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.

626–650 of 1800

  • HighCPSC·23190·2023-04-27

    Black Diamond Recon LT Avalanche Transceivers Recalled for Communication Loss Risk

    Black Diamond is recalling about 1,550 Recon LT avalanche transceivers because they can unexpectedly enter search mode due to beacon interference, potentially failing to transmit a skier's position during an avalanche rescue.

    Product
    Recon LT Avalanche Transceivers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1399-2023·2023-04-26

    Tobii Dynavox TD I-110 Speech Device Recalled Over Loose Battery Risk

    The FDA is recalling the Tobii Dynavox TD I-110, a speech-generating device, because the battery may become loose from its housing and potentially be damaged. This affects users worldwide who depend on this device for communication.

    Product
    Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1408-2023·2023-04-26

    Medtronic SenSight Extension Tunneler Kit: manufacturing defect prevents dual-extension passage

    Medtronic recalled approximately 1414 SenSight Extension Tunneler Kits due to a manufacturing defect where dual carriers were machined on only one side, preventing use for passing two extensions simultaneously.

    Product
    Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of extensions for deep brain stimulation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1379-2023·2023-04-19

    Swan-Ganz Thermodilution Catheter May Bend and Cause Monitor Error

    Edwards Lifesciences is recalling Swan-Ganz CCOmbo V thermodilution catheters because the distal end may bend beyond its intended curvature, potentially causing the patient monitoring device to display an error message.

    Product
    Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm)
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-1380-2023·2023-04-19

    Thermodilution Catheter May Bend During Use, Causing Monitor Errors

    Edward Lifesciences Swan-Ganz thermodilution catheters may bend during use, potentially causing patient monitoring devices to display error messages. The FDA has recalled 326 affected units distributed nationwide.

    Product
    Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 8.5F (2.8 mm)
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-1343-2023·2023-04-12

    Stryker Color Cuff Tourniquet Cuff pressure failure recall

    Stryker is recalling 1,730 units of Color Cuff Non-Sterile Tourniquet Cuffs due to failures in achieving and maintaining pressure during setup, which could result in operative site blood loss or hemorrhage.

    Product
    Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1312-2023·2023-04-05

    Defibtech DDU-100 Lifeline AED Recalled for Untested Component Risk

    Defibtech is recalling 29 units of the DDU-100 Lifeline AED due to an untested component that could cause device failure. The affected device may not deliver therapy if a malfunction occurs.

    Product
    DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1279-2023·2023-03-29

    Cardiosave IABP Pneumatic Interface Module Recalled for Performance Issue

    Datascope Corp. recalls the Cardiosave IABP Pneumatic Interface Module due to a Safety Disk performance issue that may reduce balloon inflation. Ten specific units with identified serial numbers are affected.

    Product
    Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM) , Model Number 0997-00-1178
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1277-2023·2023-03-29

    Cardiosave Hybrid Intra-Aortic Balloon Pump Performance Issue Recall

    Datascope Corp. is recalling specific Cardiosave Hybrid intra-aortic balloon pumps due to a Safety Disk performance issue that may reduce balloon inflation and therapeutic benefit.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1230-2023·2023-03-15

    Cardiosave Rescue IABP Helium Regulator Failures May Impair Function

    Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to helium regulator failures that may cause insufficient helium levels when the pump console is docked. The defect may affect device operation.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1228-2023·2023-03-15

    Tri-Staple 2.0 Surgical Stapler Reloads Recalled for Malfunction Risk

    Covidien is recalling certain Tri-Staple 2.0 surgical stapler reloads due to a mechanical defect that may cause the device to malfunction during surgery. Affected units may fail to form staples properly, potentially causing serious surgical complications.

    Product
    Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1229-2023·2023-03-15

    Cardiosave Hybrid Intra-Aortic Balloon Pump recalled for helium regulator failure

    Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pump models due to helium regulator failures that may prevent proper device operation and replenishment.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-08
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1191-2023·2023-03-08

    Stryker Hoffmann LRF Transport Strut Locking Mechanism Recall

    Stryker is recalling Hoffmann LRF Transport Strut devices due to oversized thread pitch that prevents the distal ring fixation from locking, affecting 488 units nationwide.

