FDA Medical Device Recalls (openFDA)
WNCK, Inc: 0.10% BreathScan Alcohol Detector manufactured for WNCK, Inc., The Woodlands, TX by Howard Industries, Inc., Columbus, OH (crystals) and James Alexander Corp., Blairstown, NJ (general device assembly). Product sold in bulk and individually packaged. Bulk product (500-1000 units) distributed in unlabeled clear plastic bags. Individually packaged product packaged and sealed in clear plastic bags with labeling and sold in boxes containing 100 units/box.
- Recall number
- Z-0323-06
- Recalling firm
- WNCK, Inc
- Product
- 0.10% BreathScan Alcohol Detector manufactured for WNCK, Inc., The Woodlands, TX by Howard Industries, Inc., Columbus, OH (crystals) and James Alexander Corp., Blairstown, NJ (general device assembly). Product sold in bulk and individually packaged. Bulk product (500-1000 units) distributed in unlabeled clear plastic bags. Individually packaged product packaged and sealed in clear plastic bags with labeling and sold in boxes containing 100 units/box.
- Status
- Terminated
- Initiated
- 2005-11-30
- Posted
- 2005-12-23
- Terminated
- 2007-04-25
- Reason
- Device marketed without 510(k) as required; 0.10% BreathScan Alcohol Detector turning positive with breath alcohol samples 50% below the test cutoff.
- Root cause
- Other
- Action
- The firm initiated recall on 11/29/05 via letter to all distributor consignees.
- Quantity
- 126,552 total units.
- Distribution
- Nationwide; product distributed to distributors, retailers and consumers/users in CA, CO, FL, LA, MN, MS, NY, OH, PA, TN, TX, VA, WA. Product also distributed to Markham, Ontario, Canada and Kfar Saba, Israel.
- Lot, serial or model codes
- D121898
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DJZ
- Firm FEI
- 3004057121
- Firm city
- The Woodlands
- 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