The Recall Desk

Hazard

Use Error recalls

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

What the numbers show

Total
15
Critical
0
Severe
0
Most recent
2026-07-22

Of the 15 use error 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 use error 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.

1–15 of 15

  • ModerateFDA (Devices)·Z-2731-2026·2026-07-22

    Orthofix Articulated Minirail Fixator devices recalled for incorrect labeling

    Orthofix U.S. LLC is recalling Articulated Minirail Fixator external fixation devices due to incorrect model labeling. Three models were mislabeled: M101 labeled as M103, M103 labeled as M101, and M122 labeled as M111.

    Product
    Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral orthopedic/trauma external fixation device
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1482-2024·2024-04-17

    RayStation Software Use Error Could Cause Incorrect Radiation Dose Calculations

    RayStation radiation therapy planning software versions 8B through 2024A contain a use error that can incorrectly select silicon material for silicone gel polymer implant dose calculations, potentially resulting in incorrect radiation doses.

    Product
    RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1966-2023·2023-06-21

    bellavista 1000 Ventilator Recalled for Software Hang and Use Error Risk

    Vyaire Medical is recalling approximately 910 units of the bellavista 1000 Ventilator due to a software issue that can cause the touchscreen to become unresponsive and a potential use error risk if operators do not confirm settings are appropriate for the patient.

    Product
    bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1967-2023·2023-06-21

    bellavista 1000e Ventilator Software May Hang, Affecting Device Interface

    Vyaire Medical is recalling certain bellavista 1000e ventilators due to software issues that may cause the touchscreen to become unresponsive. The recall also addresses potential operator error risks if ventilator settings are not confirmed before application.

    Product
    bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0024-2020·2019-10-09

    Stryker C2 Nerve Monitor Recalled for Potential Nerve Injury Risk

    Stryker is recalling 135 C2 Nerve Monitor units because design and instruction issues may lead to use errors that cause nerve injury.

    Product
    C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative monitoring and stimulation for localization and identification of cranial and peripheral motor and mixed motor sensory nerves during surger
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0934-2015·2015-01-14

    Vision RT AlignRT 3D Imaging System Recalled for Potential Use Error

    Vision RT Inc. is recalling 55 AlignRT 3D surface imaging systems due to a potential use error when the external Gate Controller is turned on after software startup.

    Product
    AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1398-2013·2013-06-05

    Stryker Orthobiologics Aliquot Beveled Needle Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 12 units of the Aliquot Beveled Needle due to reported catheter breakage during vertebroplasty procedures.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 6", Part Number 2110-0524 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1399-2013·2013-06-05

    Stryker Orthobiologics Aliquot Catheter Recall for Use Error

    Stryker Orthobiologics is recalling 69 Aliquot Catheters due to reported breakage during vertebroplasty procedures attributed to use errors.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6", Part Number 2110-0503 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1392-2013·2013-06-05

    Stryker Orthobiologics Aliquot Catheter Recall for Use Error Revision

    Stryker Orthobiologics is recalling 27 Aliquot Catheters to revise instructions after reported breakage during vertebroplasty procedures.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1391-2013·2013-06-05

    Stryker Orthobiologics Aliquot Beveled Needle Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 35 units of the Aliquot Beveled Needle because the catheter may break during removal. The issue is attributed to user error, and the correction involves updating the Directions for Use.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4", Part Number 2110-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1394-2013·2013-06-05

    Stryker Orthobiologics Aliquot Diamond Needle Recall for Catheter Breakage

    Stryker Orthobiologics is recalling 19 units of the Aliquot Diamond Needle due to reported catheter breakage during vertebroplasty procedures.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamond Needle, 4", Part Number 2110-0506 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1396-2013·2013-06-05

    Stryker Orthobiologics Aliquot Reamer Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 7 units of the Aliquot Reamer, 6" (Part Number 2110-0504) because the catheter may break during removal from the needle.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number 2110-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1390-2013·2013-06-05

    Stryker Orthobiologics Aliquot Delivery System Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 155 units of the Aliquot Syringe Delivery System because the catheter may break during removal from the needle.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6", Part Number 2090-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1395-2013·2013-06-05

    Stryker Orthobiologics Aliquot Reamer Recalled for Catheter Breakage Risk

    Stryker Orthobiologics is recalling five Aliquot Reamer units because the catheter may break during removal from the needle. The issue is attributed to user error, and the correction involves revised instructions.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1387-2013·2013-06-05

    Stryker Orthobiologics Aliquot Plunger Delivery System Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 78 units of the Aliquot Plunger Delivery System because the catheter may break during vertebroplasty procedures.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide