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 the agency’s own highest classification or reported deaths or serious injuries, 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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Any3+ (High and above)4+ (High and above)5+ (High and above)

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22801–22825 of 40339

  • HighFDA (Devices)·Z-2916-2018·2018-08-29

    Johnson & Johnson Recalls 1-Day ACUVUE MOIST Contact Lenses

    Johnson & Johnson Vision Care is recalling specific lots of 1-Day ACUVUE MOIST contact lenses due to reports of partially formed lenses that appear smaller and stiffer.

    Product
    Johnson and Johnson Vision Care 1-Day ACUVUE MOIST Daily Wear, 8.5 Base Curve, -3.25 Power. Master Lot, containing 12 split lots, repackaged in 30 and 90-packs . Intended for daily disposable wear for the optical correction of refractive ametropia (myopia and hyperopia) in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2833-2018·2018-08-29

    Liebel-Flarsheim Hydra Vision Urology X-Ray System Recalled for Software Issue

    Liebel-Flarsheim is recalling 313 Hydra Vision Urology X-Ray Systems due to a software issue causing significant discrepancies between display and dosimeter readings in pediatric modes.

    Product
    Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate radiologic and/or fluoroscopic procedures requiring a beam of diagnostic quality radiation, primarily for urological applications such as functional x-ray diagnostics…
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-2886-2018·2018-08-29

    Arrow Pediatric Central Venous Catheter Kit Recalled for Labeling Error

    Arrow International is recalling 166 kits of pediatric central venous catheters because the packaging incorrectly identifies the catheter length.

    Product
    Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, Cat. No. AK-22502 Product Usage: The multiple-lumen catheter permits venous access to the central circulation of pediatric patients. The ARROWg+ard antimicrobial surface is…
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-2882-2018·2018-08-29

    Ortho Kinematics Recalls Vertebral Motion Analyzer Software Due to Error

    Ortho Kinematics is recalling Vertebral Motion Analyzer (VMA) software version 2.3.252 due to a software bug that caused errors in released testing results.

    Product
    Vertebral Motion Analyzer (VMA) Version 2.3.252. VMA software is a quantitative imaging software application intended to be used to process digital image files.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2891-2018·2018-08-29

    Ortho Kinematics Recalls Vertebral Motion Analyzer Software Due to Report Errors

    Ortho Kinematics is recalling VMA software versions 2.3.239 through 2.3.254 because administrative errors caused incorrect data in radiological and VMA reports.

    Product
    Vertebral Motion Analyzer (VMA), 2.3.239 - 2.3.254. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2890-2018·2018-08-29

    Ortho Kinematics Recalls Vertebral Motion Analyzer Software Due to Bug

    Ortho Kinematics, Inc. is recalling VMA DataLink Software versions 2.3.231 and 2.3.232 because a software bug caused erroneous test results.

    Product
    Vertebral Motion Analyzer (VMA), VMA DataLink Software.2.3.231, 2.3.232. Product Usage: VMA software is a quantitative imaging software application intended to be used to process digital image files.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2876-2018·2018-08-29

    Zimmer Biomet Recalls Persona Partial Knee System Spacer Block Alignment Tower

    Zimmer Biomet is recalling 385 units of the Persona Partial Knee System Spacer Block Alignment Tower because an undersized mating feature could cause device connection issues and minor surgical delays.

    Product
    Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2918-2018·2018-08-29

    Euro Diagnostica Immunoscan CCPlus Test Kits Recalled for Decreasing Performance

    Euro Diagnostica AB is recalling 25 Immunoscan CCPlus test kits due to decreasing performance over time. The kits were distributed in Minnesota, Texas, and Iran.

    Product
    Immunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semiquantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2881-2018·2018-08-29

    Back 2 Basics Recalls Dymaxeon 5.5 Curved Spinal Rods Due to Labeling Error

    Back 2 Basics Direct LLC is recalling 10 Dymaxeon 5.5 Curved Rods because packages labeled as 110mm may contain 100mm rods.

    Product
    Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The Dymaxeon Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2888-2018·2018-08-29

    Civco Infiniti Needle Guide Bracket Recalled for Leak Testing Failure

    Civco Medical Instruments is recalling Infiniti Needle Guide Brackets because a cover failed leak testing during validation of new needle guides.

    Product
    CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers. Product Usage: The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2889-2018·2018-08-29

    Ortho Kinematics Recalls Vertebral Motion Analyzer Software Due to Report Error

    Ortho Kinematics is recalling the Vertebral Motion Analyzer (VMA) software because a bug caused errors in the Radiological Read Report.

