The Recall Desk

Archive

August 2018 recalls

863 recalls were announced in August 2018.

What the numbers show

Critical
26
Severe
214
High
393
Moderate
191
Low
39

Of the 863 recalls this month scored against our rubric, 3% are Critical, 25% are Severe.

Which agencies issued them

501–600 of 863

  • ModerateFDA (Devices)·Z-2645-2018·2018-08-15

    ICU Medical Recalls Blood Tubing Accessories Due to DEHP Labeling Error

    ICU Medical is recalling specific blood tubing accessories because they were labeled as not containing DEHP, despite potentially containing small amounts.

    Product
    98" (249 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang 4-Way Stopcocks, Luer Lock, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2606-2018·2018-08-15

    ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

    ICU Medical is recalling 119-inch blood sets labeled as DEHP-free because they may contain small amounts of DEHP. The recall covers 160,016 units distributed in the US and internationally.

    Product
    119" Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2649-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 units of Y-Type Blood Sets because they were labeled as not containing DEHP, despite potentially containing small amounts.

    Product
    159" (404 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, 3 Pre-Pierced Ports, Luer Lock, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2740-2018·2018-08-15

    Beaver Visitec Recalls Mislabeled Ophthalmic Slit Knives

    Beaver Visitec is recalling 440 ophthalmic slit knives due to mislabeling on individual packages within correctly labeled cartons.

    Product
    Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic surgery.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Food)·F-1754-2018·2018-08-15

    Matiz Raw Apricot Bar Recalled Due to Foreign Plastic Contamination

    Power Selles Imports is recalling Matiz Raw Apricot Bars because customers found small plastic pieces in the product.

    Product
    Matiz Raw Apricot Bar Demi-luna 8.8 ounces bar, packaged in shrink wrap plastic, UPC 8 32924 00543 0. Product is labeled in parts: "***matiz RAW APRICOT ***100% Natural Ingredients: 92% dried apricots and almonds ****PRODUCED BY: Bio Vera, Losar de la Vera, C¿ceres***product
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2640-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling specific blood tubing sets because they are labeled as not containing DEHP, even though they may contain small amounts of the chemical.

    Product
    112" (284 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 3 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1044-2018·2018-08-15

    PharMEDium Recalls Ephedrine Sulfate Syringes Due to CGMP Deviations

    PharMEDium Services is recalling 450 syringes of Ephedrine Sulfate because the product was released while a hood certification discrepancy was under investigation.

    Product
    5 mg/mL Ephedrine Sulfate (Preservative Free) in 0.9% Sodium Chloride 5 mL in 5 mL BD Syringe Kit Check Tagged, PharMEDium Services, LLC.
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2615-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets labeled as DEHP-free because they may contain small amounts of DEHP.

    Product
    112" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-fre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1074-2018·2018-08-15

    Teva Recalls Omega-3 Capsules Due to Unapproved Manufacturing Material

    Teva Pharmaceuticals is recalling 13,715 bottles of Omega-3-Acid Ethyl Esters Capsules because an API material used in manufacturing did not receive regulatory approval prior to release.

    Product
    Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265. Manufactured for: Teva Pharmaceuticals USA Inc. North Wales, PA 19454 NDC 0093-5401-89
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1043-2018·2018-08-15

    PharMEDium Recalls Fentanyl Citrate IV Bags Due to CGMP Deviations

    PharMEDium Services is recalling specific lots of Fentanyl Citrate IV bags because they were released while a hood certification discrepancy was under investigation.

    Product
    10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 250 mL in 250 mL Intravia Bag and 10 mcg/mL Fentanyl Citrate (Preservative Free) in 0.9% Sodium Chloride 100 mL in 150 mL Intravia Bag, PharMEDium Services, LLC.
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2651-2018·2018-08-15

    ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets labeled as DEHP-free that may contain small amounts of DEHP.

    Product
    139" (353 cm) Y-Type Blood Set w/ 170 Micron Filter, Hand Pump, BCV, 3-Gang w/2 4-Way Stopcocks w/Baseplate, 1o2¿ Valve, 2 Clave¿, Pre-Pierced Port, Luer Lock, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2646-2018·2018-08-15

    ICU Medical Recalls Blood Tubing Accessories Due to DEHP Labeling Error

    ICU Medical is recalling 160,016 units of blood tubing accessories because some were labeled as not containing DEHP, despite potentially containing small amounts.

