Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

NOVADAQ SPY-PHI Drape Recalled by NOVADAQ TECHNOLOGIES INC. Due to The sterile drape material may contain a pinhole...

Date: June 27, 2017
Company: NOVADAQ TECHNOLOGIES INC.
Status: Terminated
Source: FDA (Device)

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 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.

Quantity: 3/20-drape boxes

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.

Affected (51 states)Not affected

About NOVADAQ TECHNOLOGIES INC.

NOVADAQ TECHNOLOGIES INC. has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report