Z-0717-2013Class II

Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavors and...

Name: Z-0717-2013 Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavors and...
Creator: Ansell Healthcare Products LLC
Published: 2012-11-05
License: https://open.fda.gov/license/

Ansell Healthcare Products LLC / initiated 2012-11-05 / Terminated / root cause: packaging

FDA source

Ansell Healthcare Products LLC began a recall of Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Thryll, Thyn, and Ultra Thin. UPC... on 2012-11-05. FDA classified it as Class II and gives the reason as "One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0717-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-05
Posted: 2013-01-24
Terminated: 2013-07-31
Recalling firm: Ansell Healthcare Products LLC
Product: Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Thryll, Thyn, and Ultra Thin. UPC 0-70907-02625-0.
Product code: HIS Condom
Reason for recall: One lot of Lifestyles Pleasure Collection Lubricated Condoms is misbranded. Ultra Thin was included rather than Skyn.
Root cause tag: packaging
FDA root cause: Packaging
Action: Ansell Healthcare Products LLC sent an "URGENT: VOLUNTARY CONDOM RECALL" letter/return response form dated November 5, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm's Customer Service Department at 1-800-305-1054 for questions or if additional information is needed.
Quantity in commerce: 445 cases (10680 consumer units)
Distribution: Nationwide Distribution.
Product codes and lots: Lot Code: 120921021C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0717-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0717-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-30	2013-01-24

Product code HIS

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)