Intuitive Surgical Recalls 8mm Maryland Bipolar Forceps Due to Cautery Plug Defect
Intuitive Surgical is recalling 8mm Maryland Bipolar Forceps used with the da Vinci Surgical System because the cautery plug insert may dislodge, preventing proper cable connection and causing loss of cautery function.
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: The recall is classified as FDA Class II. The hazard involves a functional failure (loss of cautery) in a surgical instrument, which poses a risk of harm during a procedure, but the source text does not report specific injuries or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Intuitive Surgical, Inc. is recalling 8mm Maryland Bipolar Forceps (Model 400172-08) used in conjunction with the da Vinci Surgical System, Model IS1200. The recall involves 697 units of these multiple use electrosurgical endoscopic instruments.
The recall was initiated due to reports of the Cautery Plug Insert dislodging from the Cautery Plug Riser. This defect prevents a bipolar cautery cable from being properly connected, which results in the loss of cautery function for the bipolar instruments.
The affected products were distributed worldwide, including nationwide in the United States and in various countries such as Austria, Australia, Belgium, Canada, and others. Specific lot numbers are listed in the recall documentation. Users of these instruments should stop using the affected units and contact Intuitive Surgical for further instructions.
The recalled product
- Product
- 8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 697
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model number: 400172-08
Distribution
Part of a larger recall action
This product is one of 3 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 3 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 · functional failure
See all →- HighAccuVu Angiographic Catheter, Omni Flush, Non-Braided Defect Recall
FDA (Devices) · 2026-04-29
- HighSoftware Malfunction Disables Back Control on Baxter TruSystem 7500
FDA (Devices) · 2025-04-02
- HighBaxter TruSystem 7500 Hybrid software issue disables upper back adjustment
FDA (Devices) · 2025-04-02
- SevereCardiac catheters recalled due to polyurethane layer delamination defects
FDA (Devices) · 2024-05-22
- HighBard PreVent Anti-Reflux Filter with ENFit Recall for Reduced Suction
FDA (Devices) · 2024-01-31