The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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3451–3475 of 5038

  • SevereFDA (Devices)·Z-1253-2018·2018-04-04

    Stryker Recalls iVAS System Kits Due to Sterility Assurance Issues

    Stryker is recalling 51 iVAS System Kits for spinal orthopedic use because bioburden levels were found to be higher than acceptable rates, posing a risk of infection.

    Product
    10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1236-2018·2018-04-04

    Zimmer Biomet Recalls Phoenix Nail System Inserter Connectors Due to Fracturing

    Zimmer Biomet is recalling specific lots of Phoenix Nail System 3.5mm Inserter Connectors because they have fractured and remained in the device implant.

    Product
    Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1175-2018·2018-04-04

    ConMed Mini Infant Radiotranslucent Electrodes Recalled for Adhesive Conductivity Issues

    ConMed is recalling 18,720 Mini Infant Radiotranslucent Electrodes because adhesive on contact wires may impede conductivity and cause failure.

    Product
    MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrode
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1123-2018·2018-03-28

    MedComp Recalls 12F Modified Tesio Catheter Sets Due to Connection Failures

    Medical Components, Inc. is recalling 40 kits of 12F Modified Tesio Catheter Sets because connection failures could cause blood loss or air emboli.

    Product
    12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1133-2018·2018-03-28

    Boston Scientific Recalls SpyScope DS Biliary Catheters Due to Sleeve Defect

    Boston Scientific is recalling 5,026 units of SpyScope DS Access and Delivery diagnostic biliary catheters because a sleeve may protrude, causing tissue damage or bleeding.

    Product
    SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1122-2018·2018-03-28

    MedComp Recalls 12F Tesio Catheter Sets Due to Connection Failure Risk

    Medical Components, Inc. is recalling 385 12F Tesio Catheter Sets because connection failures may cause blood loss or air emboli.

    Product
    12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1075-2018·2018-03-28

    Iridex TruFocus LIO Premiere Laser Indirect Ophthalmoscope Recalled for Misdirected Energy

    Iridex Corporation is recalling the TruFocus LIO Premiere Laser Indirect Ophthalmoscope because laser energy was not directed as intended, causing focal cataracts and iris burns.

    Product
    Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO ) The LIO is a headmounted indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a patient s retina. It allows binocular visualization of the peripheral retina and
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1119-2018·2018-03-28

    MedComp Repair Kit Recalled for Potential Connection Failures

    Medical Components, Inc. is recalling 5 MedComp Repair Kits due to potential connection failures that could cause blood loss or air emboli.

    Product
    REPAIR KIT, REF ARA101, UDI 884908083637 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1100-2018·2018-03-28

    Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Breakage

    Boston Scientific is recalling Malecot Nephrostomy Catheter Sets because they may break at the mid-shaft bond during use.

    Product
    Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1125-2018·2018-03-28

    MedComp Two Part Adapter Recall for Potential Connection Failures

    Medical Components, Inc. is recalling 35 MedComp Two Part Adapter kits due to potential connection failures that could cause blood loss or air emboli.

    Product
    TWO PART ADAPTER, REF MCTLA2000, UDI 884908027310 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1118-2018·2018-03-28

    MedComp Recalls Catheter Repair Kits Due to Connection Failure Risk

    Medical Components, Inc. is recalling 93 Catheter Repair Kits because potential connection failures could lead to blood loss or air emboli.

    Product
    CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1124-2018·2018-03-28

    MedComp Recalls 12F Tesio Catheter Sets Due to Connection Failure Risk

    Medical Components, Inc. is recalling 12F Tesio Catheter Sets because connection failures may cause blood loss or air emboli.

    Product
    12F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1127-2018·2018-03-28

    MedComp Repair Kit Recalled for Potential Connection Failures and Blood Loss Risk

    Medical Components, Inc. is recalling 1,575 MedComp Repair Kits due to potential connection failures that could lead to blood loss or air emboli.

