The Recall Desk

Manufacturer

Novadaq Technologies, Inc.

7 recalls in our database name Novadaq Technologies, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2017-10-04

Of the 7 recalls from Novadaq Technologies, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–7 of 7

  • HighFDA (Devices)·Z-3235-2017·2017-10-04

    Novadaq SPY-PHI PAQ Sterile Drape Recall Due to Pinholes

    Novadaq is recalling SPY-PHI PAQ kits because pinholes in the sterile drape may compromise the sterile barrier. The product is used in medical procedures.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3234-2017·2017-10-04

    Novadaq SPY-PHI Drape Recalled for Potential Sterile Barrier Breach

    Novadaq is recalling SPY-PHI Drapes because pinholes may compromise the sterile barrier. The product is intended for equipment coverage, not patient contact.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3236-2017·2017-10-04

    Novadaq SPY-PHI Drape Recall Due to Potential Sterile Barrier Breach

    Novadaq is recalling SPY-PHI Drapes because pinholes may compromise the sterile barrier. The product is used to cover surgical equipment, not patients.

    Product
    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 th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2767-2016·2016-09-14

    Novadaq Recalls SK6000 PAQ Sterile Drape Pouches Due to Pinhole Defect

    Novadaq is recalling 20 units of SK6000 PAQ sterile drape pouches because pinholes were found in the film material during shipping validation testing.

    Product
    Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular su
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1032-2016·2016-03-09

    Novadaq PINPOINT Endoscopic Imaging System Recalled for Manual Error

    Novadaq is recalling 110 PINPOINT Endoscopic Fluorescence Imaging Systems because the operator's manual lacks validated sterilization parameters for specific components.

    Product
    PINPOINT Endoscopic Fluorescence Imaging System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0470-2015·2014-12-03

    Novadaq Non-Sterile Drape Recalled for Incorrect Sterile Labeling

    Novadaq Technologies is recalling 324 non-sterile LUNA drapes that were inadvertently mislabeled with an additional contents sterile label.

    Product
    Non-sterile drape
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0469-2015·2014-12-03

    Novadaq LUNA Chest Recalled for Sterile Labeling Error

    Novadaq Technologies is recalling 828 LUNA Chest units because non-sterile drapes were inadvertently mislabeled as sterile.

    Product
    LUNA Chest, Model No. LU4006
    Category
    Medical Device
    Distribution
    Distributed nationwide