The Recall Desk

Archive

January 2020 recalls

534 recalls were announced in January 2020.

What the numbers show

Critical
40
Severe
215
High
178
Moderate
85
Low
16

Of the 534 recalls this month scored against our rubric, 7% are Critical, 40% are Severe.

501–534 of 534

  • HighFDA (Food)·F-0439-2020·2020-01-01

    White Castle Sliders Recalled for Possible Listeria Contamination

    White Castle is recalling 894,078 cartons of Original Slider Hamburgers due to possible Listeria monocytogenes contamination. The product was distributed to 52 centers in 24 states.

    Product
    White Castle Sliders - The Original Slider Hamburgers
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0727-2020·2020-01-01

    GE Healthcare CARESCAPE Central Station Recalled for Cybersecurity Vulnerabilities

    GE Healthcare is recalling CARESCAPE Central Station units due to cybersecurity vulnerabilities in specific network-connected versions.

    Product
    CARESCAPE Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE Central Station is intended to collect information from a network and display this data. T
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0438-2020·2020-01-01

    White Castle Cheeseburgers Recalled for Possible Listeria Contamination

    White Castle is recalling specific lots of cheeseburgers due to possible contamination with Listeria monocytogenes. The product was distributed to 52 centers in 24 states.

    Product
    White Castle Sliders - Cheese Sliders - Cheeseburgers UPC 8298801006 (6pk Cheeseburger), UPC 829880116 (16pk Cheeseburger)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0561-2020·2020-01-01

    LivaNova SenTiva VNS Therapy Generators Recalled for Potential Device Reset

    LivaNova is recalling SenTiva VNS Therapy generators that may reset and become disabled within 60 days of enabling, potentially requiring additional surgery or causing a return of symptoms.

    Product
    VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Food)·F-0461-2020·2020-01-01

    Northern Fisheries Recalls Frozen Yellowfin Tuna Steaks Due to Histamine Levels

    Northern Fisheries Ltd. is recalling 1,052 cases of frozen yellowfin tuna steaks in Florida, Georgia, New York, Illinois, and Rhode Island due to potential scombrotoxin fish poisoning.

    Product
    Frozen Yellowfin Tuna Steak, 4 oz. and 6 oz., Keep Frozen, Imported/Distributed: Mical Seafood Inc., 10400 Griffin Rd, Suite #209, Cooper City, Florida 33328
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0721-2020·2020-01-01

    Mazor Robotics Recalls Snapshot Tracker Kits Due to Manufacturing Defects

    Mazor Robotics is recalling 93 Snapshot Tracker Kits because they were not manufactured to specifications, potentially causing navigational inaccuracies and patient injury.

    Product
    Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0744-2020·2020-01-01

    Axis-Shield Homocysteine Reagent Recalled for Potential Performance Issues

    Axis-Shield Diagnostics is recalling 740 units of Liquid Stable 2-Part Homocysteine Reagent due to potential performance issues detected during routine testing.

    Product
    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR1000 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0736-2020·2020-01-01

    RayStation Radiation Therapy Software Recalled for Beam Editing Bug

    RaySearch Laboratories is recalling RayStation software versions 4.0 through 9.0 because a bug may reset beam settings, requiring dose recalculation.

    Product
    RayStation stand-alone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0 - Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0726-2020·2020-01-01

    GE Healthcare Recalls CIC Pro Central Stations Due to Cybersecurity Vulnerabilities

    GE Healthcare is recalling 41,848 CIC Pro Clinical Information Center Central Stations worldwide due to cybersecurity vulnerabilities in connected telemetry systems.

    Product
    CIC Pro Clinical Information Center Central Station - Product Usage: The intended use is to provide clinicians with adult, pediatric and neonatal patient data in a centralized location within a hospital or clinical environment. CIC Pro Clinical Information Center central station
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0020-2020·2020-01-01

    Galemed Babi.Plus Pressure Relief Manifold Recalled for Low Venting Pressure

    Galemed Corporation is recalling Babi.Plus 12.5 cm H2O Pressure Relief Manifolds because they may vent gas below standard pressure.

