8MM Maryland Bipolar Forceps Recalled Due to Frayed Grip Cables
Intuitive Surgical is recalling 8MM Maryland Bipolar Forceps due to increased complaints about frayed or broken grip cables on these reusable surgical instruments. Approximately 7,132 units have been distributed.
What this means for you
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 recall of surgical instruments with grip cable defects. No injuries reported. The defects present a risk of harm during surgical procedures, meeting the Score 3 criterion for risk-of-harm products without reported injury.
Plain-English summary
Intuitive Surgical, Inc. is recalling the 8MM Maryland Bipolar Forceps (Model 470172), a reusable surgical instrument. The device is used in operating rooms for surgical procedures. Approximately 7,132 units have been distributed throughout the United States and to 49 additional countries.
The recall is due to increased complaints regarding frayed or broken grip cables on the affected instruments.
Healthcare facilities and surgical centers that have received these devices should discontinue use of affected instrument lots. Contact Intuitive Surgical for instructions on device inspection, repair, replacement, or return.
The recalled product
- Product
- 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 7,132
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.
See all 37 products in this recall →Related recalls
Same manufacturer · Intuitive Surgical, Inc.
See all →- Moderateda Vinci SP Instrument Arm Drape may detach during surgical procedures
FDA (Devices) · 2026-07-22
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- HighDa Vinci 5 tower may unintentionally activate the infrared handheld camera
FDA (Devices) · 2026-06-10
- Highda Vinci X and Xi Surgical Systems Recalled for Manipulator Arm Screw Breakage
FDA (Devices) · 2026-05-13
- SevereIntuitive 8 mm SureForm 30 Gray Reloads Incomplete Staple Defect
FDA (Devices) · 2026-05-13
Same hazard · grip cable failure
See all →- HighIntuitive Surgical Needle Driver Recall Due to Grip Cable Failures
FDA (Devices) · 2025-01-22
- HighHEM-O-LOK Clip Applier Recalled for Frayed or Broken Grip Cables
FDA (Devices) · 2025-01-22
- HighIntuitive Surgical Micro Forceps Recalled Due to Grip Cable Defects
FDA (Devices) · 2025-01-22
- HighIntuitive Surgical Tenaculum Forceps Recalled for Frayed or Broken Grip Cables
FDA (Devices) · 2025-01-22
- HighIntuitive Surgical recalls 8MM Force Bipolar surgical instruments due to grip cable failures
FDA (Devices) · 2025-01-22