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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13526–13550 of 27471

  • HighFDA (Devices)·Z-2278-2020·2020-06-17

    Genicon GENILook Medical Device Recalled for Potential Tip Detachment

    Genicon, Inc. is recalling GENILook Model 200-105-252 devices because the plastic optical tip may detach from the metal shaft.

    Product
    Genicon GENILook Model 200-105-252, 5mm diameter, 150mm length (2 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2334-2020·2020-06-17

    Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error

    Smith & Nephew is recalling 4,172 R3 Acetabular Shells distributed worldwide because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331942 46MM 71331946 48MM 71331948 50MM 71331950 52MM 71331952 54MM 71331954 56MM 71331956 58MM 71331958 60MM 71331960 62MM…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2283-2020·2020-06-17

    Siemens Atellica CH Enzymatic Creatinine Recalled for Acetaminophen Interference

    Siemens Healthcare Diagnostics is recalling Atellica CH Enzymatic Creatinine reagents because acetaminophen metabolites may interfere with test results.

    Product
    Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2338-2020·2020-06-17

    Philips Recalls IntelliSpace PACS 4.4 Due to Potential Image Corruption

    Philips Healthcare Informatics is recalling 26 units of IntelliSpace PACS 4.4 because images may potentially become corrupt while using the system.

    Product
    IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2270-2020·2020-06-17

    Genicon GENILook Cannula Recalled Due to Potential Tip Detachment

    Genicon, Inc. is recalling GENILook Model 200-105-151 cannulas because the plastic optical tip may detach from the metal shaft.

    Product
    Genicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2282-2020·2020-06-17

    Siemens ADVIA Chemistry Enzymatic Creatinine Recalled for Acetaminophen Interference

    Siemens is recalling ADVIA Chemistry Enzymatic Creatinine reagents because acetaminophen metabolites may interfere with test results.

    Product
    ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2351-2020·2020-06-17

    RayStation 9B Software Recall for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation 9B Service Pack 1 due to a software error in dose calculation algorithms that could result in local underestimation of expected radiation dose.

    Product
    RayStation 9B Service Pack 1, UDI # 07350002010297 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2299-2020·2020-06-17

    Inari Medical Recalls Triever20 Aspiration Guide Catheter for Valve Failure

    Inari Medical is recalling 318 Triever20 Aspiration Guide Catheters because the hemostasis valve may fail to seal, causing loss of vacuum during thrombus aspiration.

    Product
    Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-2345-2020·2020-06-17

    RayStation 8A Software Recall for Dose Calculation Error

    RaySearch Laboratories is recalling RayStation 8A Service Pack 1 software due to a dose calculation error that could underestimate radiation therapy doses.

    Product
    RayStation 8A Service Pack 1, UDI # 07350002010136 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2354-2020·2020-06-17

    Acuity A Link Z Spinal Fusion Device Recalled for Manufacturing Defect

    Acuity Surgical Devices is recalling 178 A Link Z intervertebral body fusion devices because a manufacturing issue prevented bone screws from seating properly.

    Product
    A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Plate-Cage 32x21x15 7 A Link Z Ti Unitary Plate-Cage 32x21x15 12 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage 32x21x15 16 A Link Z Ti Unitary Plate-Cage…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2352-2020·2020-06-17

    RayStation 6 Service Pack 1 Radiation Therapy Software Recall

    RaySearch Laboratories is recalling RayStation 6 Service Pack 1 software due to a calculation error that may underestimate radiation dose.

    Product
    RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2265-2020·2020-06-17

    ROi CPS Recalls Custom Procedure Kits Containing Recalled BD Syringes

    ROi CPS LLC is recalling 40 custom procedure kits because they contain PosiFlush Syringes from a lot previously recalled by BD.

    Product
    Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2350-2020·2020-06-17

    RayStation 9B Software Recalled for Dose Calculation Error

    RaySearch Laboratories is recalling RayStation 9B software due to a dose calculation error that could underestimate radiation therapy doses.

    Product
    RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2262-2020·2020-06-17

    Ventana HE 600 Recalled for Electrical Short Risk

    Ventana Medical Systems is recalling 461 HE 600 instruments due to a cleaning solution leak that can cause electrical shorts and burned components.

