The Recall Desk

Archive

July 2018 recalls

502 recalls were announced in July 2018.

What the numbers show

Critical
34
Severe
167
High
225
Moderate
62
Low
14

Of the 502 recalls this month scored against our rubric, 7% are Critical, 33% are Severe.

Which agencies issued them

401–500 of 502

  • ModerateFDA (Devices)·Z-2334-2018·2018-07-11

    St. Jude Medical Confirm Rx Insertable Cardiac Monitor Recall

    St. Jude Medical is recalling 986 Confirm Rx Insertable Cardiac Monitors because exposure to sub-freezing temperatures caused a transient battery voltage drop, resulting in an incorrect low battery indicator display.

    Product
    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2360-2018·2018-07-11

    Biocare Medical Recalls Vulcan Fast Red Chromogen Kit Due to Stability Issue

    Biocare Medical is recalling Vulcan Fast Red Chromogen Kit 2 because a stability issue in the buffer prevents the chromogen from developing.

    Product
    Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP) detection system. Catalog numbers FR805-5L and FR805S
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Food)·F-1606-2018·2018-07-11

    Icelandic Provisions Recalls Vanilla Skyr Cups Due to Coconut Mislabeling

    Icelandic Provisions Inc. is recalling Vanilla Skyr cups that may contain coconut skyr yogurt. The recall addresses a labeling error regarding the product flavor.

    Product
    Icelandic Provisions Vanilla Skyr cups, 5.3oz package, UPC: 854074006068
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2335-2018·2018-07-11

    St Jude Medical Recalls Merlin PCS Programmer Software for ICM Battery Display Error

    St Jude Medical is recalling Merlin PCS Programmer Software to address an incorrect low battery indicator on Confirm Rx ICM devices caused by supply chain temperature exposure.

    Product
    Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the programmer (software model 3330) is the method of delivery of the new firmware.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0907-2018·2018-07-11

    Equate ClearLAX Recalled for Unfiled NDC Numbers on Labeling

    Lupin Somerset is recalling Equate ClearLAX laxative bottles due to unfiled NDC numbers on the labels. This is a Class III recall with no reported health risks.

    Product
    Equate ClearLAX, Polyethylene Glycol 3350 Powder for Solution, OS Osmotic Laxative, OTC, packaged in a) 119 g bottle (NDC 49035-312-07), b) 238 g bottle (NDC 49035-312-08), Distributed by: Wal-mart Stores, Inc., Bentonville, AR 72716
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0892-2018·2018-07-11

    Qualgen Recalls Estradiol Pellets Due to Incorrect or Missing Lot and Expiration Dates

    Qualgen, LLC is recalling Estradiol 20mg Pellets because the vials have incorrect or missing lot and expiration dates.

    Product
    ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2333-2018·2018-07-11

    Ecolab Microtek Rolled Probe Cover Recalled for Incorrect Instructions

    Ecolab Inc. is recalling 65 cases of Microtek Rolled Probe Covers because the products were shipped with incorrect instructions for use.

    Product
    ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body fluid
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Drugs)·D-0893-2018·2018-07-11

    Qualgen Recalls Testosterone Pellets Due to Incorrect Lot and Expiration Dates

    Qualgen, LLC is recalling Testosterone 200 mg Pellets because the vials have incorrect or missing lot and expiration dates.

    Product
    TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-120-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2377-2018·2018-07-11

    Medtronic MiniMed Paradigm Veo Insulin Pump Recalled for Arabic Translation Error

    Medtronic is recalling 239,859 MiniMed Paradigm Veo insulin pumps due to an error in the Arabic language translation of the Predictive Alerts setting screen.

    Product
    Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2332-2018·2018-07-11

    Ecolab Microtek Rolled Probe Cover Recalled for Incorrect Instructions

    Ecolab Inc. is recalling 65 cases of Microtek Rolled Probe Covers because they were shipped with incorrect instructions for use.

    Product
    ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905, packaged 1 probe cover/pouch, 25 pouches/carton, 2 cartons/shipping case, Sterile, RX. To be used as a physical barrier for protection against the effects of environmental exposure (e.g. body flui
    Category
    Medical Device
    Distribution
    6 states
  • SevereNHTSA·18V458000·2018-07-10

    MV Agusta Recalls 2018 Motorcycles Due to Fork Axle Thread Damage

    MV Agusta is recalling 2018 Brutale 800 Dragster RC, F3 800, and F3 800 RC motorcycles because damaged fork axle threads may cause wheel clamping screw play and loss of control.

    Product
    MV AGUSTA — MV AGUSTA BRUTALE 800 DRAGSTER RC, F3 800, F3 800 RC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V457000·2018-07-10

    Mercedes-Benz Recalls 2017 AMG G65 for Reverse Speed Software Defect

    Mercedes-Benz is recalling 2017 AMG G65 vehicles because incorrect reverse speed limitation software may cause instability and rollover risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG G65
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18185·2018-07-10

    Ortovox Recalls Avalanche Transceivers Due to Software Error

    Ortovox is recalling about 20,000 avalanche transceivers because a software error may prevent them from transmitting survivor location data, delaying rescue efforts.

    Product
    Avalanche transceivers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·060-2018·2018-07-09

    Afandina Halal Recalls Raw Chicken Produced Without Federal Inspection

    Afandina Halal is recalling raw chicken products produced and distributed without federal inspection. No adverse reactions have been reported.

    Product
    Afandina Halal — Afandina Halal Recalls Raw Chicken Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • CriticalNHTSA·18V452000·2018-07-06

    Nissan Recalls 2007-2008 Versa Models Due to Air Bag Inflator Defect

    Nissan is recalling 2007-2008 Versa sedans and hatchbacks because the passenger air bag inflators may explode. This defect could cause metal fragments to strike occupants, resulting in serious injury or death.

    Product
    NISSAN — NISSAN VERSA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V453000·2018-07-06

    BMW Recalls 2018-2019 X3 and X4 Models for Brake Caliper Defect

    BMW is recalling 2018-2019 X3 and 2019 X4 vehicles because insufficient coating on rear brake caliper pistons may reduce braking performance.

    Product
    BMW — BMW X3, X4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • LowUSDA FSIS·059-2018·2018-07-06

    Tillamook Country Smoker Recalls Teriyaki Beef Jerky Due to Misbranding

    Tillamook Country Smoker is recalling approximately 102 pounds of teriyaki beef jerky because the products may contain undeclared monosodium glutamate (MSG).

    Product
    Tillamook Country Smoker, LLC — Recall Notification Report 059-2018 (Beef Jerky Products)
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·18V445000·2018-07-05

    Jayco Recalls 2019 Alante and Precept Motorhomes for Wiper Defect

    Jayco is recalling 2019 Alante and Precept motorhomes because windshield wiper arms may lift at highway speeds, reducing visibility and increasing crash risk.

    Product
    JAYCO — JAYCO PRECEPT, ALANTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V446000·2018-07-05

    Entegra Recalls 2019 Motorhomes for Windshield Wiper Defect

    Entegra is recalling 2019 Emblem and Vision motorhomes because windshield wiper arms may lift at highway speeds, reducing visibility and increasing crash risk.

    Product
    ENTEGRA — ENTEGRA EMBLEM, VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V449000·2018-07-05

    Jayco Recalls 2019 White Hawk Trailers Due to Ladder Screw Defect

    Jayco is recalling 2019 White Hawk recreational trailers because screws securing ladder steps may break, posing a fall risk.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER WHITE HAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V451000·2018-07-05

    Jayco Recalls 2018-2019 Motorhomes Due to Incorrect Cargo Capacity Label

    Jayco is recalling 2018-2019 Alante, Precept, Seneca, Redhawk, and Melbourne motorhomes because the cargo capacity label overstates limits, increasing crash risk.

