The Recall Desk

Hazard

Premature Failure recalls

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

What the numbers show

Total
13
Critical
0
Severe
0
Most recent
2024-07-24

Of the 13 premature failure 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 premature 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.

1–13 of 13

  • HighFDA (Devices)·Z-2360-2024·2024-07-24

    Abbott Proclaim XR 7 Implantable Pulse Generator Service Life Shorter Than Labeled

    Abbott Proclaim XR 7 implantable pulse generators may have a shorter service life than indicated in product labeling. Approximately 9,006 units distributed worldwide are affected.

    Product
    Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2367-2024·2024-07-24

    Abbott Proclaim DRG implantable pulse generator service life shorter than labeled

    Abbott is recalling 21,843 Proclaim DRG implantable pulse generators because the duration between the device's elective replacement indicator and end of service may be shorter than stated in product labeling.

    Product
    Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1535-2023·2023-05-10

    Knee Implant Recalled for Inadequate Surgical Technique Guidance

    Linkbio is recalling 15 LINK SLED Knee Systems due to potential aseptic loosening and wear from suboptimal implant positioning or inadequate cementing during surgery. Updated surgical technique training is required.

    Product
    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2030/12
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1362-2023·2023-04-19

    Inflatable Penile Prosthesis Pump Risk of Premature Failure

    Coloplast is recalling Titan Touch NB Infr Zero 18cm inflatable penile prostheses due to decreased pump wall thickness that may cause premature device failure after repeated use.

    Product
    Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1368-2023·2023-04-19

    Inflatable Penile Prosthesis Recalled for Risk of Premature Pump Failure

    Coloplast is recalling Titan Touch inflatable penile prostheses with reduced pump wall thickness, which could cause premature failure during use. The defect affects 8 units distributed across the US and multiple European countries.

    Product
    Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0482-2022·2022-01-19

    Instavac Portable Suction Pumps Recalled for Premature Device Failures

    Ohio Medical Corporation is recalling Instavac Portable Suction Pumps (models 757000, 756000, and replacement pump part #AI5511) due to an increase in premature device failures. Affected units were distributed nationwide.

    Product
    Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 756000 and 757000.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1295-2019·2019-05-15

    Siemens Cios Alpha C-arm X-ray System Recalled for Component Wear

    Siemens is recalling two Cios Alpha mobile X-ray systems because continuous high-output operation may cause premature failure of radiation components.

    Product
    Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200 Product Usage: The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1265-2014·2014-03-26

    Clarity Medical Systems Recalls RetCam 3 Halogen Lamps for Premature Failure

    Clarity Medical Systems is recalling 234 RetCam 3 halogen lamps that may fail early, potentially damaging internal electrical components.

    Product
    Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1558-2013·2013-06-26

    Verathon Recalls GlideScope Reusable Laryngoscope Blades Due to Breakage Risk

    Verathon is recalling GlideScope reusable laryngoscope blades because the tips may break prematurely without visible signs, posing a risk to patients during intubation.

    Product
    GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable blades Product Usage: The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical proced
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0279-2013·2012-11-21

    Terumo HX2 Temperature Management System Recalled for Board Defect

    Terumo is recalling 15 HX2 Temperature Management Systems because AC Control boards were manufactured with incorrect flux, which may cause premature failure.

    Product
    Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0278-2013·2012-11-21

    Terumo HX2 Temperature Management System Recalled for Board Defects

    Terumo is recalling 19 HX2 Temperature Management Systems because AC Control boards were manufactured with incorrect flux, which may cause premature failure.

    Product
    HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.
    Category
    Medical Device
    Distribution
    Distributed nationwide