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
ReasonThe products' cut, coagulate, or blend function may not operate with the use of the Foot Pedal.
ProductLEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120
Quantity358
DistributionNationwide domestic distribution. International distribution to Canada and Costa Rica.
Initiated2019-06-18
Classified2019-07-23
Terminated2020-06-15
Recall numberZ-2057-2019
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-2057-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83100/

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