RegWardenFDA facility compliance records
Recall

Class II — Safe N Simple, LLC

Recalling firmSafe N Simple LLC
Registered facilitySAFE N SIMPLE LLC (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonThe firm received a customer complaint of observed spots on the wipes. The manufacturer confirmed that the product had bacterial contamination. This leads to a potential risk of infection.
ProductSafe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807
Quantity17592
DistributionDistributors in CA, FL, OH, MI, NJ, NY, PA, TX, and VA.
Initiated2012-06-18
Classified2018-06-28
Terminated2020-05-28
Recall numberZ-2330-2018
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 — Safe N Simple, LLC (Z-2330-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80232/

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