FDA Medical Device Recalls (openFDA)
Memphis Fertility Laboratory Inc: ConceiveEase (TM), Fertility Friendly Lubricant, Reproductive Lab, Memphis, TN Intended Use: Personal Lubricant.
- Recall number
- Z-1904-2009
- Recalling firm
- Memphis Fertility Laboratory Inc
- Product
- ConceiveEase (TM), Fertility Friendly Lubricant, Reproductive Lab, Memphis, TN Intended Use: Personal Lubricant.
- Status
- Terminated
- Initiated
- 2009-07-10
- Posted
- 2009-08-27
- Terminated
- 2009-10-05
- Reason
- Product was marketed without a 510(k).
- Root cause
- PMA
- Action
- The firm notified its sole consignee on 07/10/2009 by telephone and followed by an Urgent Medical Device Recall letter. The letter requested that they examine their inventory and quarantine all products subject to recall and immediately contact Dr. William Kutteh for return instructions. The enclosed response form should be completed and returned. Questions should be directed to Dr. Kutteh at 901-261-2401.
- Quantity
- 800 units
- Distribution
- Nationwide Distribution -- USA, including the state of MA.
- Lot, serial or model codes
- lot: WK0608
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NUC
- Firm FEI
- 3005682148
- Firm city
- Memphis
- Firm state
- TN
- 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