The Recall Desk

Hazard

Verification Failure recalls

5 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2023-02-08

Of the 5 verification failure recalls 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 hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all verification failure recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–5 of 5

  • HighFDA (Devices)·Z-1039-2023·2023-02-08

    Non-Invasive Patient Tracker Verification Failure During Image-Guided Surgery

    Medtronic is recalling AxiEM Non-Invasive Patient Trackers due to increasing complaints that users cannot verify their navigation instruments work properly during image-guided surgery. The verification failure affects approximately 1,867 devices worldwide.

    Product
    AxiEM" Non-Invasive Patient Tracker
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-3058-2017·2017-08-30

    Medtronic ENT Navigation Suction Devices Recalled for Verification Failure

    Medtronic Navigation is recalling six kits of ENT suction devices because they fail required pre-use verification checks.

    Product
    Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733452 containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction). The firm name on the label is Medtronic Navigation, Inc.,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3056-2017·2017-08-30

    Medtronic Fusion ENT Instrument Kit Recalled for Verification Failure

    Medtronic is recalling 15 Fusion ENT Instrument Kits because the instruments fail pre-use verification. The kits were distributed in the US and Canada.

    Product
    Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes Kit 9733452 (containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction). The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The su
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3053-2017·2017-08-30

    Medtronic Curved Suction 90 Recalled for Verification Failure

    Medtronic is recalling 75 Curved Suction 90 ENT instruments because they fail required pre-use verification checks.

    Product
    Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. Th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3055-2017·2017-08-30

    Medtronic ENT Instrument Set Recalled for Verification Failure

    Medtronic is recalling 13 reusable ENT instrument sets because they fail required pre-use verification checks. The devices are used with the StealthStation AxiEM surgical navigation system.

    Product
    Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The sucti
    Category
    Medical Device
    Distribution
    Distributed nationwide