NOVADAQ TECHNOLOGIES INC.: Medical Device Recall in 2017 - (Recall #: Z-3235-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as single-use drug components, Manufactured for and Distributed by Novadaq Technologies Inc., Burnaby, BC, Canada, Assembled by Carestream Health, Inc., Rochester, NY. 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.

Product Classification:

Class II

Date Initiated: June 27, 2017

Date Posted: October 4, 2017

Recall Number: Z-3235-2017

Event ID: 77901

Reason for Recall:

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

Status: Terminated

Product Quantity: 16/6-drape kits

Code Information:

PAQ lot #1704B containing drape lot #1703251; PAQ lot #1704F containing drape lot #1703291; and PAQ lot #17046 containing drape lot #1703251.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated