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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81964

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

Open FDA event record

Event summary

Timeline bucket
December 19, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Reckitt Benckiser 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

Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-95767-00 02340-89456-14 02340-89457-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-89455-00 02340-95767-00 02340-95767-00

Z-0993-2019
Recall number
Z-0993-2019
Initiated
December 19, 2018
Classification
Class II
Status
Terminated
Recalling firm
Reckitt Benckiser LLC
Quantity
1761044

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.

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

Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.

Code information

1000314778 1000289702 1000322841 1000329839 1000317735 1000323210 1000318792 1000170515 1000240186 1000378288 1000183941 1000350794 1000270527 1000277098

Distribution pattern

Nationwide domestic distribution. Foreign distribution to Barbados, Jamaica, Aruba, Guyana, Haiti, and St Maarten.

device · product 2 of 2

Durex Pleasure Pack (60 ct), synthetic polisoprene male condom, SKU 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00 02340-98729-00

Z-0994-2019
Recall number
Z-0994-2019
Initiated
December 19, 2018
Classification
Class II
Status
Terminated
Recalling firm
Reckitt Benckiser LLC
Quantity
34920

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.

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

Five batches of the product have failed the specification of 1.0kPa for Burst Pressure.

Code information

WO00905865 WO00905864 WO00901945 WO00900899 WO00900900 WO00900901

Distribution pattern

Nationwide domestic distribution. Foreign distribution to Barbados, Jamaica, Aruba, Guyana, Haiti, and St Maarten.