FDA Device recall Z-0861-2025

8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230

FDA Device
Class II
ongoing
Published 2025-01-22

On 2025-01-22 the FDA classified a Class II recall of 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230 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-0861-2025
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,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230

Reason

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Identifiers

code_info	Model Number: 470230 Part Number: 470230-12 UDI-DI code: 00886874112380 Batch Numbers: K10230103 K10230122 K10230123 K1… Model Number: 470230 Part Number: 470230-12 UDI-DI code: 00886874112380 Batch Numbers: K10230103 K10230122 K10230123 K10230212 K10230226 K10230302 K10230310 K10230315 K10230323 K10230405 K10230420 K10230427 K10230504 K10230511 K10230518 K10230525 K10230602 K10230608 K10230615 K10230622 K10230706 K10230713 K10230727 K10230803 K10230810 K10230817 K10230921 K10231005 K10231012 K10231019 K10231027 K10231109 K10231123 K10231130 K10231207 K10231214 K10231218 K10240119 K10240125 K10240208 K10240215 K10240222 K10240229 K10240307 K10240327 K10240404 K10240411 K10240418 K10240516 K10240523 K10240606 K10240620 K10240627 K10240702 K10240711 K10240718 K10240808 K10240822 K11230103 K11230108 K11230212 K11230302 K11230315 K11230511 K11230518 K11230615 K11230622 K11230727 K11230817 K11230921 K11231005 K11231123 K11231214 K11240119 K11240125 K11240229 K11240404 K11240523 K11240620 K12230103 K12230108 K12230315 K12231116 K12240125 K12240404 K13230108 Model Number: 470230 Part Number: 470230-14 UDI-DI c

code_info

Model Number: 470230 Part Number: 470230-12 UDI-DI code: 00886874112380 Batch Numbers: K10230103 K10230122 K10230123 K1…

Model Number: 470230 Part Number: 470230-12 UDI-DI code: 00886874112380 Batch Numbers: K10230103 K10230122 K10230123 K10230212 K10230226 K10230302 K10230310 K10230315 K10230323 K10230405 K10230420 K10230427 K10230504 K10230511 K10230518 K10230525 K10230602 K10230608 K10230615 K10230622 K10230706 K10230713 K10230727 K10230803 K10230810 K10230817 K10230921 K10231005 K10231012 K10231019 K10231027 K10231109 K10231123 K10231130 K10231207 K10231214 K10231218 K10240119 K10240125 K10240208 K10240215 K10240222 K10240229 K10240307 K10240327 K10240404 K10240411 K10240418 K10240516 K10240523 K10240606 K10240620 K10240627 K10240702 K10240711 K10240718 K10240808 K10240822 K11230103 K11230108 K11230212 K11230302 K11230315 K11230511 K11230518 K11230615 K11230622 K11230727 K11230817 K11230921 K11231005 K11231123 K11231214 K11240119 K11240125 K11240229 K11240404 K11240523 K11240620 K12230103 K12230108 K12230315 K12231116 K12240125 K12240404 K13230108 Model Number: 470230 Part Number: 470230-14 UDI-DI c

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-0861-2025%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.