    Product
    stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achieved
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1098-2023·2023-02-15

    Zimmer Identity Shoulder Resection Planer Units Recalled for Malfunction

    Zimmer, Inc. is recalling 84 units of the Identity Shoulder System Resection Planer due to defects discovered during training testing. Some units are unusable, potentially affecting surgical performance in shoulder procedures.

    Product
    Identity Shoulder System Resection Planer 35mm Resection Planer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1102-2023·2023-02-15

    Smart Correction External Fixation Struts: Collar Release Pin May Back Out

    The collar release pin on affected Smart Correction Dual Joint Express Struts may back out, preventing proper length adjustment and potentially delaying surgical correction.

    Product
    WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-080095-0 XS 10-702-095115-0 Short 10-702-115150-0 Medium 10-702-140200 Long 10-702-190300-0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1103-2023·2023-02-15

    Thoracic Navigation System Recalled for Incorrect Cable Causing Grainy Imaging

    Olympus is recalling the SPiN Thoracic Navigation System (model SYS-4000) due to an incorrect DVI cable that produces grainy images during bronchoscopy procedures, requiring extended troubleshooting time.

    Product
    SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1027-2023·2023-02-08

    Temperature Monitoring Adapter Detachment in Cardiopulmonary Bypass Oxygenators

    Medtronic is recalling cardiopulmonary bypass equipment because the Temperature Monitoring Adapter can come loose during setup or disassembly, potentially compromising temperature monitoring during heart surgery.

    Product
    Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1040-2023·2023-02-08

    Siemens Fluoroscopic X-ray Systems Risk of Boot Failure After Shutdown

    Certain Siemens fluoroscopic X-ray systems may only boot into backup mode after an abrupt shutdown, preventing full operation. This could necessitate cancelling or switching to alternative treatment systems.

    Product
    System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 108
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1024-2023·2023-02-08

    Affinity Fusion Oxygenator temperature monitoring adapter may loosen during cardiac surgery

    The temperature monitoring adapter on Medtronic's Affinity Fusion Oxygenator may come loose during cardiopulmonary bypass procedures. The manufacturer has received multiple complaints about this issue.

    Product
    Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1022-2023·2023-02-08

    SynCardia Total Artificial Heart System Recalled for Cannula Tears

    SynCardia Systems is recalling its Total Artificial Heart System due to reported tears in the cannula caused by wear and tear stress. Approximately 1,732 systems worldwide are affected.

    Product
    SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1050-2023·2023-02-08

    Ultrasound system hard drive defect causes device freezing and failure

    FDA recall of NovaGuide Intelligent Ultrasound System due to faulty hard drive causing device freezing and eventual system failure.

    Product
    NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and Lucid TCD 2.0 Transcranial Doppler Ultrasound (Model: NA-LUCM1)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1006-2023·2023-02-01

    FUSION Dual Pump Packs recalled for weld defect affecting surgery

    FUSION Dual Pump Packs are being recalled for weld defects that may impair vacuum delivery during eye surgery, risking surgical delays and corneal swelling. No injuries have been reported.

    Product
    FUSION Dual Pump Packs, REF: OPO73
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0991-2023·2023-01-25

    Cardinal Health Jackson-Pratt Surgical Drains Recalled for Performance Defects

    Cardinal Health is recalling 1920 Jackson-Pratt Channel Drains (15 Fr, model JP-2233) distributed worldwide due to multiple reported performance issues including lack of radiopacity, dull trocars, reduced flexibility, and broken wound tips.

    Product
    Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0924-2023·2023-01-18

    Pediatric Craniotome Recalled for Ball Bearing Detachment Risk

    The Anspach Effort, Inc. is recalling 6,059 Pediatric Craniotome units (CRANI-P-G1) because ball bearings in the CRANI-A attachment may detach during surgery, potentially causing serious patient injury.

    Product
    Pediatric Craniotome Ref:CRANI-P-G1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0913-2023·2023-01-18

    Medtronic Neurostimulation Programmer Software Errors Affect 18 Devices

    Medtronic is recalling 18 units of its Vanta/Seqenita LT Clinician Programmer Application due to software anomalies causing error messages that may prevent proper operation.

    Product
    Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C
    Category
    Medical Device
    Distribution
    0 states