The Recall Desk

Hazard

Device Malfunction recalls

1,800 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1,800
Critical
31
Severe
370
Most recent
2026-09-02

Of the 1,800 device malfunction recalls we have scored against our rubric, 31 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 370 (21%) 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 malfunction 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.

726–750 of 1800

  • HighFDA (Devices)·Z-0906-2022·2022-04-20

    Integra Universal Flexible Arm Recall: Internal Cable May Break

    Integra LifeSciences is recalling the Universal Flexible Arm (part number REF 1362275) because excess tightening force can break the internal cable at the tip, rendering the device unusable.

    Product
    Integra Universal Flexible Arm part number REF 1362275
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0893-2022·2022-04-13

    SPECT/CT Imaging Systems Recalled Due to Defective Balancing Weight Bolts

    Siemens is recalling seven Symbia Intevo SPECT/CT imaging systems due to a quality defect in the bolts that secure the CT balancing weights, which could create a safety issue.

    Product
    Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0881-2022·2022-04-13

    Philips HeartStart HS1 AED Pads: Potential Gel Separation Defect

    Philips is recalling adult Smart PADS cartridges for HeartStart HS1 defibrillators due to potential gel separation from the pad backing. Affected pads may have reduced gel contact, potentially affecting device performance.

    Product
    Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0885-2022·2022-04-13

    SyncVision Systems cardiac imaging measurement error in same-session workflow

    SyncVision cardiac imaging systems may display incorrect measurements during same-session procedures if workflow steps are performed out of order, potentially affecting patient treatment.

    Product
    SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-0836-2022·2022-04-06

    Revogene diagnostic device recalled for photomultiplier tube malfunction

    Meridian Bioscience is recalling Revogene diagnostic devices due to compromised photomultiplier tubes that may produce false-positive or indeterminate test results.

    Product
    Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Catalog Number 130840
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0854-2022·2022-04-06

    Illumina NextSeq 550Dx DNA Analyzer Recalled for Short Circuit Risk

    Illumina is recalling 674 NextSeq 550Dx DNA sequence analyzers worldwide. A short circuit may occur after reconnecting circuit components, causing the device to become inoperable.

    Product
    Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0827-2022·2022-04-06

    Hand Pendant Malfunction in Proton Therapy Systems Poses Patient Injury Risk

    Mevion S250 and S250i Proton Therapy Systems hand pendants may malfunction, causing unintended motion of the therapy couch and nozzle. This poses a risk of patient injury if they contact moving equipment.

    Product
    Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0813-2022·2022-03-30

    Outset Tablo Hemodialysis Console Recalled for Heat Damage Risk

    Outset Medical is recalling Tablo hemodialysis consoles (models PN-0003000 and PN-0006000) nationwide due to a component that may cause heat-related damage to the device.

    Product
    Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0794-2022·2022-03-23

    FDA Recalls SAFE-T PLUS Lumbar Puncture Trays for Device Malfunction

    Bard Peripheral Vascular is recalling 49,760 SAFE-T PLUS lumbar puncture trays for adults due to manometer leaking and mating issues. Healthcare providers should discontinue use and contact the manufacturer.

    Product
    SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0791-2022·2022-03-23

    Lumbar Puncture Tray Pediatric Recalled Due to Manometer Failure

    Bard Peripheral Vascular Inc is recalling pediatric lumbar puncture trays due to manometer leaking and mating failures that could prevent proper pressure measurement during procedures.

    Product
    LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0793-2022·2022-03-23

    Adult Lumbar Puncture Drug Free Tray Recalled for Manometer Leaking

    Bard Peripheral Vascular Inc is recalling 1,260 Adult Lumbar Puncture Drug Free Trays due to manometer leaking and mating issues that could affect device function.

    Product
    ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0797-2022·2022-03-23

    Lumbar Puncture Tray Devices Recalled for Manometer Leaking and Mating Issues

    Bard Peripheral Vascular Inc. recalls SAFE-T PLUS lumbar puncture trays due to manometer leaking and mating issues affecting device function. The FDA Class II recall covers 15,650 devices distributed nationwide and internationally.