    Product
    132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Luer Lock, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2641-2018·2018-08-15

    ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

    ICU Medical is recalling specific blood tubing sets labeled as DEHP-free that may contain small amounts of the chemical.

    Product
    88" (224 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2620-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets labeled as DEHP-free that may contain small amounts of DEHP. The devices were distributed in the US and several international countries.

    Product
    135" (343 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or ven
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2656-2018·2018-08-15

    ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

    ICU Medical is recalling specific lots of Y-Type Blood Sets because they were labeled as not containing DEHP, despite potentially containing small amounts of the chemical.

    Product
    117" (297 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 3 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing set
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2643-2018·2018-08-15

    ICU Medical Recalls Blood Sets With Inaccurate DEHP Labeling

    ICU Medical is recalling specific blood tubing sets labeled as DEHP-free because they may contain small amounts of the chemical.

    Product
    99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2635-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 105-inch Y-Type Blood Sets because some were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    105" (267 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, MicroClave¿ Clear, Rotating Luer, 1 Ext, Approx Priming Volume: 59.3 mL, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2577-2018·2018-08-15

    Qiagen AmniSure ROM Test Recalled for Potential Control Line Failure

    Qiagen Sciences is recalling 1,620 AmniSure ROM Test kits because the control line may not appear on the test strip, potentially affecting result validity.

    Product
    AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2616-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Inaccurate DEHP Labeling

    ICU Medical is recalling specific blood tubing sets labeled as DEHP-free because they may contain small amounts of DEHP.

    Product
    137" (348 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 3 Gang 4-Way Stopcock, Luer Lock, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipunctu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1036-2018·2018-08-15

    Baxter Recalls Levofloxacin Injection Due to High Concentration Levels

    Baxter Healthcare is recalling 711,216 bags of Levofloxacin Injection in 5% Dextrose because the solution concentration was higher than specified.

    Product
    LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2623-2018·2018-08-15

    ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets labeled as DEHP-free that may contain small amounts of DEHP. The recall covers devices distributed in the US and several international countries.

    Product
    84" (213 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Cylindrical Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2637-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling specific blood tubing sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    80" (203 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2639-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets because some were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    128" (325 cm) Y-Type Blood Set with 170 Micron Filter, Hand Pump, 2 Clave¿, Removable 2 Gang (Blue, Yellow) 1o2¿ Manifold, Baseplate, 1 Ext, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2626-2018·2018-08-15

    ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood tubing sets because they were labeled as not containing DEHP, though they may contain small amounts.

    Product
    99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2618-2018·2018-08-15

    ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets labeled as DEHP-free that may contain small amounts of DEHP.

    Product
    88" (224 cm) Y-Type Blood Set w/200 Micron Filter, Hand Pump, MicroClave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for need
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2733-2018·2018-08-15

    INOmeters for INOflo Cylinders Recalled Due to Incorrect Expiration Date Programming

    INO therapeutics LLC is recalling 108 INOmeter devices affixed to INOflo cylinders in Japan because they were programmed with an incorrect expiration date.

    Product
    Mallinckrodt Pharmaceuticals INOflo DS, NO Gas Control System. Product Usage; Device Classification: The INOmeter is an accessory to the nitric oxide delivery device which is used for the delivery of inhaled nitric oxide to patient. An INOmeter is affixed to each cylinder
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2652-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Inaccurate DEHP Labeling

    ICU Medical is recalling specific blood tubing sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    125" (318 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 3 Gang 4-Way Stopcock w/Baseplate, Rotating Luer, 3 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1034-2018·2018-08-15

    Baxter Recalls Levofloxacin Injection Due to High Potency Levels

    Baxter Healthcare is recalling 191,256 bags of Levofloxacin Injection in 5% Dextrose due to high out-of-specification potency results.

    Product
    LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1047-2018·2018-08-15

    Right Value Drug Stores Recalls Testosterone Pellets Due to Labeling Error

    Right Value Drug Stores is recalling 4,800 Testosterone 200 mg Pellets because the label contains an incorrect expiration date.

    Product
    Testosterone 200 mg Pellet, Rx only, Carie Boyd's Prescription Shop 122 Grapevine Hwy., Hurst, TX 76054, 800-930-4361
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1755-2018·2018-08-15

    Stavis Seafoods Recalls Decomposed Vacuum Packed Ahi Tuna Saku

    Stavis Seafoods is recalling vacuum-packed Ahi Tuna Saku because the product is decomposed. The recall covers specific lots distributed to multiple states.

    Product
    Ocean Delight Individually Vacuum Packed AHI TUNA SAKU, 8-12 oz. NET WT. 10 LB (4.54 kg) and 12-16 oz. NET WT. 22LB (9.98 kg), Carbon Monoxide Treated, DISTRIBUTED BY: Stavis Seafoods, WILD CAUGHT, PRODUCT OF SRI LANKA
    Category
    Food
    Distribution
    13 states
  • LowFDA (Drugs)·D-1035-2018·2018-08-15

    Baxter Recalls Levofloxacin Injection Due to High Potency Levels

    Baxter Healthcare is recalling specific lots of Levofloxacin Injection in 5% Dextrose because the solution concentration was higher than specified.

    Product
    LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1768-2018·2018-08-15

    Kraft Heinz Recalls Asian Style Sesame Ginger Dressing Due to Spoilage

    Kraft Heinz is recalling 19,560 cases of Food Network Kitchen Inspirations Asian Style Sesame Ginger Dressing due to premature spoilage caused by lactic acid producing bacteria.

    Product
    Food Network Kitchen Inspirations Asian Style Sesame Ginger Dressing. 12 oz glass bottle, 6 bottles per case Shelf Stable and Refrigerate After Opening UPC 0021000068876
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·18E082000·2018-08-14

    Akoury Recalls AK88S Motorcycle Helmets for Impact Protection Defect

    Akoury is recalling AK88S motorcycle helmets because they may not adequately protect the wearer in a crash, increasing the risk of injury.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V528000·2018-08-13

    Roadtrek Motorhomes Recalled for Potential Diesel Fuel Tank Damage

    Erwin Hymer is recalling 2017-2018 Roadtrek motorhomes because the diesel fuel tank may have been damaged during seat installation, increasing fire risk.

    Product
    ROADTREK — ROADTREK E-TREK, RS ADVENTUROUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V529000·2018-08-13

    Roadtrek Zion Motorhomes Recalled for Rear Brake Line Damage Risk

    Erwin Hymer is recalling 2015-2018 Roadtrek Zion motorhomes because sofa installation may have damaged the rear brake line, increasing stopping distance and crash risk.

    Product
    ROADTREK — ROADTREK ZION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V527000·2018-08-13

    Forest River Recalls Recreational Trailers Due to Awning Deployment Risk

    Forest River is recalling specific 2018-2019 recreational trailers because the awning may deploy while moving, increasing the risk of a crash.

    Product
    FOREST RIVER — FOREST RIVER, COACHMEN ROCKWOOD, ADRENALINE, FORESTER, XLR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E081000·2018-08-10

    Cummins Recalls Diesel Engines Due to Fuel Line Burst Risk

    Cummins is recalling ISX15 and X15 diesel engines because a restricted fuel pump screen can cause the nylon fuel line to burst, leading to fuel leaks or engine stalling.

    Product
    FUEL SYSTEM, OTHER:DELIVERY:FUEL PUMP recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V526000·2018-08-10

    KZRV Sportsmen Travel Trailers Recalled for Propane Line Fire Risk

    KZRV is recalling 2018-2019 Sportsmen 333BHK travel trailers because liquid propane lines routed through the wheel well may be damaged by road debris, increasing fire risk.

    Product
    KZRV — KZRV SPORTSMEN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V523000·2018-08-09

    Chrysler Recalls 2018-2019 Vehicles for Rear Brake Caliper Coating Defect

    Chrysler is recalling specific 2018-2019 Dodge and Jeep vehicles because rear brake caliper pistons may have insufficient coating, potentially reducing braking performance.

