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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22976–23000 of 27663

  • HighFDA (Devices)·Z-2438-2015·2015-09-02

    Otto Bock Genium X3 Knee Joint Prosthesis Recalled for Hydraulic Failure

    Otto Bock Healthcare Products GmbH is recalling the Genium X3 knee joint prosthesis because its hydraulic resistance control may fail under certain conditions.

    Product
    Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH. Intended to be used solely for lower limb prosthetic fittings.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2447-2015·2015-09-02

    Roche cobas b 123 Fluid Pack Recall for Low PO2 Results

    Roche is recalling 82 cobas b 123 Fluid Packs due to a calibration issue that may cause erroneously low PO2 results in patient samples.

    Product
    cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2470-2015·2015-09-02

    GE Healthcare Recalls Centricity Universal Viewer Software Due to Image Loss

    GE Healthcare is recalling 26 Centricity Universal Viewer Version 6.0 systems because medical images may be missing when a specific system parameter is set to a value greater than 1.

    Product
    Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2446-2015·2015-09-02

    Roche cobas b 123 Fluid Pack Recall for Low PO2 Results

    Roche is recalling 82 cobas b 123 Fluid Packs due to a calibration issue that may cause erroneously low PO2 results in patient samples.

    Product
    cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2458-2015·2015-09-02

    Medline Recalls Central Line Kits Due to Incorrect Age Labeling

    Medline Industries is recalling Central Line kits due to a printing error that mislabels the intended patient age. The error could lead to use on the wrong patient population.

    Product
    Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called a central line, is a long, thin, flexible tube used to give medicines, fluids…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2455-2015·2015-09-02

    Omnilife Recalls Offset Femoral Alignment Guides Due to Incorrect Markings

    Omnilife Science Inc. is recalling 15 Offset Femoral Alignment Guides because the markings are reversed, which may prevent proper alignment during surgery.

    Product
    Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems. Product Usage: The instrumentation has been designed to facilitate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2454-2015·2015-09-02

    Omnilife Recalls Offset Femoral Alignment Guides Due to Incorrect Markings

    Omnilife Science Inc. is recalling 15 Offset Femoral Alignment Guides because the markings are reversed, which may prevent proper alignment during surgery.

    Product
    Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2443-2015·2015-09-02

    Recall of Infant Heel Warmers Due to Potential Breakage and Spillage

    The FDA is recalling 68,800 units of Infant Heel Warmers because they may break during activation, causing spillage of contents that could irritate skin or eyes.

    Product
    Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2444-2015·2015-09-02

    FDA Recalls Covidien Infant Heel Warmers Due to Breakage Risk

    The FDA is recalling 164,749 units of Covidien Infant Heel Warmers because they may break during activation, causing spillage and potential skin or eye irritation.

    Product
    Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2467-2015·2015-09-02

    Sunrise Medical Recalls Quickie IRIS Wheelchairs with Dynamic Backrest

    Sunrise Medical is recalling 64 Quickie IRIS wheelchairs because the backrest system may break, posing a risk of falls or injury to the occupant.

    Product
    Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2457-2015·2015-09-02

    RayStation 4.7.1 Radiation Therapy Software Recalled for Algorithm Error

    RaySearch Laboratories is recalling RayStation 4.7.1 software due to an algorithm error that reverses contraction distances in radiation therapy planning.

    Product
    RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2466-2015·2015-09-02

    Sunrise Medical Recalls Quickie and Zippie IRIS Wheelchairs with MONO Backrest

    Sunrise Medical is recalling 64 Quickie and Zippie IRIS wheelchairs because the MONO Backrest System may break, posing a risk of falls or injury to the occupant.

    Product
    Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2439-2015·2015-09-02

    PTW UNIDOS webline Dosimeters Recalled for Potential Radiation Over-Exposure

    PTW-Freiburg is recalling PTW UNIDOS webline dosimeters because measurement errors at high dose rates could display too-low doses, potentially leading to radiation over-exposure.

