The Recall Desk

Hazard

Device Malfunction recalls

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

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.

151–175 of 877

  • HighFDA (Devices)·Z-0144-2026·2025-10-22

    LGX Preconnect TENACIO Pump Devices Recalled for Inflation and Deflation Issues

    Boston Scientific is recalling LGX Preconnect with TENACIO Pump devices that may experience inflation or deflation performance problems. Approximately 490 units were distributed to the US and Canada.

    Product
    LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6) 72404456 (15CM IP IZ), (7) 72404457 (18CM IP IZ), (8) 72404458 (21CM IP IZ);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0028-2026·2025-10-15

    NOxBOXi Nitric Oxide Delivery System may cause dose fluctuations under specific conditions

    NOxBOXi Nitric Oxide Delivery Systems may experience dose fluctuations when operating at certain parameters, potentially affecting treatment reliability. The FDA issued a Class I recall affecting 1,667 units.

    Product
    NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0120-2026·2025-10-15

    PERIFIX FX Epidural Anesthesia Tray Recalled for Catheter Connector Positioning Defect

    B Braun is recalling 2,760 units of PERIFIX FX Continuous Epidural Anesthesia Trays due to a potential defect where the catheter connector lid may be positioned incorrectly, which could affect proper catheter connector function.

    Product
    PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFS. Product Description: CE17TKFS EPIDURAL TRAY.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0118-2026·2025-10-15

    Epidural catheter connector lid may be in incorrect position

    B. Braun is recalling PERIFIX FX Continuous Epidural Anesthesia Trays because the catheter connector lid may be incorrectly positioned. The product was distributed nationwide.

    Product
    PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFSDT. Product Description: CE17TKFSDT EPID TRAY W/17GA FIXED WING.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0129-2026·2025-10-15

    NutraGlide Nasal Feeding Tubes recalled due to distal tip detachment risk

    Applied Medical Technology is recalling 840 units of NutraGlide Nasal Feeding Tubes distributed in Massachusetts and Rhode Island because the distal tips may detach at lower than expected forces.

    Product
    NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2670-2025·2025-10-08

    Medline Catheter Valve Kits Recalled for Shape-Retention Defect

    Medline is recalling 828 units of VALVE PACK-LF catheter kits because the catheter may not retain its shape, potentially causing device malfunction.

    Product
    Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2672-2025·2025-10-08

    Blood pressure monitor may trigger error message during high-pressure inflation

    Schiller's Argus PB-3000 blood pressure monitor may display an error message during measurements when initial inflation pressure is set to high levels. Approximately 266 units were distributed in Montana, Wisconsin, and Illinois.

    Product
    Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2566-2025·2025-10-01

    Medline intubation kit laryngoscope handles recalled for light illumination failure

    Medline is recalling specific intubation kits with Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to light illumination failure. The handles may not illuminate properly, potentially affecting visibility during intubation procedures.

    Product
    Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATION TRAY, Kit Number ACC010379A; 3. INTUBATION TRAY, Kit Number ACC010392; 4. INTUBATION KIT, Kit Number ACC010467A; 5. ADULT AIRWAY TRAY, Kit Number ACC01
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2568-2025·2025-10-01

    Impella Heart Assist Controller Units Recalled for Potential Pump Stop

    Abiomed is recalling 71 Impella heart assist pump controllers with a defective pump driver circuit assembly that may cause decreased pump performance or pump stop, triggering failure alarms.

    Product
    Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 2. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 3. Impella Controller, Package
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2624-2025·2025-10-01

    Medical imaging system recalled due to component deterioration affecting motorized positioning

    Philips Allura Xper FD10/10 X-ray systems may lose motorized positioning due to internal component deterioration. Manual positioning and imaging functions remain available.

    Product
    Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2627-2025·2025-10-01

    Philips Allura Xper FD20 Biplane System Motorized Component Deterioration

    Philips Allura Xper FD20 biplane X-ray systems may experience deterioration of internal components, causing loss of motorized movements. Manual movements and imaging functionality remain available.

    Product
    Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2586-2025·2025-09-24

    Heartstring III Proximal Seal System Recalls Due to Deployment and Hemostasis Failures

    The FDA is recalling the Heartstring III Proximal Seal System due to failures in loading, deploying, or providing hemostasis during aortotomy closure. Affected devices may not properly seal, creating a risk of bleeding during cardiac surgery.

