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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31676–31700 of 40449

  • HighFDA (Devices)·Z-0201-2016·2015-11-11

    Exactech Recalls Eight Hip Implant Stems Lacking Coating

    Exactech is recalling eight Novation Element femoral hip implant stems that did not receive the specified Hydroxyapatite coating.

    Product
    Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0204-2016·2015-11-11

    Philips HeartStart MRx Monitor/Defibrillators Recalled for Capacitor Degradation

    Philips is recalling 1,553 HeartStart MRx Monitor/Defibrillators because automated tests may degrade capacitors and the low battery indicator may fail.

    Product
    Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0229-2016·2015-11-11

    FDA Recalls Regard Custom Surgical Packs Due to Flow Restriction Issues

    Resource Optimization & Innovation LLC is recalling 255 Regard Custom Surgical Packs due to flow restriction issues in the trifurcated IV set.

    Product
    Regard Custom Surgical Pack, Item Number 880239, Sterile IV Pack. Custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0207-2016·2015-11-11

    Arrow International Recalls PICC Kits Due to Hub Tab Detachment

    Arrow International Inc is recalling 12,157 units of various PICC and midline catheter kits because the peel-away component hub tabs may prematurely detach during use.

    Product
    ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow¿ Pressure Injectable Arrow¿ PICC powered by Arrow¿ VPS¿ Stylet ARROW Pressure Injectable JACC with Chlorag+ard Technology For short-term or…
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0213-2016·2015-11-11

    Ivoclar Recalls Helioseal F Dental Sealant Due to Production Defect

    Ivoclar A. G. is recalling specific lots of Helioseal F dental sealant because a production defect caused particles to be larger than defined, resulting in difficulties during extrusion.

    Product
    Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a syringe packed sealed foil bag. Helioseal F is a light-curing, white-shaded…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0228-2016·2015-11-11

    Pyng Medical Recalls Tourniquets Not Reset to Ready Position

    Pyng Medical is recalling MATResponder and MATCombat tourniquets because some were not returned to the Ready position before packaging.

    Product
    MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; MATResponder Tourniquet and MATCombat Tourniquet are essentially the same product with different color schemes manual nonpneumatic tourniquet…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0216-2016·2015-11-11

    ELITech Clinical Systems reagents recalled for potential drug interference

    ELITech Clinical Systems is recalling specific reagents used on Selectra ProS and ProM systems due to potential drug interference. No complaints have been received.

    Product
    ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following product reference numbers and names: GPSL-025O: Glucose PAP SL AUML-0250: URIC ACID MONO SL CHSL-0250: CHOLESTEROL SL, TGML-0250…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0231-2016·2015-11-11

    Ortho-Clinical VITROS 5,1 FS Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a software anomaly where user-modified parameters revert to default values during ADD installation.

    Product
    VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644. Intended for use in the in vitro…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0203-2016·2015-11-11

    Biomet Spine Recalls MaxAn Cervical Spine Screws Due to Labeling Error

    Biomet Spine is recalling 17 MaxAn cervical spine screws because 4.5 mm units were mislabeled as 4.0 mm.

    Product
    MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0214-2016·2015-11-11

    ELITech Eon 100 Reagents Recalled for Potential Drug Interference

    ELITech Clinical Systems is recalling Eon 100 reagents due to potential drug interference. No complaints have been received.

    Product
    Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Reference no. 77450- Uric acid (AUVD) Reference no. 77435- Triglycerides (TGML) Reference no. 77295- Cholesterol (CHVD) Reference no. 77301- Cholesterol HDL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0227-2016·2015-11-11

    Barco Surgical Display Recalled for Loss of User Settings After Power Cycle

    Barco Inc. is recalling specific surgical display models because user settings are lost when the systems are powered off and back on.

    Product
    Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-2242 (42 inch)
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0220-2016·2015-11-11

    Dako EnVision FLEX Visualization Reagent Recalled for Staining Defect

    Dako North America Inc. is recalling specific lots of EnVision FLEX visualization reagent kits due to a buffer defect causing non-specific background staining that interferes with result interpretation.

    Product
    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0222-2016·2015-11-11

    Stryker UniVise Spinous Process Fixation Plate System Inserter Recalled

    Stryker Spine is recalling 41 units of the UniVise Spinous Process Fixation Plate System Inserter because the inner shaft does not fit through the device.

    Product
    Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0215-2016·2015-11-11

    ELITech Eon 300 Reagents Recalled for Potential Drug Interference

    ELITech Clinical Systems is recalling Eon 300 reagents due to potential drug interference. No complaints have been received.

    Product
    Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Glucose (GPSL) Reference no. 79450 Uric acid (AUVD) Reference no. 79435 Triglycerides (TGML) Reference no. 79295 Cholesterol (CHVD) Reference no. 79301 Cholesterol HDL (HDLL)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0217-2016·2015-11-11

    ELITech Envoy 500 Reagent Kits Recalled for Potential Drug Interference

    ELITech Clinical Systems is recalling Envoy 500 reagent kits due to potential drug interference. No complaints have been received.

    Product
    Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT 55435 ENVOY 500 TRIGLYCERIDES REAGENT KIT, 55297 ENVOY 500 CHOLESTEROL REAGENT KIT, 55335 ENVOY 500 CREATININE REAGENT KIT 55301…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0197-2016·2015-11-11

    Philips Recalls GEMINI PET/CT Systems Due to Servo Controller Failure Risk

    Philips is recalling 264 GEMINI PET/CT systems because the CT subsystem's Spindle Block Servo Controllers may fail prematurely.

    Product
    GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-0206-2016·2015-11-11

    Bausch + Lomb Recalls Biotrue ONEday Lenses Due to Surface Defects

    Bausch + Lomb is recalling Biotrue ONEday contact lenses because a manufacturing defect on the lens surface may cause visual disturbances like halos or poor vision.

    Product
    BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available in 5 pack, 30 pack and 90 pack sizes; Biotrue ONEday Foil - Part Number 8098001, Biotrue ONEday 5 pack Carton International - Part Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0210-2016·2015-11-11

    Steris Recalls AMSCO Steam Sterilizers Due to Foot Pedal Software Issue

    Steris Corporation is recalling 32 AMSCO 400 and AMSCO C Small Steam Sterilizers because a software defect prevents the foot pedal from operating the door.

    Product
    AMSCO 400 and AMSCO C Small Steam Sterilizers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0202-2016·2015-11-11

    Ortho-Clinical VITROS Calibrator Kit 9 Recall for Wash Errors

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 9, Lot 0954, due to an increase in wash error condition codes.

    Product
    VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical Diagnostics, Inc. --- VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950/5,1 FS and 4600…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0198-2016·2015-11-11

    C.R. Bard Recalls Antibacterial Hydro Personal Catheters Due to Labeling Error

    C.R. Bard is recalling 4,170 units of Antibacterial Hydro Personal Catheters because the unit label may incorrectly state the product code and size.

    Product
    Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0168-2016·2015-11-04

    Siemens Medical Solutions Recalls 158 Radiation Therapy Machines

    Siemens Medical Solutions is recalling 158 radiation therapy machines due to a potential safety risk of the gantry colliding with patients or treatment tables.

    Product
    ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE; intended use is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0188-2016·2015-11-04

    FDA Recalls Pediatric Heart Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 57 pediatric heart surgical kits because compromised package integrity may affect sterility assurance.

    Product
    Regard, Item Number 830565001, CV0654A - PEDIATRIC HEART - Custom surgical kit for cardiovascular surgery.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0181-2016·2015-11-04

    Elekta Monaco Radiation Treatment Planning Software Recalled for Dose Errors

    Elekta is recalling Monaco Radiation Treatment Planning software due to unintended updates to dose and MU values and incorrect bolus assignments.

    Product
    Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0169-2016·2015-11-04

    Welch Allyn KleenSpec Corded Illuminator Recalled for Electric Shock Risk

    Welch Allyn is recalling KleenSpec Corded Illuminators because they may be connected to AC power, posing a shock hazard.

    Product
    Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78x Series Illuminator, REF 901070, Catalog Numbers 78800, 73410, 73412, 73414, 73416, 78810, 78812, 78814 and 78816, Rx ONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0191-2016·2015-11-04

    Resource Optimization Recalls Custom Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 10 custom surgical kits distributed in Texas and Louisiana because compromised package integrity may affect sterility.

    Product
    Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical kit for surgery.
    Category
    Medical Device
    Distribution
    2 states