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.

8801–8825 of 21595

  • ModerateFDA (Devices)·Z-1957-2019·2019-07-17

    Richard Wolf Recalls E-Line Cutting Electrode Due to Incorrect Product Packaging

    Richard Wolf Medical Instruments Corp. is recalling E-Line Cutting Electrodes because some packages contain the wrong electrode type.

    Product
    E-Line Cutting Electrode 11.5Fr Mono 0 degrees, Sterile. One electrode is placed in a plastic tray and then inserted into a Tyvek pouch. Five packaged electrodes are placed in a white box. Product Usage: Resectoscopes are used for endoscopically controlled ablation of tissue. T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1846-2019·2019-07-17

    GE Healthcare Recalls Giraffe Infant Radiant Warmers Due to Panel Cracking

    GE Healthcare is recalling 9,094 Giraffe Infant Radiant Warmers because bedside panels and latch areas can crack or break if the unit is moved using the panels instead of the designated handles.

    Product
    Giraffe Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1535-2019·2019-07-17

    Hallmark Fisheries Recalls IQF Shrimp Meat Due to Foreign Object

    California Shellfish, Inc. dba Hallmark Fisheries is recalling Ocean Supreme and Yaquina Bay IQF shrimp meat because a foreign object was found inside the product packaging.

    Product
    Ocean Supreme and Yaquina Bay IQF shrimp meat, product of USA wild caught, cooked and peeled, 5 lb. bag, 4/5 lb. bags per box, net wt. 20#. The BAG label is read in parts: "***Ocean Supreme *** Cooked & Peeled I.Q.F SHRIMP MEAT ***Ingredients: Shrimp Meat and Salt ***Net Wt. 5
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1958-2019·2019-07-17

    Canon Radrex-i X-Ray System Software Malfunction Recall

    Canon Medical System is recalling 46 Radrex-i X-Ray Systems due to a software malfunction that prevents image transmission from the wireless flat panel detector.

    Product
    Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software version: v5.00ER005 Product Usage: The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after appropriat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1949-2019·2019-07-17

    Helena Laboratories Recalls ColoCARE In-Vitro Diagnostic Kits

    Helena Laboratories is recalling ColoCARE diagnostic kits because the positive control failed to react properly, potentially affecting test accuracy.

    Product
    ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-1847-2019·2019-07-17

    GE Healthcare Recalls Panda Infant Radiant Warmers Due to Bedside Panel Cracking

    GE Healthcare is recalling 28,094 Panda Infant Radiant Warmers because the bedside panels and latch areas can crack or break if the unit is moved using them instead of the designated handles.

    Product
    Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1533-2019·2019-07-17

    Reily Foods Recalls Blue Plate Light Olive Oil Mayonnaise Due to Yeast

    Reily Foods is recalling Blue Plate Light Olive Oil Mayonnaise because yeast caused gas formation, leading to bloated bottles and mayonnaise release.

    Product
    Blue Plate Light Olive Oil Mayonnaise 30oz / 18oz, PET jars and PET squeeze bottles
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1916-2019·2019-07-10

    Siemens SOMATOM go.Now CT Scanner Recall for Workflow Interruptions

    Siemens Medical Solutions is recalling 53 SOMATOM go.Now CT scanners due to potential sporadic performance problems that may cause scanning workflow interruptions and delays in diagnosis.

    Product
    SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1915-2019·2019-07-10

    Siemens SOMATOM go.Up CT Scanner Recalled for Performance Issues

    Siemens Medical Solutions is recalling nine SOMATOM go.Up CT scanners due to sporadic performance problems that may interrupt scanning workflows and delay patient diagnosis.

    Product
    SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images deli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1893-2019·2019-07-10

    Recall of 25GA Vitrectomy Cutters Due to Packaging Error

    Johnson & Johnson is recalling 392 units of 25GA Vitrectomy Cutters because 20GA cutters may be found in the packaging, posing a surgical risk.

    Product
    Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The product provides the item necessary to perform one vitrectomy procedure. It is used to remove vitreous from the eye. It has been designed as a disposable (single use)
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1918-2019·2019-07-10

    Siemens SOMATOM go.Top CT Systems Recalled for Performance Issues

    Siemens Medical Solutions is recalling 30 SOMATOM go.Top CT systems due to potential performance problems that may interrupt scanning workflows and delay patient diagnoses.

