The Recall Desk

Archive

June 2020 recalls

478 recalls were announced in June 2020.

What the numbers show

Critical
9
Severe
97
High
240
Moderate
118
Low
14

Of the 478 recalls this month scored against our rubric, 2% are Critical, 20% are Severe.

Which agencies issued them

201–300 of 478

  • ModerateFDA (Devices)·Z-2301-2020·2020-06-17

    Immuno-Mycologics Recalls Histoplasma ID Antigen Due to Contamination

    Immuno-Mycologics is recalling 155 vials of Histoplasma ID Antigen because potential reagent contamination may cause false positive test results.

    Product
    Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple products which included Fungal Antigens, Positive Controls and ID Plates,and Immunodiffusion (ID) Plates for use in the ID Test, Histoplasma ID Antigen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2314-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plate Templates Due to Incomplete Design Files

    Biomet is recalling A.L.P.S. Proximal Humerus Plate Templates because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 234MM Item Number: 110025473 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2281-2020·2020-06-17

    Siemens Atellica CH Fructosamine Reagent Recalled for Acetaminophen Interference

    Siemens Healthcare Diagnostics is recalling Atellica CH Fructosamine Reagent because acetaminophen metabolites may interfere with test results.

    Product
    Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580 use in the quantitative measurement of glycated protein (fructosamine) in human serum and plasma for monitoring the blood glucose levels of diabetic patients over the preceding…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2322-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plating System Due to Incomplete Design History

    Biomet is recalling specific lots of the A.L.P.S. Proximal Humerus Plating System because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 7 HOLE 140MM, Item Number: 110030407 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2337-2020·2020-06-17

    Philips SureSigns VM1 Monitor Recalled Due to Unverified Manufacturing Records

    Philips is recalling a specific SureSigns VM1 patient monitor because it was not intended for commercial distribution and lacks manufacturing records.

    Product
    Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen saturation (Sp02), respiration and CO2. The user interface is designed for fast and intuitive operation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2317-2020·2020-06-17

    Biomet Recalls Proximal Humerus Plating System Due to Design History Deficiencies

    Biomet is recalling the A.L.P.S. Proximal Humerus Plating System because it was distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 11 HOLE 190MM, Item Number: 110030208 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2360-2020·2020-06-17

    Physio-Control Recalls Infant Child Starter Kits Due to Packaging Seal Issues

    Physio-Control is recalling 6,732 Infant Child Starter Kits because the packaging for the reduced energy electrodes was not properly sealed.

    Product
    Infant Child Starter Kits, Part Number: 3202784-009, containing Infant/Child Reduced Energy Defibrillation Electrodes, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Usage: intended to be used by personnel…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2321-2020·2020-06-17

    Biomet Recalls A.L.P.S. Proximal Humerus Plating System for Design Documentation Issues

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System plates because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item Number: 110030309 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2320-2020·2020-06-17

    Biomet A.L.P.S. Proximal Humerus Plating System Recalled for Design History Deficiencies

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System units because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 11 HOLE 197MM, Item Number: 110030308 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2311-2020·2020-06-17

    Biomet A.L.P.S. Proximal Humerus Plating System Locking Pegs Recalled

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System 3.2mm Locking Pegs 60mm because they were distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number: 110025460 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2359-2020·2020-06-17

    Physio-Control Recalls Infant Defibrillation Electrodes Due to Packaging Seal Issues

    Physio-Control is recalling infant and child defibrillation electrodes because the packaging was not properly sealed. The recall affects units manufactured between August 2017 and October 2019.

    Product
    Infant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use with LIFEPAK 1000 defibrillator, LIFEPAK 500 defibrillator, and LIFEPAK CR Plus/EXPRESS defibrillator - Product Usage: intended to be used by personnel who are trained on the device…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2318-2020·2020-06-17

    Biomet A.L.P.S. Proximal Humerus Plating System Recalled for Design Documentation Deficiencies

    Biomet is recalling A.L.P.S. Proximal Humerus Plating System units distributed without completed design history files or design transfer activities.

    Product
    A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM, Item Number: 110030209 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1340-2020·2020-06-17

    Akorn Recalls Prednisolone Sodium Phosphate Oral Solution Due to Discoloration

    Akorn, Inc. is recalling specific lots of Prednisolone Sodium Phosphate Oral Solution because the product failed a color test.

    Product
    Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-040-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·20V358000·2020-06-16

    Recreational vehicles with incorrect automatic parking function manual

    Forest River, Coachmen, and Dynamax recreational vehicles have an Operator's Manual that incorrectly describes the automatic parking function, potentially causing drivers to rely on it incorrectly and risking vehicle rollaway or movement.

    Product
    DYNAMAX — DYNAMAX, FOREST RIVER, COACHMEN ISATA, SUNSEEKER, BATTISTI, PRISM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V357000·2020-06-15

    Blue Bird Recalls 2020 Vision Buses Due to Steering Drag Link Issue

    Blue Bird is recalling 2020 Vision buses because steering drag link connections may not be tightened correctly, potentially causing loss of steering control.

    Product
    BLUE BIRD — BLUE BIRD VISION TRANSIT BUS, VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V355000·2020-06-15

    BMW and Toyota Recall Vehicles for Steering Tie Rod Fracture Risk

    BMW and Toyota are recalling specific 2019-2020 models because a steering tie rod may fracture, increasing crash risk. Dealers will replace the parts free of charge.

    Product
    BMW — BMW, TOYOTA X3, X4, 330I, M340I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V356000·2020-06-15

    Blue Bird Recalls 2019-2021 Vision School Buses for Steering Defect

    Blue Bird is recalling 2019-2021 Vision school buses because steering drag link connections may not be tightened, risking loss of control.

    Product
    BLUE BIRD — BLUE BIRD VISION, VISION TRANSIT BUS, VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20E039000·2020-06-15

    Lippert 3000 Series Frameless RV Windows Recalled for Adhesive Failure

    Lippert Components is recalling 3000 Series Frameless windows for recreational vehicles because the adhesive bond may fail, allowing glass to detach and become a projectile.

    Product
    VISIBILITY:GLASS, SIDE/REAR recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V353000·2020-06-15

    Spartan Fire Gladiator Recall for Wireless Remote Controller Battery Issue

    Spartan Fire is recalling one 2019 Gladiator firefighting vehicle because a disabled sleep mode on the wireless remote controller causes batteries to discharge faster than normal.

    Product
    SPARTAN FIRE — SPARTAN FIRE GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·012-2020·2020-06-13

    Lakeside Refrigerated Services Recalls Ground Beef Due to E. coli O157:H7 Risk

    Lakeside Refrigerated Services is recalling approximately 42,922 pounds of ground beef products that may be contaminated with E. coli O157:H7.

    Product
    Lakeside Refrigerated Services — Lakeside Refrigerated Services Recalls Beef Products due to Possible E.coli O157:H7 Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V347000·2020-06-12

    Mazda Recalls 2020 CX-30 AWD Vehicles for Fuel Leak Risk

    Mazda is recalling 2020 CX-30 all-wheel drive vehicles because a disconnected fuel hose may leak, increasing fire and crash risks.

    Product
    MAZDA — MAZDA CX-30
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V346000·2020-06-12

    Mazda Recalls 2020 Mazda3 and CX-30 for Brake Caliper Bolt Issue

    Mazda is recalling 2020 Mazda3 and CX-30 vehicles because front brake caliper mounting bolts may not have been tightened properly, which could reduce braking performance.

    Product
    MAZDA — MAZDA MAZDA3, CX-30
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V352000·2020-06-12

    MCI Recalls 2018-2020 Buses Due to Alternator Voltage Issue

    Motor Coach Industries is recalling 1,067 buses because debris or water may cause excessive alternator voltage, leading to engine shutdown and increased crash risk.

    Product
    MCI — MCI J4500, D45 CRT LE, D4005, D4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V351000·2020-06-12

    Keystone Recalls 2020 Trailers Due to Window Glass Detachment Risk

    Keystone RV Company is recalling 428 model-year 2020 trailers because window glass may detach while moving, creating a projectile hazard.

    Product
    KEYSTONE — KEYSTONE, CROSSROADS, DUTCHMEN RAPTOR, REDWOOD, VOLTAGE, ALPINE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V350000·2020-06-12

    KYMCO Recalls 2018-2019 Like 150i Scooters for ABS Sensor Defect

    KYMCO is recalling 2018-2019 Like 150i scooters because excessive grease on the ABS sensor may cause deterioration and system failure, increasing crash risk.

    Product
    KYMCO — KYMCO LIKE 150I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V348000·2020-06-12

    Coach and Equipment Phoenix Mini-Buses Recalled for Seat Belt Defect

    Coach and Equipment is recalling 2019-2020 Phoenix mini-buses because seat belt retractors may not secure occupants properly, increasing injury risk in crashes.

    Product
    COACH AND EQUIPMENT — COACH AND EQUIPMENT PHOENIX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V344000·2020-06-11

    Vermeer Recalls 2020 Wood Chippers Due to Wheel Lug Nut Loosening

    Vermeer is recalling 2020 BC1200XL and BC1500 wood chippers because wheel lug nuts may loosen, allowing the wheel to detach and increasing crash risk.

    Product
    VERMEER — VERMEER BC1200XL, BC1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20E038000·2020-06-11

    Dana Heavy Vehicle Output Shafts Recalled for Fracture Risk

    Dana Incorporated is recalling certain heavy vehicle output shafts that may not have been properly heat treated, posing a risk of shaft fracture and detachment.

    Product
    POWER TRAIN:DRIVELINE:DRIVESHAFT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V343000·2020-06-11

    Jeep Cherokee Recall for Power Transfer Unit Spline Wear

    FCA US LLC is recalling 2014-2017 Jeep Cherokee vehicles due to a defect in the Power Transfer Unit that may cause loss of drive or Park function.

    Product
    JEEP — JEEP CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20E037000·2020-06-11

    Chrysler Recalls Jeep Cherokee Power Transfer Units for Drive Loss Risk

    Chrysler is recalling specific Two-Speed Power Transfer Units for Jeep Cherokee vehicles because worn splines can cause a loss of drive or Park function, increasing crash risk.

    Product
    POWER TRAIN:DRIVELINE:DIFFERENTIAL UNIT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20135·2020-06-11

    Bonnsu Recalls Miniware Teething Spoons Due to Choking Hazard

    Bonnsu is recalling Miniware teething spoons because they can break in an infant's mouth, posing a choking hazard. One injury report has been received.

    Product
    Miniware Teething Spoons
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V345000·2020-06-11

    Lode King Prestige Semi-Trailer Recalled for Incorrect Load Rating Decal

    Lode-King is recalling one 2021 Prestige SDG semi-trailer because the load rating decal exceeds the frame's strength capability, increasing crash risk if overloaded.

    Product
    LODE KING — LODE KING PRESTIGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20750·2020-06-11

    Davina Wellness Recalls Wintergreen Essential Oils Due to Packaging Defect

    Davina Wellness is recalling wintergreen essential oils because the packaging is not child-resistant, posing a risk of poisoning to young children.

    Product
    Davina Wintergreen Essential Oil and Davina Kneads Relief Sore Muscle Blend
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1299-2020·2020-06-10

    Acella Recalls NP Thyroid 15 Tablets Due to Superpotent Drug Risk

    Acella Pharmaceuticals is voluntarily recalling 29,304 bottles of NP Thyroid 15 tablets because the drug is superpotent. The recall covers products distributed nationwide in the US and Puerto Rico.

    Product
    NP THYROID 15 — NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1298-2020·2020-06-10

    Acella Recalls Superpotent NP Thyroid 15 Tablets Nationwide

    Acella Pharmaceuticals is voluntarily recalling 112,140 bottles of NP Thyroid 15 tablets because the drug is superpotent. The recall covers distribution across the US and Puerto Rico.

    Product
    NP THYROID 15 — NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0974-2020·2020-06-10

    KFK Organic Ground Oregano Recalled for Undeclared Tree Nuts and Crustacea

    K F K Seasonings Llc is recalling Organic Ground Oregano due to undeclared tree nuts and Crustacea. The product was distributed in Oregon and Utah.

    Product
    Organic Ground Oregano, Item # 90206. Packaged in 40 lbs. or 50 lbs. cases and sold under brand KFK Seasoning. This product contains Organic Oregano.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1300-2020·2020-06-10

    Acella Recalls Superpotent NP Thyroid 15 Thyroid Tablets Nationwide

    Acella Pharmaceuticals is voluntarily recalling 49,128 bottles of NP Thyroid 15 tablets because they are superpotent. The FDA classified this as a Class I recall.

    Product
    NP THYROID 15 — NP THYROID 15 (LEVOTHYROXINE, LIOTHYRONINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0985-2020·2020-06-10

    Sienna Cranberry Orange Muffins Recalled for Undeclared Walnuts

    BAKE'N JOY FOODS, INC. is recalling Sienna brand Cranberry Orange Muffins because they may contain undeclared walnuts.

    Product
    Sienna brand 4.25 oz. Cranberry Orange Muffins coded 20 071 31B
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2219-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because the extended tab screws may not lock properly, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X35MM, Item Number 810M6535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2210-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because the extended tab screws may not lock properly, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X30MM, Item Number 810M4530 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2205-2020·2020-06-10

    Umano Medical Recalls AC Powered Hospital Adjustable Beds

    Umano Medical is recalling 3,259 AC powered hospital adjustable beds due to a potential hazard of unsupervised patients falling out of bed.

    Product
    AC Powered hospital adjustable bed.
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2261-2020·2020-06-10

    Spacelabs Xhibit Central Recall for Audio Alarm Loss After Power Failure

    Spacelabs Healthcare is recalling Xhibit Central software due to reports of audio alarm loss after power failures or cable disconnections, which could delay alarm recognition.

    Product
    Xhibit Central, Model No. 96102 - Product Usage: intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2206-2020·2020-06-10

    Medtronic Implantable Insulin Pump Recalled for Endotoxin Contamination

    Medtronic is recalling 24 implantable insulin pumps due to endotoxin levels exceeding specifications. The devices were distributed only in the Netherlands, France, and Sweden.

    Product
    Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2258-2020·2020-06-10

    GE Healthcare Recalls Nuclear Medicine Systems Due to Software Defect

    GE Healthcare is recalling 526 Nuclear Medicine systems because outdated software caused a patient's finger to be injured during an automatic unload process.

    Product
    System, Tomography Computed Emmission
    Category
    Medical Device
    Distribution
    40 states
  • SevereFDA (Food)·F-0971-2020·2020-06-10

    Ventura Foods Recalls Garlic Sauce Due to Undeclared Milk and Wheat

    Ventura Foods LLC is recalling 1,876 cases of 8-pound Garlic Sauce because the product contains undeclared milk and wheat allergens.

    Product
    Garlic Sauce; Net Wt. 8LB. (3.62 kg); PJ Item #1104; UPC 26700 16345; Manufactured for: PJ Foods Service, Inc; Louisville, KY 40299, USA. Ingredients: Soybean oil, water, salt, vegetable mono & diglycerides, contains less than 2% of garlic*, natural flavors, soy lecithin…
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0972-2020·2020-06-10

    K F K Seasonings Recalls Azure Market Chili Powder for Undeclared Allergens

    K F K Seasonings LLC is recalling 96 lbs of Azure Market Chili Powder, Mild, Organic due to undeclared tree nuts and Crustacea.

    Product
    Chili Powder, Mild, Organic is a blend, Item # 90030. Packaged in 1 lb. bags and sold under brand Azure Market. This product contains "Organic Chili Peppers, Salt, Organic Spices, Organic Garlic, Organic Sunflower Oil". The Azure Market label listed the lot # 90030041520 and…
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2257-2020·2020-06-10

    Siemens ARTIS icono X-Ray Systems Recalled for Incorrect Vessel Quantification

    Siemens is recalling five ARTIS icono X-ray systems because software may fail to detect vessels or provide incorrect measurements, potentially leading to wrong diagnoses.

    Product
    ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2165-2020·2020-06-10

    Insulet Recalls Omnipod DASH Insulin Systems Due to Bolus Calculation Error

    Insulet Corporation is recalling 1,773 Omnipod DASH Insulin Management Systems (mmol/L configuration) because the Bolus Calculator may fail to accurately subtract insulin on board after two months of use.

    Product
    Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2254-2020·2020-06-10

    Multifire Endo Hernia Stapler Recalled for Manufacturing Assembly Error

    Covidien is recalling Multifire Endo Hernia Staplers due to a manufacturing error that may cause staples to fail to advance properly during use.

    Product
    Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2174-2020·2020-06-10

    FDA Recalls Sterile Surgical Packs Due to Unregistered Facility

    American Contract Systems is recalling 2,868 sterile surgical packs because they were manufactured in a facility not registered by the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V341000·2020-06-10

    KME Fire Trucks Recalled for Potential Braking Mechanism Separation

    KME is recalling specific fire trucks because the optional Telma induction braking mechanism may separate from the vehicle while moving, increasing crash risk.

    Product
    KME — KME PREDATOR, PREDATOR PANTHER, PREDATOR SS, COMMERCIALCAB/ CHASSIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2231-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because the extended tab screws may not lock adequately, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, Item Number 811M8555 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0973-2020·2020-06-10

    K F K Seasonings Recalls Organic Chipotle Chile Ground for Undeclared Tree Nuts

    K F K Seasonings is recalling 230 lbs of Organic Chipotle Chile Ground sold as Blue Chip in Oregon and Utah due to undeclared tree nuts.

    Product
    Organic Chipotle Chile Ground, Item # 90033. Packaged in 40 lbs. box and sold under brand Blue Chip. This product contains Chipotle Chile pepper. The Blue Chip label listed the lot # 032918. No UPC. Product distributed by Blue Chip Corp. UT.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2228-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the extended tab screws may not lock adequately, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X40MM, Item Number 811M8540 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2211-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the extended tab screws may not lock adequately, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X35MM, Item Number 810M4535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2229-2020·2020-06-10

    FDA Recalls Zimmer Biomet Vital MIS Spinal Fixation Implants

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants due to reports of inadequate locking of extended tab screws and post-operative backing out of the closure top.

    Product
    Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X45MM, Item Number 811M8545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2255-2020·2020-06-10

    FDA Recalls Multifire Endo Hernia Staplers Due to Assembly Error

    The FDA is recalling 12,610 Multifire Endo Hernia Staplers due to a manufacturing error that may cause staples to fail to advance properly.

    Product
    Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2217-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Failure

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the closure top may back out of the screw post-operatively.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM, Item Number 810M5550 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2207-2020·2020-06-10

    Nobel Biocare Recalls Dental Implants Due to Incorrect Length Labeling

    Nobel Biocare is recalling 221 dental implants because the label may incorrectly state the length as 11.5mm instead of the actual 15mm, posing a risk of nerve damage.

    Product
    NobelActive Internal NP 3.5x15mm Endosseus dental implant, REF: 34128, Rx Only, Sterile R, CE, UDI: (01)07332747010619
    Category
    Medical Device
    Distribution
    28 states
  • SevereFDA (Devices)·Z-2233-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the extended tab screws may not lock adequately, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants VITAL MIS TAB BREAKER, Item Number 850M0055 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2214-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the extended tab screws may not lock adequately, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM, Item Number 810M5535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2232-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the extended tab screws may not lock adequately, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X60MM, Item Number 811M8560 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2253-2020·2020-06-10

    FDA Recalls Multifire VersaTrack Auto Suture Hernia Stapler Due to Assembly Error

    The FDA is recalling 12,610 units of the Multifire VersaTrack Auto Suture Hernia Stapler because a manufacturing error may prevent staples from advancing properly.

    Product
    Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0991-2020·2020-06-10

    Plucker's Wing Bar Wing Sauce Recalled for Undeclared Milk and Wheat

    Zilks Foods is recalling Plucker's Wing Bar World Famous Wing Sauce Spicy Mandarin due to potential undeclared milk and wheat allergens.

    Product
    Plucker's Wing Bar World Famous Wing Sauce Spicy Mandarin 12 FL OZ. (355 mL) packaged in a glass bottle
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2213-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because the extended tab screws may not lock properly, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X45MM, Item Number 810M4545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2194-2020·2020-06-10

    Baxter Gambro Cartridge Blood Transport System Recalled for Tubing Disconnection Risk

    Baxter Healthcare is recalling Gambro Cartridge Blood Transport Systems due to a potential disconnection of the tubing set. The recall covers 53,895 units distributed worldwide.

    Product
    Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2243-2020·2020-06-10

    Med Tec Type S Extension Recalled for Potential Disengagement Risk

    Med Tec Inc is recalling Type S Extensions used for patient positioning due to a risk of disengagement during repositioning, which could cause a patient fall.

    Product
    Type S Extension For use with Varian, CIVCO, Prescription Only - Product Usage: Device is intended for patient positioning.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2234-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the extended tab screws may not lock adequately, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X40MM, Item Number 810M7540 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1001-2020·2020-06-10

    Cherrybrook Kitchen Sugar Cookie Mix Recalled for Wheat Content

    Cell-nique Corp is recalling Cherrybrook Kitchen Sugar Cookie Mix because the product is labeled gluten-free and wheat-free but contains wheat.

    Product
    Cherrybrook Kitchen***Gluten Free***Wheat Free***SUGAR COOKIE MIX***NET WT. 13 OZ
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2167-2020·2020-06-10

    FDA Recalls Sterile Surgical Packs from Unregistered Facility

    American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered with the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2215-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Failure

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because the extended tab screws may not lock properly, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X40MM, Item Number 810M5540 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2177-2020·2020-06-10

    FDA Recalls Sterile Surgical Packs from Unregistered Facility

    American Contract Systems is recalling sterile custom surgical packs because they were manufactured in a facility not registered with the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2237-2020·2020-06-10

    Beckman Coulter Access Free T4 Thyroxine Assay Recalled for Biotin Interference

    Beckman Coulter is recalling Access Free T4 Thyroxine assays because biotin can cause significant result bias, potentially affecting patient care.

    Product
    Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880 (UDI:15099590225834) for use with Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and…
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-2164-2020·2020-06-10

    Insulet Recalls Omnipod DASH Insulin Systems Due to Bolus Calculation Error

    Insulet is recalling 400 Omnipod DASH insulin systems because the Bolus Calculator may fail to subtract insulin on board correctly after two months of use.

    Product
    Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2225-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because the extended tab screws may not lock properly, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X45MM, Item Number 810M7545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2171-2020·2020-06-10

    FDA Recalls Sterile Custom Surgical Packs from Unregistered Facility

    American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered by the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0992-2020·2020-06-10

    Plucker's Wing Bar Teriyaki Sauce Recalled for Undeclared Wheat

    Zilks Foods is recalling Plucker's Wing Bar Teriyaki Sauce due to potential undeclared wheat. The product was distributed in Texas and Louisiana.

    Product
    Plucker's Wing Bar World Famous Wing Sauce Teriyaki 12 FL OZ. (355 mL) packaged in a glass bottle
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2224-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because the extended tab screws may not lock adequately, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X40MM, Item Number 810M6540 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0987-2020·2020-06-10

    Plucker's Wing Bar Gochujang Sauce Recalled for Undeclared Wheat

    Zilks Foods is recalling 288 bottles of Plucker's Wing Bar Gochujang sauce in Texas and Louisiana due to potential undeclared wheat.

    Product
    Plucker's Wing Bar World Famous Wing Sauce Gochujang 12 FL OZ. (355 mL) packaged in a glass bottle
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2226-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because the extended tab screws may not lock properly, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X50MM, Item Number 810M7550 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·20134·2020-06-10

    Ushio America Recalls Indiglow LED T8 Lamps Due to Overheating Hazard

    Ushio America is recalling Indiglow LED T8 lamps because they can overheat and fall, posing an injury risk. Consumers should stop using them and contact the company for a refund or replacement.

    Product
    Indiglow LED T8 Lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2212-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the extended tab screws may not lock adequately, causing the closure top to back out post-operatively.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X40MM, Item Number 810M4540 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2223-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation System Implants

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants due to reports of inadequate locking of extended tab screws and post-operative backing out of the closure top.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X35MM, Item Number 810M7535 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2220-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the extended tab screws may not lock adequately, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X45MM, Item Number 810M6545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2216-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because the extended tab screws may not lock properly, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X45MM, Item Number 810M5545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2170-2020·2020-06-10

    FDA Recalls Sterile Custom Surgical Packs Due to Unregistered Facility

    American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered with the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1287-2020·2020-06-10

    Teva Recalls Mixed Amphetamine Salts Tablets Due to Mixed Strengths

    Teva Pharmaceuticals USA is recalling 84,209 bottles of 20 mg Mixed Amphetamine Salts tablets because some bottles may contain mixed strengths.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2195-2020·2020-06-10

    Baxter Gambro Hemodialysis Blood Set Recalled for Tubing Disconnection Risk

    Baxter Healthcare is recalling 19,800 Gambro Cartridge Low Volume Blood Transport Systems due to a potential tubing disconnection hazard.

    Product
    Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2221-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation System Implants

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants due to reports of inadequate locking of extended tab screws.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X50MM, Item Number 810M6550 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2218-2020·2020-06-10

    Zimmer Biomet Recalls Vital MIS Spinal Fixation Implants Due to Locking Issues

    Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because the extended tab screws may not lock properly, causing the closure top to back out after surgery.

    Product
    Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X55MM, Item Number 810M5555 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2260-2020·2020-06-10

    Intuitive Recalls 17 da Vinci SP Surgical Systems Due to Software Anomaly

    Intuitive Surgical is recalling 17 da Vinci SP surgical systems because a software anomaly may cause mechanical vibration of instrument tips and the endoscope under rare conditions.

    Product
    da Vinci SP surgical system
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2259-2020·2020-06-10

    GE Healthcare Recalls Nuclear Medicine Systems Due to Software Defect

    GE Healthcare is recalling 526 Discovery NM 530c systems because outdated software caused a patient finger injury during an automatic unload process.

    Product
    System, Tomography Computed Emmission
    Category
    Medical Device
    Distribution
    40 states

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