    Product
    JAYCO — JAYCO REDHAWK, PRECEPT, ALANTE, SENECA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·18V448000·2018-07-05

    Keystone Recalls 2018-2019 Dutchmen Aerolite Trailers for Incorrect Rim Label

    Keystone RV Company is recalling 2018-2019 Dutchmen Aerolite recreational trailers because the Federal Certification Label lists the wrong rim size, which could lead to unsafe rim replacements.

    Product
    DUTCHMEN — DUTCHMEN AEROLITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0889-2018·2018-07-04

    Advanced Pharma Recalls Subpotent Fentanyl Citrate Prefilled Syringes

    Advanced Pharma Inc. is recalling 100 prefilled syringes of fentanyl citrate because the final drug concentration is subpotent compared to the label.

    Product
    fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2281-2018·2018-07-04

    Konica Minolta CS-7 Medical Device Recall Due to Laptop Fire Risk

    Konica Minolta is recalling CS-7 medical devices because the Panasonic Toughbook laptops used in some configurations have a potential battery ignition risk.

    Product
    CS-7, Model No. A4C1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2302-2018·2018-07-04

    Intersurgical Flexible Breathing Circuit Recall Due to Exhalation Port Blockage Risk

    Intersurgical Inc is recalling 1,340 Flexible Smoothbore Breathing Circuits because the tubing may block the exhalation port during assembly, posing a serious health risk to patients.

    Product
    Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-2301-2018·2018-07-04

    Philips OmniDiagnost X-ray System Recalled for Tilt Actuator Failure Risk

    Philips is recalling 477 OmniDiagnost Classic X-ray systems because a broken tilt actuator could cause the table to rotate uncontrollably, posing a risk of injury.

    Product
    OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2300-2018·2018-07-04

    Philips OmniDiagnost-Eleva X-ray System Recalled Due to Table Rotation Hazard

    Philips is recalling 508 OmniDiagnost-Eleva X-ray systems because a broken actuator fixation can cause the table to rotate uncontrollably, posing a risk of injury.

    Product
    OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1587-2018·2018-07-04

    New Seasons Market Recalls Vegan Chocolate Almond Muffins for Allergen Labeling

    New Seasons Market LLC is recalling Vegan Chocolate Almond Muffins because the packaging fails to declare almonds as an ingredient.

    Product
    Vegan Chocolate Almond Muffin, 4-pack, packaged in a clear clamshell container, net wt. 13.6 oz., UPC 8 40600 10955 6
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2322-2018·2018-07-04

    St Jude Medical Recalls High Voltage Implantable Cardiac Devices for Security Firmware

    St Jude Medical is releasing new firmware for high voltage implantable cardiac devices to strengthen security against unauthorized access.

    Product
    Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001, 60013879-307, 60013879-407, 60013879-707; CD3211-36/100006984,100012548, 100012550, 100016680, 100031621, 100035618, 100035619, 100042487, 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2283-2018·2018-07-04

    Siemens ARTIS Pheno X-Ray System Recalled for C-Arm Drop Hazard

    Siemens is recalling 39 ARTIS Pheno Interventional Fluoroscopic X-Ray Systems because the C-arm may drop up to 20 mm, potentially injuring patients.

    Product
    ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2329-2018·2018-07-04

    St Jude Medical Recalls Merlin PCS Programmer Firmware for Security

    St Jude Medical is releasing new firmware for Merlin PCS programmers to strengthen security against unauthorized access to cardiac devices.

    Product
    Merlin PCS programmer (Model # 3650), Software (Model # 3330)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2320-2018·2018-07-04

    St Jude Medical Recalls Fortify ICDs and CRT-Ds for Security Firmware Update

    St Jude Medical is recalling Fortify ICDs and CRT-Ds to release new firmware that strengthens security against unauthorized access. Older devices may require permanent disabling of RF communication.

    Product
    Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1602-2018·2018-07-04

    Utz Recalls Golden Flake Tortilla Chips for Undeclared Milk Allergen

    Utz Quality Foods is voluntarily recalling select Golden Flake tortilla chips due to potential contamination with undeclared milk allergen.

