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.

Filters

Agency

Category

Minimum severity

Clear filters

25401–25425 of 27722

  • HighFDA (Devices)·Z-1098-2014·2014-03-05

    Fresenius Optiflux Dialyzers Recalled for Dialysate Port Leak During Priming

    Fresenius Medical Care is recalling Optiflux F160NRe dialyzers because the dialysate port may leak during priming. The recall covers 3.4 million units distributed in the US and Mexico.

    Product
    Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1086-2014·2014-03-05

    Stryker Recalls Static Inserter Assemblies Due to Weld Fracture Complaints

    Stryker Spine is recalling 21 units of Specialty Straight Static Inserter Assemblies because customers reported fractures along the weld binding the handle to the shaft.

    Product
    Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It is used for implant insertion in to the disc space. The AVS navigator Peek Spacer System offers implants that are interbody fusion devices intended for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1110-2014·2014-03-05

    Philips HeartStart MRx Defibrillators Recalled for Wear Risk

    Philips is recalling HeartStart MRx monitor/defibrillators because therapy connections may wear prematurely, posing a risk to patients and caregivers.

    Product
    Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1104-2014·2014-03-05

    Fresenius Optiflux F200A Dialyzers Recalled for Dialysate Port Leak

    Fresenius Medical Care is recalling 5,244 Optiflux F200A dialyzers due to a dialysate port leak during priming.

    Product
    Optiflux F200A High Flux Dialyzers; Product Number: 0500320A. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1112-2014·2014-03-05

    Remel Recalls Oxoid Legionella BCYE Growth Supplement Due to Contamination

    Remel Inc is recalling specific lots of Oxoid Legionella BCYE Growth Supplement because the product may contain high levels of microbial contamination.

    Product
    Oxoid Legionella BCYE Growth Supplement, For 500 ml of medium, SR0110C, packaged 10 vials/box, lyophilized. The firm name on the label is Oxoid Ltd., Basingstoke, Hants, England. The product is used for the isolation of Legionella species from clinical and environmental…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1078-2014·2014-03-05

    GE Healthcare Wireless Digital Radiography Software Recall for Patient Safety

    GE Healthcare is recalling Wireless Digital Radiography Option (WDR1) software due to a defect that may cause patient exams to display incorrectly, potentially impacting patient safety.

    Product
    GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option (WDR1). The Wireless DR Imaging Option ( WDR1), when used with a radiographic imaging system, is indicted for use in general radiographic images of human anatomy. It is intended…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1117-2014·2014-03-05

    Winco XL Convalescent Recliner Recalled Due to Assembly Defect

    Winco Mfg. is recalling 369 XL Convalescent Recliners due to a manufacturing defect in the right-hand recline mechanism that may cause loss of the position lock bar functionality.

    Product
    XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down side-tables, Removable side panels, Built-in head-rest. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1116-2014·2014-03-05

    Winco Drop-Arm Convalescent Recliners Recalled for Mechanism Defect

    Winco Mfg. is recalling 369 drop-arm convalescent recliners due to a manufacturing defect that may cause the three-position lock bar to lose functionality.

    Product
    DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in headrest, Padded push-handle, Three-position lock, Over-lap tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1100-2014·2014-03-05

    Fresenius Optiflux F180NRe Dialyzers Recalled for Port Leak During Priming

    Fresenius Medical Care is recalling Optiflux F180NRe dialyzers because the dialysate port may leak during priming, potentially compromising treatment.

    Product
    Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1115-2014·2014-03-05

    Winco Convalescent Recliners Recalled for Recline Mechanism Defect

    Winco Mfg. is recalling 369 convalescent recliners due to a manufacturing defect in the right hand recline mechanism that may cause the position lock bar to lose functionality.

    Product
    CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered side-panels, Recessed hand-grips, Webbed suspension seating, Non-porous tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1101-2014·2014-03-05

    Fresenius Optiflux F180NR Dialyzers Recalled for Dialysate Port Leak

    Fresenius Medical Care is recalling Optiflux F180NR dialyzers due to a dialysate port leak during priming. The recall covers 52,752 units distributed in the US and Mexico.

    Product
    Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1092-2014·2014-03-05

    Zimmer Trabecular Metal Shoulder Humeral Stem Recalled for Bond Strength Defect

    Zimmer, Inc. is recalling 10 units of Trabecular Metal Shoulder Humeral Stems because testing found bond strength below the minimum required specification in one zone.

