FDA Medical Device Recalls (openFDA)
Novadaq Technologies, Inc.: Non-sterile drape
- Recall number
- Z-0470-2015
- Recalling firm
- Novadaq Technologies, Inc.
- Product
- Non-sterile drape
- Status
- Terminated
- Initiated
- 2014-11-04
- Posted
- 2014-12-01
- Terminated
- 2015-11-06
- Reason
- Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.
- 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
- 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.
- Lot, serial or model codes
- Kit Lot Numbers: 14082, 14091, 14104, 14106 Drape Lot Numbers: D132712, D133102, D141022, D130282
- 510(k) numbers
- ["K071619"]
- PMA numbers
- not on file
- Product code
- IZI
- Firm FEI
- 3008177327
- Firm city
- Canada
- Firm state
- British Columbia
- 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