The Recall Desk

Archive

July 2019 recalls

903 recalls were announced in July 2019.

What the numbers show

Critical
24
Severe
150
High
252
Moderate
463
Low
14

Of the 903 recalls this month scored against our rubric, 3% are Critical, 17% are Severe.

701–800 of 903

  • SevereNHTSA·19V526000·2019-07-12

    Blue Bird Recalls School Buses Due to Roof Hatch Handle Defect

    Blue Bird is recalling 2018-2020 Vision and All American school buses because the roof emergency exit handle may break, preventing easy opening during an emergency.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN, VISION, VISION SCHOOL BUS, ALL AMERICAN SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V523000·2019-07-12

    Spartan Gladiator and MetroStar Front Shock Separation Recall

    Spartan is recalling 2014-2020 Gladiator and MetroStar vehicles because front shocks may separate, potentially causing a loss of power steering assist and increasing crash risk.

    Product
    SPARTAN — SPARTAN GLADIATOR, METROSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V529000·2019-07-12

    American Coach Motorhomes Recalled for Rear Air Deflector Detachment Risk

    REV Recreation Group is recalling 2016-2019 American Coach motorhomes because rear air deflectors may detach, creating a road hazard.

    Product
    AMERICAN COACH — AMERICAN COACH AMERICAN HERITAGE, AMERICAN EAGLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V525000·2019-07-12

    Heartland Recalls Fifth-Wheel Trailers Due to A/C Electrical Connector Fire Risk

    Heartland is recalling specific 2016-2020 fifth-wheel trailers because an improperly installed A/C electrical connector may overheat and increase the risk of a fire.

    Product
    HEARTLAND — HEARTLAND PIONEER, NORTH PEAK, MILESTONE, ELKRIDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V528000·2019-07-12

    KME Fire Trucks Recalled for Cab Hydraulic Velocity Fuse Defect

    KME is recalling various 2016-2020 Predator and Predator Panther fire trucks because hydraulic velocity fuses may fail to lock the cab during a system failure, posing an injury risk to occupants.

    Product
    KME — KME PREDATOR PANTHER PUMPER, PREDATOR SS PUMPER, PREDATOR SS RESCUE, PREDATOR AERIAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V524000·2019-07-12

    Blue Bird Recalls 2020 School Buses for Roof Hatch Handle Defect

    Blue Bird is recalling 2020 Vision and All American school buses because the roof hatch handle may break, preventing emergency exit.

    Product
    BLUE BIRD — BLUE BIRD VISION SCHOOL BUS, ALL AMERICAN SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19164·2019-07-11

    Lidl Recalls Wooden Grasping Toys Due to Choking Hazard

    Lidl is recalling Playtive Junior Wooden Grasping Toys because the wheels can detach, posing a choking hazard to young children.

    Product
    Playtive Junior Wooden Grasping Toy
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19165·2019-07-11

    Lifetime Brands Recalls Fitz and Floyd Can Mugs Due to Burn Hazards

    Lifetime Brands is recalling Fitz and Floyd Nevaeh White can mugs because they can crack or break when exposed to hot liquids, posing burn and laceration hazards.

    Product
    Fitz and Floyd® Nevaeh White® Can Mugs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19761·2019-07-11

    Levolor Recalls Custom Cellular Shades Due to Strangulation Hazard

    Levolor is recalling about 30,000 custom cellular shades because the pull cords are joined by a non-breakaway connector, posing a strangulation hazard to small children.

    Product
    Levolor Two-Corded Custom Cellular Shades
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V520000·2019-07-11

    Micro Bird Recalls 2019 MB II Buses Due to Fire Risk

    Micro Bird is recalling 52 model-year 2019 MB II propane-powered buses because a melted grounding wire could cause an engine compartment fire.

    Product
    MICRO BIRD — MICRO BIRD MB II TRANSIT BUS, MB II SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1488-2019·2019-07-10

    PharMEDium Recalls Hydromorphone Syringes Due to Sulfite Mislabeling

    PharMEDium Services is recalling 28,140 hydromorphone syringes because the product is labeled as sulfite-free but contains sulfites.

    Product
    Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave Cleveland, MS 38732, 800-523-7749, NDC 61553-352-78
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1528-2019·2019-07-10

    Signature Select Avocado Chunks Recalled Due to Listeria monocytogenes

    Nature's Touch Frozen Foods is recalling Signature Select Avocado Chunks after Washington State Department of Agriculture testing detected Listeria monocytogenes.

    Product
    Signature Select Avocado Chunks, 12 oz. (340 g) Stand-up pouch Re-sealable, Keep Frozen; UPC 2113009412 Ingredient: Avocado Chunks, Key Lime Juice Distributed by Better Living Brands Pleasanton, CA Product of Peru, Packed in Canada
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Devices)·Z-1899-2019·2019-07-10

    Siemens Artis X-Ray Systems Recalled for Ceiling Mount Screw Failure Risk

    Siemens is recalling 131 Artis X-ray systems because ceiling mount screws may loosen or snap, posing a risk of severe injury to patients and staff.

    Product
    Siemens Artis Q ceiling--Interventional Fluoroscopic X-Ray System Model Number: 10848281
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1900-2019·2019-07-10

    Siemens Artis X-Ray Systems Recalled for Potential Ceiling Mount Failure

    Siemens is recalling 73 Artis X-ray systems because ceiling-mounted support screws may loosen or snap, posing a risk of severe injury.

    Product
    Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1905-2019·2019-07-10

    Siemens Fluoroscopic X-Ray Systems Recalled for Potential Screw Failure

    Siemens is recalling eight Artis fluoroscopic X-ray systems because screws on the ceiling-mounted support may loosen or snap, posing a risk of severe injury.

    Product
    Siemens Artis pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1904-2019·2019-07-10

    Siemens Artis X-Ray Systems Recalled for Ceiling Mount Screw Failure Risk

    Siemens is recalling 11 Artis X-ray systems because ceiling-mounted support screws may loosen or snap, posing a risk of severe injury to patients and staff.

    Product
    Siemens Artis Q.zen biplane-Interventional Fluoroscopic X-Ray System Model Number: 10848355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1903-2019·2019-07-10

    Siemens Artis X-Ray Systems Recalled for Ceiling Mount Screw Failure

    Siemens is recalling 15 Artis X-ray systems because ceiling mount screws may loosen or snap, posing a risk of severe injury to patients and staff.

    Product
    Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model Number: 10848354
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1901-2019·2019-07-10

    Siemens Artis X-Ray Systems Recalled Due to Ceiling Mount Screw Failure Risk

    Siemens is recalling two Artis Q zeego X-ray systems because ceiling-mounted support screws may loosen or snap, posing a risk of severe injury to patients and staff.

    Product
    Siemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System Model Number: 10848283
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1945-2019·2019-07-10

    Bio-Detek Recalls ZOLL Pro-padz Liquid Gel Radiolucent Electrodes

    Bio-Detek, Inc. is recalling ZOLL Pro-padz Liquid Gel Radiolucent electrodes because some may be assembled incorrectly, preventing the delivery of defibrillation or pacing therapy.

    Product
    ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1897-2019·2019-07-10

    Siemens Artis X-Ray Systems Recalled for Ceiling Mount Screw Failure Risk

    Siemens is recalling 29 Artis X-ray systems because ceiling mount screws may loosen or snap, posing a risk of severe injury to patients and staff.

    Product
    Siemens Artis zeego--Interventional Fluoroscopic X-Ray System Model Number: 10280959
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1588-2019·2019-07-10

    Ozark Country Sorghum Recalled Due to High Nitrate Levels and Illness Reports

    Ozark Country Kitchen is recalling sorghum jars due to high nitrate levels. Public health officials are investigating two cases of methemoglobinemia linked to the product.

    Product
    Sorghum, Mfg. by Ozark Country Sorghum, Dunnegan, MO 65640, Net Wt. 2 lb. 14 OZ. packaged in glass jars
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1924-2019·2019-07-10

    Draco Enzymatic Deep-Cleaning Pad Recalled for Bacterial Contamination

    Madison Polymeric Engineering is recalling Draco Enzymatic Deep-Cleaning Pads due to contamination with Stenotrophomonas lactiubi. The affected units were distributed to 13 US states.

    Product
    Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305Z
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1902-2019·2019-07-10

    Siemens Artis X-Ray Systems Recalled for Potential Screw Failure

    Siemens is recalling eight Artis X-ray systems because screws on the ceiling-mounted support may loosen or snap, posing a risk of severe injury to patients and staff.

    Product
    Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System Model Number: 10848353
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1895-2019·2019-07-10

    Siemens Artis zee Ceiling X-Ray System Recall for Loose Screws

    Siemens is recalling 276 Artis zee ceiling-mounted X-ray systems because screws joining the pivot bearing to the ceiling support may work loose or snap off, posing a risk of severe injury.

