The Recall Desk

Hazard

Device Defect recalls

184 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 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.

26–50 of 184

  • SevereFDA (Devices)·Z-1756-2025·2025-05-28

    Bard Blakemore Esophageal-Nasogastric Tube Plastic Plugs Difficult to Remove

    The Bard Blakemore Esophageal-Nasogastric Tube (Adult) may have plastic plugs that are difficult or impossible to remove, preventing proper inflation of the gastric and esophageal balloons. C.R. Bard Inc is recalling all affected lots.

    Product
    Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100
    Category
    Medical Device
    Distribution
    51 states
  • SevereFDA (Devices)·Z-1759-2025·2025-05-28

    Bard Intragastric Linton Balloon Tube Recall Due to Plug Removal Defect

    C.R. Bard Inc is recalling the Bard® Single Intragastric Linton Balloon Tube because users may be unable to remove plastic plugs needed to inflate the device's balloons. This is an FDA Class I recall affecting all lots within expiration.

    Product
    Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1787-2025·2025-05-28

    Cook Recalls Check=Flo Performer Introducer for Incorrect Sheath Sizing

    Cook Incorporated is recalling Check=Flo Performer Introducer (14.0Fr) because affected devices may contain an incorrectly sized introducer sheath.

    Product
    Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1701-2025·2025-05-07

    Knee Replacement Femoral Augment Screw Delivered Missing Thread

    Waldemar Link femoral augment screws for knee replacement surgery were distributed preassembled but missing the thread needed for proper attachment. Affected units shipped nationwide to 17 states.

    Product
    L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2 - cemented lg), (5) 880-323/13 (Sz. 3-4 - cemented sm), (6) 880-323/23 (Sz. 3-4 - cemented lg), (7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1700-2025·2025-05-07

    Posterior Femoral Augment Surgical Implant with Missing Screw Thread Recalled

    Waldemar Link is recalling Posterior Femoral Augment orthopedic implants distributed nationwide due to missing threads on preassembled screws. Patients should contact their surgeon immediately.

    Product
    Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5) 880-313/11 (Sz. 3-4 - cemented sm), (6) 880-313/12 (Sz. 3-4 - cemented md), (7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1644-2025·2025-04-30

    Amplatzer Catheter Recalled Due to Hidden Shaft Defect

    Abbott's Amplatzer TorqVue LP Catheter is recalled due to a hidden shaft breach that could cause blood loss, prolonged procedures, or air embolism. Approximately 2,683 units with specific lot numbers are affected.

    Product
    Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1456-2025·2025-04-16

    Medline Medical Procedure Kits With Aortic Cannula Recalled

    Medline is recalling 1310 medical procedure kits containing Medtronic Aortic Root Cannula distributed across nine U.S. states. The FDA classified this as a Class I recall.

    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 HEART
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-1505-2025·2025-04-16

    Medline medical kits recalled due to defective endotracheal tubes

    Medline Industries is recalling approximately 1,550 medical convenience kits containing defective endotracheal tubes manufactured by Smiths Medical. The affected kits include neonatal and pediatric intubation and resuscitation equipment distributed in California.

    Product
    Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION KIT, REF ACC010381A; 3) NEWBORN RESUSCITATION KIT, REF ACC010381B; 4) NEWBORN RESUSCITATION KIT, REF ACC010381C; 5) PEDS GREY-PINK-RED, REF ACC010395; 6
    Category
    Medical Device
    Distribution
    0 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 PACK-LF
    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-1165-2025·2025-02-19

    Exactech AcuMatch XLE Hip Implants Recalled for Missing Barrier Layer

    Exactech, Inc. is recalling AcuMatch XLE hip replacement components due to a missing Ethylene Vinyl Alcohol (EVOH) barrier layer. The recall affects 42 units distributed across multiple U.S. states and international locations.

    Product
    AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-32-28 AM EHXL 0¿ LNR H 32MM 140-28-29 AM EHXL 0¿ LNR J 28MM 140-32-29 AM EHXL 0¿ LNR J 32MM 140-36-29 AM EHXL 0¿ LNR J 36MM 140-32-30 AM EHXL 0¿ LNR K 32MM
    Category
    Medical Device
    Distribution
    22 states
  • 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-0919-2025·2025-01-22

    OsteoCove and Cove Putty bone graft substitutes recalled for hydration defect

    IsoTis OrthoBiologics is recalling OsteoCove Putty and Cove Putty bone graft substitutes due to a hydration issue related to a polymer defect. The affected products are less cohesive and moldable than intended.

    Product
    OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
    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-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-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-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-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 esop
    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
  • HighFDA (Devices)·Z-3042-2024·2024-09-18

    Medline Medical Convenience Kits Recalled Due to Defective Plastic Syringes

    Medline is recalling multiple medical convenience kits containing plastic syringes due to identified leaks, breakage, and quality issues. These defects may pose a risk to patient health.

    Product
    Medline Convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327AA; 2) CORONARY ANGIO PACK-LF, Pack Number 00-401594R ; 3) IR NEURO INTERVENTIONAL PACK, Pack Number 00-401808S ; 4) NEURO CDS , Pack Number CDS780056K ; 5) NEURO CDS , Pack Number CDS78005
    Category
    Medical Device
    Distribution
    0 states