RegWardenFDA facility compliance records
Recall

Class II — CooperSurgical, Inc.

Recalling firmCOOPERSURGICAL, INC.
Registered facilityView this company's 6 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonPotential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot pedal is used for activation.
ProductQuantam 2000 Electrosurgical Generator, Part number 909075-05W.
Quantity4
DistributionUS: AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, LA, MA, ME, Ml, MT, ND, NJ, NV, NY, OK, PA, SC, SD, TN, TX, UT, VA, WA, & WV. International: China, Indonesia, South Africa, & Tanzania.
Initiated2019-10-16
Classified2019-12-05
Terminated2020-06-30
Recall numberZ-0602-2020
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — CooperSurgical, Inc. (Z-0602-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84132/

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