NOVADAQ TECHNOLOGIES INC.: Medical Device Recall in 2017 - (Recall #: Z-3234-2017)

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 Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape), 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.

Product Classification:

Class II

Date Initiated: June 27, 2017

Date Posted: October 4, 2017

Recall Number: Z-3234-2017

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: 6 drapes

Code Information:

Lot number 1704121

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