    Product
    Model Number: 06917259001 UDI: 04015630976010 - Product Usage: The System s intended use environment includes anatomic pathology (AP) laboratories and histology facilities within hospital, clinic, reference, or private lab settings. The System is to be operated by qualified…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2332-2020·2020-06-17

    Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error

    Smith & Nephew is recalling 1,450 R3 Zero Hole HA Coated Hemispherical Stiktite Coated Shells because a manufacturing error resulted in out-of-specification devices.

    Product
    smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71332242 46MM 71332246 48MM 71332248 50MM 71332250 52MM 71332252 54MM 71332254 56MM 71332256 58MM 71332258 60MM 71332260 62MM…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2296-2020·2020-06-17

    BioFire FilmArray BCID Panel Recalled for False Positive Proteus Results

    BioFire Diagnostics is recalling FilmArray BCID Panels due to a risk of false positive Proteus results when used with specific blood culture media, which may lead to improper antibiotic treatment.

    Product
    FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT¿ FA Plus 410852/BACT/ALERT¿ FN Plus 410853/BACT/ALERT¿ PF Plus 259790/BACT/ALERT¿ SN…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2297-2020·2020-06-17

    Elekta Unity Software Recall for Motion Monitoring Data Mismatch

    Elekta Limited is recalling specific Unity software versions due to a potential mismatch between contour data and motion monitoring images.

    Product
    Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2355-2020·2020-06-17

    Acuity Surgical Devices Recalls A Link Z Intervertebral Body Fusion Devices

    Acuity Surgical Devices is recalling A Link Z Intervertebral Body Fusion Devices due to a manufacturing issue that may prevent vertebral body bone screws from seating properly.

    Product
    A LINK Z INTERVERTEBRAL BODY FUSION DEVICE Product Description: A Link Z Ti Unitary Open Interbody 32x24x12 7 A Link Z Ti Unitary Open Interbody 32x24x12 12 A Link Z Ti Unitary Open Interbody 32x24x16 7 A Link Z Ti Unitary Open Interbody 32x24x16 12 Product Usage: is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2298-2020·2020-06-17

    HardyCHROM MRSA Recall for False Positive Results

    Hardy Diagnostics is recalling HardyCHROM MRSA kits because they may produce false positive results for methicillin-susceptible Staphylococcus aureus.

    Product
    HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromogenic medium for the qualitative direct detection of nasal colonization by methicillin-resistant Staphylococcus aureus (MRSA). Not intended to diagnose infection of guide therapy. Further testing required…
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-2284-2020·2020-06-17

    Siemens Dimension Enzymatic Creatinine Recalled for Acetaminophen Interference

    Siemens Healthcare Diagnostics is recalling Dimension Enzymatic Creatinine reagents because acetaminophen metabolites may interfere with test results.

    Product
    Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2325-2020·2020-06-17

    Canon Medical System Recalls Infinix-8000V Catheterization Tables Due to Loose Bolts

    Canon Medical System is recalling 46 Infinix-8000V systems because loose bolts may cause the catheterization table to tilt.

    Product
    Infinix-8000V with Catheterization Table CAT-850B or CAT-860B - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2285-2020·2020-06-17

    Siemens Dimension Vista Enzymatic Creatinine Recalled for Acetaminophen Interference

    Siemens Healthcare Diagnostics is recalling Dimension Vista Enzymatic Creatinine test kits because acetaminophen metabolites may interfere with results.

    Product
    Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 - Product Usage: use in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2275-2020·2020-06-17

    Genicon Natura Trocar Handle Recall Due to Detaching Optical Tip

    Genicon, Inc. is recalling Natura Model 210-005-152 trocar handles because the plastic optical tip may detach from the metal shaft.

    Product
    Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, threaded) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2339-2020·2020-06-17

    RayStation Radiation Therapy Software Recalled for Dose Calculation Error

    RaySearch Laboratories is recalling RayStation software versions 4.0 to 5.0 Service Pack 2 due to a dose calculation error that may underestimate radiation dose.

    Product
    RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2302-2020·2020-06-17

    Siemens Artis X-Ray Systems Recalled for Electrical Contact Issues

    Siemens is recalling 15 Artis X-ray systems in the US because a power distributor defect may cause electrical contact interruptions, leading to procedure termination.

    Product
    Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-Ray System) as follows: Artis Q floor Model: 10848280; Artis Q ceiling Model: 10848281; Artis Q biplane Model:10848282; Artis zee ceiling Model: 10094137; Artis zee floor Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide