The Recall Desk

Hazard

Device Defect recalls

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

What the numbers show

Total
451
Critical
11
Severe
66
Most recent
2026-09-23

Of the 451 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 66 (15%) 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.

51–75 of 451

  • SevereFDA (Devices)·Z-1457-2025·2025-04-16

    Medline Medical Procedure Kits with Aortic Root Cannula Recalled

    Medline is recalling medical procedure kits containing a Medtronic Aortic Root Cannula due to potential excess material in the male lures on the cannula. The recall affects 468 units distributed across nine US states.

    Product
    Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-1456-2025·2025-04-16

    Medline medical procedure kits with Medtronic Aortic Root Cannula recalled

    Medline Industries is recalling medical procedure kits containing a Medtronic Aortic Root Cannula due to a Class I defect. The kits were distributed to healthcare facilities in nine states.

    Product
    Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, Z OPEN…
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1514-2025·2025-04-09

    Ethicon Surgical Sutures Recalled Due to Silicone Curing Manufacturing Defect

    Ethicon Endo Surgery recalls approximately 1,080 surgical sutures due to silicone curing issues identified during manufacturing. The defect may affect suture performance during surgical use.

    Product
    PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1448-2025·2025-04-02

    Medline C-section procedure kits recalled for syringe quality defects

    Medline is recalling C-section procedure kits because plastic syringes in the kits may leak or break. The defect was identified in connection with an FDA safety alert and poses a potential risk to patient health.

    Product
    Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) C SECTION PACK, Pack Number DYNJ48483B; 3) C SECTION PACK, Pack Number DYNJ61573; 4) C SECTION PACK, Pack Number DYNJ66801; 5) C SECTION PACK-LF, Pack Number DYNJ0367951P; 6) C SECTION…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1285-2025·2025-03-26

    Smiths Medical ProPort Plastic Venous Access System Recalled for Port Housing Separation Risk

    Smiths Medical is recalling certain ProPort Plastic Venous Access System devices due to a manufacturing defect that may cause the port housing and reservoir to separate.

    Product
    smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1394-2025·2025-03-26

    Medline Medical Convenience Kits Recalled for Defective Plastic Syringes

    Medline is recalling 880 medical convenience kits containing plastic syringes with potential leaks and breakage. The syringes were identified as defective and may pose health risks to patients.

    Product
    Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1011-2025·2025-01-29

    Baxter Continu-Flo Solution Set with Duo-Vent Spike recalled for inverted clamps

    Baxter is recalling specific lots of Continu-Flo Solution Sets due to potentially inverted side clamps that render the tubing unusable. Distribution included eight US states.

    Product
    Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0622-2025·2024-12-11

    Medline Tracheostomy Convenience Kits Recalled Due to Defective Component

    Medline is recalling 88 units of tracheostomy convenience kits containing a defective smoke evacuation pencil component that was previously recalled by Stryker. Products were distributed nationwide.

    Product
    MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0539-2025·2024-12-04

    Philips Breast MRI System Recalled for Patient Safety Risk

    Philips is recalling 5,231 units of the dS Breast 7ch 1.5T breast MRI system due to a potential safety issue that could harm patients during preparation or scanning.

    Product
    dS Breast 7ch 1.5T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0331-2025·2024-11-20

    VYGON 250 mL IV Fluid Containers Recalled for Leaks During Filling

    The Metrix Company is recalling VYGON 250 mL IV fluid containers that have been found to leak during filling. Leaking containers cannot properly contain intravenous fluid.

    Product
    VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0440-2025·2024-11-20

    Halyard Biopsy Pack surgical instruments recalled due to loose metal flakes

    AVID Medical is recalling Halyard BIOPSY PACK surgical kits due to loose metal flakes from sponge forceps and towel clamps. Metal flakes could enter a patient's surgical site, potentially causing local or foreign body reactions.

    Product
    Halyard BIOPSY PACK - Medical convenience kits Model Number: VANW019-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0345-2025·2024-11-20

    Imed EVA IV bags recalled for leaking during filling

    The Metrix Company is recalling Imed EVA IV bags due to leakage discovered during the filling process. A limited number of bags were found to leak, potentially affecting the safety of intravenous therapy.

    Product
    Imed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0343-2025·2024-11-20

    Imed EVA IV Fluid Bags Recalled Due to Leakage During Filling

    The Metrix Company is recalling Imed EVA IV fluid bags that may leak during filling. A limited number of units have been found defective across multiple U.S. states and Canada.

    Product
    Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0197-2025·2024-10-30

    Smiths Medical Recalls TranStar KIDS KIT Blood Sample Kits

    Smiths Medical ASD, Inc. is recalling 800 units of medex TranStar KIDS KIT closed blood sample kits due to a manufacturing defect that may cause inaccurate pressure monitoring.