    Product
    Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2874-2018·2018-08-29

    BioMérieux VITEK 2 NH ID Test Kit Recalled for Missing Desiccant

    BioMérieux Inc. is recalling 57 cartons of VITEK 2 NH ID Test Kits because they are missing desiccant, which may affect product stability.

    Product
    bioM¿rieux VITEK 2 NH ID Test Kit Product Usage: Is an automated system consisting of instruments, software and reagent cards designed for the ID and antimicrobial susceptibility testing of bacteria and yeast.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2879-2018·2018-08-29

    In2Bones Recalls CoLink Lapidus Plates Due to Incorrect Laser Marking

    In2Bones USA, LLC is recalling 47 CoLink Lapidus Plate XP units because right and left plates were incorrectly laser-marked.

    Product
    CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2883-2018·2018-08-29

    Smith & Nephew Recalls Mispackaged Genesis II Knee Prosthesis Components

    Smith & Nephew is recalling two lots of Genesis II knee prosthesis components because they were packaged with the wrong size and side.

    Product
    GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2880-2018·2018-08-29

    In2Bones Recalls CoLink Lapidus Plates Due to Incorrect Laser Marking

    In2Bones USA, LLC is recalling 48 units of CoLink Lapidus Plates because right and left plates were laser marked incorrectly.

    Product
    CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2921-2018·2018-08-29

    Euro Diagnostica Anti-Cardiolipin ELISA Kits Recalled for Labeling Error

    Euro Diagnostica AB is recalling six lots of anti-cardiolipin ELISA kits due to an incorrect distribution label. The kits were distributed in Minnesota.

    Product
    is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess anti-cardiolipin IgM…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2919-2018·2018-08-29

    Euro Diagnostica Anti-Ro ELISA Kits Recalled for Incorrect Labeling

    Euro Diagnostica is recalling Anti-Ro (SS-A) ELISA kits due to incorrect labeling. The label incorrectly states 'Manufactured by DiaSorin' instead of 'Distributed by DiaSorin'.

    Product
    is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of autoantibodies specific for Anti-Ro (SS-A) antigen in human serum or plasma. EDTA, lithium heparin, citrated plasma. It is intended to aid in the diagnosis of systemic rheumatic…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2920-2018·2018-08-29

    Euro Diagnostica Anti-Cardiolipin ELISA Kits Recalled for Labeling Error

    Euro Diagnostica AB is recalling Anti-Cardiolipin ELISA kits due to incorrect labeling. The kits were incorrectly labeled as 'Manufactured by DiaSorin' instead of 'Distributed by DiaSorin.'

    Product
    is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG and IgM autoantibodies specific for the phospholipid cardiolipin in human serum and EDTA, lithium heparin or citrated plasma. It is intended to assess of anti-cardiolipin IgG…
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2922-2018·2018-08-29

    Euro Diagnostica Scl-70 ELISA Kits Recalled for Labeling Error

    Euro Diagnostica AB is recalling four Scl-70 ELISA kits due to incorrect distribution labeling. The kits were manufactured by DiaSorin but incorrectly labeled as manufactured by them.

    Product
    is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2824-2018·2018-08-22

    Sorin Platinium CRT-D Recall Due to Pacing and Sensing Loss

    Sorin CRM SAS is recalling 16 Platinium CRT-D devices because a hardware defect may cause loss of pacing and sensing, preventing the device from delivering necessary defibrillation.

    Product
    Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-2811-2018·2018-08-22

    ICU Medical Recalls Smallbore I.V. Administration Sets Due to Leak Risk

    ICU Medical is expanding a recall of specific smallbore I.V. administration sets because they may leak or separate at the manifold connection.

    Product
    61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer, 2 Ext.
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2589-2018·2018-08-22

    Spacelabs Arkon Anesthesia Delivery System Recalled for Ventilation Failure Risk

    Spacelabs Healthcare is recalling 328 Arkon Anesthesia Delivery Systems because they may stop providing mechanical ventilation while in use or idle.

    Product
    Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2791-2018·2018-08-22

    Cook Inc. Recalls VentriClear Ventricular Drainage Catheter Sets Due to Endotoxin Failure

    Cook Inc. is recalling 250 units of the VentriClear Ventricular Drainage Catheter Set because the product failed endotoxin testing. The recall involves one distributor in Indiana, and the product was not distributed to end users.

    Product
    VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular Drainage Catheter Set has been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2825-2018·2018-08-22

    Sorin Platinium CRT-D Recall Due to Loss of Pacing and Sensing

    Sorin CRM SAS is recalling 10 Platinium CRT-D devices because a hardware issue may cause loss of pacing and sensing, preventing the device from detecting arrhythmias.

    Product
    Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
    Category
    Medical Device
    Distribution
    9 states