CLASS II Device recall · Reported 4 Oct 2017 · FDA Enforcement Report

Novadaq Spy-phi Drape, 7" x 104" recalled by Novadaq Technologies

Novadaq Technologies is recalling Novadaq Spy-phi Drape, 7" x 104", distributed nationwide in the US. The recall was initiated on 27 Jun 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots #1703291, #1704141, and #1704101

Quantity recalled3/20-drape boxes

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-3236-2017
FDA event ID: 77901
Recalling firm: Novadaq Technologies, Burnaby, N/A
Classification: Class II
Status: Terminated
Recall initiated: 27 Jun 2017
FDA classified: 28 Sep 2017
Reported: 4 Oct 2017
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Device type: Other Medical Devices

Timeline

27 Jun 2017	Recall initiated by company
28 Sep 2017	Classified by FDA	+93 days
4 Oct 2017	Published in enforcement report	+6 days

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

Reason for recall

The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020 (box of 20 HH2000 drapes), Sterile, Rx.. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.

Where it was distributed

Worldwide Distribution. US (nationwide) to states of: CA, CO, ID, IL, NY, OR, and VA; and countries of: Canada, Belgium, and Lithuania.

Nationwide California Colorado Idaho Illinois New York Oregon Virginia

Questions about this recall

Is Novadaq Spy-phi Drape, 7" x 104" recalled?

Yes. Novadaq Technologies recalled Novadaq Spy-phi Drape, 7" x 104" on 27 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-3236-2017.

Why was it recalled?

The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.

Which lots are affected?

Lots #1703291, #1704141, and #1704101

Where was it sold?

Worldwide Distribution. US (nationwide) to states of: CA, CO, ID, IL, NY, OR, and VA; and countries of: Canada, Belgium, and Lithuania.

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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.

More recalls from Novadaq Technologies

All 7

Reported	Class	Recall	Company	Reason	Where
4 Oct 2017Device	CLASS II	Novadaq Spy-phi Paq Intended for use recalled by Novadaq Technologies	Novadaq Technologies	Sterility	Nationwide
4 Oct 2017Device	CLASS II	Novadaq Spy-phi Drape, 7" x 104" recalled by Novadaq Technologies	Novadaq Technologies	Sterility	Nationwide
14 Sep 2016Device	CLASS II	Sterile Drape, SK6000 PAQ drape pouch (for use recalled	Novadaq Technologies	Sterility	FL, MI, VA
9 Mar 2016Device	CLASS II	Pinpoint Endoscopic Fluorescence Imaging System recalled	Novadaq Technologies	Sterility	Nationwide
3 Dec 2014Device	CLASS III	Non-sterile drape recalled by Novadaq Technologies	Novadaq Technologies	Labeling Errors	Nationwide

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