RegWardenFDA facility compliance records
Recall

Class II — Southmedic, Inc.

Recalling firmSOUTHMEDIC, INC.
Registered facilitySOUTHMEDIC, INC. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonScalpels lot contains non-sterile products labeled as sterile.
ProductSouthmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.
Quantity3,300 scalpels
DistributionUS Distribution to the states of : IA, IL, NE, NY and TX
Initiated2017-11-06
Classified2018-05-17
Terminated2020-04-02
Recall numberZ-1892-2018
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 — Southmedic, Inc. (Z-1892-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80074/

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