The Recall Desk

Hazard

Device Failure recalls

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

What the numbers show

Total
881
Critical
30
Severe
255
Most recent
2026-09-02

Of the 881 device failure recalls we have scored against our rubric, 30 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (29%) 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 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.

851–875 of 881

  • SevereFDA (Devices)·Z-0548-2013·2012-12-26

    Zimmer Recalls Persona Knee System Tibial Broach and Associated Tools

    Zimmer, Inc. is recalling 92 units of Persona Knee System Tibial Broaches and associated tools due to a risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Broach, Cemented, Size E-F, Nonsterile, This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Coll
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0540-2013·2012-12-26

    Zimmer Recalls Persona Knee Implants Due to Tibial Perforation Risk

    Zimmer, Inc. is recalling 518 units of Persona Knee System tibial implants and tools to reduce the risk of tibial perforation and fracture.

    Product
    Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disord
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0567-2013·2012-12-26

    Medtronic Recalls 140 DBS Extension Kits with Damaged Connector Boots

    Medtronic is recalling 140 Deep Brain Stimulation Extension Kits because the connector boots may be cracked or improperly molded.

    Product
    Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba, Puerto Rico. Medtronic¿ DBSTM Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subtha
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0555-2013·2012-12-26

    Zimmer Recalls Persona Knee System Tibial Sizing Plates

    Zimmer, Inc. is recalling 189 Persona Knee System Tibial Sizing Plates to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size H Left; Size H Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0496-2013·2012-12-19

    Medtronic SynchroMed EL Pumps Recalled Due to Unapproved Drug Interactions

    Medtronic is recalling SynchroMed EL implantable infusion pumps because using unapproved drugs can cause the pump to stop working, halting drug delivery.

    Product
    SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump is part of an implanted infusion system that consists of a SynchroMed EL pump and a catheter. The SynchroMed EL Infusion System is indicated fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0435-2013·2012-12-05

    Terumo Advanced Perfusion System 1 Recalled for Total Loss of Functionality

    Terumo is recalling 1,647 Advanced Perfusion System 1 units because they may shut down completely, stopping pumps and failing to activate battery backup.

    Product
    100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qua
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0436-2013·2012-12-05

    Terumo Advanced Perfusion System 1 Recalled for Power Loss

    Terumo is recalling Advanced Perfusion System 1 units that may lose power and shut down during use, causing pumps to stop.

    Product
    220/240V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qua
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0348-2013·2012-11-28

    NuVasive Recalls 240 Screw Tulip Implants Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 6.25mm Screw Tulip implants because the tulip portion can disengage from the shank after implantation.

    Product
    Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0367-2013·2012-11-28

    NuVasive Recalls 240 Screw Tulip Medical Devices for Disengagement Risk

    NuVasive Inc is recalling 240 units of Screw Tulip, 5.5mm Rod devices because the tulip portion can disengage from the shank after implantation.

    Product
    Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0374-2013·2012-11-28

    NuVasive Recalls 6.5mm Noncannulated Screw Shanks Due to Disengagement Risk

    NuVasive Inc is recalling 240 units of 6.5mm x 45mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.

    Product
    6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0403-2013·2012-11-28

    Spacelabs Qube Compact Patient Monitor Recalled for Input Circuit Failure

    Spacelabs Healthcare is recalling Qube Compact Patient Monitors because the input circuit may fail, causing the device to shut down when batteries deplete or fail to turn on.

    Product
    qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.1 inches) LCD display with 1024 x 768 resolution. The Spacelabs Healthcare Qube Compact Monitor
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0296-2013·2012-11-21

    Zimmer Recalls ATS 3000 Tourniquets Due to Counterfeit Chip Failures

    Zimmer is voluntarily removing 204 ATS 3000 Automatic Tourniquet Systems worldwide after complaints of failures caused by counterfeit chips.

    Product
    ATS 3000 Automatic Tourniquet System w/HOSES AND LOP SENSOR Intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0160-2013·2012-11-07

    Maquet Cardiovascular Recalls QUADROX Oxygenators Due to Connector Detachment Risk

    Maquet Cardiovascular is recalling QUADROX oxygenators because the blood outlet connector may detach from the device during use.

