The Recall Desk

Hazard

Device Defect recalls

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

What the numbers show

Total
450
Critical
11
Severe
45
Most recent
2026-08-26

Of the 450 device defect recalls we have scored against our rubric, 11 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 45 (10%) 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 defect 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.

226–250 of 450

  • HighFDA (Devices)·Z-2674-2020·2020-07-29

    Boston Scientific Recalls IcePearl Cryoablation Needles Due to Surface Deterioration

    Boston Scientific is recalling IcePearl 2.0 CX 90 Cryoablation Needles because the needle surface deteriorated due to unexpected electrolysis during procedures.

    Product
    Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2676-2020·2020-07-29

    Boston Scientific Recalls IcePearl Cryoablation Needles Due to Surface Deterioration

    Boston Scientific is recalling 48 IcePearl 2.1 CX Cryoablation Needles because the needle surface deteriorated due to unexpected electrolysis during procedures.

    Product
    Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2682-2020·2020-07-29

    Boston Scientific Recalls IcePearl Cryoablation Needles Due to Surface Deterioration

    Boston Scientific is recalling 205 IcePearl 2.1 CX Cryoablation Needles because the needle surface deteriorated due to unexpected electrolysis during procedures.

    Product
    Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2677-2020·2020-07-29

    Boston Scientific Recalls IceFORCE 2.1 CX Cryoablation Needles

    Boston Scientific is recalling 39 IceFORCE 2.1 CX Cryoablation Needles because the needle surface deteriorated due to unexpected electrolysis during procedures.

    Product
    Ablation Galil Technology, IceFORCE 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2655-2020·2020-07-29

    Carefusion Safe-T Thora-Para Tray Recalled Due to Potential Air Leak

    Carefusion 2200 Inc is recalling Safe-T 8 Fr Thora-Para Trays because internal valve leaks may introduce up to 30cc of air into patients.

    Product
    Safe-T 8 Fr Thora-Para Tray With 8 Fr. Catheter and Sharps Injury Protection - Drug Free
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2646-2020·2020-07-29

    Carefusion Thora-Para Catheter Drainage Tray Recalled for Valve Leakage

    Carefusion 2200 Inc is recalling Thora-Para 5 Fr Non-Valved Catheter Drainage Trays because internal valve leaks may introduce up to 30cc of air into patients.

    Product
    Thora-Para 5 Fr Non-Valved Catheter Drainage Tray
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2680-2020·2020-07-29

    Boston Scientific Recalls Prostate Cryoablation Kits Due to Needle Deterioration

    Boston Scientific is recalling 88 Prostate Cryoablation Kits because needle surfaces deteriorated during procedures due to unexpected electrolysis.

    Product
    Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2681-2020·2020-07-29

    Boston Scientific Recalls Prostate Cryoablation Kits Due to Needle Surface Deterioration

    Boston Scientific is recalling 71 IceFORCE 2.1 Prostate Cryoablation Kits because needle surfaces deteriorated due to unexpected electrolysis during procedures.

    Product
    Ablation Galil Technology, Three IceFORCE 2.1 Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2615-2020·2020-07-22

    Skeletal Kinetics Recalls Osteovation RMX Bone Void Filler Kits

    Skeletal Kinetics is recalling Osteovation RMX bone void filler kits because they may not maintain setting characteristics for the labeled shelf life, potentially increasing surgical time or causing bone formation issues.

    Product
    OSTEOVATION RMX 10CC. Product Number: 390-6002, UDI: 813845021099 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from tra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2604-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits

    Skeletal Kinetics is recalling 35 units of Craniosculpt Flow bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    CRANIOSCULPT FLOW, OUS, 5CC Product Number: C-FLOW5CC-OUS, UDI: 813845020351 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects creat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2532-2020·2020-07-15

    Bound Tree Medical Recalls Ambu King LTS-D Supraglottic Airway Kits

    Bound Tree Medical is recalling 167 Ambu King LTS-D Supraglottic Airway Kits because they contain an incompatible catheter-tip syringe that may prevent the airway balloon from inflating properly.