    Product
    medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0188-2025·2024-10-30

    Smiths Medical Recalls TranStar Disposable Pressure Transducers Due to Defects

    Smiths Medical ASD, Inc. is recalling 1,100 units of medex TranStar Disposable Transducers due to manufacturing defects that may cause inaccurate pressure monitoring.

    Product
    medex TranStar Disposable Transducer 1/EA, Product Code REF MX950
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0184-2025·2024-10-30

    Smiths Medical Recalls 50 medex NICU Monitoring Kits Due to Defect

    Smiths Medical ASD, Inc. is recalling 50 medex NICU Monitoring Kits due to a manufacturing defect that may cause inaccurate pressure monitoring.

    Product
    medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3271-2024·2024-10-02

    WallFlex Esophageal Stent System Recalled for Potential Catheter Tip Detachment

    Boston Scientific Corporation is recalling WallFlex Esophageal Stent Systems and Agile Esophageal Over-the-Wire Stent Systems due to potential delivery catheter tip detachment during insertion procedures.

    Product
    WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3256-2024·2024-10-02

    Biodesign Fistula Plug Implant Recalled for Premature Expiration

    Cook Biotech is recalling the Biodesign Fistula Plug implant because devices expire before their labeled expiration dates. Thirty-nine units distributed worldwide are affected.

    Product
    Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G46372
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3261-2024·2024-10-02

    Biodesign Inguinal Hernia Graft Recall Due to Premature Expiration

    Cook Biotech is recalling Biodesign Inguinal Hernia Graft units because products expire before their labeled expiration date, potentially affecting surgical outcomes.

    Product
    Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias. Order Number (GPN): G46603
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3026-2024·2024-09-18

    Medline ER Suture Kits Recalled Due to Syringe Quality Issues

    Medline is recalling ER Suture Convenience Kits because the included plastic syringes have leaks, breakage, or other quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: KIT,ER SUTURE #1, Pack Number DYNDS1130A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3039-2024·2024-09-18

    Medline Medical Convenience Kits Recalled for Syringe Defects

    Medline Convenience kits containing defective plastic syringes are being recalled worldwide due to leaks, breakage, and quality issues that may pose patient health risks.

    Product
    Medline Convenience kits labeled as: 1) OR CLEAN UP KIT, Pack Number DYK1002355X3, 2) CLEANING & CUTTING, Pack Number DYNJ84657
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3044-2024·2024-09-18

    Medline medical convenience kits recalled for syringe leaks and breakage

    Medline Industries is recalling medical convenience kits containing plastic syringes with quality defects including leaks and breakage. These defects may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) PACK VAGINAL DELIVERY , Pack Number AM185B ; 2) LABOR & DELIVERY CDS, Pack Number CDS830039AF; 3) LABOR & DELIVERY CDS, Pack Number CDS830039AI; 4) LABOR & DELIVERY CDS, Pack Number CDS830039AJ; 5) LABOR & DELIVERY CDS, Pack Number…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3054-2024·2024-09-18

    Medline Recalls Arthroscopy Kits with Defective Plastic Syringes

    Medline Industries is recalling various arthroscopy and arthrogram convenience kits because they contain plastic syringes affected by a March 2024 FDA Safety Alert. The syringes have leaks, breakage, or other quality issues that may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) ARTHROGRAPHY DRAPE PACK , Pack Number 00-399027M ; 2) ARTHROSCOPY CDS , Pack Number CDS940242I ; 3) ARTHROSCOPY-LF, Pack Number CDS940859J ; 4) KNEE ARTHROSCOPY CDS-LF , Pack Number CDS940869U ; 5) ARTHROSCOPY CDS , Pack Number…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3131-2024·2024-09-18

    Surgical Dissector Recalled for Brown Discoloration on Hinge Area

    Technomed Europe is recalling NEUROSIGN Disposable Stimulating Dissectors due to brown discoloration or substance on the hinge area. The recall affects 71 units distributed across seven US states.

    Product
    NEUROSIGN Disposable Stimulating Dissector, REF 5888-00
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2995-2024·2024-09-18

    Medline cardiac and surgical procedure convenience kits recalled worldwide

    Medline Industries recalled cardiac and surgical procedure convenience kits distributed worldwide including pacemaker, angiography, and open heart surgery kits.

    Product
    Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2) NORTON CHILDRENS CATH LAB-LF, Pack Number 00-401185Q ; 3) PACEMAKER TRAY, Pack Number 00-401521F ; 4) FEMORAL PACK, Pack Number 00-401525G ; 5) CARDIAC CATH PACK , Pack Number 00-401561K…
    Category
    Medical Device
    Distribution
    0 states