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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62919

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

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Event summary

Timeline bucket
June 01, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Advanced Sterilization Products

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

CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection.

Z-2276-2012
Recall number
Z-2276-2012
Initiated
June 01, 2012
Classification
Class II
Status
Terminated
Quantity
1,310,844 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
missing labels

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The recall was initiated because Advanced Sterilization Products has discovered instances of missing labels on bottles of CIDEX OPA Solution, Part # 20390 manufactured between May 2011 and April 2012.

Code information

Product codes: 20390 (US).

Distribution pattern

Nationwide (USA) and Puerto Rico.