    Product
    Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2561-2025·2025-09-24

    Exactech Equinoxe Reverse Shoulder Humeral Liners Recalled for Dimensional Defect

    Exactech is recalling Equinoxe Reverse Shoulder Humeral Liners due to articular surface positioning outside manufacturing specifications. Approximately 61,334 units distributed worldwide may be affected.

    Product
    Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2588-2025·2025-09-24

    Heartstring III Proximal Seal System Recall Due to Device Failure Risks

    Maquet Cardiovascular is recalling the Heartstring III Proximal Seal System (4.3 MM) due to three failure modes: failure to load, deploy, or provide adequate hemostasis. Healthcare providers should contact the manufacturer for guidance.

    Product
    Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2536-2025·2025-09-17

    Boston Scientific UroMax Ultra Kit inflation devices recalled for foreign material contamination

    Boston Scientific is recalling 1,369 UroMax Ultra Kit inflation devices worldwide due to potential migration of foreign material particles into balloon dilation catheters.

    Product
    Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. M0062251230, 5. M0062251240, 6. M0062251260, 7. M0062251290, 8. M0062251300, 9. M0062251310. 10. M0062251350, 11. M0062251360, 12. M0062251370.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2556-2025·2025-09-17

    Spinal fusion punch awl instruments recalled due to field failure

    Omnia Medical is recalling the TiBrid Stand Alone spinal fusion punch awl instruments due to failure in the field. The recall involves 15 units distributed in Arizona, California, New Jersey, Nevada, Oklahoma, and Washington.

    Product
    TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2544-2025·2025-09-17

    Internal Pump Failure in NOxBOXi Nitric Oxide Delivery Systems

    NOXBOX LTD is recalling 1,667 NOxBOXi Nitric Oxide Delivery Systems due to high failure rates of the internal pump. Affected units require pump replacement.

    Product
    NOxBOXi Nitric Oxide Delivery System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2550-2025·2025-09-17

    ICEfx Cryoablation System recalls: loose desiccant tube end caps

    Boston Scientific is recalling certain ICEfx Cryoablation System units worldwide due to desiccant tube end caps that were not correctly tightened during manufacturing.

    Product
    ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2554-2025·2025-09-17

    Reef TA Inserter may fail to disengage properly during spinal surgery

    SeaSpine Orthopedics is recalling 74 Reef TA Inserters due to potential difficulty disengaging the device during spinal fusion surgery, which may require surgical revision and alternate instrumentation.

    Product
    Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2480-2025·2025-09-10

    Medtronic DLP Left Heart Vent Catheter May Not Retain Shape

    Medtronic is recalling 34,549 DLP Left Heart Vent Catheters (Model 12113) because the catheters may not retain their shape. The defect affects devices distributed worldwide and could compromise catheter function during cardiac surgery.

    Product
    DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2482-2025·2025-09-10

    DLP Left Heart Vent Catheter May Not Retain Shape During Use

    Medtronic is recalling 25,261 DLP Left Heart Vent Catheters (Model 12115) because they may not retain their shape. This Class I recall affects catheters distributed worldwide and in the US.

    Product
    DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2481-2025·2025-09-10

    DLP Left Heart Vent Catheter Recalled for Loss of Shape Retention

    Medtronic is recalling DLP Left Heart Vent Catheters (Model 12110) because they may not retain their shape during use. This defect could affect device function in cardiac surgical procedures.

    Product
    DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2503-2025·2025-09-10

    Philips Allura Imaging Systems May Shut Down During Power Loss Events

    Philips Allura medical imaging systems configured with certain power supplies may shut down or fail to start if power is lost, potentially disrupting patient care. Affected facilities should contact Philips to verify configuration and arrange remediation.

    Product
    Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2415-2025·2025-09-03

    Spectrum IQ Infusion Pumps Recalled for Potential Lubricant Failure

    Baxter is recalling six Spectrum IQ Infusion Pumps distributed to Arizona and Florida due to potential grease breakdown in the motor mechanism, which could result in excessive medication delivery.

    Product
    Spectrum IQ Infusion Pump, Product Code 3570009
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2421-2025·2025-09-03

    Dental Prosthetics Device Atlantis IO FLO-S Recalled for Thread Engagement Defect

    The Atlantis IO FLO-S dental prosthetics device has a defect preventing proper thread engagement with dental implants. Threads engage only about 2 rotations instead of the required 5, resulting in approximately 1mm less depth of engagement.

    Product
    Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure wit
    Category
    Medical Device
    Distribution
    Distributed nationwide