    Product
    DODGE — DODGE, JEEP GRAND CARAVAN, CHEROKEE, JOURNEY, COMPASS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V525000·2018-08-09

    Freightliner Trucks Recalled for Insufficiently Tightened Brake Caliper Bolts

    Daimler Trucks North America is recalling 2018-2019 Freightliner trucks because brake caliper mounting bolts may be loose, which can reduce braking effectiveness and increase crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER 108SD, 114SD, CASCADIA, 122SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E080000·2018-08-09

    TRW Recalls Outer Tie Rods for Loss of Steering Risk

    TRW is recalling specific outer tie rods sold as replacement parts for 1988-2000 GM vehicles because the locking nut may fail, causing a loss of steering.

    Product
    STEERING:LINKAGES:TIE ROD ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V524000·2018-08-09

    Chrysler, Jeep, and Ram Vehicles Recalled for Powertrain Control Module Defect

    FCA US LLC is recalling specific 2017-2019 Chrysler, Jeep, Ram, Dodge, and Fiat vehicles because a faulty voltage regulator chip may cause the vehicle to stall or fail to start.

    Product
    CHRYSLER — CHRYSLER, RAM, JEEP PACIFICA PLUG-IN HYBRID, PACIFICA, 1500, RENEGADE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V511000·2018-08-09

    Gillig Recalls Low Floor Buses Due to Turn Signal Flashing Defect

    Gillig is recalling 2012-2018 Low Floor buses because front and rear turn signals may flash at different rates, potentially confusing other drivers.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18202·2018-08-09

    Vitamix Recalls Ascent and Venturist Blending Containers Due to Laceration Hazard

    Vitamix is recalling Ascent and Venturist series blending containers because they can separate from the blade base, exposing blades and posing a laceration hazard.

    Product
    Ascent™ and Venturist™ Series 8-ounce and 20-ounce blending containers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1675-2018·2018-08-08

    Probiotic Supplement Recalled for Potential Undeclared Allergens

    LL'S Magnetic Clay Inc. is recalling Prescript-Assist Probiotic & Prebiotic supplements because they may contain undeclared almonds, shellfish, milk, eggs, or peanuts.

    Product
    Prescript-Assist Broad Spectrum Probiotic & Prebiotic Gastrointestinal Support Dietary Supplement, 60-capsule or 90-capsule bottles; UPC Codes: 853956003157, 853956003539
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1022-2018·2018-08-08

    Valsartan tablets recalled due to carcinogen impurity in active ingredient

    H.J. Harkins Co. is recalling Valsartan tablets 160 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient used to manufacture the product.

    Product
    Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 43547-0369-09. Tablet is yellow, capsule-shaped, biconvex, film-coated tablets debossed with 343 on one side and HH on the other side.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2563-2018·2018-08-08

    Galt Medical Recalls Centeze Centesis Catheters Due to Bacterial Endotoxins

    Galt Medical Corporation is recalling 300 units of Centeze Centesis Catheters because they may contain unsafe levels of bacterial endotoxins introduced during manufacturing.

    Product
    Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Food)·F-1806-2018·2018-08-08

    Sugar Foods Recalls Garlic Butter Focaccia Crumbles Due to Whey Powder Issue

    Sugar Foods Corporation is recalling Garlic Butter and Black Pepper Focaccia Crumbles because they were made with recalled whey powder.

    Product
    Garlic Butter and Black Pepper Focaccia Crumbles: 400 lb. Gaylord Tote Item # 78939 Sugar Foods Corporation 6190 E. Slauson Ave. Los Angeles, CA 90047
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-1800-2018·2018-08-08

    Sugar Foods Recalls Seasoned Croutons Due to Whey Powder Contamination

    Sugar Foods Corporation is recalling First Street Restaurant Style Seasoned Croutons because they were made with recalled whey powder.

    Product
    First Street Restaurant Style Seasoned Croutons: 24 oz. foil pouch Item # 31424 Sugar Foods Corporation 6190 E. Slauson Ave. Los Angeles, CA 90047
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-1804-2018·2018-08-08

    Sugar Foods Recalls Italian Seasoned Croutons Due to Whey Powder Contamination

    Sugar Foods Corporation is recalling 1 lb. foil pouches of Homestyle Italian Seasoned Croutons because they were made with recalled whey powder.

