The Recall Desk

Hazard

Component Defect recalls

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

What the numbers show

Total
126
Critical
0
Severe
14
Most recent
2026-06-24

Of the 126 component defect recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 14 (11%) 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 component defect 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.

101–125 of 126

  • HighFDA (Devices)·Z-1257-2023·2023-03-22

    Beckman Coulter Access Immunoassay Analyzers Recalled for Defective Nut Bands

    Beckman Coulter is recalling approximately 4,100 laboratory immunoassay analyzers due to defective nut bands that may cause operational failures and erroneous patient test results.

    Product
    Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0609-2023·2022-12-21

    DeRoyal HEART PACK procedure kits recalled for defective component

    DeRoyal Industries is recalling 102 HEART PACK procedure kits (Lot 57367401, expiration 3/1/2025) distributed across 23 U.S. states because they contain recalled 3M Health Care Steri Drapes.

    Product
    DeRoyal HEART PACK, REF 89-8351.12
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0648-2023·2022-12-21

    DeRoyal Myelogram Packs Recalled for Inclusion of Defective 3M Drapes

    DeRoyal Industries is recalling 480 myelogram procedure packs because they contain 3M Steri Drapes that have been recalled. These packs were distributed to medical facilities in 23 states.

    Product
    DeRoyal MYELOGRAM PACK, REF 89-9304.06
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0269-2023·2022-11-30

    MicroScan autoSCAN-4 Instrument Recall Due to Incorrect Diffuser Plate

    Beckman Coulter is recalling MicroScan autoSCAN-4 Instruments due to manufacturing with an incorrect diffuser plate component. Affected units were distributed worldwide including multiple U.S. states and countries.

    Product
    MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0088-2023·2022-10-19

    Medline Venclose cardiovascular procedure kits recalled for wrong component size

    Medline Industries is recalling 1,760 Venclose procedure packs due to incorrect introducer/sheath component size. Affected kits contain 12cm components instead of the required 7cm.

    Product
    VENCLOSE, VENCLOSE PROCEDURE PACK, 7VM, REF VC-PPH-67A. Cardiovascular procedure convenience kit.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1815-2022·2022-10-05

    Olympus POWERSEAL 5MM Electrosurgical Sealer Recalled Due to Loose Retention Ring

    Olympus is recalling POWERSEAL 5MM electrosurgical sealers due to a component defect that may cause the rotation knob to loosen and delay surgical treatment.

    Product
    Olympus POWERSEAL 5MM, 44CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0544CJDA. An electrosurgical device use in laparoscopic/minimally invasive or open surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1480-2022·2022-08-03

    Medtronic Cobalt Implantable Cardioverter Defibrillators Recalled for Cathode Component Defect

    Medtronic is recalling three Cobalt Implantable Cardioverter Defibrillators (CRT-D) due to a manufacturing error that may have resulted in a cathode component being out of specification. Affected patients should contact their physician.

    Product
    Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1275-2022·2022-06-29

    EVIS EXERA II Gastrointestinal Videoscope Recalled for Incorrect Component Fit

    Olympus is recalling 8 EVIS EXERA II gastrointestinal videoscopes (Model GIF-HQ190) because an incorrect rubber component may have been installed during repair. The incorrect part does not meet the device's design specifications.

    Product
    EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1085-2022·2022-05-25

    Medical diagnostic instrument recalled for electrical connector assembly defect

    Beckman Coulter is recalling 40 DxM 1040 MicroScan WalkAway laboratory instruments due to an assembly defect: some units have an AC power connector inlet rated at 1 ampere instead of the correct 10-ampere rating, which could impair power delivery.

    Product
    DxM 1040 MicroScan WalkAway Instrument REF B1018-440
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0786-2022·2022-03-23

    Wright Medical ORTHOLOC Surgical Screw Recalled for Incorrect Component Packaging

    Wright Medical Technology's ORTHOLOC Non-Locking Screw was recalled due to a packaging error in lot #73967511638696, where locking screws were mistakenly packaged instead. The affected product was distributed to France.

    Product
    Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0663-2022·2022-03-09

    Philips Respironics V60 Plus Ventilators with Defective Adhesive Recalled

    Respironics California is recalling 294 V60 Plus ventilators assembled with expired adhesive. The adhesive may fail, causing the bracket to loosen and damage capacitors, potentially stopping ventilation delivery.

