The Recall Desk

Archive

August 2018 recalls

863 recalls were announced in August 2018.

What the numbers show

Critical
26
Severe
242
High
366
Moderate
190
Low
39

Of the 863 recalls this month scored against our rubric, 3% are Critical, 28% are Severe.

501–600 of 863

  • 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 (Devices)·Z-2622-2018·2018-08-15

    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
    84" Y-Type Blood Set w/170 Micron Filter, 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 devices for needle-free…
    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-2644-2018·2018-08-15

    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 they may contain small amounts of the chemical.

    Product
    99" (251 cm) 20 Drop Y-Type Blood Set w/200 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2633-2018·2018-08-15

    ICU Medical Recalls Bifuse Blood Sets Due to DEHP Labeling Error

    ICU Medical is recalling 160,016 Bifuse Blood Sets because they are labeled as DEHP-free but may contain small amounts of DEHP.

    Product
    125" (318 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 4 MicroClave¿ Clear, 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 sets or venipuncture…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2647-2018·2018-08-15

    ICU Medical Recalls Blood Tubing Accessories Due to Mislabeling

    ICU Medical is recalling 160,016 units of Y-Type Admin Sets because they were labeled as not containing DEHP, though they may contain small amounts.

    Product
    134" (340 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang 4-Way Stopcocks, Rotating Luer w/Filter Cap, 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1756-2018·2018-08-15

    Genestra AFA-gen Capsules Recalled for Excess Microcystins

    Seroyal International is recalling Genestra AFA-gen capsules because microcystin levels exceeded the specified limit of 1 ppm.

    Product
    Genestra brand AFA-gen capsule 15 mg Niacin/ capsule 300 mg Blue Green Algae / capsule 2 capsules, twice daily Dietary supplement 90 capsules, White 150cc HDPE Bottle with Desiccant and white cap, packed as 12 bottles / shipper case
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1042-2018·2018-08-15

    Morton Grove Recalls Prednisolone Sodium Phosphate Oral Solution Due to Seal Defect

    Morton Grove Pharmaceuticals is recalling 38,280 bottles of Prednisolone Sodium Phosphate Oral Solution because the tamper-evident foil seal is not completely intact.

    Product
    Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-212-08.
    Category
    Drug
    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…
    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…
    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…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2658-2018·2018-08-15

    ICU Medical Recalls Blood Tubing Accessories Due to DEHP Labeling Error

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

    Product
    120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-Way Stopcock, Y-Connector, 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2634-2018·2018-08-15

    ICU Medical Recalls Blood Administration Sets with Incorrect DEHP Labeling

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

    Product
    164" (417 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, Remv 4 Gang 4-Way Stopcocks w/Baseplate, 4 MicroClave¿ Clear, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2609-2018·2018-08-15

    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
    168 cm (66") 20 Drop Blood Set w/200 Micron Filter, 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2655-2018·2018-08-15

    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, even though the product may contain small amounts of the chemical.

    Product
    107" (272 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2636-2018·2018-08-15

    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, even though the product may contain small amounts of the chemical.

    Product
    94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, MicroClave¿ Clear, Rotating Luer, Approx Priming Volume: 57.2 mL, 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 (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2624-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 85-inch Y-Type Blood Sets because some units are labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    85" (216 cm) Y-Type Blood Set w/170 Micron Filter, 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 devices for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2625-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

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

    Product
    99" (251 cm) 20 Drop Y-Type Blood Set w/200 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2627-2018·2018-08-15

    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, despite potentially containing small amounts.

    Product
    120" (305cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, 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 venipuncture devices for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2648-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

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

    Product
    143" (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Drop-In Ext w/3 Gang 4 Way Stopcocks, MicroClave¿, Luer Lock, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2657-2018·2018-08-15

    ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

    ICU Medical is recalling 116-inch Y-Type Blood Sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave¿, 2 Ext, 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…
    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
  • 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
  • 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-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
  • 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·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
  • 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
  • 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·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
  • 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·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
  • 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
  • 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
  • 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
  • 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 (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 (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 (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-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…
    Category
    Medical Device
    Distribution
    19 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 #…
    Category
    Medical Device
    Distribution
    19 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 (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-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
  • 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 (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 (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 (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 (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 (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-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 (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 (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-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 (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 (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 (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…
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Food)·F-1810-2018·2018-08-08

    Innova Flavors Recalls Natural Butter Flavor Due to Salmonella Risk

    Innova Flavors is voluntarily recalling specific lots of Natural Butter Flavor because a supplier's sweet whey powder ingredient is potentially contaminated with Salmonella.

    Product
    Natural Butter Flavor, 40 pounds, Powder in a blue poly-lined cardboard box, Ambient
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1724-2018·2018-08-08

    Holmquist Hazelnut Orchards Recalls Butter Toffee Flavored Hazelnuts for Allergen Labeling

    Holmquist Hazelnut Orchards is recalling Butter Toffee Flavored Hazelnuts because the packaging fails to declare milk as an allergen, despite containing butter.

    Product
    Butter Toffee Flavored Hazelnuts, packaged in a clear plastic bag, net wt 6 oz. UPC 7 39059 30612 1. The label is read in parts: "***Butter Toffee Flavored Hazelnuts *** Ingredients: Dry Roasted Hazelnuts, Sugar, Butter, Sea Salt and Natural Vanilla Extract *** Contains…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1894-2018·2018-08-08

    Griffith Labs Herb Crouton Seasoning Recalled for Potential Salmonella

    Griffith Labs U.S.A. is recalling 50-pound bags of Herb Crouton Seasoning due to the potential presence of Salmonella from a recalled whey ingredient.