    Product
    Homestyle Italian Seasoned Croutons: 1 lb. foil pouch Item # 74384 Sugar Foods Corporation 6190 E. Slauson Ave. Los Angeles, CA 90047
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-1802-2018·2018-08-08

    Sugar Foods Recalls Cheese Garlic Croutons Due to Whey Powder Contamination

    Sugar Foods Corporation is recalling HMS Cheese Garlic Croutons because they were produced using recalled whey powder.

    Product
    HMS Cheese Garlic Croutons: 2.5 lb. foil pouch Item # 74906 Sugar Foods Corporation 6190 E. Slauson Ave. Los Angeles, CA 90047
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2594-2018·2018-08-08

    Integra LifeSciences Recalls Mayfield Infinity XR2 Base Units Due to Fracture Risk

    Integra LifeSciences is recalling Mayfield Infinity XR2 Low Profile Base Units because the knob assembly in the swivel adapter may fracture or break during use.

    Product
    MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1028-2018·2018-08-08

    Bryant Ranch Recalls Valsartan 320 mg Tablets Due to Carcinogen Impurity

    Bryant Ranch Prepack Inc. is recalling Valsartan 320 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (NDC 6362-96905-3), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2601-2018·2018-08-08

    Polysorb Suture Recalled for Potential Propylene Glycol Contamination

    Covidien LLC is recalling Polysorb Braided Absorbable Sutures due to potential propylene glycol contamination. The recall affects 972 units distributed in California, New York, and Texas.

    Product
    Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Food)·F-1728-2018·2018-08-08

    Bengard Ranch Recalls Fresh Cilantro Due to Salmonella Contamination

    Bengard Ranch is recalling fresh cilantro after FDA surveillance samples tested positive for Salmonella. The product was distributed directly to Texas.

    Product
    Fresh Cilantro: Boxed by Sabor Farms, Salinas, CA 60 bunches of cilantro per box
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2559-2018·2018-08-08

    Galt Medical Recalls Vascular Dilators and Introducer Kits Due to Endotoxins

    Galt Medical Corporation is recalling specific vascular dilators and introducer kits because they may contain unsafe levels of bacterial endotoxins introduced during manufacturing.

    Product
    1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile EO, Rx Only, Catalog #: DIL-600-11; 3) Tearaway Introducer, Sterile EO, Rx Only, Catalog #: a) INT-028-14; b) INT-028-24; c) INT-029-05; d) INT-106-01; e) INT-106-14; 4) Micro-Access Te
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Drugs)·D-1021-2018·2018-08-08

    RemedyRepack Recalls Valsartan/HCTZ Tablets Due to Carcinogen Impurity

    RemedyRepack Inc. is recalling specific lots of Valsartan/HCTZ tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1798-2018·2018-08-08

    Sugar Foods Recalls Homestyle Seasoned Croutons Due to Whey Powder Contamination

    Sugar Foods Corporation is recalling 4 oz. pouches of Homestyle Seasoned Croutons because they were produced using recalled whey powder.

    Product
    Homestyle Seasoned Croutons: 4 oz. foil pouch Item # 73689 UPC 10083661736898 Sugar Foods Corporation 6190 E. Slauson Ave. Los Angeles, CA 90047
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-1027-2018·2018-08-08

    Bryant Ranch Recalls Valsartan 80 mg Tablets Due to Carcinogen Impurity

    Bryant Ranch Prepack Inc. is recalling specific lots of Valsartan 80 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Food)·F-1807-2018·2018-08-08

    Sugar Foods Croutons Recalled Due to Contaminated Whey Ingredient

    Sugar Foods Corporation is recalling seasoned croutons because they were made with recalled whey powder.

    Product
    Classic Sysco cube seasoned croutons: 0.25 oz. plastic pouch Item # 20602 Sugar Foods Corporation 6190 E. Slauson Ave. Los Angeles, CA 90047
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2599-2018·2018-08-08

    Beckman Coulter MicroScan Pos Combo Panel Type 43 Recalled for Incorrect Moxifloxacin Dilution

    Beckman Coulter is recalling MicroScan Pos Combo Panel Type 43 because an incorrect Moxifloxacin dilution sequence may cause inaccurate antimicrobial susceptibility results.

    Product
    MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-2558-2018·2018-08-08

    Galt Medical Recalls Sterile Hemostasis Valve Introducer Systems Due to Endotoxins

    Galt Medical Corporation is recalling specific sterile hemostasis valve introducer systems and kits because they may contain unsafe levels of bacterial endotoxins introduced during manufacturing.

