Surgical Forceps Recalled Due to Frayed or Broken Grip Cables
Intuitive Surgical is recalling 8,578 units of Cadiere Forceps surgical instruments due to reports of frayed or broken grip cables. These reusable instruments were distributed throughout the United States and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall of surgical forceps with reported mechanical failures (frayed or broken grip cables). No injuries or hospitalizations are reported in the source material. This is a risk-of-harm product where injury has not yet been reported, warranting a High (3) severity score per the rubric.
Plain-English summary
Intuitive Surgical, Inc. is recalling 8,578 units of 8MM Cadiere Forceps (Model 470049) due to increased complaints regarding frayed or broken grip cables on reusable instruments.
The grip cables on the instrument handles have frayed or broken according to user complaints reported to the manufacturer. These reusable surgical forceps were distributed nationwide across the United States and to numerous international locations.
Affected batch numbers include K10221218, K10221220, K10230219, K10230226, K10230302, K10230310, K10230316, K10230323, K10230330, K10230405, K10230413, K10230420, K10230601, K10230608, K10230615, K10230706, K10230720, K10230921, K10230928, K10231005, K10231012, K10231109, K10231130, K10240327, K10240404, K10240418, K10240425, K10240502, K10240515, K11230413, K11230420, K11230720, K11231130, K11240502, and K11240515.
Healthcare providers should identify instruments matching these batch numbers, part number 470049-08, or UDI-DI code 00886874112250, and contact Intuitive Surgical for instructions on replacement or corrective action.
The recalled product
- Product
- 8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 8,578
Distribution
Part of a larger recall action
This product is one of 37 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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