    Product
    Golden Flake TORTIYAHS! Superior Dipping Chips; Net Wt 12.5 oz Tortilla Chips; Golden Flake Snack Foods, Inc. Birmingham, AL 35201; UPC: 0-72080-41000-0; Exp date: JUN 2 18 to JUN 23 18;
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1600-2018·2018-07-04

    Utz Organic Yellow Corn Tortillas Recalled for Undeclared Milk Allergen

    Utz Quality Foods is recalling specific expiration dates of Utz Organic Yellow Corn Tortillas due to potential contamination with undeclared milk.

    Product
    Utz Organic Yellow Corn Tortillas, Net Wt 9 oz; UTZ Quality Foods, Inc., Hanover, PA 17331; UPC: 0-41780-01337-8; Exp date: MAY 26 18 to JUN 16 18;
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1588-2018·2018-07-04

    New Seasons Market Recalls Mini Butter Croissants for Undeclared Egg

    New Seasons Market LLC is recalling Mini Butter Croissants because the packaging fails to declare egg as an ingredient.

    Product
    Mini Butter Croissants, 8-Pack, packaged in a clear plastic clam-shell container, net wt. 6 oz., UPC 8 40600 10904 4
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1599-2018·2018-07-04

    Utz Organic Blue Corn Tortillas Recalled for Undeclared Milk Allergen

    Utz Quality Foods is recalling specific expiration dates of Utz Organic Blue Corn Tortillas due to potential contamination with undeclared milk.

    Product
    Utz Organic Blue Corn Tortillas; Net Wt 9 oz; UTZ Quality Foods, Inc., Hanover, PA 17331; UPC: 0-41780-01317-0; Exp date: JUN 16 18;
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1603-2018·2018-07-04

    Utz Recalls Tortilla Chips for Undeclared Milk Allergen

    Utz Quality Foods is voluntarily recalling select tortilla chip items due to potential contamination with undeclared milk allergen.

    Product
    Good Health Organic Tortillas; Black Bean & Rice; Net Wt 5.5 oz; Distributed by Good Health Natural Products, Inc. Greensboro, NC; UPC: 274077-55355-04100-9; Exp date: DEC 29 18; Mexico only: Good Health Totopos Organicos; Frijol Negro y Arroz; Cont. Neto 538,6 g; Distribuid
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1598-2018·2018-07-04

    Utz and Weis Tortilla Chips Recalled for Undeclared Milk Allergen

    Utz Quality Foods is voluntarily recalling select tortilla chip products due to potential contamination with undeclared milk allergen.

    Product
    Utz Restaurant Style Tortilla Chips; Net Wt 17 oz; White Corn Tortilla Chips; UPC: 0-41780-00383-6; Exp. Date Jun 16 18; UTZ Quality Foods, Inc., Hanover, PA 17331; Utz Restaurant Style Tortilla Chips; Net Wt 11.5 oz; White Corn Tortilla Chips; UPC: 0-41780-00384-3; Exp dat
    Category
    Food
    Distribution
    32 states
  • HighFDA (Food)·F-1601-2018·2018-07-04

    Utz Recalls Tortilla Chips Due to Undeclared Milk Allergen

    Utz Quality Foods is voluntarily recalling select tortilla chip items due to potential contamination with undeclared milk allergen.

    Product
    Weis Signature Collection No Salt Added White Corn Tortilla Chips; Net Wt 11 oz; Manufactured For Weis Markets, Sunbury, PA 17801; UPC: 0-41497-00427-0; Exp date: May 26 18 to JUN 16 18;
    Category
    Food
    Distribution
    32 states
  • HighFDA (Devices)·Z-2277-2018·2018-07-04

    Philips Ingenuity Core128/Elite X-Ray Tube Recall for Oil Leakage

    Philips is recalling specific Ingenuity Core128/Elite X-ray tubes due to a production defect that allows oil leakage, posing a risk to patients and users.

    Product
    Ingenuity Core128/Elite China 728324
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2305-2018·2018-07-04

    Siemens Artis Q.zen Biplane Recalled for Display Failure

    Siemens Medical Solutions is recalling two Artis Q.zen biplane systems because the display may fail to show images after power save mode, potentially requiring treatment cancellation or patient transfer.