    Product
    SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0626-2022·2022-02-23

    Arrow-Trerotola Percutaneous Thrombolytic Device Kits Recalled for Tip Separation

    Teleflex is recalling Arrow-Trerotola Percutaneous Thrombolytic Device kits worldwide due to reports of tip separation during use, affecting approximately 1,874 units.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65709-HS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits me
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0624-2022·2022-02-23

    Teleflex Arrow-Trerotola Percutaneous Thrombolytic Device PTD Kit recalled for tip separation

    Teleflex recalls approximately 1,400 Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) kits due to reports of tip separation during use. The medical device is used for dialysis graft declotting and has been distributed worldwide.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0623-2022·2022-02-23

    Arrow-Trerotola Thrombolytic Device Tip Separation During Use Recalled

    Teleflex Medical is recalling Arrow-Trerotola PTD kits due to reports of tip separation during use. The affected device is used for declotting dialysis grafts and fistulae.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0653-2022·2022-02-23

    Smiths Medical Medfusion Syringe Infusion Pumps Recalled for Alarm System Failures

    Smiths Medical is recalling certain Medfusion syringe infusion pumps due to intermittent alarm system failures that may occur during power-on self-tests outside the warranty period.

    Product
    Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and G6002728
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0649-2022·2022-02-23

    Wireless Foot Switch Firmware Issue in Philips Veradius Unity Devices

    The wireless foot switch in Philips Veradius Unity medical systems can lose function due to a firmware issue. This could cause delays or interruption of medical procedures if alternative input methods are not used.

    Product
    Veradius Unity, Model #718132
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0647-2022·2022-02-23

    Wireless Foot Switch May Stop Responding During Medical Procedures

    Philips is recalling Zenition 50 wireless foot switches (Model #718096) because a firmware issue can cause them to suddenly stop responding, potentially delaying medical procedures.

    Product
    Zenition 50, Model #718096
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0548-2022·2022-02-09

    INTEGRA SURFIX ALPHA Torx 10 Screwdriver Out of Specification Recalled

    Smith & Nephew recalls INTEGRA SURFIX ALPHA Screwdriver Torx 10 units because they are out of specification and may not mate properly with the Surfix Alpha Lock screw.

    Product
    INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0526-2022·2022-02-02

    Footrest accessory recalled for missing friction rubber block

    FDA recalls Intelli-C footrest accessories due to missing friction rubber blocks in the clamping mechanism. The defect may cause the footrest to slip during use.

    Product
    1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0520-2022·2022-02-02

    GE Vscan Extend Ultrasound Device Battery Power Failure Recall

    GE Healthcare recalls the Vscan Extend portable ultrasound device because the battery may become depleted and prevent the device from powering on if not turned off before battery removal or when used without AC power.

    Product
    GE Vscan Extend, being sold as "Vscan Extend Dual USB"
    Category
    Medical Device
    Distribution
    50 states
  • ModerateFDA (Devices)·Z-0523-2022·2022-02-02

    GE Vscan Extend portable ultrasound may not power on due to battery depletion

    GE Healthcare is recalling GE Vscan Extend portable ultrasound devices that may fail to power on if not turned off before battery removal or when connected to a computer without AC power.

    Product
    GE Vscan Extend, being sold as "Vscan Extend Sector USB"
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-0495-2022·2022-01-19

    LigaSure Blunt Tip Laparoscopic Sealer Devices Recalled for Jaw Opening Defect

    Covidien is recalling LigaSure Blunt Tip Laparoscopic Sealer/Divider devices (lot 11320187X) due to an assembly defect that may prevent the device jaws from opening after tissue application, creating a risk of bleeding and tissue injury.

    Product
    LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0458-2022·2022-01-12

    UROMEDICA Implantation Instrument Sheath May Damage ProACT Implants

    Uromedica is recalling nonsterile implantation instrument sheaths (Lot UM00794 and UM00817) because the U-channel sheaths may damage ProACT implant devices during implantation procedures. Affected devices were distributed nationwide.

    Product
    UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0463-2022·2022-01-12

    Abbott Alinity m System camera firmware installation issue

    Abbott Molecular is recalling 74 Alinity m Systems due to an issue with the installation of updated camera firmware. Affected devices were distributed in the United States and internationally.

    Product
    Alinity m System, Part No. 08N53-002
    Category
    Medical Device
    Distribution
    16 states