Z-0393-2012

Kotex Natural Balance Security tampons, regular absorbency, unscented. packaged in 18 count or 36 count...

Name: Z-0393-2012 Kotex Natural Balance Security tampons, regular absorbency, unscented. packaged in 18 count or 36 count...
Creator: Kimberly-Clark Corporation
Published: 2011-11-03
License: https://open.fda.gov/license/

Kimberly-Clark Corporation / initiated 2011-11-03 / Terminated / root cause: manufacturing process

FDA source

Kimberly-Clark Corporation began a recall of Kotex Natural Balance Security tampons, regular absorbency, unscented. packaged in 18 count or 36 count retail containers. Consumer Services, Kimberly-Clark... on 2011-11-03. The reason FDA records is "A limited number of Kotex Natural Balance Security Unscented Tampons, regular absorbency, are being recalled after a raw material contaminated with a bacterium, Enterobacter sakazakii, was found when testing the plunger...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0393-2012
Status: Terminated
Initiated: 2011-11-03
Posted: 2012-01-11
Terminated: 2012-12-13
Recalling firm: Kimberly-Clark Corporation
Product: Kotex Natural Balance Security tampons, regular absorbency, unscented. packaged in 18 count or 36 count retail containers. Consumer Services, Kimberly-Clark Corp. Dept. KNBTR-18, P.O. Box 2020, Neenah, WI 54957-2020 USA. To absorb menstrual or other vaginal discharge.
Product code: HEB Tampon, Menstrual, Unscented
Reason for recall: A limited number of Kotex Natural Balance Security Unscented Tampons, regular absorbency, are being recalled after a raw material contaminated with a bacterium, Enterobacter sakazakii, was found when testing the plunger portion of the applicator.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Kimberly-Clark sent an Urgent Product Recall letter, dated 11/09/2011, via FedEx to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify, quarantine, and discontinue use immediately. Customers were asked to complete the response form and fax to +1 (920) 380-6467. A Kimberly-Clark representative would contact them regarding return of the product, replenishement and/or account credit. For questions regarding this recall call +1 (920) 216-8152.
Quantity in commerce: 1400 Cases (216 tampons per case)
Distribution: Nationwide Distribution
Product codes and lots: Lot numbers (found in the red box located on bottom of package): 18-count: AC129321X, AC129421X, AC129521X, AC129621X, AC129721X, AC129821X, AC129921X 36 count: AC129325X, AC129425X, AC129525X, AC129625X, AC129725X, AC129825X, AC129925X

Product code HEB

K896994Class IIKotex Security Tampons (Several Type)Kimberly-Clark Corp. / cleared 1989-12-22

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)