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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86352

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

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Event summary

Timeline bucket
August 19, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
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

MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner s hand or finger to prevent contamination between patient and examiner.

Z-0051-2021
Recall number
Z-0051-2021
Initiated
August 19, 2020
Classification
Class II
Status
Terminated
Quantity
1312 Cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Examination gloves were shipped inadvertently, without to verify barrier integrity.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Examination gloves were shipped inadvertently, without to verify barrier integrity.

Code information

Lot: 2003LG, Batch: 20035314LG

Distribution pattern

U.S. Nationwide distribution including in the states of IL, OK, WI, PA, TX, OH, MI, IN, VA, AR, KS, MO, NV, OR, FL, QC, NJ, NE, KY, AL, TN, LA, NY, SC, MS, MD, CA, GA, SD.

Field note

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