FDA Medical Device Recalls (openFDA)
BioMed Laboratories: Safen' simple Ostomy Appliance Deodorant (8 oz , 1 oz package sizes)
- Recall number
- Z-2428-2010
- Recalling firm
- BioMed Laboratories
- Product
- Safen' simple Ostomy Appliance Deodorant (8 oz , 1 oz package sizes)
- Status
- Terminated
- Initiated
- 2010-08-16
- Posted
- 2010-09-17
- Terminated
- 2011-01-24
- Reason
- The product may contain the mold Aspergillus ssp.
- Root cause
- Material/Component Contamination
- Action
- Biomed Laboratories, Inc. of Garland, TX is conducting a recall of the Reliamed Odor Eliminator Drops, Securi-T Ostomy Deodorant, and the Safe n' Simple (Sn'S) Ostomy Appliance Deodorant. Lots being recalled were distributed between June 9, 2009 though June 28, 2010. Biomed will work with their 3 consignees to inform sub-distributors and down to any firm that keeps the product in stock to have the product removed from further distribution and returned. If there are any questions or concerns, please contact Biomed Laboratories, Inc. at (972) 282-8008 or email them at biomedlabs.net.
- Quantity
- 22,253 (18,060 8oz bottles. 4,193 1oz bottles)
- Distribution
- OH, FL, MI
- Lot, serial or model codes
- Safe n Simple (SnS) Ostomy Appliance Deodorant, 8 oz Part # SNS40208, UPS Code 40208 Lots H09001, N09011, N09015, M09020, N09016. Safe n Simple (SnS) Ostomy Appliance Deodorant, 1 oz Lots H09001.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GDS
- Firm FEI
- 3006784948
- Firm city
- Garland
- Firm state
- TX
- 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