Z-1904-2009

ConceiveEase (TM), Fertility Friendly Lubricant, Reproductive Lab, Memphis, TN

Name: Z-1904-2009 ConceiveEase (TM), Fertility Friendly Lubricant, Reproductive Lab, Memphis, TN
Creator: Memphis Fertility Laboratory Inc
Published: 2009-07-10
License: https://open.fda.gov/license/

Memphis Fertility Laboratory Inc / initiated 2009-07-10 / Terminated

FDA source

Memphis Fertility Laboratory Inc began a recall of ConceiveEase (TM), Fertility Friendly Lubricant, Reproductive Lab, Memphis, TN Intended Use: Personal Lubricant on 2009-07-10. The reason FDA records is "Product was marketed without a 510(k)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1904-2009
Status: Terminated
Initiated: 2009-07-10
Posted: 2009-08-27
Terminated: 2009-10-05
Recalling firm: Memphis Fertility Laboratory Inc
Product: ConceiveEase (TM), Fertility Friendly Lubricant, Reproductive Lab, Memphis, TN Intended Use: Personal Lubricant.
Product code: NUC Lubricant, Personal
Reason for recall: Product was marketed without a 510(k).
FDA 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 in commerce: 800 units
Distribution: Nationwide Distribution -- USA, including the state of MA.
Product codes and lots: lot: WK0608

Product code NUC

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)