    Product
    1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-36; 2) Elite HV Introducer Set, Sterile EO, Rx Only, Catalog #: a) CLI-105-14; 3) AngioGate HV Introducer Kit, Sterile EO, Catalog #: a
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Drugs)·D-1029-2018·2018-08-08

    Bryant Ranch Recalls Valsartan Tablets Due to Carcinogen Impurity

    Bryant Ranch Prepack Inc. is recalling specific lots of Valsartan 320 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    VALSARTAN — VALSARTAN (VALSARTAN)
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1020-2018·2018-08-08

    RemedyRepack Recalls Valsartan/HCTZ Tablets Due to Carcinogen Impurity

    RemedyRepack Inc. is recalling Valsartan/HCTZ 160 mg/12.5 mg tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1023-2018·2018-08-08

    Pfizer Recalls Daptomycin Injection Due to Microbial Contamination

    Pfizer is recalling Daptomycin for Injection due to reports of adverse events indicative of infusion reactions related to microbiological contamination.

    Product
    Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1679-2018·2018-08-08

    LAXMI Corn Flour Recalled Due to High Aflatoxin Levels

    House of Spices (India) Inc. is recalling LAXMI Corn Flour because it contains high levels of aflatoxin.

    Product
    LAXMI Corn Flour Fine Net Wt./Poids Net. 2LB (907g) Distributed by: House of Spices (India) Inc.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1805-2018·2018-08-08

    Sugar Foods Recalls Sizzler Seasoned Croutons Due to Whey Powder Contamination

    Sugar Foods Corporation is recalling Sizzler HMS Seasoned Croutons because they were made with recalled whey powder. The product was distributed in six states.

    Product
    Sizzler HMS Seasoned Croutons: 2.5 lb. foil pouch Item # 74803 Sugar Foods Corporation 6190 E. Slauson Ave. Los Angeles, CA 90047
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1879-2018·2018-08-08

    Griffith Labs Recalls Basil Pesto Due to Potential Salmonella

    Griffith Labs U.S.A. is recalling 50-pound bags of Basil Pesto because a whey ingredient used in the product was recalled for potential Salmonella.

    Product
    Basil Pesto 50 pound bag, Item 859081100
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2477-2018·2018-08-08

    Siemens SOMATOM Scope Power Recalled for Software Radiation Risk

    Siemens is recalling SOMATOM Scope Power units due to a software issue that may cause unnecessary radiation exposure.

    Product
    SOMATOM Scope Power (Model 10967888)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1783-2018·2018-08-08

    Mondelez Recalls Ritz White Cheddar Crackers Due to Salmonella Risk

    Mondelez Global is recalling Ritz Whole Wheat White Cheddar Crackers because an ingredient, whey powder, may contain Salmonella.

    Product
    10.8Z RITZ WHLE WT WHTE CHDDR 14 (10 &15) 10.8 Oz per tray, Plastic sleeve in tray,14 trays per case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1882-2018·2018-08-08

    Griffith Labs Recalls Caesar Crouton Seasoning Due to Salmonella Risk

    Griffith Labs U.S.A. is recalling 50-pound bags of Caesar Crouton Seasoning because they may contain Salmonella from a recalled whey ingredient.

    Product
    Caesar Crouton Seasoning 50 pound bag Item 1000014383
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1890-2018·2018-08-08

    Griffith Labs Recalls Country Ranch Crouton Seasoning Due to Salmonella Risk

    Griffith Labs U.S.A. is recalling 50-pound bags of Country Ranch Crouton Seasoning because a whey ingredient used in the product was recalled for potential Salmonella contamination.

    Product
    Country Ranch Crouton Seasoning 50 pound bag Item 859075400
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2566-2018·2018-08-08

    Merge Unity Software Recalled for Incorrect Breast Cancer Risk Calculations

    Merge Healthcare is recalling Merge Unity software versions 10.0.6 and 10.0.7 because the software fails to identify atypical hyperplasia, leading to incorrect Gail Risk calculations for breast cancer.

    Product
    Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1861-2018·2018-08-08

    Griffith Labs Queso Snack Seasoning Recalled for Potential Salmonella

    Griffith Labs U.S.A. is recalling Queso Snack Seasoning due to the potential presence of Salmonella from a recalled whey ingredient.