    Product
    00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter 130 mm Stem Length Trabecular Metal Humeral Stem 48 Degree 11mm x 130mm, Sterile, QTY 1, Rx Product Usage: Zimmer Trabecular Metal TM Humeral Stem is a shoulder…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0978-2014·2014-03-05

    Elekta Recalls DMLC IV-ERGO Systems Due to Gantry Sensor Error

    Elekta, Inc. is recalling 35 DMLC IV-ERGO systems because an intermittent error may occur in the gantry sensor. The devices are used with linear accelerators for radiation therapy.

    Product
    DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so that adjacent non-diseased tissues are spared to the extent possible.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1118-2014·2014-03-05

    Philips HeartStart MRx Monitor/Defibrillator Recalled for ECG Cable Wear

    Philips is recalling HeartStart MRx Monitor/Defibrillators because the ECG trunk cable and connector block may wear prematurely, causing an interrupted ECG signal.

    Product
    Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC. Used for the termination of ventricular tachycardia and ventricular fibrillation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1114-2014·2014-03-05

    Winco Premier Care Recliner 5570 Recalled for Lock Bar Defect

    Winco Mfg. is recalling 369 Premier Care Recliner 5570 units due to a manufacturing defect that may cause the lock bar to fail.

    Product
    PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully upholstered, OPTIONAL Heat or Heat & Massage, OPTIONAL LiquiCell. The products are a multi position recliners with a steel frame used primarily in long term care or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1120-2014·2014-03-05

    Philips HeartStart MRx Defibrillator Batteries Recalled for Shutdown Risk

    Philips is recalling 43,792 HeartStart MRx defibrillator batteries because they may shut down unexpectedly when exposed to high electromagnetic interference.

    Product
    HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1097-2014·2014-03-05

    Ossur Recalls Symbionic Leg Due to Battery Warning Failure

    Ossur is recalling 144 Symbionic Leg prosthetics because they fail to display a low battery warning before powering down.

    Product
    The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. Product Usage: SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25 30 and less…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1066-2014·2014-03-05

    Smith & Nephew Recalls Reflection Interfit Shell Due to Undersized Radius

    Smith & Nephew is recalling 10 units of Reflection Interfit Shells because the inner spherical radius is undersized. The affected devices were distributed in the US and internationally.

    Product
    Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post traumatic arthritis, avascular necrosis; femoral and neck…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1099-2014·2014-03-05

    Fresenius Optiflux F160NR Dialyzers Recalled for Dialysate Port Leak

    Fresenius Medical Care is recalling Optiflux F160NR dialyzers because the dialysate port may leak during priming. The recall covers 6,720 units distributed in the US and Mexico.

    Product
    Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1075-2014·2014-03-05

    Radiometer D788 pCO2 Membranes Recalled for Biased Measurement Results

    Radiometer America is recalling D788 pCO2 membranes because they may cause biased measurement results for patients and quality control.

    Product
    pCO2 D788 Membranes. Distributed by Radiometer America, Inc., Westlake, OH. An automatic or semi-automatic instrument used to identify and quantify two or more gases, and sometimes electrolytes, in whole blood using multiple special electrodes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1108-2014·2014-03-05

    Philips HeartStart MRx Defibrillators Recalled for Wireless Data Transmission Defect

    Philips is recalling 220 HeartStart MRx defibrillators because the Wireless Link upgrade may fail to transmit data in specific configurations.

    Product
    M3536A HeartStart MRx with Wireless Link Upgrade (861289) The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by…
    Category
    Medical Device
    Distribution
    21 states
  • HighFDA (Devices)·Z-1106-2014·2014-03-05

    Fresenius Recalls Optiflux F18Nre Dialyzers Due to Port Leak Risk

    Fresenius Medical Care is recalling 34,752 Optiflux F18Nre Flux Dialyzers because the dialysate port may leak during priming.

    Product
    Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1080-2014·2014-03-05

    Siemens Artis zee Ceiling Systems Recalled for Cable Damage Risk

    Siemens Medical Solutions USA is recalling 284 Artis zee Ceiling Systems due to potential cable damage from sub-optimal guidance.

    Product
    Siemens Artis zee Ceiling Systems. Angiographic x-ray system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1103-2014·2014-03-05

    Fresenius Optiflux F200NR Dialyzers Recalled for Dialysate Port Leak

    Fresenius Medical Care is recalling 19,596 Optiflux F200NR dialyzers due to a dialysate port leak during priming. The units were distributed in the US and Mexico.

    Product
    Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide