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FDA (Device enforcement)Recalled 2024-12-19class ii

Intuitive Surgical, Inc.: 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205

Hazard

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

Details from the source

Reason for recall: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Distribution: U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Ok Quantity: 147,006 Lot/code info: 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 K11230122 K11230129 K11230205 K11230212 K11230226 K11230310 K11230316 K11230323 K11230405 K11230413 K11230420 K11230427 K11230515 K11230518 K11230526 K11230601 K11230608 K11230615 K11230622 K11230706 K11230713 K11230720 K11230727 K11230803 K11230810 K11230817 K11230824 K11230831 K11230907 K11230914 K11230921 K11230928 K11231012 K11231019 K11231027 K11231109 K11231123 K11231201 K11231207 K11231220 K11240130 K11240131 K11240201 K11240202 K11240208 K11240215 K11240222 K11240229 K11240307 K11240314 K11

UPC codes

00886874119808

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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