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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40251–40275 of 40356

  • HighFDA (Devices)·Z-1858-2012·2012-07-04

    Hartmann Sterilux Gauze Sponges Recalled for Sterile Barrier Defects

    Hartmann USA is recalling Sterilux gauze sponges because micro holes were found in the sterile barrier, potentially compromising sterility.

    Product
    Hartmann Sterilux Ref 56910000 Sterile Premium gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1869-2012·2012-07-04

    Siemens B12 Reagent Cartridges Recalled for False Test Results

    Siemens is recalling B12 Flex reagent cartridges because Intrinsic Factor Blocking Antibodies can cause false high Vitamin B12 results.

    Product
    Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista System for the in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1865-2012·2012-07-04

    GE OEC Uroview 2800 Recalled for Intermittent Safety Issues

    GE OEC Medical Systems is recalling 717 OEC Uroview 2800 fluoroscopic imaging systems due to intermittent safety issues, including navigation tracking inaccuracy and system lock-ups.

    Product
    OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1896-2012·2012-07-04

    Philips HeartStart MRx Monitor/Defibrillators Recalled for ECG Failure

    Philips is recalling HeartStart MRx monitor/defibrillators because they may fail to display ECG signals, potentially delaying the treatment of cardiac arrhythmias.

    Product
    Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 Product Usage: The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1889-2012·2012-07-04

    Terumo Recalls Sarns Cardioplegia Cannula Kits Due to Foreign Substance

    Terumo is recalling Sarns Cardioplegia Cannula Kits because a foreign substance was found on the inner surface of some cannula tips that could be dislodged.

    Product
    CPB CATHETER KIT-DR GERHARDT Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1882-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannula Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance was found on the inner surface of some tips that could dislodge.

    Product
    X-COATED TRANSPLANT PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1866-2012·2012-07-04

    Stryker Endoscopy Recalls Formula Shaver Handpieces Due to Routine Check Concerns

    Stryker Endoscopy is recalling 34 Formula and Formula 180 Shaver Handpieces because routine checks to ensure accuracy and fitness for use may not have been adequately determined.

    Product
    Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA.: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Components within the Crossfire System that provided abrasion, resection, debridement and removal of bone and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1877-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance was found on the inner surface of some tips that could be dislodged.

    Product
    SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 14-GAUGE WHITE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) LONG Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1885-2012·2012-07-04

    Terumo Recalls Sarns Cardioplegia Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance was found on the inner surface of some tips that can be dislodged.

    Product
    MAYO MN XCOATED 3/8X1/2 AV Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1881-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannula Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulae because a foreign substance was found on the inner surface of some tips that could be dislodged.

    Product
    XC HEART/LUNG PACK W/SX25RX Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1859-2012·2012-07-04

    Stryker Recalls GoBed+ Model FL20E Hospital Beds Due to Scale Failures

    Stryker is recalling 6,325 GoBed+ Model FL20E hospital beds worldwide because loadcell failures can cause scale errors or disable bed exit functions.

    Product
    GoBed+ . Model FL20E Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1887-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance was found on the inner surface of some tips that can be dislodged.

    Product
    X-COATED H/L PK W/FX15RW40 Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1864-2012·2012-07-04

    Hill-Rom Recalls Advanta 2 Hospital Beds Due to Siderail Screw Stripping

    Hill-Rom is recalling 7,843 Advanta 2 hospital beds because screws used to attach siderails were found to be stripping from the plastic cavity.

    Product
    Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1878-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance was found on the inner surface of some tips that could be dislodged.

    Product
    SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 12-GAUGE BLUE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) LONG Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1890-2012·2012-07-04

    Terumo Recalls Sarns Antegrade Cardioplegia Cannula Kits Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannula kits because a foreign substance was found on the inner surface of some cannula tips that could be dislodged.

    Product
    CPB CATHETER KIT- DR OWEN Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1880-2012·2012-07-04

    Terumo Recalls Sarns Cardioplegia Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance on the inner surface of the tips can be dislodged during use.

    Product
    INDIANA/OHIO HEART Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1867-2012·2012-07-04

    Siemens BCS Behring Coagulation System Recalled for Potential Test Errors

    Siemens Healthcare Diagnostics is recalling 186 BCS Behring Coagulation Systems because a specific sequence of tests may result in shortened clotting times.

    Product
    BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1891-2012·2012-07-04

    Terumo Recalls Sarns Cardioplegia Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance was found on the inner surface of some tips that can be dislodged.

    Product
    CPB CATHETER KIT- DR HENDRICKSO Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1861-2012·2012-07-04

    Stryker Rose Bed Recall Due to Loadcell Failure in Scale Function

    Stryker is recalling Rose Model FL14E beds because loadcell failures cause scale errors and disabled bed exit functions.

    Product
    Stryker Rose Bed Model (FL14E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1879-2012·2012-07-04

    Terumo Recalls Sarns Cardioplegia Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance on the inner surface may dislodge during use.

    Product
    FX PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1904-2012·2012-07-04

    Abbott Recalls Architect CA 19-9 Reagent Kits Due to Result Shifts

    Abbott Laboratories is recalling specific lots of ARCHITECT CA 19-9XR Reagent Kits because they are causing an upward shift in patient test results.

    Product
    ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1895-2012·2012-07-04

    Zimmer Recalls Shoulder Surgery Drill Due to Labeling Error

    Zimmer, Inc. is recalling 87 units of a shoulder surgery drill because the catalog number on the packaging did not match the actual product.

    Product
    Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the products are medical instruments intended for use when performing surgery of the shoulder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1863-2012·2012-07-04

    Stryker Recalls Go Bed II+ Model FL 28 Ex Due to Scale Failures

    Stryker is recalling 9,440 Go Bed II+ Model FL 28 Ex hospital beds due to an abnormally high failure rate of loadcells, which can cause scale errors or disabled functions.

    Product
    Go Bed II+ Model FL 28 Ex Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1862-2012·2012-07-04

    Stryker MA204 Bed Recall Due to Loadcell Failure in Scale Function

    Stryker is recalling MA204 beds because loadcells in the scale and bed exit systems are failing at an abnormally high rate.

    Product
    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1868-2012·2012-07-04

    MedComp 8F Plastic Pro-Fuse CT Low Profile Port Recall

    Medical Components, Inc. is recalling 30 kits of the MedComp 8F Plastic Pro-Fuse CT Low Profile Port because the kits contain the wrong port model.

    Product
    MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide