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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80232

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 18, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Safe N Simple, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807

Z-2330-2018
Recall number
Z-2330-2018
Initiated
June 18, 2012
Classification
Class II
Status
Terminated
Recalling firm
Safe N Simple, LLC
Quantity
17592

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
bacterial contamination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The 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.

Code information

20120115.

Distribution pattern

Distributors in CA, FL, OH, MI, NJ, NY, PA, TX, and VA.