    Product
    Artis Q.zen biplane, Material no. 10848355, for angiography and whole body radiographic/fluoroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2285-2018·2018-07-04

    B. Braun Recalls Infusomat Space Pump IV Sets Due to Missing Filter

    B. Braun Medical is recalling 1,872 Infusomat Space Pump IV Sets because some units may lack the required air-eliminating filter.

    Product
    Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV Set, 2 Caresites, ASV with 0.2 Micron Air Eliminating Filter and Anti-Syphon Valve (ASV) is a latex-free product intended to be used with the Infusomat Space
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2324-2018·2018-07-04

    St Jude Medical Recalls Quadra Assura ICDs for Security Firmware Update

    St Jude Medical is recalling 72,673 Quadra Assura implantable cardiac devices to release new firmware that strengthens security against unauthorized access.

    Product
    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2318-2018·2018-07-04

    St Jude Medical Recalls Implantable Cardiac Devices for Security Firmware Update

    St Jude Medical is recalling implantable cardiac devices to release new firmware that strengthens security against unauthorized access.

    Product
    Current, Sterile EO, Model #/ Part #: 1207-30/50020236-001, 60010739-207, 60010739-407; 1207-36/50020237-001, 60010742-207, 60010742-307, 60010742-407, 60010742-707; 2207-30/ 50020238-001, 60010738-207; 2207-36/ 50020239-001, 60010741-207, 60010741-307, 60010741-407, 600107
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2280-2018·2018-07-04

    Randox Liquid Assayed Specific Protein Control Recalled for Stability Issues

    Randox Laboratories is recalling Liquid Assayed Specific Protein Control - Level 3 because Free Kappa light chains increase over shelf life, potentially delaying diagnostic results.

    Product
    Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2323-2018·2018-07-04

    St Jude Medical Recalls Promote Quadra ICDs for Security Firmware Update

    St Jude Medical is recalling Promote Quadra implantable cardiac devices to release new firmware that strengthens security against unauthorized access.

    Product
    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2308-2018·2018-07-04

    Siemens Artis zee Biplane Recalled for Display Failure After Power Save

    Siemens is recalling 68 Artis zee biplane systems because the large display may remain black after exiting power save mode, potentially requiring treatment cancellation or patient transfer.

    Product
    Artis zee biplane, Material no. 10094141, for angiography and whole body radiographic/fluoroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2325-2018·2018-07-04

    St Jude Medical Recalls Quadra Assura MP Implantable Cardiac Devices for Security Update

    St Jude Medical is recalling 68,117 Quadra Assura MP implantable cardiac devices to release new firmware that strengthens security against unauthorized access.

    Product
    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2291-2018·2018-07-04

    Exsurco Medical Recalls Amalgatome SD Coaxial Pneumatic Hoses

    Exsurco Medical is recalling 70 Amalgatome SD coaxial pneumatic hoses due to improper installation that may cause hose bursts or pressure loss.

    Product
    Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2274-2018·2018-07-04

    Philips Ingenuity Core X-Ray Tube Recall for Oil Leakage Risk

    Philips is recalling 28 Ingenuity Core systems due to a production defect in the X-Ray Tube that allows oil leakage, posing a risk to patients or users.

    Product
    Philips Ingenuity Core 728321
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-1589-2018·2018-07-04

    New Seasons Market Recalls Mini Chocolate Croissants for Undeclared Egg and Soy

    New Seasons Market LLC is recalling Mini Chocolate Croissants because the packaging fails to declare egg and soy lecithin as ingredients.

    Product
    Mini Chocolate Croissants, 8-Pack, packaged in a clear plastic clam-shell container, net wt. 7.6 oz., UPC 8 04600 10905 1
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2303-2018·2018-07-04

    Siemens Artis Q Biplane Recalled for Display Failure After Power Save

    Siemens is recalling five Artis Q biplanes because the display may fail to show an image after power save mode, potentially requiring procedure cancellation or patient transfer.

