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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64246

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

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Event summary

Timeline bucket
January 14, 2013
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

LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections).

Z-0838-2013
Recall number
Z-0838-2013
Initiated
January 14, 2013
Classification
Class II
Status
Terminated
Quantity
469,134 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condom (regular) product. The condom has met or exceeded test and quality standards required by the Food and Drug Administration. However, we are experiencing a number of complaints concerning the difficulty in unrolling and subsequent breakage, and so we are asking to have all products returned.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condom (regular) product. The condom has met or exceeded test and quality standards required by the Food and Drug Administration. However, we are experiencing a number of complaints concerning the difficulty in unrolling and subsequent breakage, and so we are asking to have all products returned.

Code information

Zero Regular 10-Ct: SKU# 0-70907-20510-5 Master Case: 30070907205106.

Distribution pattern

.Nationwide Distribution including the states of AL, AZ, CA, CO, DE, FL, GA, IA, IN, IL, KS, KY, LA, MI, MN, MO.MS, NC, NH, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, WI and UT.