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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62577

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

Open FDA event record

Event summary

Timeline bucket
December 31, 2010
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Kimberly-Clark Corporation

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

ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

Z-2425-2012
Recall number
Z-2425-2012
Initiated
December 31, 2010
Classification
Class III
Status
Terminated
Quantity
32 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The impacted product was not intended for commercial distribution to end users.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The impacted product was not intended for commercial distribution to end users.

Code information

Product Code: 95221-35, Unit Code: 90372

Distribution pattern

US (nationwide) including the states of CA, CO, LA, NM, OK, TX and WA.