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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86351

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

Open FDA event record

Event summary

Timeline bucket
August 13, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Sobel Westex

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

SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use in patient/healthcare personnel interactions. AAMI Level II isolation gowns are intended for relatively low risk procedures, including blood draws, lab work, or similar.

Z-0281-2021
Recall number
Z-0281-2021
Initiated
August 13, 2020
Classification
Class II
Status
Terminated
Recalling firm
Sobel Westex
Quantity
3,380,850 gowns

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to non-surgical isolation gowns not meeting all performance test requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to non-surgical isolation gowns not meeting all performance test requirements.

Code information

Catalog: HGCR4958.45D-C Batch/Lot Numbers: - 20200405 (293,250 gowns manufactured) - 20200425 (1,054,050 gowns manufactured) - 20200502 (60,000 gowns manufactured) - 20200508 (2,033,550 gowns manufactured)

Distribution pattern

U.S. Nationwide distribution including in the state of TN. O.U.S.: None