Z-0091-2019Class II

Polyisoprene condomns

Name: Z-0091-2019 Polyisoprene condomns
Creator: Reckitt Benckiser LLC
Published: 2018-08-06
License: https://open.fda.gov/license/

Reckitt Benckiser LLC / initiated 2018-08-06 / Terminated / root cause: manufacturing process

FDA source

Reckitt Benckiser LLC began a recall of Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent... on 2018-08-06. FDA classified it as Class II and gives the reason as "Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0091-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-06
Posted: 2018-10-10
Terminated: 2019-11-12
Recalling firm: Reckitt Benckiser LLC
Product: Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
Product code: MOL Condom, Synthetic
Reason for recall: Product marketed in U.S. does not have sufficient data to ensure that it will meet the internal burst pressure specifications at the end of 5 yrs shelf-life
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On August 6,. 2018, Reckitt Benckiser issued Urgent Medical Device Recall notices to customers. Customers were advised to take the following action: Wholesale Customers: 1. Examine inventory and quarantine affected product 2. Contact customers and notify them of the recall and provide them with the recall instructions (copy of the letter). 3. Customers are encouraged to contact Stericycle Expert Solutions at 877-448-5308 for assistance if additional return labels are required or help with coordination of pickup and removal of product from your facility.
Quantity in commerce: 34 cartons/12 condoms each (408 condoms total)
Distribution: US in the states of NY
Product codes and lots: Lot Number - 1000490884

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0091-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0091-2019	Class II	Terminated	Voluntary: Firm initiated	2018-10-17	2018-10-09

Product code MOL

K072169Class IIDurex Synthetic Polyisoprene Male CondomSsl Americas, Inc. / cleared 2008-06-19

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)