FDA Medical Device Recalls (openFDA)
Harmony Brands Llc: Lover brand lubricated latex condoms, spermicidal, Nuevo Innovations, Farmingdale, NY ; item number 29043.
- Recall number
- Z-0911-05
- Recalling firm
- Harmony Brands Llc
- Product
- Lover brand lubricated latex condoms, spermicidal, Nuevo Innovations, Farmingdale, NY ; item number 29043.
- Status
- Terminated
- Initiated
- 2005-03-25
- Posted
- 2005-06-21
- Terminated
- 2007-04-17
- Reason
- Lack of assurance of safety and efficacy; products are from unknown sources.
- Root cause
- Other
- Action
- Harmony issued a press release on 3/25/05. Consignees to the retail level were notified by letter beginning on 3/28/05.
- Quantity
- unknown.
- Distribution
- United States .
- Lot, serial or model codes
- All lots.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 3003990373
- Firm city
- Oak Park
- Firm state
- MI
- 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