    Product
    Herb Crouton Seasoning 50 pound bag Item 702046300
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2562-2018·2018-08-08

    Galt Medical Elite HV Introducer Recalled for Bacterial Endotoxins

    Galt Medical Corporation is recalling Elite HV Introducers due to potential unsafe levels of bacterial endotoxins introduced during manufacturing.

    Product
    Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2602-2018·2018-08-08

    Zimmer Dermatone AN Skin Graft Device Recalled for Loose Control Bar

    Zimmer Surgical Inc is recalling 140 units of the Zimmer Dermatone AN skin graft device due to a loose control bar that may compromise graft thickness control.

    Product
    Zimmer Dermatone AN, Model No. 88710100
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Food)·F-1864-2018·2018-08-08

    Griffith Labs Recalls Low Sodium Brown Gravy Mix for Salmonella Risk

    Griffith Labs U.S.A. is recalling Low Sodium Brown Gravy Mix due to the potential presence of Salmonella from a recalled whey ingredient.

    Product
    Low Sodium Brown Gravy Mix 12 oz unit, 8 units per carton Item 860143100 UPC 9624817431
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1869-2018·2018-08-08

    Griffith Labs Recalls Reduced Whey Cold Dough Premix Due to Salmonella Risk

    Griffith Labs U.S.A. is recalling Reduced Whey Cold Dough Premix because it may contain Salmonella from a recalled whey ingredient. The product was distributed nationwide and in Canada.

    Product
    Reduced Whey Cold Dough Premix 2.3 pound bag, 18 units per carton Item 127038500
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1808-2018·2018-08-08

    New Seasons Cauliflower Pilaf Meal Kit Recalled for Allergen Mislabeling

    New Seasons Market LLC is recalling Cauliflower Pilaf meal kits because the almond container was mislabeled as peanut. The recall covers 86 units distributed in Oregon and Washington.

    Product
    Cauliflower Pilaf with Fresh Turmeric and Fennel, New Seasons Kitchen Collective Meal Kits, Net wt. 2 lb 4 oz (1007 gr), UPC 840600109563. The ingredients statement of the finished product package is labeled in parts: ***INGREDIENTS: Cauliflower, Water, Fennel, Onion, Lemon…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1858-2018·2018-08-08

    Griffith Labs Recalls Biscuit Mix Due to Potential Salmonella Risk

    Griffith Labs U.S.A. is recalling specific lots of Biscuit Mix because it may contain Salmonella from a recalled whey ingredient.

    Product
    Biscuit Mix 4.5 pound bag, 8 bags per carton Item 127042301
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1863-2018·2018-08-08

    Griffith Labs Recalls Beef Flavored Gravy Mix Due to Salmonella Risk

    Griffith Labs U.S.A. is recalling Beef Flavored Gravy Mix because it may contain Salmonella from a recalled whey ingredient.

    Product
    Beef Flavored Gravy Mix 12 oz unit, 8 units per carton Item 860143801 UPC 9624817621
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1788-2018·2018-08-08

    General Mills Recalls Cheerios Protein Oats and Honey Cereal

    General Mills is recalling Cheerios Protein Oats and Honey cereal due to potential Salmonella contamination. Consumers should check expiration dates and stop eating the product.

    Product
    Cheerios Protein Oats & Honey, Packaged in the following sizes: Net Wt. 19 oz. (583g) UPC 16000-44473. 12 boxes/case, Net Wt. 14.1 oz. (399g) UPC 16000-45137. 16 boxes/case. Dist. By General M ills Sales, Inc., Minneapolis, MN 55440 USA.
    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 (Food)·F-1778-2018·2018-08-08

    Mondelez Recalls Ritz Bitz Cookies Due to Potential Salmonella in Ingredient

    Mondelez Global is recalling Ritz Bitz cookies because a whey powder ingredient may contain Salmonella. The recall covers products shipped to the U.S. and several international locations.

    Product
    20Z NAB CKIES CLASSIC MULTI PK 4 20 Oz, Carton, 5 Ritz Bitz 1 Oz Pouches per box 4 boxes per case
    Category
    Food
    Distribution
    2 states
  • HighCPSC·18758·2018-08-08

    Polaris Recalls Gravely Utility Vehicles Due to Fire and Burn Hazards

    Polaris is recalling about 2,100 Gravely Atlas JSV 3000 and 6000 utility vehicles because a cracked exhaust header pipe poses fire and burn risks.

    Product
    Gravely Atlas JSV 3000 and 6000 utility vehicles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • 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-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-2595-2018·2018-08-08

    Integra LifeSciences Recalls Mayfield Spine Table Adaptors Due to Fracture Risk

    Integra LifeSciences is recalling 95 Mayfield Spine Table Adaptors because the knob assembly may fracture during use, posing a risk to patients.

    Product
    MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R 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 is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2587-2018·2018-08-08

    GE Healthcare Recalls CT Systems with Potential Electrical Wiring Defect

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

    Product
    CT Goldseal BrightSpeed 16 PWR TIO 2 YR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1896-2018·2018-08-08

    Griffith Labs Italian Crouton Seasoning Recalled for Potential Salmonella

    Griffith Labs U.S.A. is recalling 555 bags of Italian Crouton Seasoning due to the potential presence of Salmonella from a recalled whey ingredient.

    Product
    Italian Crouton Seasoning 50 pound bag Item 1000017039
    Category
    Food
    Distribution
    Distributed nationwide

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