    Product
    REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1104-2018·2018-03-28

    Boston Scientific Recalls Malecot Nephrostomy Catheters Due to Mid-Shaft Breakage

    Boston Scientific is recalling certain Malecot Nephrostomy Catheters because they are breaking at the mid-shaft bond during use.

    Product
    Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot Nephrostomy Catheter Set is intended to establish percutaneous nephrostomy drainage and is indicated for the following: Diagnostic Indications: " Antegrade pyelography " Pressure/perfusion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1073-2018·2018-03-21

    Smiths Medical Recalls Misassembled Port-A-Cath Implantable Port Kits

    Smiths Medical ASD Inc. is recalling certain Port-A-Cath II kits that may contain incorrect introducer sizes or locking collars due to misassembly.

    Product
    PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (1/EA)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0981-2018·2018-03-21

    Alden Optical Recalls NovaKone Daily Wear Soft Contact Lenses

    Alden Optical is recalling NovaKone Daily Wear Soft contact lenses because they lack sterility assurance. The recall covers units distributed in the US and Canada.

    Product
    NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia) in aphakic and not aphakic persons with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0984-2018·2018-03-21

    Alden Optical Recalls HP49 Sphere Daily Wear Soft Contact Lenses

    Alden Optical is recalling 23 units of HP49 Sphere Daily Wear Soft contact lenses because they lack sterility assurance.

    Product
    Alden HP49 Sphere Daily Wear Soft contact; Catalog Number: AOHPS49 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0991-2018·2018-03-21

    Alden Optical Recalls ASTERA Multifocal Toric Contact Lenses for Sterility Issues

    Alden Optical is recalling ASTERA Multifocal Toric Daily Wear Soft contact lenses because they lack sterility assurance. The recall affects units distributed in the US and Canada.

    Product
    ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0985-2018·2018-03-21

    Alden Optical Recalls Contact Lenses Lacking Sterility Assurance

    Alden Optical is recalling specific daily wear soft contact lenses because they lack sterility assurance. Consumers should stop using the affected lenses.

    Product
    Alden HP54 Sphere Daily Wear Soft contact; Catalog Number: AOHPS54 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia). T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0990-2018·2018-03-21

    Alden HP59 Toric Contact Lenses Recalled for Lack of Sterility Assurance

    Alden Optical is recalling HP59 Toric Daily Wear Soft contact lenses because they lack sterility assurance. Consumers should stop using the affected lenses.

    Product
    Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia) and/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1071-2018·2018-03-21

    Zimmer Biomet Recalls TunneLoc Tibial Fixation Devices Due to Sterilization Concerns

    Zimmer Biomet is recalling 14,461 TunneLoc Tibial Fixation Devices because gamma sterilization testing suggests the sterilization dose may be inadequate.

    Product
    TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0908-2018·2018-03-14

    FDA Recalls 163 Endo GIA Radial Reloads Due to Manufacturing Error

    The FDA is recalling 163 Endo GIA Radial Reloads with Tri-Staple Technology because the device cartridge disengaged during use due to a manufacturing error.

    Product
    Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gynecologic and thoracic surgery for resection and transection of tissue and creation of anastomosis,
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1171-2018·2018-03-07

    Circulatory Technology Recalls Cardiopulmonary Bypass Blood Reservoirs

    Circulatory Technology Inc is recalling specific models of cardiopulmonary bypass blood reservoirs because they may collapse during use, potentially causing a drop in circuit blood flow.

    Product
    **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, pouched) and BBB38NS (sold bulk to kit manufacturers)
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Devices)·Z-0775-2018·2018-03-07

    Zimmer Biomet Recalls 337 Femoral Intramedullary Nail Loaner Kits

    Zimmer Biomet is recalling 337 femoral intramedullary nail loaner kits because the bolt connecting the insertion guide to the nail can fracture during insertion.

    Product
    979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide