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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93045

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 03, 2023
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

2 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 2

GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290

Z-0096-2024
Recall number
Z-0096-2024
Initiated
August 03, 2023
Classification
Class II
Status
Ongoing
Quantity
1511

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some surgical glove sterile pouches were not completely sealed.

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

Some surgical glove sterile pouches were not completely sealed.

Code information

Lot: 2203434204, REF/UDI-DI: 20685255/00884792385206, 20685260/00884792385213, 20685265/00884792385220, 20685270/00884792385237, 20685275/00884792385244, 20685280 00884792385251, 20685285 00884792385268, 20685290 00884792385275.

Distribution pattern

Worldwide - US Nationwide distribution in the states of IN, OH, NY, VA, IL, TN, GA, NY, SC, WI, FL and the country of CA.

device · product 2 of 2

NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290

Z-0097-2024
Recall number
Z-0097-2024
Initiated
August 03, 2023
Classification
Class II
Status
Ongoing
Quantity
378

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some surgical glove sterile pouches were not completely sealed.

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

Some surgical glove sterile pouches were not completely sealed.

Code information

Lot: 2203434604, REF/UDI-DI: V20685255/10014566400553, V20685260/10014566400607, V20685265/10014566400652, V20685270/10014566400706, V20685275/10014566400751, V20685280/10014566400805, V20685285/10014566400850, V20685290/10014566400904.

Distribution pattern

Worldwide - US Nationwide distribution in the states of IN, OH, NY, VA, IL, TN, GA, NY, SC, WI, FL and the country of CA.