    Product
    Siemens Artis zee ceiling -Interventional Fluoroscopic X-Ray System Model Number: 10094137
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1908-2019·2019-07-10

    Baxter Recalls Revaclear 300 Dialyzers Due to Potential Fiber Rupture

    Baxter Healthcare is recalling Revaclear 300 dialyzers because ruptured fibers may cause blood leaks during hemodialysis treatment.

    Product
    REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1898-2019·2019-07-10

    Siemens Artis X-Ray Systems Recalled for Ceiling Support Screw Failure

    Siemens is recalling 12 Artis X-ray systems because ceiling-mounted support screws may loosen or snap, posing a risk of severe injury to patients and staff.

    Product
    Siemens Artis Q floor --Interventional Fluoroscopic X-Ray System Model Number: 10848280
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1896-2019·2019-07-10

    Siemens Artis X-Ray Systems Recalled for Ceiling Mount Screw Failure

    Siemens is recalling 120 Artis X-Ray systems because ceiling-mounted support screws may loosen or snap, posing a risk of severe injury to patients and staff.

    Product
    Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System Model Number: 10094141
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V517000·2019-07-10

    Keystone Recalls 2020 Crossroads Trailers Due to Brake Wiring Defect

    Keystone is recalling 2020 Crossroads Hampton and Sunset trailers because an incorrectly wired breakaway switch may prevent brakes from functioning if the trailer separates from the tow vehicle.

    Product
    CROSSROADS — CROSSROADS HAMPTON, SUNSET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1894-2019·2019-07-10

    Siemens Artis zee X-Ray Systems Recalled for Ceiling Support Screw Failure

    Siemens is recalling 63 Artis zee X-ray systems because ceiling support screws may loosen or snap, posing a risk of severe injury to patients and staff.

    Product
    Siemens Artis zee floor -Interventional Fluoroscopic X-Ray System Model Number: 10094135
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1931-2019·2019-07-10

    ZOLL AED PRO Defibrillators Recalled for Potential Energy Delivery Failure

    ZOLL Medical Corporation is recalling 1,969 AED PRO units because they may fail to deliver energy to patients during cardiac arrest.

    Product
    ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1936-2019·2019-07-10

    Ortho-Clinical VITROS 350 Chemistry System Recalled for CK Drift

    Ortho-Clinical Diagnostics is recalling VITROS 350 Chemistry Systems due to potential negative drift in Creatine Kinase (CK) test results.

    Product
    VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) 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) test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·19161·2019-07-10

    Custom Molded Products Recalls Hot Tub Valve Caps Due to Impact Hazard

    Custom Molded Products is recalling about 16,000 diverter valve caps sold with certain Master Spas hot tubs and swim spas because the caps can pop off and strike bystanders.

    Product
    Diverter valve caps sold with Master Spas hot tubs and swim spas
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1911-2019·2019-07-10

    GE Healthcare Recalls Centricity PACS Foundation Software

    GE Healthcare is recalling Centricity PACS Foundation software because it may allow users to view incorrect patient images from external archives.

    Product
    Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·19759·2019-07-10

    Office Depot Recalls Realspace Magellan Desks Due To Shock Hazard

    Office Depot is recalling about 19,000 Realspace Magellan Performance Electric Height-Adjustable Desks because a control box issue creates a shock hazard.

    Product
    Realspace® Magellan Performance Electric Height-Adjustable Desks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19760·2019-07-10

    Bose Recalls Commercial Loudspeakers Due to Falling Injury Hazard

    Bose is recalling approximately 77,500 commercial loudspeakers because mounting components can break, causing the speakers to fall and pose an injury hazard.

    Product
    Professional use flush and surface mount loudspeakers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1525-2019·2019-07-10

    Will's Fresh Foods Macaroni Salad Recalled for Undeclared Wheat Allergen

    Woolery Enterprises Inc. is recalling Will's Fresh Foods Macaroni Salad because wheat is not declared as an ingredient or allergen.

    Product
    Will's Fresh Foods Macaroni Salad, All Natural; A true Classic salad made astonishingly delicious - semolina pasta, real mayonnaise and crunchy vegetables; NET WT. 12 oz.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1933-2019·2019-07-10

    Ortho-Clinical Diagnostics Recalls VITROS 250 Chemistry System for CK Drift

    Ortho-Clinical Diagnostics is recalling 5,020 VITROS 250 Chemistry Systems due to potential negative drift in Creatine Kinase results.

    Product
    VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) 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) test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1909-2019·2019-07-10

    Baxter Recalls Revaclear 400 Dialyzers Due to Potential Fiber Rupture

    Baxter Healthcare is recalling Revaclear 400 dialyzers because ruptured fibers may cause blood leaks during hemodialysis treatment.

    Product
    REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1930-2019·2019-07-10

    RaySearch Recalls Radiation Therapy Planning Software Due to Dose Calculation Errors

    RaySearch Laboratories AB is recalling RayStation and RayPlan software versions because electron Monte Carlo dose calculations may be incorrect when using a very large number of histories.

    Product
    RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatment planning and analysis of radiation therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1935-2019·2019-07-10

    Ortho-Clinical VITROS 250 Chemistry System Recalled for CK Result Drift

    Ortho-Clinical Diagnostics is recalling 2,411 refurbished VITROS 250 Chemistry Systems due to potential negative drift in Creatine Kinase (CK) test results.

    Product
    VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 10758750001330) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1910-2019·2019-07-10

    GE Healthcare Recalls Centricity Universal Viewer 6.0 Software

    GE Healthcare is recalling Centricity Universal Viewer 6.0 software due to a risk of displaying incorrect patient images from archives.

    Product
    Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1527-2019·2019-07-10

    Woodstock Organic Grilled Red Pepper Recalled for Listeria Contamination

    UNFI General Corporate is recalling Woodstock Organic Grilled Red Pepper because testing confirmed the presence of Listeria monocytogenes.

    Product
    WOODSTOCK ORGANIC GRILLED RED PEPPER, NET WT 10. OZ, packaged in a plastic packaged marked with UPC Code: 4256301714. Frozen.
    Category
    Food
    Distribution
    33 states
  • 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-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 (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
  • ModerateFDA (Devices)·Z-1917-2019·2019-07-10

    Siemens SOMATOM go.All CT Systems Recalled for Performance Issues

    Siemens is recalling 24 SOMATOM go.All CT systems due to sporadic performance problems that may interrupt scanning workflows and delay diagnoses.

    Product
    SOMATOM go.All (Model #11061630), 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-1937-2019·2019-07-10

    Beckman Coulter iChem VELOCITY Urine Strips Recalled for False Positives

    Beckman Coulter is recalling iChem VELOCITY Urine Chemistry Strips because increased sensitivity causes falsely elevated urobilinogen results.

    Product
    iChem VELOCITY Urine Chemistry Strips, REF 800-7212, 100 test strips/vial. The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland, Made in Germany.
    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-1947-2019·2019-07-10

    Zimmer Biomet Recalls DVR Crosslock ePAK Depth Gauges for Packaging Defects

    Zimmer Biomet is recalling DVR Crosslock ePAK Depth Gauges due to a potential for weak seals in the sterile packaging.

    Product
    DVR Crosslock ePAK Depth Gauge, Model Number 212000003 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-1907-2019·2019-07-10

    Phadia EliA RF IgM Well Recalled for Potential Low Assay Results

    Phadia Ab is recalling EliA RF IgM Well kits due to a potential for reporting low assay results, which may affect rheumatoid arthritis diagnosis.

    Product
    EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction w
    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-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-1946-2019·2019-07-10

    Zimmer Biomet Recalls DVR Crosslock ePAK Screw Drivers Due to Packaging Seal Risk

    Zimmer Biomet is recalling 3,022 DVR Crosslock ePAK Screw Drivers because sterile packaging seals may be weak, potentially compromising sterility.

    Product
    DVR Crosslock ePAK Screw Driver, Model Number 212000002 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-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-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-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-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 (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-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-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-1926-2019·2019-07-10

    Infinium Medical Recalls CLEO and Tranquility VS Patient Monitors

    Infinium Medical is recalling 95 CLEO and Tranquility VS patient monitors because their FDA clearance did not include the temperature monitor accessory option.

    Product
    CLEO Patient Monitor /Tranquility VS Patient Monitor
    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-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
  • LowFDA (Drugs)·D-1439-2019·2019-07-10

    Amneal Recalls Subpotent Esterified Estrogens and Methyltestosterone Tablets

    Amneal Pharmaceuticals is recalling specific lots of Esterified Estrogens & Methyltestosterone Tablets because they failed potency testing.

    Product
    Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-172-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1526-2019·2019-07-10

    Tate & Lyle Recalls Food Starch Due to Potential Wire Contamination

    Tate & Lyle is recalling specific lots of Miraqk Mgl and Nustar food starch because a screen failure may have allowed small pieces of wire to enter the product.

    Product
    Food starch, brand names Miraqk Mgl and Nustar 120 and Nustar 140
    Category
    Food
    Distribution
    0 states
  • LowFDA (Drugs)·D-1438-2019·2019-07-10

    Amneal Recalls Subpotent Esterified Estrogens and Methyltestosterone Tablets

    Amneal Pharmaceuticals is recalling specific lots of Esterified Estrogens & Methyltestosterone tablets due to out-of-specification assay results.

    Product
    Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-171-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1928-2019·2019-07-10

    Roche cobas p 701 Post-Analytical Units Recalled for Loose Flap

    Roche Diagnostics is recalling nine cobas p 701 post-analytical units because the tray input flap may become loose and detach.

    Product
    cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1927-2019·2019-07-10

    Roche cobas p 501 Post-Analytical Units Recalled for Loose Flap

    Roche Diagnostics is recalling four cobas p 501 post-analytical units because the tray input flap may become loose and detach from the instrument.

    Product
    cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V516000·2019-07-09

    Jayco Recalls 2019-2020 White Hawk Travel Trailers Due to Brake Wiring Defect

    Jayco is recalling 2019-2020 White Hawk travel trailers because incorrectly wired breakaway switches may prevent trailer brakes from functioning if the trailer separates from the tow vehicle.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER WHITE HAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·072-2019·2019-07-09

    Fairmont Foods Recalls Pork and Beef Gravy Due to Plastic Contamination

    Fairmont Foods is recalling ready-to-eat pork and beef gravy products due to possible contamination with clear pliable plastic. No illnesses have been reported.

    Product
    Fairmont Foods, Inc. — Fairmont Foods, Inc. Recalls Ready-To-Eat Pork and Beef Gravy Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • HighCPSC·19159·2019-07-08

    Disney Recalls Forky Plush Toys Due to Choking Hazard

    Disney is recalling approximately 80,000 Forky plush toys because the plastic eyes can detach, posing a choking hazard to young children.

    Product
    Forky 11" Plush Toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V515000·2019-07-05

    Ford Recalls Focus Vehicles Due to Potential Engine Stall Risk

    Ford is recalling certain 2012-2017 Focus vehicles because a malfunctioning valve may cause the engine to stall while driving, increasing crash risk.

    Product
    FORD — FORD FOCUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V514000·2019-07-05

    Mazda Recalls 2019 Mazda3 Vehicles Due to Head Restraint Defect

    Mazda is recalling 2019 Mazda3 vehicles because seat cover material may prevent front head restraints from locking properly, increasing injury risk in a crash.

    Product
    MAZDA — MAZDA MAZDA3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1520-2019·2019-07-03

    Brodt Zanatti Recalls SoCo Tahini Due to Salmonella Contamination

    Brodt Zanatti Holding LLC is recalling SoCo Tahini after related Karawan brand samples tested positive for Salmonella.

    Product
    Tahini SoCo Seeds of Collaboration, 100% Stone Ground Sesame Seeds, Net WT. 13.4oz (380g)
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1519-2019·2019-07-03

    Karawan Sesame Seeds Recalled Due to Salmonella in Related Tahini

    Brodt Zanatti Holding Llc is recalling Karawan Sesame Seeds because related Karawan Tahini tested positive for Salmonella.

    Product
    Karawan, 100% Pure Sesame Seeds, Net Weight: 450g (15.87 oz)
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1521-2019·2019-07-03

    Karawan and SoCo Tahini Recalled for Salmonella Contamination

    Brodt Zanatti Holding Llc is recalling Karawan and SoCo brand tahini after laboratory tests detected Salmonella in samples.

    Product
    Karawan Tahini, Net Weight: 3Kg (105.822 oz)
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-1518-2019·2019-07-03

    Karawan and SoCo Tahini Recalled for Salmonella Contamination

    Brodt Zanatti Holding Llc is recalling Karawan and SoCo tahini after NYC lab tests found Salmonella in two samples.

