CLASS III Device recall · Reported 3 Dec 2014 · FDA Enforcement Report

LUNA Chest recalled by Novadaq Technologies

Novadaq Technologies is recalling LUNA Chest, distributed nationwide in the US. The recall was initiated on 4 Nov 2014 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesKit Lot Numbers: 13116, 14012, 14017, 14056, 14074, 14103, 14107 Drape Lot Numbers: D132172, D132602, D162692, D132602, D132712, D141002, D130282

Quantity recalled828 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0469-2015
FDA event ID: 69839
Recalling firm: Novadaq Technologies, Richmond, British Co
Classification: Class III
Status: Terminated
Recall initiated: 4 Nov 2014
FDA classified: 26 Nov 2014
Reported: 3 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

4 Nov 2014	Recall initiated by company
26 Nov 2014	Classified by FDA	+22 days
3 Dec 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.

Product as listed by the FDA

LUNA Chest, Model No. LU4006

Where it was distributed

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.

Nationwide California Connecticut Florida Georgia Iowa Idaho Indiana Kansas Kentucky Louisiana Massachusetts Maryland North Carolina Ohio Oklahoma Oregon Pennsylvania Puerto Rico South Carolina Tennessee

Questions about this recall

Is LUNA Chest recalled?

Yes. Novadaq Technologies recalled LUNA Chest on 4 Nov 2014. The recall is Class III and its status is Terminated. Recall number Z-0469-2015.

Why was it recalled?

Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label.

Which lots are affected?

Kit Lot Numbers: 13116, 14012, 14017, 14056, 14074, 14103, 14107 Drape Lot Numbers: D132172, D132602, D162692, D132602, D132712, D141002, D130282

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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