RegWardenFDA facility compliance records
Recall

Class II — CooperVision Inc.

Recalling firmCOOPERVISION, INC.
Registered facilityView this company's 14 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonLots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date.
ProductPro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA daily use disposable contact lenses
Quantity153 cartons
DistributionWorldwide Distribution - USA (nationwide) and the countries of Aruba, Canada, Colombia and Trinidad.
Initiated2013-11-20
Classified2013-12-19
Terminated2015-07-22
Recall numberZ-0542-2014
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 — CooperVision Inc. (Z-0542-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66844/

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