FDA Medical Device Recalls (openFDA)
Hardy Media Inc Dba Hardy Diag: BHI Agar with Vancomycin, for in vitro diagnostic use. Catalog # G14, Lot# 06136
- Recall number
- Z-1451-06
- Recalling firm
- Hardy Media Inc Dba Hardy Diag
- Product
- BHI Agar with Vancomycin, for in vitro diagnostic use. Catalog # G14, Lot# 06136
- Status
- Terminated
- Initiated
- 2006-06-27
- Posted
- 2006-08-29
- Terminated
- 2011-06-14
- Reason
- This recall is being conducted due to the performance failure nearing the end of the product shelf life.
- Root cause
- Other
- Action
- Customers were first notified by phone on 6/28/06, then all customers were faxed and mailed a signed recall letter via first class mail.
- Quantity
- 860 plates
- Distribution
- Nationwide in AZ, CA, IA, ID, MI, MT, NC, & WY. Plus: Puerto Rico
- Lot, serial or model codes
- Lot# 06136
- 510(k) numbers
- ["K964560"]
- PMA numbers
- not on file
- Product code
- JSO
- Firm FEI
- 2022807
- Firm city
- Santa Maria
- Firm state
- CA
- 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