FDA Device recall Z-0878-2025
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205 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-0878-2025 |
| 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,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205
Reason
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Identifiers
| code_info | Model Number: 471205 Part Number: 471205-17 UDI-DI code: 00886874119808 Batch Numbers: K10221106 K10221128 K10221204 K1…Model Number: 471205 Part Number: 471205-17 UDI-DI code: 00886874119808 Batch Numbers: K10221106 K10221128 K10221204 K10221212 K10221218 K10230103 K10230108 K10230111 K10230112 K10230122 K10230129 K10230205 K10230208 K10230212 K10230219 K10230226 K10230302 K10230310 K10230316 K10230323 K10230405 K10230413 K10230420 K10230427 K10230515 K10230518 K10230526 K10230601 K10230608 K10230612 K10230615 K10230622 K10230629 K10230706 K10230713 K10230720 K10230725 K10230727 K10230803 K10230810 K10230817 K10230824 K10230831 K10230907 K10230914 K10230921 K10230928 K10231012 K10231019 K10231027 K10231109 K10231123 K10231201 K10231205 K10231207 K10231213 K10231220 K10240130 K10240131 K10240201 K10240202 K10240208 K10240215 K10240216 K10240222 K10240229 K10240307 K10240314 K10240321 K10240325 K10240327 K10240404 K10240408 K10240411 K10240418 K10240425 K10240502 K10240509 K10240516 K10240523 K10240530 K10240606 K10240613 K10240702 K11221106 K11221118 K11221128 K11221212 K11221218 K11230108 K11230112 K11 |
|---|
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-0878-2025%22
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