Intuitive Surgical, Inc.
46 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Intuitive Surgical, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-03-19FDA-DeviceClass IIBrand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to HHE for additional details. Component: N/A
Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed
- 2025-01-22FDA-DeviceClass II8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
- 2025-01-22FDA-DeviceClass II8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.
Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments
- 2025-01-22FDA-DeviceClass II8MM,FORCE BIPOLAR,IS4000 REF 471405
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,MEGA SUTURECUT ND,IS4000 REF 471309
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,COBRA GRASPER,IS4000 REF 471190
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,PROGRASP FORCEPS,IS4000 REF 471093
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,CADIERE FORCEPS,IS4000 REF 471049
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,LONG TIP FORCEPS,IS4000 REF 471048
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,FORCE BIPOLAR,IS4000 REF 470405
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 470347
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 470344
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 470327
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 470296
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 470230
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,TENACULUM FORCEPS,IS4000¿ REF 470207
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
- 2025-01-22FDA-DeviceClass II8MM,RESANO FORCEPS,IS4000 ¿ REF 470181
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
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