    Product
    Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0459-2020·2020-01-01

    Northern Fisheries Recalls Frozen Yellowfin Tuna Loins Due to Histamine Levels

    Northern Fisheries Ltd. is recalling 200 cases of frozen yellowfin tuna loins because they may contain increased levels of histamine, posing a risk of scombrotoxin fish poisoning.

    Product
    Frozen Yellowfin Tuna Loins, 5-8 lbs, Keep Frozen, Imported/Distributed: Mical Seafood Inc., 10400 Griffin Rd, Suite #209, Cooper City, Florida 33328
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-0411-2020·2020-01-01

    Bingtangyangmei Waxberry recall due to undeclared sulfites and cyclamates

    Lin's Waha International Corp.'s Bingtangyangmei waxberry product was recalled because it contains undeclared sulfites and cyclamates.

    Product
    Bingtangyangmei Waxberry, 8.11 OZ (230g) clear plastic containers, UPC 6948576407219 and date 02.13.2020 stamped on the box
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0722-2020·2020-01-01

    Lifelines Neuro Recalls ElectroTek EEG Sensor Cables Due to Labeling Error

    Lifelines Neuro is recalling eight ElectroTek EEG temporal sensor cables because incorrect placement labels could lead to improper electrode positioning during brain activity studies.

    Product
    ElectroTek Temporal Sensor Cable Gold - Long Length, Graduated - Product Usage: The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a patient s brain obtained by placing electrodes on the patient s scalp. The Electro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0729-2020·2020-01-01

    Cordis Precise Nitinol Stent System Labeling Correction for MRI Information

    Cardinal Health is correcting labeling on Cordis Precise Nitinol Stent Systems because the instructions incorrectly stated the device was MRI Safe instead of MRI Conditional.

    Product
    Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent System devices are designed to deliver a flexible, self-expanding endoluminal stent to the carotid vasculature via over-the-wire (OTW) 5.5F or 6F sheathed delivery systems. The stent is cut from a solid ni
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0740-2020·2020-01-01

    Ortho Clinical Diagnostics Recalls Urine Electrolyte Diluent Due to Instability

    Ortho Clinical Diagnostics is recalling Urine Electrolyte Diluent because the product may become unstable when stored in a 2mL cup for 7 days.

    Product
    Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium (K+) on VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0742-2020·2020-01-01

    Axis-Shield Homocysteine Reagent Recalled for Potential Performance Issues

    Axis-Shield Diagnostics is recalling 740 units of Liquid Stable 2-Part Homocysteine Reagent due to potential under-recovery of sample results.

    Product
    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHBC100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0728-2020·2020-01-01

    Cardinal Health Recalls S.M.A.R.T. Stents for Incorrect MRI Labeling

    Cardinal Health is correcting labeling on S.M.A.R.T. Nitinol Stent Systems that incorrectly stated they were 'MRI Safe' instead of 'MRI Conditional'.

    Product
    S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System. The SMART stent system includes a self-expanding stent made of Nitinol (nickel-titanium alloy) material and a 6 French (2.0 mm) or 7 French (2.3 mm) sheathed delivery system. The stent is laser
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0743-2020·2020-01-01

    Axis-Shield Homocysteine Reagent Recalled for Potential Performance Issues

    Axis-Shield Diagnostics is recalling 740 units of Liquid Stable 2-Part Homocysteine Reagent due to potential performance issues detected during routine testing.

    Product
    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT, Part Number FHRWR100 - Product Usage: The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The device is intended for Professional use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0723-2020·2020-01-01

    Lifelines Neuro Recalls ElectroTek Temporal Sensor Cables for Labeling Errors

    Lifelines Neuro is recalling 12 ElectroTek Temporal Sensor Cables due to potential incorrect placement labels that could lead to improper electrode placement during EEG studies.

    Product
    ElectroTek Temporal Sensor Cable Gold - Long Length, Single Length - Product Usage: The electroencephalographic system ElectroTek is intended to acquire, display, and store the electrical activity of a patient s brain obtained by placing electrodes on the patient s scalp. The Ele
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0737-2020·2020-01-01

    Diagnostica Stago Recalls STA Unicalibrator Due to Positive Bias

    Diagnostica Stago is recalling 5,498 units of STA Unicalibrator because a positive bias was confirmed when compared to International Standards.

