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

All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

36376–36400 of 40449

  • 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
  • ModerateFDA (Devices)·Z-1087-2014·2014-03-05

    Ortho VITROS Sodium Slides Recalled for False Positive Results

    Ortho Clinical Diagnostics is recalling VITROS Na+ Slides and Calibrator Kit 2 because they may produce false positive sodium results in serum and plasma samples.

    Product
    VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnostics 513 Technology Blvd Rochester, NY 14652 VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1094-2014·2014-03-05

    Hologic Recalls NovaSure Radiofrequency Controllers for Electrical Standard Non-Compliance

    Hologic is recalling 93 NovaSure Radiofrequency Controllers because they may not meet the IEC 60601-1 electrical safety standard.

    Product
    NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Product Usage: The NovaSure Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1076-2014·2014-03-05

    Siemens Dimension Vista Enzyme 1 Calibrator Recalled for QC Shifts

    Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Enzyme 1 Calibrator due to quality control shifts and imprecision during Pseudocholinesterase calibration.

    Product
    Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic multi-analyte calibrator for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIPL), and Pseudocholinesterase (PCHE) methods…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1088-2014·2014-03-05

    Ortho VITROS Chemistry Calibrator Kit 2 Recalled for False Positive Results

    Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 2 because it may produce false positive serum and plasma sample results.

    Product
    VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemistry Products Calibrator Kit 2 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1068-2014·2014-03-05

    Smith & Nephew Recalls Renasys EZ PLUS Canisters for Labeling Changes

    Smith & Nephew is recalling Renasys EZ PLUS canisters to modify the bacterial overflow guard and update product labeling.

    Product
    Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1067-2014·2014-03-05

    Smith & Nephew Recalls Renasys EZ Canisters for Labeling and Filter Changes

    Smith & Nephew is recalling Renasys EZ canisters to modify the bacterial overflow guard and update product labeling.

    Product
    Renasys EZ, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1095-2014·2014-03-05

    Cardiovascular Systems Recalls Diamondback 360 Coronary Orbital Atherectomy Devices

    Cardiovascular Systems, Inc. is recalling 318 Diamondback 360 Coronary Orbital Atherectomy Devices because they mistakenly contain a saline line not approved for coronary use.

    Product
    CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1107-2014·2014-03-05

    Philips HeartStart XL+ Defibrillator Recalled for Battery Charge Time Labeling Error

    Philips is recalling 7,157 HeartStart XL+ Defibrillators because the battery charge time at high temperatures is slightly longer than the 3 hours stated in the labeling.

    Product
    Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1096-2014·2014-03-05

    Invivo Expression IP5 Information Portal Recalled for Audio Loss

    Invivo Corporation is recalling 271 Expression IP5 Information Portal devices because three units lost audio during use.

    Product
    Invivo Corporation Expression IP5 Information Portal Product Usage: The Expression Information Portal (Model IP5) a display and device controller for Philips MRI patient monitoring systems, is intended for use by trained health care professional to remotely monitor the…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1073-2014·2014-03-05

    NxStage PureFlow-B Solution Recalled for Mislabeled Product

    NxStage Medical is recalling 969 cases of PureFlow-B Solution due to mislabeling. The product is used in hemodialysis systems.

    Product
    NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. The NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1111-2014·2014-03-05

    Roche Recalls Leaking cobas PCR Urine and Swab Test Kits

    Roche Molecular Systems is recalling 84 batches of cobas PCR Urine, Female Swab, and media kits due to reports of leaking media.

    Product
    cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR media 100T IVD cobas¿ PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The…
    Category
    Medical Device
    Distribution
    Distributed nationwide