    Product
    Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Part Number: KLTSD404K Curaplex Ambu¿ King LTS-D" Supraglottic Airway Kit with ET Tube (hereafter the Kit which contains all of the components necessary to successfully obtain an open patient airway with an Ambu¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2391-2020·2020-06-24

    Medtronic Bone Void Filler Recalled for Potential Setting Defects

    Medtronic is recalling 6 units of Bone Void Filler, Large, because the product may not maintain its setting characteristics for the labeled shelf-life.

    Product
    Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2103-2020·2020-06-03

    Cardinal Health Recalls Kangaroo Epump Safety Screw Spike Sets

    Cardinal Health is recalling Kangaroo Epump Safety Screw Spike sets because they may leak at the tube and spike connector interface.

    Product
    Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2104-2020·2020-06-03

    Cardinal Health Recalls Kangaroo Epump Safety Screw Spike Sets

    Cardinal Health Inc. is recalling Kangaroo Epump Safety Screw Spike Sets because they may leak at the tube and spike connector interface.

    Product
    Kangaroo Epump Safety Screw Spike Set, Anti-free Flow, Product Code 775659
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2102-2020·2020-06-03

    Cardinal Health Recalls Kangaroo Connect ENPlus Spike Sets for Leaking

    Cardinal Health is recalling Kangaroo Connect ENPlus Spike Sets because they may leak at the tube and spike connector interface.

    Product
    Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2043-2020·2020-05-27

    Medline Silicone Foley Catheter Recalled Due to Loose Silicone Particulate

    Medline Industries is recalling specific lots of silicone Foley catheters because loose silicone particulate was found on the device shaft.

    Product
    SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1997-2020·2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Defect

    ICU Medical is recalling 260 units of Central Venous Catheters because the included guidewire cannot pass through the needles.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-23.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1715-2020·2020-04-22

    Smiths Medical Recalls Portex Arterial Blood Sampling Syringes with Broken Luer

    Smiths Medical ASD, Inc. is recalling Portex LineDraw Arterial Blood Sampling Syringes because the luer connectors may be broken.

    Product
    Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-1458-2020·2020-03-18

    Nextremity Solutions Recalls Nextra Hammertoe Correction System Due to Driver Defect

    Nextremity Solutions is recalling 190 units of the Nextra Hammertoe Correction System because the driver may be oversized, making it difficult to remove from the implant.

    Product
    Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments which is indicated for small bone reconstruction limited to inter-digital repair
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1356-2020·2020-03-04

    Zimmer Sterile Disposable Tourniquet Cuff Recalled for Bladder Leak

    Zimmer Surgical Inc is recalling 58 units of sterile tourniquet cuffs because a leak between bladders may cause both to inflate or deflate simultaneously.

    Product
    Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200, UDI (01)00889024377547 (17)230812(10)27968701 The product is a tourniquet - Product Usage: Tourniquets are intended to be used by qualified medical prof
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1134-2020·2020-02-26

    Abbott Vascular Recalls NC TREK Coronary Dilatation Catheters

    Abbott Vascular is recalling NC TREK RX Coronary Dilatation Catheters because the balloon may have difficulty or inability to deflate.

    Product
    NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myo
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0930-2020·2020-02-19

    Tytek Medical Recalls PneumoDart Devices Due to Occluded Needle Defect

    Tytek Medical Inc is recalling 3,565 PneumoDart devices because a defect involving an occluded needle was discovered during a training exercise.

    Product
    PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0978-2020·2020-02-12

    Cook Inc. Recalls Universa Soft Ureteral Stents Due to Wire Guide Loading Error

    Cook Inc. is recalling Universa Soft Ureteral Stents because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.

    Product
    Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940 G49941 G49942 G49945 G49947 G49948 G49949 G49950 G49951 G49953 G49955 G49956 G49957 G49958 G49959 G49961 G53145 G53676 G53677 G53687 G53689 G53692 G53693 G53694 G53703
    Category
    Medical Device
    Distribution
    Distributed nationwide