The Recall Desk

Hazard

Functional Failure recalls

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

What the numbers show

Total
127
Critical
0
Severe
3
Most recent
2026-04-29

Of the 127 functional 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 3 (2%) 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 functional 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.

51–75 of 127

  • ModerateFDA (Devices)·Z-2027-2019·2019-07-31

    Siemens AXIOM Artis dBC X-ray Generator Recall for Power Supply Defect

    Siemens is recalling 53 AXIOM Artis dBC units due to a power supply tolerance issue that can cause generator failure and prevent X-ray imaging.

    Product
    AXIOM Artis dBC, Model Number 7728392
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1984-2019·2019-07-24

    Medline Recalls Anti-Fog Solution in Surgical Kits Due to Degradation

    Medline Industries is recalling 14,550 units of anti-fog solution in surgical kits because the chemical properties may have degraded, preventing proper defogging.

    Product
    Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP CHOLE, GENERAL LAPAROSCOPY PACK-LF, T&A PACK, LAP CHOLE PACK-LF, LAPAROSCOPY PACK-LF, EAR ACCESSORY PACK, RF LAP CHOLEPACK (LCLUI)642-LF, GEN LA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1932-2019·2019-07-10

    Medtronic Recalls 0-arm 1000 Imaging Systems Due to Charger Board Defect

    Medtronic is recalling 832 0-arm 1000 Imaging Systems worldwide because a defective charger board prevents batteries from fully recharging, rendering the system inoperable.

    Product
    Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system voltage): Product Name Model#/ CFN OARM ASSY 8170000027 SYSTEM PRODUCT BI70000027 OARM ASSY BI70000027R SYS PRODUCT RWK BI70000027R BASE OARM 8170000027100 SYSTEM !D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1394-2019·2019-05-29

    Boston Scientific Recalls Auriga XL 4007 Laser Systems for Cooling Defect

    Boston Scientific is recalling six Auriga XL 4007 laser systems worldwide due to a mechanical cooling issue that may cause power degradation and stop laser emission.

    Product
    AURIGA XL 4007 GENERAL - ZERO COST SYSTE UPN: FS4007GZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perfo
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0602-2019·2018-12-19

    Tosoh AIA-900 Analyzer Recalled for Potential Harness Wear

    Tosoh Bioscience is recalling 258 AIA-900 Automated Immunoassay Analyzers because internal harnesses may wear prematurely, causing the device to stop functioning and delaying patient test results.

    Product
    AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0528-2019·2018-12-12

    Becton Dickinson Recalls Trypticase Soy Agar Plates Due to Growth Inhibition

    Becton Dickinson is recalling 54,300 plates of Trypticase Soy Agar with 5% Sheep Blood because a manufacturing error inhibited the growth of Gram-negative organisms.

    Product
    BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0274-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, communication, and imaging functions.

    Product
    O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV RWK, Model Number Bl70000027100R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0271-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, communication, and imaging functions.

    Product
    O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number Bl70000027 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-0279-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to software anomalies affecting startup, motion control, and image acquisition.

    Product
    O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GER, Model Number Bl70000027GER Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2
    Category
    Medical Device
    Distribution
    45 states
  • ModerateFDA (Devices)·Z-0239-2019·2018-10-31

    Philips DigitalDiagnost Software Recall for X-ray System Stitching Defects

    Philips is recalling DigitalDiagnost software for stationary X-ray systems due to intermittent stitching interruptions and incorrect baseline data on the system CD.

    Product
    Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 712225, 712226, 712227, 712228.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2991-2018·2018-09-26

    Mobius AIRO Mobile CT System Recalled for Software Fault

    Mobius Imaging is recalling 147 AIRO Mobile CT Systems because a software fault prevents the tube current modulation feature from working.

    Product
    AIRO Mobile CT System Model # MobiCT-32
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2178-2018·2018-06-20

    Datascope Recalls Maquet Cardiopulmonary Bypass Custom Tubing Kits

    Datascope Corporation is recalling 10 units of Maquet Cardiopulmonary Bypass Custom Tubing kits because the over-pressure safety valve may fail to allow flow.

    Product
    Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product cons
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2120-2018·2018-06-13

    Orthofix Locking Screws Recalled for Failure to Engage Plates

    Orthofix, Inc. is voluntarily recalling locking screws from the Rival Reduce Fracture Plating System and Rival View Plating System because they were confirmed to not properly engage plates during surgery.

    Product
    Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (002-E-20008); b) D 2.0MM X 10MM (002-E-20010); c) D 2.0MM X 12MM (002-E-20012); d) D 2.0MM X 14MM (002-E-20014); e) D 2.0MM X 16MM (002-E-20016); f) D 2.0
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2119-2018·2018-06-13

    Orthofix Non-Locking Screws Recalled Due to Failure to Engage Plates

    Orthofix, Inc. is voluntarily recalling specific non-locking screws from the Rival Reduce Fracture Plating System and Rival View Plating System because they failed to properly engage plates during surgery.

    Product
    Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (0002-D-20008); b) D 2.0MM X 10MM (002-D-20010); c) D 2.0MM X 12MM (002-D-20012); d) D 2.0MM X 14MM (002-D-20014); e) D 2.0MM X 16MM (002-D-20016); f) D 2.0MM X 18MM
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0709-2018·2018-03-07

    Siemens Medical Solutions Recalls Wireless Foot Switches for X-Ray Systems

    Siemens Medical Solutions is recalling wireless foot switches for Artis Q and Q.zen fluoroscopic systems because they may fail to release radiation due to external impacts.

    Product
    Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
    Category
    Medical Device
    Distribution
    52 states
  • ModerateFDA (Devices)·Z-0711-2018·2018-03-07

    Siemens Axiom Artis Fluoroscopic Foot Switch Recalled for Potential Failure

    Siemens is recalling 142 Axiom Artis fluoroscopic foot switches that may fail to release radiation due to external impacts.

    Product
    Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0688-2018·2018-02-28

    Merit Medical Recalls Prelude SNAP Splittable Sheath Introducers

    Merit Medical Systems is voluntarily recalling specific lots of Prelude SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub.

    Product
    PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PLS-2510.5, PLSH-1006, PLSH-1009, PLSX-1006, PLSX-1007, PLSX-1
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0529-2018·2018-02-14

    Angiodynamics Recalls Accu2i pMTA Microwave Tissue Ablation Applicators

    Angiodynamics is recalling Accu2i pMTA Microwave Tissue Ablation Applicators because coolant ingress may prevent the device from delivering the desired microwave energy.

    Product
    Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (UPN) H787900600US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0526-2018·2018-02-14

    Angiodynamics Recalls Accu2i pMTA Microwave Tissue Ablation Applicators

    Angiodynamics, Inc. is recalling Accu2i pMTA Microwave Tissue Ablation Applicators because coolant ingress may prevent the device from delivering desired microwave energy.

    Product
    Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN) H7879006000, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0472-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted during rework, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 13MM X 280MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0456-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent the set screw and sleeve assembly from staying in place.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 9MM X 340MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0432-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 11MM X 280MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0455-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced set screws and sleeves, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0474-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 units of Affixus Hip Fracture Nails because a manufacturing rework process may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 13MM X 440MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0421-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 units of Affixus Hip Fracture Nails because set screws and sleeves may have shifted during rework, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, 125 DEG 9MM X 180MM
    Category
    Medical Device
    Distribution
    Distributed nationwide