FDA Medical Device Recalls (openFDA)
Reckitt Benckiser LLC: Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 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-3241-2018
- Recalling firm
- Reckitt Benckiser LLC
- Product
- Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 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
- 2018-07-23
- Posted
- not on file
- Terminated
- 2020-03-05
- Reason
- The products failed the filed specification of 1.0kPa for Burst Pressure.
- Root cause
- Under Investigation by firm
- Action
- On 7/23/18, an Urgent Medical Device Recall notification letter was distributed to customers. The letter instructed customers to do the following: 1. Examine your inventory in your distribution center immediately to determine if you have the specified batch in your warehouse inventory. 2. Segregate and quarantine the specified batch. 3. If you have product of the specified batch, contact our Stericycle representative immediately for a RETURN AUTHORIZATION number. a. Contact Information: Phone: 877-448-5308 Fax: 877-884-9410 4. Contact Stericycle Expert Solutions at 877-448-5308 for assistance with coordination of pickup and removal of product from your facility. If arranging pick up of product, freight will be prepaid by Stericycle. A pre-paid return label has been included for your convenience. Alternatively, you may arrange shipment of product directly to Stericycle at the following address: Attn: Event 4241 2670 Executive Drive, Suite A Indianapolis, IN 46241 Dock Hours are SAM -4:30PM Monday- Friday Please call to schedule a dock appointment 5. Finally, notify Stericycle representative via email RB4241@stericycle.com that you have: a. Checked your inventory in your distribution centers and confirm you have NO product of the specified batch b. You have collected all units in your inventory and product has been shipped back in accordance with the instructions from your Stericycle representative. On 7/26/18, a second Urgent Medical Device Recall notification letter was sent to customers which included two additional batches included in the recall. This letter included the same customer instructions as the 7/23/18 letter.
- Quantity
- 487980 condoms
- Distribution
- US Nationwide.
- Lot, serial or model codes
- Batch Numbers: 1000427177, 1000408620, 1000430764
- 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