The Recall Desk

Hazard

Device Failure recalls

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

What the numbers show

Total
881
Critical
30
Severe
255
Most recent
2026-09-02

Of the 881 device failure recalls we have scored against our rubric, 30 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (29%) 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 device 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.

301–325 of 881

  • HighFDA (Devices)·Z-0666-2021·2020-12-30

    Boston Scientific Recalls IceRod Cryoablation Needles Due to Gas Leaks

    Boston Scientific is recalling 4,645 IceRod 1.5 PLUS 90° Cryoablation Needles nationwide because of a complaint trend regarding needle shaft gas leaks.

    Product
    IceRod" 1.5 PLUS 90¿ Cryoablation Needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0544-2021·2020-12-16

    Philips IntelliVue X2 Multi Measurement Server Speaker Failure Recall

    Philips is recalling 16 IntelliVue X2 Multi Measurement Servers because speaker failures may prevent audible alarms, potentially delaying patient treatment.

    Product
    Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport insi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0516-2021·2020-12-09

    Medtronic MiniMed 670G Insulin Pumps Recalled for Battery Connection Defect

    Medtronic is recalling 391 MiniMed 670G insulin pumps because a missing solder battery connection could interrupt power to the device.

    Product
    MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and detecting possible low and high glucose episodes. When using a sensor and transmitter,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0517-2021·2020-12-09

    Medtronic MiniMed 630G Insulin Pump Recalled for Battery Connection Defect

    Medtronic is recalling 206 MiniMed 630G insulin pumps due to a missing solder battery connection that could interrupt power.

    Product
    MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K, MMT-1755K - Product Usage: intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0463-2021·2020-11-25

    Medicrea Ligapass Tension Pulley Handle Recalled for Band Breakage Risk

    Medicrea International is recalling Ligapass Tension Pulley Handles because the instrument can crush the band, causing it to break during surgery and leading to infection risk.

    Product
    MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for degenerative pathologies Ref : A08200200
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0431-2021·2020-11-18

    Stryker Recalls Cranial Perforators Due to Potential Metal Fragment Risk

    Stryker is recalling Zyphr Disposable Cranial Perforators because a crack in the inner bit could release metal fragments into the surgical site or cause delayed disengagement.

    Product
    Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. Catalog Number: 5100-060-001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0427-2021·2020-11-18

    Boston Scientific AMS 700 MS Pump Recall for Activation Difficulties

    Boston Scientific is recalling AMS 700 MS Pumps due to reports of difficulty activating the device to inflate cylinders.

    Product
    AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0284-2021·2020-11-04

    Philips Recalls Sterilizable Defibrillator Paddles Due to Undetected Failure Mode

    Philips is recalling 8,942 sterilizable defibrillator paddles because standard checks may miss a specific failure mode. An updated test procedure is available to detect the issue.

    Product
    Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent pat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0285-2021·2020-11-04

    Philips Recalls Sterilizable Defibrillator Paddles Due to Undetected Failure Mode

    Philips is recalling 2,202 sterilizable defibrillator paddles because standard periodic checks may fail to detect a specific failure mode in switchless internal models.

    Product
    Philips Sterilizable Defibrillator Paddles, Switchless Internal Paddles, Model Numbers M1741A, M1742A, M1743A, M1744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0088-2021·2020-10-28

    Medtronic Recalls Rashkind Balloon Septostomy Catheters Due to Field Failures

    Medtronic Vascular is recalling 711 units of Rashkind Balloon Septostomy Catheters due to subsequent field failures and failed quality testing.

    Product
    Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007160 GTIN: 00613994760265 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a tre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0087-2021·2020-10-28

    Medtronic Rashkind Balloon Septostomy Catheter Recall for Quality Failures

    Medtronic Vascular is recalling Rashkind Balloon Septostomy Catheters due to field failures and failed quality testing. The recall covers 2,356 units distributed worldwide.

    Product
    Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen Product number: 008764 GTIN: 00613994760289 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0089-2021·2020-10-28

    Medtronic Vascular Recalls Rashkind Balloon Septostomy Catheters Due to Field Failures

    Medtronic Vascular is recalling 505 units of Rashkind Balloon Septostomy Catheters due to subsequent field failures and failed quality testing.

