Novadaq Technologies, Inc. LUNA Chest, Model No. LU4006 Recall
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LUNA Chest, Model No. LU4006
Brand
Novadaq Technologies, Inc.
Lot Codes / Batch Numbers
Kit Lot Numbers: 13116, 14012, 14017, 14056, 14074, 14103, 14107 Drape Lot Numbers: D132172, D132602, D162692, D132602, D132712, D141002, D130282
Products Sold
Kit Lot Numbers: 13116, 14012, 14017, 14056, 14074, 14103, 14107 Drape Lot Numbers: D132172, D132602, D162692, D132602, D132712, D141002, D130282
Novadaq Technologies, Inc. is recalling LUNA Chest, Model No. LU4006 due to Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026