    Product
    STA UNICALIBRATOR (ref. 00675)
    Category
    Medical Device
    Distribution
    42 states
  • ModerateFDA (Devices)·Z-0730-2020·2020-01-01

    Cardinal Health Recalls S.M.A.R.T. Stents for Incorrect MRI Labeling

    Cardinal Health is correcting labeling on S.M.A.R.T. stents that incorrectly stated they were MRI Safe. The correct classification is MRI Conditional.

    Product
    Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent Systems consist of a self-expanding stent made of Nitinol (nickel-titanium alloy) material that is pre-mounted on an over-the-wire delivery system. The stents co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0720-2020·2020-01-01

    Abbott Recalls Mislabeled Radiofrequency Cannulas Due to Manufacturing Error

    Abbott Medical is recalling 470 radiofrequency cannulas that were incorrectly labeled with a 5mm active tip length instead of 10mm.

    Product
    CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae are provided in either straight, curved, or curved blunt geometries with a stylet inserted in the cannula. Cannulae are insulated except for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0739-2020·2020-01-01

    Ortho Clinical Diagnostics Recalls VITROS 7% BSA Diluent Due to Instability

    Ortho Clinical Diagnostics is recalling VITROS 7% BSA diluent because it may become unstable when stored in a 2mL cup for seven days.

    Product
    7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using the VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0741-2020·2020-01-01

    PTS Test Strips Recalled for Under-Recovery Against Reference Method

    Polymer Technology Systems is recalling specific CHOL+HDL+GLU test strips because they show under-recovery when tested against a reference method.

    Product
    PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Drugs)·D-0628-2020·2020-01-01

    Spectrum Laboratory Products Recalls Subpotent Estriol Micronized USP

    Spectrum Laboratory Products is recalling specific lots of Estriol Micronized USP because assay results did not meet specifications.

    Product
    Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1, packaged in a) 1 G glass bottles, b) 5 G glass bottles, c) 25 G glass bottles, d) 100 G glass bottles, e) 500 G glass bottles, and f) 1 KG plastic bottles, Rx Only, Spectrum Chemical
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0732-2020·2020-01-01

    AAP Implantate Drill CS 4.0 Recalled for Incorrect Instructions

    AAP Implantate Ag is recalling 7 units of INTEGRA Drill CS 4.0 in Texas due to incorrect instructions for use.

    Product
    INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0626-2020·2020-01-01

    Pharmedium Recalls Subpotent Repinephrine Bitartrate Injection Bags Nationwide

    Pharmedium Services LLC is voluntarily recalling 864 bags of repinephrine bitartrate injection because the drug was subpotent. The recall covers nationwide distribution in the U.S.

    Product
    NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 508.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0745-2020·2020-01-01

    Tosoh AIA-PACK B12 Pretreatment Set Recalled for Barcode Reading Errors

    Tosoh Smd Inc is recalling AIA-PACK B12 Pretreatment Sets due to barcode scanning issues that may delay diagnostic results.

    Product
    AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0627-2020·2020-01-01

    Pharmedium Recalls Subpotent Repinephrine Bitartrate Injection Bags

    Pharmedium Services LLC is recalling 5,808 bags of Repinephrine Bitartrate Injection due to subpotent drug levels. The FDA classified this as a Class III recall.

    Product
    NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 254.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0625-2020·2020-01-01

    Pharmedium Recalls Subpotent Repinephrine Bitartrate Injection Bags

    Pharmedium Services LLC is voluntarily recalling 5,820 bags of subpotent repinephrine bitartrate injection. The FDA classified this as a Class III recall.

    Product
    NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total Volume 258.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0731-2020·2020-01-01

    INTEGRA Drill CS 4.5 Recalled for Incorrect Instructions for Use

    AAP Implantate Ag is recalling two units of INTEGRA Drill CS 4.5 in Texas due to incorrect instructions for use.

    Product
    INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453
    Category
    Medical Device
    Distribution
    1 state

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