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

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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

20676–20700 of 27682

  • HighFDA (Devices)·Z-0419-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducers Due to Potential Leak

    ICU Medical is recalling 380 units of Transpac IV Disposable Transducers with Stopcocks due to a potential for leak in the SafeSet Reservoir and blood sampling kits.

    Product
    TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42500-03 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0501-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk

    ICU Medical is recalling 295 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leaks.

    Product
    Cath Lab Kit W/30ML Flush Device for Monongalia General Hosp, Item No. 46090-62 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0533-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk

    ICU Medical is recalling 100 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    2 PORT RIGHT "OFF" MANIFOLD w/ADMIN SET 72" PT, 3 WAY STOPCOCK, TP4 & 1 WAY STOPCOCK, Item No. 46098-79 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0465-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducers Due to Potential Leak

    ICU Medical is recalling 120 units of Transpac IV transducers and SafeSet Reservoir kits due to a potential for leak.

    Product
    BIFURCATED TRANSPAC¿ 4 WITH 03ML FLUSH DEVICE FOR BUFFALO GENERAL HOSP., Item No. 46063-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0535-2017·2016-11-23

    ICU Medical Recalls Transpac Pressure Transducer Kits Due to Leak Risk

    ICU Medical is recalling 90 units of Transpac pressure transducer kits due to a potential leak in the SafeSet Reservoir.

    Product
    DOUBLE LINE KIT W/03ML FLUSH DEVICE & SAFESET, Item No. 46099-18 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0509-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits

    ICU Medical is recalling 20 units of SafeSet Reservoir and blood sampling kits due to a potential leak hazard.

    Product
    OPEN HEART KIT W/03ML FLUSH DEVICE FOR CUMBERLAND COUNTY HOSP., Item No. 46094-08 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0534-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 140 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Cath Lab Kit w/03 ml Squeeze Flush, Pressure Tubing, Guidewire, 10 cc Syringes and 3 Way Stopcock, Item No. 46098-87NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0498-2017·2016-11-23

    ICU Medical Recalls Transpac Transducer Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV transducer kits because of a potential leak. The recall covers 1,440 units distributed nationwide.

    Product
    TRIFURCATED DISPOSABLE TRANSDUCER KIT W/03ML FLUSH DEVICE FOR JOHNS HOPKINS/BAYVIEW, Item No. 46088-74 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0443-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV monitoring kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV MONITORING KIT, 72", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42632-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0457-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 60 units of Transpac IV transducer kits due to a potential leak in the SafeSet Reservoir system.

    Product
    CATH LAB KIT FOR ALBERT EINSTEIN M.C., Item No. 46047-19 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0608-2017·2016-11-23

    Siemens Recalls CT Systems for Software Safety Bug Fixes

    Siemens is recalling seven CT systems to install a software update that fixes bugs and corrects potential safety issues.

    Product
    SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMATOM Definition AS/ AS+ (Project P46) systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0395-2017·2016-11-23

    Roche Tina-Quant Hemoglobin A1c Test Recalled for Erroneously High Results

    Roche Diagnostics is recalling Tina-Quant Hemoglobin A1c Gen. 2 tests because they may produce erroneously high results, potentially leading to incorrect diabetes treatment.

    Product
    Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 / 05401640190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0473-2017·2016-11-23

    ICU Medical Recalls Transpac Pressure Transducers Due to Leak Risk

    ICU Medical is recalling 75 units of Transpac pressure transducers and SafeSet reservoirs due to a potential leak hazard.

    Product
    M.K. WITH 03ML FLUSH DEVICE FOR DRISCOLL FOUNDATION CHILDRENS HOSP., Item No. 46068-02 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0545-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 30 units of Transpac IV Trifurcated Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV TRIFURCATED MONITORING KIT 72", 3 DISPOSABLE TRANSDUCERS, 3 3 ML INTRAFLO¿ FLUSHES, MACRODRIP (POLE MOUNT), Item No. 46101-39 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0558-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac¿ IV Monitoring Kit w/Safeset" Blood Sampling Port and 03 ml Squeeze Flush Device 10 cc Sheathed Syringe, Item No. 46109-74 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0438-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 200 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 42598-01 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0452-2017·2016-11-23

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 740 units of Transpac IV Bifurcated Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    TRANSPAC¿ IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCERS, 2 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42652-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0532-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 380 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    4 PORT "OFF" MANIFOLD, w/HP STOPCOCK, WASTE BAG ASSY, 10 cc SYRINGE & AD SETS, Item No. 46098-78 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0592-2017·2016-11-23

    Alphatec Recalls Arsenal Spinal Fixation System Set Screws for Disengagement Risk

    Alphatec Spine is recalling Arsenal Spinal Fixation System Set Screws due to a trend of postoperative disengagement from the screw body.

    Product
    Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0521-2017·2016-11-23

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 10 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    SAFESET" KIT W/03ML FLUSH DEVICE FOR HOLMES REG. M.C., Item No. 46097-30 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0523-2017·2016-11-23

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 70 units of Transpac IV transducer kits due to a potential leak in the SafeSet Reservoir system.

    Product
    QUAD TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUBBOCK HEART HOSP., Item No. 46097-36 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0308-2017·2016-11-16

    Ev3 Neurovascular Alligator Retrieval Device Recalled for Coating Defect

    Micro Therapeutics Inc. is recalling 3,337 Alligator Retrieval Devices because the PTFE coating may delaminate and detach, potentially entering the bloodstream.

    Product
    Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-88810-40V04 FA-88810-40V06 FA-88810-50V04 FA-88810-50V06
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0307-2017·2016-11-16

    FDA Recalls Pipeline Embolization Devices Due to Coating Delamination

    Micro Therapeutics Inc is recalling Pipeline Embolization Devices because PTFE coating may delaminate and enter the bloodstream.

    Product
    Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracranial aneurysms (lAs) in the internal carotid artery from the petrous to the superior hypophyseal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0310-2017·2016-11-16

    Ev3 Neurovascular Recalls X-Celerator Hydrophilic Exchange Guidewires

    Micro Therapeutics Inc is recalling X-Celerator Hydrophilic Exchange Guidewires because PTFE coating delamination may release material into the bloodstream.

    Product
    X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 103-0602-350V10 103-0601-300V03 103-0602-300V02 103-0601-300V06 103-0602-300v06…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0328-2017·2016-11-16

    SentreHeart Recalls FindrWIRZ Guidewire Systems Due to Coating Defects

    SentreHeart Inc is recalling FindrWIRZ Guidewire Systems because the lubricious coating delaminated and flaked off three units in Germany.

    Product
    FindrWIRZ Guidewire System Catalog# 40-05 Cardiology: The system is intended for use in the cardiovascular system for introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures.
    Category
    Medical Device
    Distribution
    15 states