The Recall Desk

Hazard

Loose Parts recalls

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

What the numbers show

Total
20
Critical
0
Severe
2
Most recent
2026-09-02

Of the 20 loose parts recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (10%) 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 loose parts 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.

1–20 of 20

  • HighFDA (Devices)·Z-3014-2026·2026-09-02

    Canon Medical Alphenix X-ray Systems Recalled for Loose Ceiling Screws

    Canon Medical System, USA, INC. is recalling 10 Alphenix digital radiography systems because fixing screws in the ceiling suspended arm may become loose.

    Product
    Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the he
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0920-2023·2023-01-18

    Large Craniotome Attachment Ball Bearings Risk Loosening During Surgery

    Ball bearings in The Anspach Effort's 7.5 cm Large Craniotome Attachment may come loose during removal or surgery, potentially causing serious patient injury. 6,059 units are affected worldwide.

    Product
    7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1813-2022·2022-10-05

    Olympus POWERSEAL surgical sealer recalled for loose retention ring defect

    Olympus Corporation is recalling certain POWERSEAL electrosurgical sealers due to an out-of-specification component that may allow the retention ring to loosen, potentially delaying surgical treatment.

    Product
    Olympus POWERSEAL 5MM, 23CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0523CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1801-2020·2020-05-06

    Philips Azurion 7 M20 X-Ray System Recalled for Loose Screw Risk

    Philips is recalling 162 Azurion 7 M20 angiographic X-ray systems because unspecified torque on C-arm roll motor screws could cause them to become loose.

    Product
    Phillips Azurion 7 M20, Angiographic X-Ray System Code 722079 Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0803-2020·2020-01-22

    Flexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components

    Flexicare Medical Ltd. is recalling BriteBlade Pro laryngoscope blades because internal spring, washer, and bearing components may become loose and separate from the device.

    Product
    BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)15055788724138(17)230801(10)180900072 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0802-2020·2020-01-22

    Flexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components

    Flexicare Medical Ltd. is recalling BriteBlade Pro laryngoscope blades because internal spring, washer, and bearing components may become loose and separate from the device.

    Product
    BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·19201·2019-09-05

    STIHL PolyCut Mowing Heads Recalled Due to Injury Hazard

    STIHL is recalling about 73,000 PolyCut mowing heads because loose bolts can cause the unit to come apart, posing an injury risk.

    Product
    STIHL PolyCut ™ Mowing Heads
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0390-2018·2018-01-24

    Philips Ingenuity Core CT Scanner Recall for Fastener Torque Verification

    Philips is recalling one Ingenuity Core CT scanner because certain fasteners cannot be confirmed to be torqued to specification, posing a potential risk of harm if parts become loose during use.

    Product
    Ingenuity Core, (Code 728321) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0388-2018·2018-01-24

    Philips Brilliance iCT Recalled for Potential Fastener Torque Defect

    Philips is recalling 13 Brilliance iCT scanners because certain fasteners may not have been torqued to specification, posing a potential risk of harm if parts become loose during use.

    Product
    Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0389-2018·2018-01-24

    Philips Brilliance 64 CT Scanner Recalled for Fastener Torque Issues

    Philips is recalling one Brilliance 64 CT scanner because certain fasteners may not be torqued to specification, posing a potential risk of harm if parts become loose.

    Product
    Brilliance 64, (Code 728231) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0391-2018·2018-01-24

    Philips Ingenuity Core 128 CT Scanner Recall for Fastener Torque Issues

    Philips is recalling three Ingenuity Core 128 CT scanners because certain fasteners may not have been torqued to specification, posing a potential risk of harm if parts become loose during use.

    Product
    Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0332-2018·2018-01-17

    Philips Brilliance iCT SP CT Scanner Recall Due to Loose Screws

    Philips is recalling 134 Brilliance iCT SP CT scanners because screws holding the internal gantry may come loose, potentially causing noise.

    Product
    Philips Healthcare Brilliance iCT SP computed tomography x-ray system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0746-2017·2016-12-21

    Steris Recalls Harmony Insight Diagnostic Monitor Support Systems

    Steris Corporation is recalling 63 Harmony Insight Diagnostic Monitor Support Systems because spring arm screws may not be properly secured and could become loose.

    Product
    Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The system is intended for use in surgical operating rooms (OR) or intraoperative surgical/imaging rooms where simultaneous multiple image viewing is required
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0940-2015·2015-01-14

    Intuitive Surgical Recalls da Vinci Si Vision Side Carts Due to Wheel Loosening

    Intuitive Surgical is voluntarily correcting 202 da Vinci Si Vision Side Carts where caster wheel bolts may unthread, causing wheels to loosen.

    Product
    IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000. Product number 371683-05/Model Number VS3000 The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1514-2014·2014-05-07

    Elekta Recalls HexaPOD evo RT Couchtop Units Due to Loose Screw Risk

    Elekta is recalling 266 HexaPOD evo RT Couchtop units because screws may become loose if not properly tightened with a torque wrench.

    Product
    HexaPOD evo RT Couchtop. To support and aid in positioning a patient during radiation therapy.
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-2265-2012·2012-09-05

    Canon Solid State X-ray Imager Recall Due to Loose Screws

    Canon is recalling 468 Solid State X-ray Imagers because screws holding the 55REF circuit board are loosening and roaming inside the sealed sensor.

    Product
    Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·09284·2009-07-21

    Stamina Recalls Elliptical Cross Trainers Due to Loose Pedal Shaft Risk

    Stamina Products is recalling about 11,000 elliptical cross trainers because pedal shafts may loosen, posing a serious injury risk. Consumers should stop using the machines until they receive new instructions.

    Product
    Elliptical Cross Trainers
    Category
    Consumer Product
    Distribution
    Distributed nationwide