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.

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 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.

876–881 of 881

  • HighFDA (Devices)·Z-2177-2012·2012-08-15

    Terumo Advanced Perfusion System 1 Recall for Module Malfunctions

    Terumo is recalling 992 Advanced Perfusion System 1 units due to faulty components in the Occluder and Air Bubble Detection modules.

    Product
    System 1 base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the oper
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1983-2012·2012-07-18

    Advanced Neuromodulation Systems Recalls Eon Mini Neurostimulation Devices

    Advanced Neuromodulation Systems is recalling Eon Mini Neurostimulation devices due to a workmanship issue that can cause loss of communication or recharging, resulting in loss of pain relief.

    Product
    Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1959-2012·2012-07-18

    Cardiovascular Systems Recalls Stealth 360-degree Orbital Atherectomy Devices

    Cardiovascular Systems, Inc. is recalling 27 Stealth 360-degree Orbital Atherectomy Devices due to a potential solder defect that could cause the crown to detach from the driveshaft.

    Product
    CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system. The Stealth 360-degree Orb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1933-2012·2012-07-11

    Zimmer Recalls PathFinder NXT Pivoting Percutaneous Rod Holder

    Zimmer, Inc. is recalling 77 units of the PathFinder NXT Pivoting Percutaneous Rod Holder because the set screw may break, preventing the surgeon from removing the rod during surgery.

    Product
    PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrument used during orthopedic surgery. The intended use of the pivoting percutaneous rod holder is to attach to the rod to facilitate rod insertion, positioning, and orientation through the extender sleeves,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2012·2012-06-27

    Stryker Accolade Offset Rasp Handle Recalled for Potential Fracture

    Stryker Howmedica Osteonics is recalling 41 Accolade Offset Rasp Handles due to a potential risk of fracturing during use in total hip arthroplasty.

    Product
    Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Single offset rasp handle designed to mate to the Accolade femo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·05271·2005-09-15

    Ortovox Recalls M1 and M2 Avalanche Transceivers Due to Battery Defect

    Ortovox USA is recalling M1 and M2 avalanche transceivers because batteries can become dislodged, potentially causing the device to fail during an emergency.

    Product
    Ortovox M1 and M2 Avalanche Transceivers - A device worn to help locate a buried avalanche victim
    Category
    Consumer Product
    Distribution
    Distributed nationwide