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
ReasonIncorrect size printed on the Milex Pessary Kit packaging label
ProductCooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02
Quantity95 units
DistributionNationwide Distribution
Initiated2015-02-09
Classified2015-03-03
Terminated2016-01-15
Recall numberZ-1239-2015
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-1239-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70502/

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