The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

22876–22900 of 50430

  • HighFDA (Devices)·Z-2276-2020·2020-06-17

    Genicon Natura Cannula Recalled Due to Potential Tip Detachment

    Genicon, Inc. is recalling Natura Model 210-005-251 cannulas because the plastic optical tip may detach from the metal shaft.

    Product
    Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one 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-2346-2020·2020-06-17

    RayStation 8B Software Recall for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation 8B software due to errors in dose calculation algorithms that could underestimate radiation dose.

    Product
    RayStation 8B, UDI # 07350002010129 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0978-2020·2020-06-17

    Coastal Sunbelt Butternut Squash Recalled for Potential Listeria Contamination

    Coastal Sunbelt Produce Co. Inc. is recalling raw butternut squash due to potential Listeria monocytogenes contamination. The product was distributed in 11 states and Washington, D.C.

    Product
    Bin Butternut Squash, Bulk, Raw Product in Bins / 4, 5lb packages in each case
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-2291-2020·2020-06-17

    Biocare Medical Recalls 4plus Streptavidin HRP Label Due to Staining Failure

    Biocare Medical is recalling 4plus Streptavidin HRP Label kits because they may fail to stain, potentially causing invalid test results and delayed diagnoses.

    Product
    4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2341-2020·2020-06-17

    RayStation 6 Radiation Therapy Software Recalled for Dose Calculation Error

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

    Product
    RayStation 6, UDI # 07350002010013 - 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-2267-2020·2020-06-17

    Genicon GENILook Medical Device Recalled Due to Detachment Risk

    Genicon, Inc. is recalling GENILook Model 200-005-152 medical devices because the plastic optical tip may detach from the metal shaft.

    Product
    Genicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 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-2343-2020·2020-06-17

    RayStation 6 Service Pack 3 Radiation Therapy Software Recall

    RaySearch Laboratories is recalling RayStation 6 Service Pack 3 software due to a calculation error that could underestimate radiation dose.

    Product
    RayStation 6 Service Pack 3, UDI # 07350002010242 - 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-2353-2020·2020-06-17

    RayStation 7 Software Recalled for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation 7 software due to errors in dose calculation algorithms that may underestimate radiation dose.

    Product
    RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1290-2020·2020-06-17

    Lupin Recalls Lisinopril 5 mg Tablets Due to Product Mix-Up

    Lupin Pharmaceuticals is recalling 4,224 bottles of Lisinopril 5 mg tablets because 10 mg tablets were found in the bottles.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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
  • HighCPSC·20140·2020-06-17

    Edwards Recalls Mechanical Heat Detectors Due to Fire Alert Failure

    Edwards Fire Safety is recalling about 85,000 mechanical heat detectors that may fail to activate during a fire, posing a risk of failure to alert consumers.

    Product
    Edwards Mechanical Heat Detectors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0977-2020·2020-06-17

    La Sonorense Gorditas Recalled for Missing Wheat Allergen Labeling

    La Sonorense, Inc. is recalling 247 packs of Gorditas Sonora Style in Arizona due to missing wheat allergen labeling.

    Product
    La Sonorense Tortilla Factory, Gorditas Sonora Style, One Dozen, NET WT. 1 lb. 6 oz. (22 oz.)
    Category
    Food
    Distribution
    1 state
  • 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