The Recall Desk

Hazard

Device Misidentification recalls

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

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2026-07-22

Of the 6 device misidentification 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 device misidentification 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.

1–6 of 6

  • ModerateFDA (Devices)·Z-2729-2026·2026-07-22

    Orthofix MINIRAIL external fixation devices recalled for incorrect model labeling

    Orthofix U.S. LLC is recalling Orthofix MINIRAIL external fixation devices (Model M101) because they may be labeled with incorrect model numbers, potentially leading to use of wrong device specifications.

    Product
    Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0808-2025·2025-01-15

    Aerin Medical VivAer Stylus Recall: Programming Error Causes Device Misidentification

    Aerin Medical is recalling 479 units of VivAer Stylus (Lot #10235) due to incorrect programming in units from a single lot. When connected to the Aerin Console, affected devices will be incorrectly identified as RhinAer Stylus.

    Product
    Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0121-2025·2024-10-23

    Open Heart Surgical Kit Recalled for Incorrect Vessel Cannulae Model Labeling

    Medline Industries is recalling 123 kits of its Open Heart Pack after discovering that model 30001 vessel cannulae were incorrectly labeled as model 30000. This labeling error could lead to use of the wrong surgical instrument during open heart procedures.

    Product
    MEDLINE OPEN HEART PACK, REF DYNJ66216C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0814-2024·2024-01-31

    TactiFlex Ablation Catheter Not Properly Recognized by EnSiteX EP System

    The TactiFlex Ablation Catheter is not correctly recognized by the EnSiteX EP System, which displays it as a different model, prevents certain features from appearing, and may show an inverted image.

    Product
    TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0773-2024·2024-01-31

    Stryker Tornier Shoulder Implant Recalled for Device Packaging Mismatch

    Tornier, Inc is recalling 50 units of Stryker Tornier Perform shoulder implants because the incorrect device is contained in the labeled package. Affected batch: lot 6714AZ, serial 001–050.

    Product
    Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0186-2022·2021-11-10

    Flexor Check-Flo Introducer Sets recalled due to misplaced radiopaque marker band

    Cook Inc. recalls Flexor Check-Flo Introducer Sets where the radiopaque marker band is incorrectly positioned, which may not be discovered until the device is used in a patient under fluoroscopy, increasing procedural time.

    Product
    Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.
    Category
    Medical Device
    Distribution
    17 states