    Product
    Artis Q biplane, Material no. 10848282, for angiography and whole body radiographic/fluoroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2314-2018·2018-07-04

    Siemens Artis zeego X-ray System Recalled for Display Failure

    Siemens Medical Solutions is recalling 56 Artis zeego systems because the display may fail to show images after power save mode, potentially requiring procedure cancellation.

    Product
    Artis zeego, Material no. 10280959 , for angiography and whole body radiographic/fluoroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2287-2018·2018-07-04

    Teleflex Universal Shears Recalled Due to Handle Melting During Sterilization

    Teleflex Medical Europe Ltd is recalling 573 units of Pilling Universal Shears because incorrect plastic was used for the handles, causing them to melt during sterilization.

    Product
    Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Usage: general surgical scissors
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2328-2018·2018-07-04

    St Jude Medical Recalls Unify Quadra ICDs for Security Firmware Update

    St Jude Medical is recalling Unify Quadra implantable cardiac devices to release new firmware that strengthens security against unauthorized access.

    Product
    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2288-2018·2018-07-04

    HLD Systems Washer Pasteurizer Recalled for Terminal Block Overheating

    Cenorin, LLC is recalling 14 HLD Systems 600 Series Washer/Pasteurizers because a supplier quality issue with terminal blocks may cause overheating, charring, or burning.

    Product
    HLD Systems 600 Series Washer/Pasteurizer, UDI (01) 0085249007009 (11) 160929 (21) 61160; Model 610HT, 115V & Model 610HT, 230V Product Usage: Clean and thermally disinfect medical devices using full immersion pasteurization
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2310-2018·2018-07-04

    Siemens Artis zee Ceiling Recalled for Display Malfunction

    Siemens is recalling 73 Artis zee ceiling units because the display may fail to show images after power save mode, potentially requiring procedure cancellation.

    Product
    Artis zee ceiling, Material no. 10094137, for angiography and whole body radiographic/fluoroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1585-2018·2018-07-04

    New Seasons Market Recalls Meyer Lemon Chia Muffins for Undeclared Egg

    New Seasons Market LLC is recalling Meyer Lemon Chia Muffins because the packaging fails to declare egg as an ingredient.

    Product
    Meyer Lemon Chia Muffin, 4-pack, packaged in a clear clamshell container, net wt. 13.6 oz., UPC 8 40600 10953 2
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2290-2018·2018-07-04

    RayStation Radiation Therapy Software Recalled for Dose Calculation Accuracy Issues

    RaySearch Laboratories is recalling RayStation Radiation Therapy Treatment Planning System software versions 6.0 through 7.0 because dose calculation accuracy may be less than expected in some situations.

    Product
    RayStation Radiation Therapy Treatment Planning System; 6.0, 6.1, 6.2, 7.0 Product Usage: Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2311-2018·2018-07-04

    Siemens Artis zee floor recall due to display failure

    Siemens is recalling 14 Artis zee floor systems because the display may fail to show images after power save mode, potentially requiring treatment cancellation.

    Product
    Artis zee floor, Material no. 10094135, for angiography and whole body radiographic/fluoroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2312-2018·2018-07-04

    Siemens Artis zee floor MN recalled for display failure

    Siemens is recalling Artis zee floor MN systems because the display may fail to show images after power save mode, potentially requiring procedure cancellation.

    Product
    Artis zee floor MN, Material no. 10094142, for angiography and whole body radiographic/fluoroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1597-2018·2018-07-04

    Golden Star Recalls Al Reef Dried Apricots for Undeclared Sulfites

    Golden Star Wholesale Inc. is recalling Al Reef dried apricot sour due to undeclared sulfites. The product was distributed in 13 U.S. states.

    Product
    Al Reef dried apricot sour, 12 oz., packed in plastic, 24 packages per case
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-2327-2018·2018-07-04

    St Jude Medical Recalls Unify Assura ICDs for Security Firmware Update

    St Jude Medical is recalling Unify Assura implantable cardiac devices to release new firmware that strengthens security against unauthorized access.

    Product
    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1584-2018·2018-07-04

    Honey Oat Bran Muffins Recalled for Undeclared Egg Allergen

    New Seasons Market LLC is recalling Honey Oat Bran Muffins because the packaging fails to declare egg as an ingredient.

    Product
    Honey Oat Bran Muffin, 4-pack, packaged in a clear clamshell container, net wt. 13.6 oz., UPC 8 40600 10954 9
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1586-2018·2018-07-04

    New Seasons Market Recalls Blueberry Buckwheat Muffins for Undeclared Egg

    New Seasons Market LLC is recalling Blueberry Buckwheat Muffins because the packaging fails to declare egg as an ingredient.

    Product
    Blueberry Buckwheat Muffin, 4-pack, packaged in a clear clamshell container, net wt. 13.6 oz., UPC 8 40600 10952 5
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2317-2018·2018-07-04

    Medtronic Model 53401 Pacemakers Recalled for Unexpected Power Reset

    Medtronic is recalling 1,108 Model 53401 temporary external pacemakers because they may revert to nominal settings during use due to an unexpected power on reset.

    Product
    Single Chamber Temporary External Pacemaker, Model 53401
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-2313-2018·2018-07-04

    Siemens Artis zee MP Recall for Display Failure After Power Save

    Siemens is recalling Artis zee MP systems because the display may fail to show an image after power save mode, potentially requiring procedure cancellation or patient transfer.

    Product
    Artis zee MP, Material no. 10094139, for angiography and whole body radiographic/fluoroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2284-2018·2018-07-04

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is voluntarily recalling two Proteus 235 Proton Therapy Systems to address a software issue and reduce associated risks.

    Product
    The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2289-2018·2018-07-04

    Zimmer Biomet Recalls Vanguard Knee Bearings Due to Packaging Mix-up

    Zimmer Biomet is recalling 48 Vanguard Complete Knee System tibial bearings because two lots were commingled, creating a risk that 14mm bearings are packaged in 12mm boxes or vice versa.

    Product
    Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The product is intended for use in knee joint replacement arthroplasties.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2307-2018·2018-07-04

    Siemens Artis Q.zen floor recall for display failure after power save

    Siemens is recalling Artis Q.zen floor units because the display may fail to show images after power save mode, potentially requiring procedure cancellation or patient transfer.

    Product
    Artis Q.zen floor, Material no. 10848353, for angiography and whole body radiographic/fluoroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2306-2018·2018-07-04

    Siemens Artis Q.zeego X-ray System Display Malfunction Recall

    Siemens is recalling four Artis Q.zeego X-ray systems because the display may remain black after power save mode, preventing normal operation and requiring procedure cancellation or patient transfer.

    Product
    Artis Q.zeego, Material no. 10848283, for angiography and whole body radiographic/fluoroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2304-2018·2018-07-04

    Siemens Artis Q Ceiling Recalled for Display Failure After Power Save

    Siemens Medical Solutions is recalling five Artis Q ceiling units because the display may fail to show an image after exiting power save mode, potentially requiring treatment cancellation.

    Product
    Artis Q ceiling, Material no. 10848281, for angiography and whole body radiographic/fluoroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2319-2018·2018-07-04

    St Jude Medical Recalls Ellipse ICDs for Security Firmware Update

    St Jude Medical is recalling Ellipse ICDs and CRT-Ds to release new firmware that strengthens security against unauthorized access.

    Product
    Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2315-2018·2018-07-04

    Toshiba Diagnostic Ultrasound Systems Recalled for Power Supply Defect

    Toshiba is recalling 162 Aplio I-series diagnostic ultrasound systems because the power supply unit may be damaged and fail to start up.

    Product
    Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit may be damaged and may fail to start up when the power plug is inserted into a power outlet while the main power switch on the rear of the system is set to ON.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2309-2018·2018-07-04

    Siemens Artis zee Biplane MN Recalled for Display Failure

    Siemens is recalling two Artis zee biplane MN systems because the large display may fail to show an image after power save mode, potentially requiring procedure cancellation or patient transfer.

