The Recall Desk

Hazard

Malfunction recalls

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

What the numbers show

Total
229
Critical
2
Severe
20
Most recent
2026-09-02

Of the 229 malfunction recalls we have scored against our rubric, 2 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 20 (9%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all malfunction 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.

126–150 of 229

  • HighFDA (Devices)·Z-1553-2016·2016-05-04

    Horiba Recalls ABX Pentra 400 Analyzers Due to Malfunctions

    Horiba Instruments is recalling ABX Pentra 400 and Pentra C400 analyzers because they malfunction when specific alarms appear on the system.

    Product
    ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and meas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1554-2016·2016-05-04

    Horiba Recalls ABX Pentra 400 and C400 Clinical Chemistry Analyzers

    Horiba Instruments is recalling ABX Pentra 400 and Pentra C400 analyzers due to malfunctions triggered by specific system alarms.

    Product
    Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1305-2016·2016-04-06

    Siemens Recalls SOMATOM CT Systems Due to Cardio License Malfunction

    Siemens is recalling 124 SOMATOM Emotion and Sensation CT systems due to a potential malfunction in cardio licenses that could hazard patients and personnel.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1307-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1304-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 SOMATOM Emotion and Sensation CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1301-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1302-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 SOMATOM Emotion and Sensation CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1300-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1306-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 SOMATOM Emotion and Sensation CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1303-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1239-2016·2016-03-30

    CareFusion Recalls Alaris PC Infusion Pump Units Due to Power Supply Error

    CareFusion is recalling 170 Alaris PC Unit Infusion Pump Model 8000 devices because a power supply component may cause system error codes.

    Product
    Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1173-2016·2016-03-23

    Collagen Matrix Recalls ZCORE Porcine Xenograft Syringes for Malfunction

    Collagen Matrix Inc is recalling 200 units of ZCORE Porcine Xenograft Particulate in Syringe because the syringes were not working properly.

    Product
    ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as: -Augmentation or reconstructive treatment of alveolar ridge -filling of defects after root resection, apicoectomy and cystectomy -Filling of extraction sockets to enhance pres
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0753-2016·2016-03-02

    GE Precision MPi X-ray System Recalled for Touch Panel Boot Issues

    Regulatory Insight, Inc. is recalling 43 GE Precision MPi X-ray systems because the Remote Touch Panel may fail to boot up as intended.

    Product
    GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0747-2016·2016-02-10

    Synthes Small Electric Drive Recalled for Malfunction and Unintended Operation

    The Anspach Effort, Inc. is recalling 599 Synthes Small Electric Drive units because they may malfunction, fail to operate, or start unintentionally.

    Product
    Synthes Small Electric Drive (SED). For use in general traumatology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0481-2016·2015-12-30

    Siemens Artis Fluoroscopic X-ray Systems Recalled for Display Soldering Defect

    Siemens is recalling 17 Artis fluoroscopic X-ray systems due to improper soldering in display modules that could cause video signal loss.

    Product
    Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures.
    Category
    Medical Device
    Distribution
    12 states
  • LowFDA (Devices)·Z-0457-2016·2015-12-30

    BC Group International Recalls Defibrillator and Pacer Analyzer Units

    BC Group International is recalling five DA-2006P Defibrillator / Pacer Analyzer units because reversed wires cause inverted waveforms.

    Product
    DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0345-2016·2015-12-09

    DeRoyal Recalls Neonatal Temperature Skin Sensors Due to Soldering Defect

    DeRoyal Industries is recalling four lots of Hydro-Temp Neonatal Temperature Skin Sensors because incorrect soldering prevents temperature readings on infant warming systems.

    Product
    HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0359-2016·2015-12-09

    ConMed Recalls Altrus Thermal Tissue Fusion Energy Sources

    ConMed is recalling nine Altrus Thermal Tissue Fusion Energy Sources due to a miscalibration issue that may cause false alarms and stop heating cycles.

    Product
    Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2767-2015·2015-09-23

    Nico Myriad Console Recalled for Potential Cable Malfunction

    Nico Corp. is recalling six Myriad Console units because twisted cables may cause wire breaks or shorts, leading to unexpected aspiration increases during surgery.

    Product
    NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of a reusable console with foot pedal and a disposable handpiece. For the morcellation and removal of tissue durin
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2148-2015·2015-07-29

    EKOS EkoSonic Control Unit Recalled Due to Cable Recognition Failure

    EKOS Corporation is recalling 46 EkoSonic Control Units because the Connector Interface Cable was not recognized by the PT-3B control unit.

    Product
    The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic Endovascular System consists of three main components: -a single use EkoSonic Endovascular Device which is comprised
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1819-2015·2015-07-01

    Orthofix Centurion POCT System Drill Guide Recall for Depth Setting Risk

    Orthofix is recalling 36 Centurion POCT System Drill Guides because the thumb button may remain unlocked, allowing the drill stop to rotate unintentionally and change the depth setting.

    Product
    ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure of bone preparation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1795-2015·2015-06-24

    Neuro Kinetics Recalls I-Portal NOTC and VNG Devices Due to Malfunction

    Neuro Kinetics is recalling 140 I-Portal NOTC and VNG devices due to system malfunctions and unintended sudden movements at startup. No injuries have been reported.

    Product
    I-Portal¿ NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagnostic tool to assist trained clinicians in their analysis of vestibular disorders, which requires the separation of cent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1618-2015·2015-05-27

    Integra Recalls Camino ICP Monitors Due to Speaker Malfunction

    Integra LifeSciences is recalling Camino ICP Monitors because the audible speaker may malfunction. The recall covers 1,482 units distributed worldwide.

    Product
    The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The CAM02 monitor measures and displays intracranial ICP) and intracranial temperature (ICT).
    Category
    Medical Device
    Distribution
    0 states