    Product
    Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen Product number: 007161 GTIN: 00613994760272 The Rashkind balloon septostomy catheters are designed for creating an atrial septal defect or enlarging an existing atrial septal defect as a tre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0097-2021·2020-10-21

    Biomet Recalls RingLoc Hip Cups Due to Double Sterilization

    Biomet is recalling 48 RingLoc Bi-Polar Hip System Acetabular Cups because they were gamma sterilized twice, which may compromise functionality and shelf life.

    Product
    (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930 (2) RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup, Ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0054-2021·2020-10-14

    Luminex VERIGENE Processor SP Recalled for Heater Failure

    Luminex is recalling one VERIGENE Processor SP system in Missouri due to a hybridization heater failure that may cause incorrect test results.

    Product
    VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2986-2020·2020-09-30

    LivaNova Recalls Perceval Single Use Accessory Kits Due to Collapse Failure

    LivaNova is recalling 102 Perceval Single Use Accessory Kits because the Dual Collapser component may fail to reduce the heart valve diameter, preventing implantation.

    Product
    Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2988-2020·2020-09-30

    LivaNova Recalls Perceval Dual Collapser Due to Valve Collapse Failure

    LivaNova is recalling specific lots of the Perceval Dual Collapser because complaints indicate the device may fail to collapse the heart valve during implantation.

    Product
    Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2985-2020·2020-09-30

    LivaNova Recalls Perceval Single Use Accessory Kits Due to Collapse Failure

    LivaNova is recalling 94 Perceval Single Use Accessory Kits because the Dual Collapser component may fail to reduce the heart valve diameter, preventing implantation.

    Product
    Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only, CE, UDI: 8022057015228 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2987-2020·2020-09-30

    LivaNova Recalls Perceval Single Use Accessory Kits Due to Collapse Failure

    LivaNova is recalling specific lots of Perceval Single Use Accessory Kits because the Dual Collapser component may fail to reduce the heart valve diameter during implantation.

    Product
    Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, CE, UDI: 8022057015259 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2954-2020·2020-09-23

    Integra Padgett Dermatome Set Recalled Due to Cable Melting

    Integra LifeSciences is recalling 13 dermatome sets because the handpiece cable melts after sterilization, posing a risk to patients and staff.

    Product
    Integra Padgett Dermatome Set - Product Usage: are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. These instruments are intended only for professional use in hospitals and similar medical facilities, where the patient will be unde
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2950-2020·2020-09-16

    Intuitive Surgical Recalls ION Reprocessing Accessories Kit Due to Catheter Failure Risk

    Intuitive Surgical is recalling 27 units of the ION Reprocessing Accessories Kit because the catheter reprocessing cover may disengage, causing chemical retention and system failure.

    Product
    ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129. The kit includes an ION Catheter Reprocessing Cover (Part Number: 490114-02).
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2949-2020·2020-09-16

    Intuitive Surgical Recalls Ion Catheter Reprocessing Covers

    Intuitive Surgical is recalling 67 Ion Catheter Reprocessing Covers because they may fail to engage correctly, potentially causing catheter or system failure.

    Product
    Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2921-2020·2020-09-09

    Siemens Sensis Vibe Hemo System Recalled for Connector Defect

    Siemens is recalling 110 Sensis Vibe Hemo systems because a connector may break, potentially causing the device to stop functioning and lose vital signs.

    Product
    Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2901-2020·2020-09-02

    Neurovision Nerveana x5 RLN Monitoring Kit Recalled for Insulation Defect

    Neurovision Medical Products Inc. is recalling Nerveana x5 RLN Monitoring Kits because the electrode insulating material may soften, potentially stopping EMG signal transmission and rendering the device unusable.

    Product
    Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKIT-C7-5, RxOnly, Sterile, UDI: B006NvtKITc752/$$7062818C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an ope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2900-2020·2020-09-02

    Neurovision Nerveana x5 RLN Monitoring Kit Recalled for Insulation Defect

    Neurovision is recalling Nerveana x5 RLN Monitoring Kits because the electrode insulating material may soften, potentially stopping EMG signal transmission and rendering the device unusable.

    Product
    Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx Only, Sterile, UDI: B006NVTKITC652/$$7061918A - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2759-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Failure

    Boston Scientific is recalling Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide
    Category
    Medical Device
    Distribution
    0 states