FDA Medical Device Recalls (openFDA)
Kimberly-Clark Corporation: 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.
- Recall number
- Z-0393-2012
- 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.
- Status
- Terminated
- Initiated
- 2011-11-03
- Posted
- 2012-01-11
- Terminated
- 2012-12-13
- Reason
- 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
- 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
- 1400 Cases (216 tampons per case)
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K896994"]
- PMA numbers
- not on file
- Product code
- HEB
- Firm FEI
- 1000015879
- Firm city
- Roswell
- Firm state
- GA
- 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