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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89691

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

Open FDA event record

Event summary

Timeline bucket
February 19, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Ansell Healthcare Products 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

Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2

Z-0838-2022
Recall number
Z-0838-2022
Initiated
February 19, 2022
Classification
Class II
Status
Ongoing
Quantity
74 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Transport company failed to stop at the border for required FDA inspection.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Transport company failed to stop at the border for required FDA inspection.

Code information

Model Number: 20685275 UDI Code: 00884792385244 Lot Number: 2107481604

Distribution pattern

U.S.: AZ, CA, NV, TX, UT and WA O.U.S.: None