FDA Medical Device Recalls (openFDA)
Reckitt Benckiser LLC: 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).
- Recall number
- Z-0091-2019
- 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).
- Status
- Terminated
- Initiated
- 2018-08-06
- Posted
- not on file
- Terminated
- 2019-11-12
- Reason
- 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
- 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
- 34 cartons/12 condoms each (408 condoms total)
- Distribution
- US in the states of NY
- Lot, serial or model codes
- Lot Number - 1000490884
- 510(k) numbers
- ["K072169"]
- PMA numbers
- not on file
- Product code
- MOL
- Firm FEI
- 3011015568
- Firm city
- Parsippany
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28