    Product
    QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The QUADROX oxygenators are intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0159-2013·2012-11-07

    Progressive Medical Recalls Endoscopic Dissector Due to Tip Unraveling Risk

    Progressive Medical Inc is recalling 124 boxes of PMI Endoscopic Dissectors because the tip could come loose or unravel during use.

    Product
    Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Product Usage: The product is used for pushing tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0051-2013·2012-10-17

    Terumo Sarns Centrifugal System Control Module Recalled for Power Loss

    Terumo CVS is recalling Sarns Centrifugal System Control modules due to a report of power loss during cardiopulmonary bypass.

    Product
    Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0053-2013·2012-10-17

    Terumo Sarns Centrifugal System Control Module Recalled for Power Loss

    Terumo CVS is recalling Sarns Centrifugal System Control modules due to a report of power loss during cardiopulmonary bypass.

    Product
    Sarns Centrifugal System Control module System 9000 The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0052-2013·2012-10-17

    Terumo Sarns Centrifugal System Control Module Recalled for Power Loss

    Terumo CVS is recalling Sarns Centrifugal System Control modules due to a report of power loss during cardiopulmonary bypass.

    Product
    Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2474-2012·2012-10-10

    Zimmer Recalls VerSys Provisional Femoral Heads Due to Fit Issues

    Zimmer, Inc. is recalling VerSys provisional femoral heads because they may fit too loosely or too tightly with mating components, posing a risk of intraoperative dislodging.

    Product
    00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0 00789502603 VerSys Femoral Head Provisional 26mm +3.5 00789502604 VerSys Femoral Head Provisional 26mm +7 00789502605 VerSys Femoral Head Provisional 26mm +10.5 12/14 Ne
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2489-2012·2012-10-10

    Stanley Tabs Professional Monitor Recalled for Alarm Failure

    Stanley Security Solutions is recalling 4,749 Tabs Professional Monitors because they may fail to sound an alarm, potentially increasing the risk of falls.

    Product
    Tabs Professional Monitor, without wall bracket, Model 25023. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0006-2013·2012-10-10

    US Endoscopy Raptor Grasping Device Recalled for Potential Jaw Failure

    US Endoscopy Group Inc is recalling 1,153 Raptor grasping devices because the jaws may become stuck open if excessive force is applied while the catheter is coiled.

    Product
    Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2382-2012·2012-09-26

    Spacelabs Ultraview SL Integrated Module Housing Recalled for Potential Failure

    Spacelabs Healthcare is recalling Ultraview SL Integrated Module Housings because they may fail, causing patient module parameters to drop off the monitor display or preventing modules from signing on.

    Product
    Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm prior
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2333-2012·2012-09-19

    Aesculap S4 Polyaxial Screws Recalled for Potential Channel Tolerance Defect

    Aesculap Implant Systems LLC is recalling S4 Element 4.5mm Polyaxial Screws because the screw channel may be out of tolerance, potentially preventing the screw head from locking to the bone.

    Product
    Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2250-2012·2012-09-12

    Newport HT70 Ventilators Recalled for Control Board Failure Risk

    Newport Medical Instruments is recalling 72 HT70 and HT70 Plus ventilators because a control board failure may cause the device to stop ventilating.

    Product
    Newport HT70 and HT70 Plus Ventilators, Model Number: HT70 and HT70 Plus. Product Usage: The HT70 ventilator system is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2260-2012·2012-09-12

    Respironics Recalls V60 Ventilators Due to Blower Motor Assembly Defect

    Respironics is recalling V60 ventilators because blower motor assemblies may not meet specifications, potentially causing the device to stop delivering therapy.

    Product
    V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2321-2012·2012-09-12

    AmeriWater MRO Dialysis Systems Recalled Due to Incorrect Fuse Installation

    AmeriWater Inc is recalling 80 MRO Dialysis RO+ Systems because incorrect fuses were installed, which may cause excessive heat and device failure.

    Product
    AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, OH 45404 (800) 535-5585 www.AMERIWATER.com. The AmeriWater MRO Portable Reverse Osmosis Systems are water treatment systems intended for use in hemodialysis applications. They are designed to pre-treat
    Category
    Medical Device
    Distribution
    Distributed nationwide