    Product
    SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images de
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1922-2019·2019-07-10

    Siemens CT System Recalled for Potential Scanning Workflow Interruptions

    Siemens Medical Solutions is recalling 69 SOMATOM go.Top CT systems due to potential sporadic performance problems that may cause diagnostic delays or the need for patient rescans.

    Product
    SOMATOM go.Top, Model No. 11061648 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The imag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1932-2019·2019-07-10

    Medtronic Recalls 0-arm 1000 Imaging Systems Due to Charger Board Defect

    Medtronic is recalling 832 0-arm 1000 Imaging Systems worldwide because a defective charger board prevents batteries from fully recharging, rendering the system inoperable.

    Product
    Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system voltage): Product Name Model#/ CFN OARM ASSY 8170000027 SYSTEM PRODUCT BI70000027 OARM ASSY BI70000027R SYS PRODUCT RWK BI70000027R BASE OARM 8170000027100 SYSTEM !D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1929-2019·2019-07-10

    Philips Recalls Vereos PET/CT Systems Due to Cover Misalignment

    Philips Medical Systems is recalling 70 Vereos PET/CT systems because misaligned covers may create gaps or protrude into the imaging bore.

    Product
    Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1919-2019·2019-07-10

    Siemens SOMATOM go.Up CT Systems Recalled for Performance Issues

    Siemens is recalling 69 SOMATOM go.Up CT systems due to sporadic performance problems that may cause diagnostic delays or patient rescans.

    Product
    SOMATOM go.Up, Model No. 11061628 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The image
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1454-2019·2019-07-10

    InvaGen Recalls Testosterone Topical Solution Due to Defective Container

    InvaGen Pharmaceuticals is recalling 1,776 bottles of Testosterone Topical Solution because defective containers may cause the actuator to function improperly, affecting dose delivery.

    Product
    TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1948-2019·2019-07-10

    Zimmer Biomet Recalls K-Wire Trochar Tips Due to Packaging Seal Issues

    Zimmer Biomet is recalling K-Wire Trochar Tips because the sterile packaging may have weak seals, potentially compromising the device's sterility.

    Product
    K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1934-2019·2019-07-10

    Ortho-Clinical Diagnostics Recalls VITROS 250AT Chemistry System

    Ortho-Clinical Diagnostics is recalling 57 VITROS 250AT Chemistry Systems due to potential negative drift in Creatine Kinase (CK) test results.

    Product
    VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1921-2019·2019-07-10

    Siemens SOMATOM go.All CT Scanner Recalled for Performance Issues

    Siemens is recalling 69 SOMATOM go.All CT scanners due to potential performance problems that may cause diagnostic delays or require patient rescans.

    Product
    SOMATOM go.All, Model No. 11061638 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The imag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1914-2019·2019-07-10

    Siemens Recalls Atellica CH Creatine Kinase Reagent Due to Absorbance Trend

    Siemens Healthcare Diagnostics is recalling 899 units of Atellica CH Creatine Kinase (CK_L) Reagent because a steady upward trend in blank absorbance was observed.

    Product
    Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium h
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1906-2019·2019-07-10

    Bio-Rad Recalls EVOLIS Microplate System Due to Software Error

    Bio-Rad is recalling 213 EVOLIS Microplate Systems because a software defect may cause erroneous test results to be transmitted to laboratory information systems.

    Product
    EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1920-2019·2019-07-10

    Siemens SOMATOM go.Now CT Systems Recalled for Performance Issues

    Siemens is recalling 69 SOMATOM go.Now CT systems due to potential performance problems that may cause diagnostic delays or the need for patient rescans.

    Product
    SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The imag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1913-2019·2019-07-10

    Siemens ADVIA Chemistry Creatine Kinase Reagent Recalled for Absorbance Trend

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Creatine Kinase (CK_L) reagent due to a steady upward trend in blank absorbance.

    Product
    ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithi
    Category
    Medical Device
    Distribution
    0 states