    Product
    PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2461-2015·2015-09-02

    Ferno iNX Wheeled Stretcher Wheel Caster Set Screw Recall

    Ferno-Washington Inc is recalling 26 Ferno iNX Wheeled Stretchers due to improperly installed wheel caster set screws that may allow bearing cups to back out.

    Product
    Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2445-2015·2015-09-02

    FDA Recalls Omnilife Apex Interface Acetabular Shells Due to Design Defect

    Omnilife Science Inc. is recalling 112 Apex Interface Hemi 54X and Flared 56X acetabular shells because improper screw hole placement may occur due to inaccurate index line location.

    Product
    APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2450-2015·2015-09-02

    Siemens Recalls Dimension Vista B2-Microglobulin Reagent Cartridges

    Siemens Healthcare Diagnostics is recalling 1,655 Dimension Vista B2-Microglobulin Flex Reagent Cartridges due to potential reagent contamination that may cause falsely low test results.

    Product
    Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B¿2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2383-2015·2015-09-02

    Philips DigitalDiagnost X-ray Systems Recalled for Missing Exposure Beep Signal

    Philips is recalling 62 DigitalDiagnost X-ray systems because a software defect prevents the exposure termination beep from sounding after 12 hours of operation.

    Product
    Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctors or technicians.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2367-2015·2015-08-26

    Teleflex Medical Recalls Sheridan Sher-I-BRONCH Endobronchial Tubes

    Teleflex Medical is recalling Sheridan Sher-I-BRONCH endobronchial tubes because the double swivel connector may crack or separate.

    Product
    HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2372-2015·2015-08-26

    Elite Biomedical Recalls Alaris Medley LVP Bezel Assemblies

    Elite Biomedical Solutions LLC is recalling 346 Alaris Medley LVP Bezel Assemblies used in infusion pumps due to a risk of administering inappropriate fluid quantities.

    Product
    Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2329-2015·2015-08-26

    FDA Recalls 657 Puritan Bennett 980 Ventilators Due to Volume Defects

    The FDA is recalling 657 Puritan Bennett 980 Ventilators because tidal volumes may be lower than set in neonatal mode, potentially causing respiratory compromise.

    Product
    Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2343-2015·2015-08-26

    Draeger Evita Infinity V500 Ventilator Battery Recall

    Draeger Medical is recalling 2,081 Evita Infinity V500 ventilators because the optional PS500 battery capacity did not last as long as expected.

    Product
    PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2437-2015·2015-08-26

    Siemens Intevo Series Imaging Systems Recalled for Overheating Risk

    Siemens Medical Solutions USA is recalling 185 Intevo Series imaging systems because improper fuses could cause the Power Controller assembly to overheat.

    Product
    Siemens Intevo Series system, a radiological imaging system that is a combination of a single photon emission computed tomography (SPECT) camera system for nuclear medicine images, and a computed tomography (CT) camera system for x-ray images.
    Category
    Medical Device
    Distribution
    51 states
  • SevereFDA (Devices)·Z-2399-2015·2015-08-26

    Winco Designer Care Cliner Recalled for Non-Fire Retardant Foam

    Winco Mfg. is recalling Designer Care Cliner chairs because the foam used was not fire retardant as required.

    Product
    Winco Designer Care Cliner w/Swing Arms - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2371-2015·2015-08-26

    Elite Biomedical Recalls Alaris Medley LVP Frame Membranes

    Elite Biomedical Solutions LLC is recalling 609 Alaris Medley LVP Frame Membranes because the defect could allow fluid intrusion, potentially leading to injury or death.

    Product
    Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2362-2015·2015-08-26

    CareFusion Alaris Syringe Pump Recall for Unresponsive Control Defect

    CareFusion 303, Inc. is recalling Alaris Syringe Pumps, Model 8110, because they may become unresponsive to key presses after a channel error is cleared.

    Product
    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
    Category
    Medical Device
    Distribution
    Distributed nationwide