FDA Device recall Z-0876-2025
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172 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-0876-2025 |
| 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,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172
Reason
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Identifiers
| code_info | Model Number: 471172 Part Number: 471172-16 UDI-DI code: 00886874119792 Batch Numbers: K10230831 K11230831 K12230831 K1…Model Number: 471172 Part Number: 471172-16 UDI-DI code: 00886874119792 Batch Numbers: K10230831 K11230831 K12230831 K16240508 K17240508 K18240508 Model Number: 471172 Part Number: 471172-17 UDI-DI code: 00886874119792 Batch Numbers: K10221030 K10221122 K10221128 K10221212 K10221218 K10230103 K10230122 K10230129 K10230201 K10230205 K10230212 K10230219 K10230226 K10230302 K10230427 K10230504 K10230510 K10230515 K10230518 K10230526 K10230601 K10230608 K10230615 K10230622 K10230629 K10230706 K10230713 K10230714 K10230720 K10230727 K10230803 K10230810 K10230817 K10230824 K10230907 K10230914 K10230921 K10230928 K10231005 K10231012 K10231027 K10231109 K10231123 K10231201 K10231213 K10231214 K10231218 K10240104 K10240111 K10240118 K10240120 K10240125 K10240201 K10240208 K10240215 K10240229 K10240314 K10240327 K10240404 K10240410 K10240418 K10240425 K10240502 K10240515 K10240516 K10240523 K10240530 K10240603 K10240606 K10240613 K10240618 K10240702 K10240703 K10240708 K11221030 K11221212 K1122 |
|---|
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-0876-2025%22
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