Z-0470-2015Class III

Non-sterile drape

Name: Z-0470-2015 Non-sterile drape
Creator: Novadaq Technologies, Inc.
Published: 2014-11-04
License: https://open.fda.gov/license/

Novadaq Technologies ULC / initiated 2014-11-04 / Terminated / root cause: labeling and UDI

FDA source

Novadaq Technologies, Inc. began a recall of Non-sterile drape on 2014-11-04. FDA classified it as Class III and gives the reason as "Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0470-2015
Classification: Class III
Status: Terminated
Initiated: 2014-11-04
Posted: 2014-12-01
Terminated: 2015-11-06
Recalling firm: Novadaq Technologies ULC
Product: Non-sterile drape
Product code: IZI System, X-Ray, Angiographic
Reason for recall: Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Novadaq initiated their recall by telephone and followed by an email and a Medical Device Recall Notice dated November 11, 2014, to all affected customers. Distributors were instructed to notify their customers. The firm is removing the recalled products and replacing them with correctly labeled product. Customers were instructed to confirm receipt of the Recall Notice and their understanding of the actions to be taken by completing the attached confirmation form and faxing it to Novadaq Quality Department at 1-800-886-2419. For questions regarding this recall call 604-432-9861.
Quantity in commerce: 324 units
Distribution: Nationwide Distribution to IA, LA, GA, MD, ID, FL, TN, OH, TX, NC, MA, KY, KS, WI, IN, SC, OR, CT, CA, WA, PA, OK, and PR.
Product codes and lots: Kit Lot Numbers: 14082, 14091, 14104, 14106 Drape Lot Numbers: D132712, D133102, D141022, D130282

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0470-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0469-2015	Class III	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-26
Z-0470-2015	Class III	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-26

Product code IZI

K071619Class IISpy Fluorescent Imaging SystemNovadaq Technologies, Inc. / cleared 2007-11-09

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)