Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System Recalled by NOVADAQ TECHNOLOGIES INC. Due to The sterile drape material may contain a pinhole...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact NOVADAQ TECHNOLOGIES INC. directly.
Affected Products
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.
Quantity: 16/6-drape kits
Why Was This Recalled?
The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About NOVADAQ TECHNOLOGIES INC.
NOVADAQ TECHNOLOGIES INC. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report