CLASS II Device recall · Reported 5 Jun 2013 · FDA Enforcement Report
Maryland Bipolar Forceps used in conjunction recalled
Intuitive Surgical is recalling Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, distributed nationwide in the US. The recall was initiated on 8 May 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1432-2013
- FDA event ID
- 65194
- Recalling firm
- Intuitive Surgical, Sunnyvale, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 May 2013
- FDA classified
- 29 May 2013
- Reported
- 5 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 8 May 2013 | Recall initiated by company | |
| 29 May 2013 | Classified by FDA | +21 days |
| 5 Jun 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments.
Product as listed by the FDA
8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
Where it was distributed
Worldwide Distribution-USA (nationwide) including the states of AL, CA, CO, FL, IL, KY, MI, MS, NJ, NY, PA, TX, UT, VA, WA, and WI, and the countries of Austria, Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Norway, Qatar, Romania, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Saudi Arabia, Singapore, and Venezuela.
Nationwide AlabamaCaliforniaColoradoFloridaIllinoisKentuckyMichiganMississippiNew JerseyNew YorkPennsylvaniaTexasUtahVirginiaWashingtonWisconsin
Questions about this recall
Why was it recalled?
Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipolar cautery cable from being properly connected which results in loss of cautery function of Bipolar Instruments.
Which lots are affected?
Model number: 400172-08; Lot numbers: M10120815 M10120817 M10120831 M10120913 M10120918 M10121008 M10121024 M10121120 M10121123 M10121203 M10121210 M10121215 M10130220 M10130222 M10130311 M10130315 M10130327 M10130411.
Where was it sold?
Worldwide Distribution-USA (nationwide) including the states of AL, CA, CO, FL, IL, KY, MI, MS, NJ, NY, PA, TX, UT, VA, WA, and WI, and the countries of Austria, Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Norway, Qatar, Romania, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Saudi Arabia, Singapore, and Venezuela.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 65194| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Precise Bipolar Forceps used in conjunction recalled | Intuitive Surgical | Other | Nationwide | |
| CLASS II | Fenestrated Bipolar Forceps used in conjunction recalled | Intuitive Surgical | Other | Nationwide |
More recalls from Intuitive Surgical
All 256| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | da Vinci SP Instrument Arm Drape, SP recalled by Intuitive Surgical | Intuitive Surgical | Other | Nationwide |
| Device | CLASS II | Da Vinci ASSY, PSS, SP1098 recalled by Intuitive Surgical | Intuitive Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Da Vinci 5 Assy,DV5 Tower,IS5000 recalled by Intuitive Surgical | Intuitive Surgical | Device Malfunction | 49 states |
| Device | CLASS I | Intuitive SureForm 30 Gray Reloads Reference Numbers recalled | Intuitive Surgical | Other | 49 states |
| Device | CLASS II | Da Vinci X and Da Vinci Xi da Vinci X, Xi Surgical System recalled | Intuitive Surgical | Device Malfunction | Nationwide |
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