    Product
    Artis zee biplane MN, Material no. 10094143, for angiography and whole body radiographic/fluoroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2326-2018·2018-07-04

    St Jude Medical Recalls Unify ICDs for Security Firmware Update

    St Jude Medical is recalling Unify ICDs and CRT-Ds to release new firmware that strengthens security against unauthorized access.

    Product
    Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 1000370
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2286-2018·2018-07-04

    Horiba Medical Recalls ABX Pentra Micro Albumin Reagents Due to Result Elevation

    Horiba Medical is recalling ABX Pentra Micro Albumin 2 CP reagents because they may produce elevated results if used immediately after a specific creatinine reagent.

    Product
    ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2279-2018·2018-07-04

    Randox Liquid Assayed Specific Protein Control Recalled for Stability Issues

    Randox Laboratories is recalling Liquid Assayed Specific Protein Control - Level 2 because Free Kappa light chains increase over shelf life, potentially delaying diagnostic results.

    Product
    Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2321-2018·2018-07-04

    St Jude Medical Recalls Fortify Assura ICDs for Security Firmware Update

    St Jude Medical is recalling Fortify Assura implantable cardiac devices to release new firmware that strengthens security against unauthorized access.

    Product
    Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/10004294
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1596-2018·2018-07-04

    Pacific Brand Charcoal Grilled Eel Recalled for Mebendazole Amine

    Supreme Foods is recalling Pacific Brand Charcoal Grilled Eel because FDA inspections found Mebendazole amine in imported shipments that were distributed.

    Product
    Pacific Brand Charcoal Grilled Eel. Premium Quality Unagi Kabayaki UPC: 692156201099
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2331-2018·2018-07-04

    BioMerieux Recalls VIDAS FSH Assay Kits Due to Calibration Issues

    BioMerieux SA is recalling VIDAS FSH assay kits due to invalid calibration errors. The recall affects 59 units distributed in the U.S.

    Product
    VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France. For use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) for the determination of human
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2278-2018·2018-07-04

    Randox Liquid Assayed Specific Protein Control Recalled for Stability Issues

    Randox Laboratories is recalling Liquid Assayed Specific Protein Control Level 1 because Free Kappa light chains increase over shelf life, potentially delaying diagnostic results.

    Product
    Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Food)·F-1592-2018·2018-07-04

    Absonutrix Recalls Vitamin B12 Supplement Lacking Listed Ingredient

    Absonutrix is recalling Lyfetrition Vitamin B12 supplements because the product did not contain the vitamin listed on the label.

    Product
    Lyfetrition Live Life Nutritiously Vitamin B12 2 FL. OZ bottle Supplement Facts Serving Size:***Vitamin B-12 (as Methylcobalamyn) ABSONUTRIX 5500 Adams Farm Lane, Suite 206 Greensboro NC 27407 UPC 7 00443 88822 6
    Category
    Food
    Distribution
    22 states
  • LowFDA (Food)·F-1621-2018·2018-07-04

    McEvoy Ranch Extra Virgin Olive Oil Recalled for Cracking Bottles

    McEvoy of Marin, LLC. is recalling 6,000 bottles of 1-liter McEvoy Ranch 100% Certified Extra Virgin Olive Oil because inconsistent filling caused bottles to crack and break.

    Product
    McEvoy Ranch 100% Certified Extra VirginOlive Oil; Made in California; 1 L, 33,8 FL OZ UPC 6 34832 00291
    Category
    Food
    Distribution
    0 states
  • HighNHTSA·18V444000·2018-07-03

    Forest River and Coachmen RVs Recalled for Power Window Fire Risk

    Forest River and Coachmen are recalling specific RV models because liquid leaks into the driver's power window switch, causing corrosion and increasing the risk of a fire.

    Product
    COACHMEN — COACHMEN, FOREST RIVER FREELANDER, LEPRECHAUN, CONCORD, FORESTER
    Category
    Vehicle
    Distribution
    Distributed nationwide

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