Z-0323-06

0.10% BreathScan Alcohol Detector manufactured for WNCK, Inc., The Woodlands, TX by Howard Industries, Inc...

Name: Z-0323-06 0.10% BreathScan Alcohol Detector manufactured for WNCK, Inc., The Woodlands, TX by Howard Industries, Inc...
Creator: WNCK, Inc
Published: 2005-11-30
License: https://open.fda.gov/license/

WNCK, Inc / initiated 2005-11-30 / Terminated

FDA source

WNCK, Inc began a recall of 0.10% BreathScan Alcohol Detector manufactured for WNCK, Inc., The Woodlands, TX by Howard Industries, Inc., Columbus, OH (crystals) and James Alexander Corp... on 2005-11-30. The reason FDA records is "Device marketed without 510(k) as required; 0.10% BreathScan Alcohol Detector turning positive with breath alcohol samples 50% below the test cutoff". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0323-06
Status: Terminated
Initiated: 2005-11-30
Posted: 2005-12-23
Terminated: 2007-04-25
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.
Product code: DJZ Devices, Breath Trapping, Alcohol
Reason for recall: Device marketed without 510(k) as required; 0.10% BreathScan Alcohol Detector turning positive with breath alcohol samples 50% below the test cutoff.
FDA root cause: Other
Action: The firm initiated recall on 11/29/05 via letter to all distributor consignees.
Quantity in commerce: 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.
Product codes and lots: D121898

Product code DJZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)