    Product
    Karawan, 100% Raw Ethiopian Sesame Seeds, Net Weight: 17 Kg (599.6 oz)
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1385-2019·2019-07-03

    Vyaire Medical Recalls enFlow Cartridges Due to Aluminum Elution

    Vyaire Medical is recalling enFlow Disposable Cartridges because testing showed aluminum elution during fluid warming. The recall covers 5,782,820 units distributed worldwide.

    Product
    enFlow Disposable Cartridge, used for intravenous warming therapy with fluid and blood solutions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1413-2019·2019-07-03

    Premier Pharmacy Labs Recalls Chlorpromazine Injection Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 824 vials of Chlorpromazine HCL Injection because an FDA inspection found insufficient environmental controls that may compromise sterility.

    Product
    ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites*, 1mL in a 5mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-122-28, barcode 7 69623 12228 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1414-2019·2019-07-03

    Premier Pharmacy Labs Recalls Dexamethasone Syringes Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 86 syringes of Dexamethasone Sodium Phosphate due to potential sterility issues found during an FDA inspection.

    Product
    Dexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-252-10, barcode 0 69623 25210 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1415-2019·2019-07-03

    Premier Pharmacy Labs Recalls Droperidol Syringes Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 2,315 syringes of Droperidol Injectable Sterile Solution because FDA inspections found insufficient environmental controls and lack of sterility assurance.

    Product
    Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-185-10, barcode 0 69623 18510 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1424-2019·2019-07-03

    Premier Pharmacy Labs Recalls Phenylephrine Injection Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 1,040 syringes of Phenylephrine HCL injection nationwide because FDA inspections found insufficient environmental controls that may compromise sterility.

    Product
    Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *Contains Sulfites*, 10mL Single-Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-236-16, barcode 8 69623 23616 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1420-2019·2019-07-03

    Premier Pharmacy Labs Recalls Mitomycin Irrigation Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 1,834 vials of Mitomycin Preservative Free Irrigation because FDA inspections found insufficient environmental controls that may compromise sterility.

    Product
    Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35, barcode 5 69623 16035 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V513000·2019-07-03

    BMW Recalls Multiple Models for High Pressure Fuel Pump Defect

    BMW is recalling specific 2019-2020 models because a high pressure fuel pump may not be properly attached, potentially causing a fuel leak and fire risk.

    Product
    BMW — BMW M5, X7, 750I, X5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1888-2019·2019-07-03

    Ethicon ENSEAL X1 Curved Jaw Tissue Sealer Recalled for Bleeding Risk

    Ethicon Endo-Surgery Inc is recalling ENSEAL X1 Curved Jaw Tissue Sealers due to reported intraoperative bleeding.

    Product
    Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1412-2019·2019-07-03

    Premier Pharmacy Labs Recalls Brilliant Blue Ophthalmic Injection for Sterility Concerns

    Premier Pharmacy Labs is recalling 578 vials of Brilliant Blue Ophthalmic Injection due to a lack of assurance of sterility identified during an FDA inspection.

    Product
    Brilliant Blue Ophthalmic PF INJ, 0.5mg/mL (0.05%), 1 mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-211-31, barcode 2 69623 21131 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1421-2019·2019-07-03

    Premier Pharmacy Labs Recalls Naloxone HCL Injection Due to Sterility Concerns

    Premier Pharmacy Labs is recalling Naloxone HCL Preserved Injection because FDA inspections found insufficient environmental controls and lack of process validations, raising concerns about sterility assurance.

    Product
    Naloxone HCL Preserved INJ, 500mg/50mL (10mg/mL), 50mL Sterile MDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-235-39, barcode 6 69623 23539 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1488-2019·2019-07-03

    Parivar Dry Dates Recalled for High Sulfite Levels

    Parivar brand Dry Dates are being recalled due to high levels of sulfites. The product was distributed to retail grocery stores in Florida, North Carolina, Georgia, and South Carolina.

    Product
    Parivar brand Dry Dates (Kharek) Net Wt.14 oz. (400 g) Product of India Batch No. 127/BHBI
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1429-2019·2019-07-03

    Acetaminophen Children's Liquid Recalled for Microbial Contamination Risk

    H J Harkins Company is recalling 40 bottles of Acetaminophen Children's Liquid due to potential contamination with Burkholderia cepacia and Ralstonia pickettii.

    Product
    Acetaminophen Children's Liquid, 160 mg/5 mL, 4 oz bottle, Manufactured by Torrent Pharma, Inc., Levittown, PA 19057, NDC 52959-0309-04
    Category
    Drug
    Distribution
    Distributed nationwide

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