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.

176–200 of 229

  • ModerateFDA (Devices)·Z-2037-2014·2014-07-16

    Philips Gemini TF PET/CT Systems Recalled for E-Stop Malfunction

    Philips is recalling 33 Gemini TF PET/CT systems because a software error can prevent the emergency stop from closing, rendering the equipment inoperable for clinical use.

    Product
    GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2031-2014·2014-07-16

    Hospira Recalls GemStar Infusion Pumps Due to Beeper Connection Failure

    Hospira is recalling 36,881 GemStar infusion pumps because the beeper subassembly connection may fail, rendering the device inoperable.

    Product
    GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1977-2014·2014-07-09

    BD FACS Canto Flow Cytometer Recalled for Non-Operational Cooling Fans

    BD Biosciences is recalling 35 BD FACS Canto flow cytometers and associated fluidics carts because the laser cooling fans and internal fans are not operational.

    Product
    BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2014·2014-07-02

    Zynex IF 8000 Interferential Electrical Stimulation Device Recalled for Overheating

    Zynex Medical is recalling 1,461 IF 8000 devices because a malfunction can cause them to stop working or overheat, posing a burn risk.

    Product
    IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed for use in physical therapy, rehabilitation, and pain relief applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1789-2014·2014-06-25

    Philips Smart Monitor 2 Professional Series Infant Apnea Monitor Recall

    Children's Medical Ventures is recalling 112 infant apnea monitors due to a battery wire harness defect that renders the devices inoperable.

    Product
    Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1195-2014·2014-03-19

    Veridex Recalls CELLTRACKS Analyzer II Microscopes Due to Camera Failures

    Veridex, LLC is recalling 19 CELLTRACKS Analyzer II fluorescence microscopes because of reported camera failures. The devices are used for analyzing rare cells in biological fluids.

    Product
    CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0994-2014·2014-02-26

    Integra CUSA Excel CEM Nosecone Recalled for Sticking Button

    Integra LifeSciences is recalling CUSA Excel CEM nosecones because the blue COAG button may stick in the activated position.

    Product
    Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides De
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0907-2014·2014-02-12

    Siemens SOMATOM CT Systems Recalled for Potential Display Freeze Malfunction

    Siemens Medical Solutions is recalling 147 SOMATOM CT systems due to a potential display freeze malfunction during clinical operation.

    Product
    Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0862-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff is recalling 369 Certas Programmable Valves used for hydrocephalus because they may not operate properly.

    Product
    Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories Product Code: 82-8805 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrosp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0859-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff is recalling 895 Certas Programmable Valves used for hydrocephalus because they may not operate properly.

    Product
    Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product Code: 82-8801 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0860-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff, Inc. is recalling 431 Codman Certas Programmable Valves because they may not operate properly. These implantable devices are used to manage hydrocephalus.

    Product
    Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0858-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff is recalling 1,460 Certas Programmable Valves used for hydrocephalus because they may not operate properly.

    Product
    Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocepha
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0861-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff is recalling 1,481 Codman Certas Programmable Valves because they may not operate properly, potentially affecting hydrocephalus management.

    Product
    Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: 82-8804 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0864-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff, Inc. is recalling 746 Codman Certas Programmable Valves because they may not operate properly. The devices are used to manage hydrocephalus.

    Product
    Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories Product Code: 82-8807 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and dra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0852-2014·2014-02-05

    ACUTE Innovations RibLoc U plus System Recalled for Malfunction Risk

    ACUTE Innovations is recalling 176 units of the RibLoc U plus system because the implants may malfunction during surgical installation.

    Product
    The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are used to stabilize rib fractures, fusions and osteotomies during the normal bone healing process. The plates are manufactured from titanium and the screws are manufact
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0273-2014·2013-11-20

    Nobel Biocare Recalls Osseocare Pro Dental Devices Due to Malfunction Risk

    Nobel Biocare is recalling Osseocare Pro dental consoles because they may malfunction when used with a specific iPad software version.

    Product
    Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, el
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0142-2014·2013-11-13

    Sorin Recalls S5 Heart-Lung Machines Due to Cardioplegia Control Malfunction

    Sorin Group is recalling 84 S5 Heart-Lung Machines because of a malfunction in the cardioplegia control system.

    Product
    S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0027-2014·2013-10-23

    SonoSite P21x/5-1 Transducer Recalled for Biopsy Bracket Sensor Defect

    SonoSite, Inc. is recalling 10 P21x/5-1 MHz transducers because the Biopsy Bracket Sensor is not working as intended.

    Product
    P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technolo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0010-2014·2013-10-23

    GE Healthcare Recalls Ventilators and Anesthesia Machines with Unresponsive Buttons

    GE Healthcare is recalling 911 ventilators and anesthesia machines because manufacturing defects may cause display buttons to fail, preventing access to menu functions.

    Product
    GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1870-2013·2013-08-07

    SpineFrontier Recalls Three S-LIFT Slap Hammers Due to Malfunction

    SpineFrontier, Inc. is recalling three S-LIFT Slap Hammers (Lot 56H26) distributed in Kansas and Texas because they malfunctioned.

    Product
    S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial instruments that are used to estimate sizes of intervertebral body fusion devices intended to promote fusion. These devices were used in conjunction with lumbar interverte
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1773-2013·2013-07-31

    Physio Control Recalls LIFEPAK 500 AEDs Due to Assembly Error

    Physio Control is recalling 139 LIFEPAK 500 AEDs because an assembly error could cause internal shorting, rendering the device inoperable.

    Product
    The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·13236·2013-07-11

    Hollis Recalls Digital Dive Computers Due to Drowning Hazard

    Hollis is recalling DG03 dive computers because a malfunctioning pressure reading could cause divers to deplete their air supply and drown.

    Product
    Hollis DG03 Dive Computers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1607-2013·2013-07-03

    Medtronic Recalls Specific CRT-P Pacemakers for Potential Malfunction

    Medtronic is recalling specific Consulta and Syncra CRT-P pacemakers manufactured in April and May 2013 due to a production issue that could cause malfunction. No device failures have been reported.

    Product
    Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra¿ CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-1444-2013·2013-06-12

    I-Flow ON-Q Pain Relief System T-Block Needle/Catheter Tray Recall

    I-Flow LLC is voluntarily removing 450 units of the ON-Q Pain Relief System T-Block Needle/Catheter Tray because the devices may have malfunctioned.

    Product
    I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1445-2013·2013-06-12

    I-Flow ON-Q Pain Relief System T-Block Needle/Catheter Kit Recalled

    I-Flow LLC is voluntarily removing 75 units of the ON-Q Pain Relief System T-Block Needle/Catheter Kit because they may have potentially malfunctioned.

    Product
    I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
    Category
    Medical Device
    Distribution
    Distributed nationwide