Intuitive Surgical DeBakey Forceps Recalled for Frayed or Broken Grip Cables
Intuitive Surgical is recalling 1,739 8MM DeBakey Forceps (Model 470036) used in surgical procedures due to increased reports of frayed or broken grip cables. Cable failure could impair instrument function during surgery.
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 addressing mechanical component failure on surgical instruments. No injuries or deaths are reported in the source, but the defect poses a risk-of-harm to surgical patients if instruments malfunction during procedures.
Plain-English summary
Intuitive Surgical, Inc. is recalling 1,739 units of its 8MM DeBakey Forceps (Model 470036), a reusable surgical instrument. The recall addresses increased reports of frayed or broken grip cables in these instruments.
Grip cables are critical to instrument operation during surgery. When frayed or broken, the forceps may not function properly, potentially compromising surgical performance. The affected batches were manufactured between 2023 and 2024.
The recalled units have been distributed across the United States and internationally to over 40 countries. Affected instruments can be identified by their batch numbers and UDI-DI codes provided in recall notices from the manufacturer.
The recalled product
- Product
- 8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 1,739
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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