    Product
    Queso Snack Seasoning 25 pound bag, 1 bags per carton Item 1000033198
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1870-2018·2018-08-08

    Griffith Labs Broccoli Cheddar Premix Recalled for Potential Salmonella

    Griffith Labs U.S.A. is recalling 50-pound bags of Broccoli Cheddar Premix due to potential Salmonella from a recalled whey ingredient.

    Product
    Premix Broccoli Cheddar no Mustard 50 pound bag, 1 units per carton Item 1000013989
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2596-2018·2018-08-08

    QIAGEN Recalls EZ1 DSP Virus Kit Due to Underfilled Reagent Wells

    QIAGEN is recalling 287 units of the EZ1 DSP Virus Kit (48) because underfilled reagent wells could lead to incorrect diagnostic results.

    Product
    EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1876-2018·2018-08-08

    Griffith Labs Recalls Ranch Seasoning Due to Potential Salmonella

    Griffith Labs U.S.A. is recalling 50-pound bags of Ranch Seasoning because a whey ingredient used in the product was recalled for potential Salmonella.

    Product
    Ranch Seasoning 50 pound bag Item 860146600
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1782-2018·2018-08-08

    Mondelez Recalls Ritz Bacon and Cheese Sandwiches Due to Salmonella Risk

    Mondelez Global is recalling Ritz Bacon and Cheese sandwiches because a whey powder ingredient may contain Salmonella.

    Product
    10.8Z RITZ BACON AND CHEESE 14,(9 & 14) 10.8 Oz per tray, Plastic sleeve in tray 14 trays per case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2578-2018·2018-08-08

    GE Healthcare Recalls CT Systems with Potential UPS Wiring Defect

    GE Healthcare is recalling 42 Discovery IQ 2.0 CT systems installed with a specific electrical panel that may not be properly wired to the uninterruptible power supply.

    Product
    Discovery IQ 2.0 20cm, 4 ring, Model Number 5432539-22
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2580-2018·2018-08-08

    GE Healthcare Recalls CT Systems With Potential Electrical Wiring Defect

    GE Healthcare is recalling 42 Discovery MI CT systems installed with a specific electrical panel that may not be properly wired to the UPS.

    Product
    Discovery MI, labeled as Discovery DMI 15 cm 3 ring, and Discovery DMI 20cm 4 ring
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1871-2018·2018-08-08

    Griffith Labs Recalls Deep Pan Pizza Dough Due to Salmonella Risk

    Griffith Labs U.S.A. is recalling Deep Pan Pizza Dough because it may contain Salmonella from a recalled whey ingredient. The product was distributed nationwide and in Canada.

    Product
    Deep Pan Pizza Dough 1 pound 4 oz bag, 24 units per carton Item 129032500
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2472-2018·2018-08-08

    Siemens SOMATOM Emotion 6 CT Scanner Recalled for Radiation Risk

    Siemens Medical Solutions is recalling SOMATOM Emotion 6 CT scanners due to a software issue that may cause unnecessary radiation exposure.

    Product
    SOMATOM Emotion 6 (Model 10165888)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2565-2018·2018-08-08

    Galt Medical Recalls Tearaway Introducers Due to Bacterial Endotoxins

    Galt Medical Corporation is recalling specific lots of Tearaway Introducers because they may contain unsafe levels of bacterial endotoxins introduced during manufacturing.

    Product
    Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2570-2018·2018-08-08

    XLTEK EMU40EX EEG Headbox Recalled for Component Degradation

    Natus Neurology is recalling 462 XLTEK EMU40EX EEG Headboxes because an internal electronic component may degrade, causing the unit to overheat and the plastic case to melt.

    Product
    XLTEK EMU40EX EEG Headbox
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Food)·F-1868-2018·2018-08-08

    Griffith Labs Cold Dough Premix Recalled for Potential Salmonella

    Griffith Labs U.S.A. is recalling Cold Dough Premix due to the potential presence of Salmonella from a recalled whey ingredient.

    Product
    Cold Dough Premix 6.8 pound bag, 6 units per carton Item 127033700
    Category
    Food
    Distribution
    Distributed nationwide

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