The Recall Desk

Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

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.

14451–14475 of 21645

  • ModerateFDA (Devices)·Z-2037-2016·2016-06-29

    Siemens Biograph 16 TruePoint PET/CT Scanners Recalled for Calibration Error

    Siemens is recalling 63 Biograph 16 TruePoint PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph 16 TruePoint, MATERIAL NUMBER 10249555 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2030-2016·2016-06-29

    Siemens Biograph mCT-S PET/CT Scanner Recall for Calibration Error

    Siemens is recalling 47 Biograph mCT-S PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2035-2016·2016-06-29

    Siemens Biograph TruePoint PET/CT Scanner Recall for Calibration Error

    Siemens Medical Solutions is recalling four Biograph TruePoint PET/CT scanners due to a risk of unexpected SUV values when using non-Siemens phantoms for calibration.

    Product
    SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2033-2016·2016-06-29

    Siemens Biograph mCT-S PET/CT scanners recalled for calibration error risk

    Siemens is recalling 127 Biograph mCT-S PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2018-2016·2016-06-29

    Siemens Biograph TruePoint PET/CT Scanner Recall for Calibration Error

    Siemens is recalling four Biograph TruePoint PET/CT scanners due to a potential for unexpected SUV values when non-Siemens phantoms are used for calibration.

    Product
    BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2015-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling 49 Biograph PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2029-2016·2016-06-29

    Siemens Biograph TruePoint PET/CT Scanners Recalled for Calibration Error

    Siemens is recalling five Biograph TruePoint PET/CT scanners because using a non-Siemens phantom for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2036-2016·2016-06-29

    Siemens Biograph TruePoint PET/CT Scanner Recall for Calibration Error

    Siemens is recalling two Biograph TruePoint PET/CT scanners due to a potential for unexpected SUV values when using non-Siemens phantoms for calibration.

    Product
    SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2023-2016·2016-06-29

    Siemens Biograph mCT Flow 40-4R Recalled for Calibration Error Risk

    Siemens Medical Solutions is recalling nine Biograph mCT Flow 40-4R scanners due to a potential for unexpected SUV values if non-Siemens phantoms are used for calibration.

    Product
    BIOGRAPH mCT Flow 40-4R, MATERIAL NUMBER 10529159 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2041-2016·2016-06-29

    Siemens ADVIA Centaur Tnl-Ultra Assay Recalled for Biotin Interference

    Siemens Healthcare is recalling ADVIA Centaur Tnl-Ultra Assay kits because biotin in patient samples can alter test results by more than 10%.

    Product
    Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponin For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2028-2016·2016-06-29

    Siemens Biograph mCT S(20) - 3R PET/CT Scanner Recall

    Siemens is recalling 143 Biograph mCT S(20) - 3R scanners due to a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

    Product
    BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2011-2016·2016-06-29

    Siemens Biograph PET/CT Scanner Recall for Calibration Error Risk

    Siemens is recalling Biograph 6 TP scanners due to a potential for unexpected SUV values when using non-Siemens phantoms for calibration.

    Product
    Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2026-2016·2016-06-29

    Siemens Biograph mCT Flow Edge-3R Recalled for Calibration Error

    Siemens is recalling two Biograph mCT Flow Edge-3R scanners due to a potential for unexpected SUV values when using non-Siemens phantoms for calibration.

    Product
    BIOGRAPH mCT Flow Edge-3R, MATERIAL NUMBER 10528954 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1046-2016·2016-06-29

    Sandoz Recalls Dicloxacillin Sodium Capsules Due to Impurity Test Failure

    Sandoz, Inc. is recalling specific lots of Dicloxacillin Sodium Capsules, 500mg, because testing revealed an out-of-specification result for a known impurity.

    Product
    Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2032-2016·2016-06-29

    Siemens Biograph mCT-S PET/CT Scanners Recalled for Calibration Error

    Siemens is recalling 51 Biograph mCT-S PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2010-2016·2016-06-29

    Siemens Biograph TruePoint CT/PET Scanner Upgrade Recalled for Calibration Error

    Siemens is recalling a Biograph TruePoint upgrade kit because using a non-Siemens phantom for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1566-2016·2016-06-29

    Trader Joe's Recalls Triple Ginger Brew Due to Bursting Bottle Risk

    Trader Joe's is recalling Triple Ginger Brew glass bottles because unopened bottles may burst. The recall covers 75,240 cases sold nationwide.

    Product
    Triple Ginger Brew, 25.4 FL OZ (750 mL) glass bottles, SKU 51857 Bottles are sold individually; there are 9 bottles per case
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1042-2016·2016-06-29

    Profarma Recalls Vermox Tablets Due to Manufacturing Deviations

    Profarma Distributors LLC is recalling 254 boxes of Vermox Tablets 500 mg due to CGMP deviations. The recall is voluntary and nationwide.

    Product
    VERMOX Tablets 500 mg, 1-count box, UPC 501109900596
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2012-2016·2016-06-29

    Siemens Biograph 6 TruePoint Scanners Recalled for Calibration Error Risk

    Siemens Medical Solutions is recalling 102 Biograph 6 TruePoint scanners due to a potential for unexpected SUV values when non-Siemens phantoms are used for calibration.

    Product
    BIOGRAPH 6 TruePoint, Material Number 10097289 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2016-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling Biograph 6-4R TruePoint PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH 6-4R TruePoint w/TrueV, MATERIAL NUMBER 10097290 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2020-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling nine Biograph mCT Flow 20-3R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH mCT Flow 20-3R, MATERIAL NUMBER 10528956 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2024-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling 12 Biograph mCT Flow 64-3R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2019-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling two Biograph PET/CT scanners due to a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.

    Product
    BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2021-2016·2016-06-29

    Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk

    Siemens is recalling 28 Biograph mCT Flow 20-4R PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2008-2016·2016-06-29

    Siemens Biograph 40 TruePoint PET/CT Scanner Recall for Calibration Error

    Siemens is recalling 48 Biograph 40 TruePoint PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.

    Product
    BIOGRAPH 40 TruePoint, Material Number 10097303 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide