Z-2339-2012Class II

Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The...

Name: Z-2339-2012 Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The...
Creator: Intuitive Surgical, Inc.
Published: 2012-08-09
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2012-08-09 / Terminated / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of the Tip Cover Accessory is to provide... on 2012-08-09. FDA classified it as Class II and gives the reason as "There is potential for the sterility of the product to be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2339-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-09
Posted: 2012-09-10
Terminated: 2012-12-31
Recalling firm: Intuitive Surgical, Inc.
Product: Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of the Tip Cover Accessory is to provide dielectric insulation over a section of the Monopolar Curved Scissor instrument so that RF energy is only available at the scissor blades. The Monopolar Curved Scissors are intended for endoscopic manipulation of tissue, including: cutting, blunt and sharp dissection, electrocautery. This accessory is to be used with the Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Models IS1200, 12000, ISSOQO).
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: There is potential for the sterility of the product to be compromised.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Intuitive Surgical sent a "MEDICAL DEVICE CORRECTION" letter dated August 9, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. An Acknowledgement Form was included for customers to complete and return via fax to (408) 716-3040. Contact Customer Service at 1-800-876-1310 for questions regarding this recall.
Quantity in commerce: 11,121 Boxes
Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Canada, and Lebanon
Product codes and lots: Model No. 400180-12 Lot No: M10120601 M10120430 M10120329 M10120312 M10111214 M10120516 M10120426 M10120321 M10120208 M10111208 M10120510 M10120419 M10120317 M10120207 M10111201 M10120507 M10120413 M10120315 M10120130 M10111028

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2339-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2339-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-10

Product code NAY

K112263Class IIMonopolar Curved Scissors Tip Cover AccessoryIntuitive Surgical, Inc. / cleared 2011-10-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)