    Product
    Philips Respironics V60 Plus Ventilator Part Number 1138747
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0252-2022·2021-11-24

    REGARD Ear Tray recalled due to out-of-spec swabstick component

    ROi CPS LLC is recalling the REGARD Ear Tray because it contains a Povidone-Iodine swabstick component that does not meet specifications. The product was distributed in Florida, Louisiana, and Missouri.

    Product
    REGARD Ear Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0256-2022·2021-11-24

    REGARD Vitrectomy Tray Recalled for Out-of-Specification Antiseptic Component

    ROi CPS LLC is recalling 22 REGARD Vitrectomy Trays because the povidone-iodine swab component was manufactured out of specifications. Distribution was limited to Florida, Louisiana, and Missouri.

    Product
    REGARD Vitrectomy Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2046-2021·2021-07-21

    Canon MRI System Recalled for Flame-Retardancy Component Defect

    Canon Medical System recalled its Vantage Titan 3T MRI systems due to a component lacking proper flame-retardancy standards. The defect could produce smoke or fire during use.

    Product
    Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this syste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2686-2017·2017-07-26

    Siemens Artis zee X-ray System Recalled for Component Defect

    Siemens is recalling specific Artis zee angiographic x-ray systems due to a component defect that can cause failures.

    Product
    Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Ar
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1605-2017·2017-04-05

    Recall of Custom Procedure Trays with Defective Light Gloves

    Resource Optimization & Innovation Llc is recalling 276 custom procedure trays because the included light gloves can split, breaking the sterile field.

    Product
    Regard, Item Number: 800546002, Sterile, GS0635B - Abdominal - Medical Center Santa Rosa
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0861-2016·2016-03-02

    Centurion Convenience Kits Recalled Due to Cracking IV Connector Threads

    Centurion Medical Products is recalling convenience kits containing In-Vision-Plus Needleless IV Connectors because molding defects may cause threads to crack and tubing to detach.

    Product
    Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code RYM5001 InVision-Plus¿ Needless IV Connectors are used for single patient use in IV and blood administration sets without the need for needles, thus eliminating the potential
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0163-2016·2015-11-04

    Abbott Recalls ARCHITECT i2000SR Systems Due to Incorrect Tubing

    Abbott Laboratories is recalling 65 ARCHITECT i2000SR diagnostic systems worldwide because they contain incorrect tubing.

    Product
    ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system is designed to perform automated immunoassay tests, utilizing CMIA (chemiluminescent microparticle assay) detection technology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2788-2015·2015-09-30

    Terumo Custom Cardiovascular Procedure Kits Recalled Due to Component Defect

    Terumo is recalling 30 custom cardiovascular procedure kits because they contain recalled Medivators HPH700 Hemoconcentrators.

    Product
    Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N: 7928-03 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2543-2015·2015-09-09

    Roche Recalls cobas Liat Analyzers Due to Incorrect LED Components

    Roche Molecular Systems is recalling five cobas Liat Analyzers because incorrect LED components were used in the printed circuit board assemblies.

    Product
    cobas Liat Analyzer, for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1466-2015·2015-04-29

    Biomet Recalls Torque Limiting Handles for Spinal Fixation Devices

    Biomet Spine is recalling 874 Torque Limiting Handles used in spinal fixation due to supplier component updates.

    Product
    Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous fixation device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0193-2015·2014-11-19

    GE OEC MiniView 6800 C-Arm Recall for Component Revision

    GE Healthcare is recalling 26 OEC MiniView 6800 C-Arms because prior component revisions may have been incorrectly installed.

    Product
    OEC¿ MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric imagin
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0194-2015·2014-11-19

    GE Healthcare Recalls FlexiView 8800 Digital Mobile Imaging Systems

    GE Healthcare is recalling five FlexiView 8800 systems because prior component revisions were potentially installed on these units.

    Product
    FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System is designed to provide fluoroscopic and spot film, imaging of the patient during diagnostic, surgical and interventional procedures.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0192-2015·2014-11-19

    GE OEC UroView 2800 Imaging Systems Field Correction for Component Revision

    GE Healthcare is correcting OEC UroView 2800 systems because prior component revisions may have been incorrectly installed.

    Product
    OEC¿ UroView 2800. The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical. and interventional procedures
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1862-2014·2014-07-02

    Philips Ingenia 3.0T MRI Systems Recalled for Incorrect Nut Components

    Philips is recalling 21 Ingenia 3.0T MRI systems because some were shipped with incorrect M10 nuts instead of A4 stainless steel nuts.

    Product
    Ingenia 3.0T R5, magnetic resonance imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide