UDI-DI code: 00886874112267 Batch Numbers: K10221211 K10230302 K10230413 K10230420 K10230615 K10231025 K10231027 K10231123 K10240222 K10240327 K10240404 |
|---|
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-0854-2025%22
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