The Recall Desk

Archive

December 2018 recalls

451 recalls were announced in December 2018.

What the numbers show

Critical
15
Severe
134
High
189
Moderate
96
Low
17

Of the 451 recalls this month scored against our rubric, 3% are Critical, 30% are Severe.

Which agencies issued them

301–400 of 451

  • SevereFDA (Devices)·Z-0533-2019·2018-12-12

    Zimmer Biomet Recalls Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling 2,080 units of ZMS Intramedullary Fixation Smooth Guide Wires because creases in the packaging may compromise sterility.

    Product
    Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2237-033-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0548-2019·2018-12-12

    Philips Brilliance 6 Slice CT Scanner Recalled for Gantry Cover Separation Risk

    Philips Medical Systems is recalling Brilliance 6 Slice CT scanners because fiberglass resin may separate, causing the gantry front cover to fail or fall.

    Product
    Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0749-2019·2018-12-12

    Tres Hermanos Bakery Recalls Telera and Bolillo Bread for Undeclared Milk

    Tres Hermanos Bakery is voluntarily recalling Telera and Bolillo Mexican White Bread because it contains undeclared milk, a major allergen.

    Product
    Tres Hermanos Bakery Telera and Bolillo Mexican White Bread, 1lb and 2 ounces per pkg
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0689-2019·2018-12-12

    Frito-Lay Recalls Smartfood Delight Variety Packs for Undeclared Milk

    Frito-Lay is recalling 16-count Smartfood Delight Variety Packs because they may contain undeclared milk. Consumers should check their pantries for affected items.

    Product
    16 count Smartfood Delight Variety Pack Sack
    Category
    Food
    Distribution
    29 states
  • HighFDA (Food)·F-0736-2019·2018-12-12

    Ottogi Jin Ramen Spicy Recalled for Undeclared Egg Allergen

    Ottogi America Inc. is recalling Ottogi Jin Ramen Spicy 5-packs due to an undeclared egg allergen. The product was distributed in five U.S. states and Canada.

    Product
    Ottogi Jin Ramen Spicy NET WT. 1lb 5.16oz, 600g (120gx5) 5PK Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottogi America, Inc. 1650 W. El Segundo Bl. Gardena, CA 90249
    Category
    Food
    Distribution
    5 states
  • HighNHTSA·18V882000·2018-12-12

    Van Hool Recalls 2015-2018 Buses Due to Fire Extinguisher Defect

    Van Hool is recalling 2015-2018 TD925 and TDX25 buses because the fire suppression system actuator may fail to discharge during a fire.

    Product
    VAN HOOL — VAN HOOL TD925, TDX25
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0558-2019·2018-12-12

    Siemens Artis Zee and Zeego X-ray Systems Recalled for Cooling Hose Leak

    Siemens is recalling 64 Artis Zee and Zeego angiography systems due to a possible cooling hose leak that can cause the X-ray tube to overheat and block imaging.

    Product
    Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0538-2019·2018-12-12

    Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling 57,241 Natural Nail System Tear Drop Guide Wires because creases in the sealing area may compromise product sterility.

    Product
    Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2490-097-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0560-2019·2018-12-12

    Atrium Medical Recalls 28Fr Thoracic Catheters Due to Seal Defect

    Atrium Medical Corporation is recalling 2,930 units of 28Fr PVC Thoracic Catheters due to a seal defect in sterile barrier pouches that could compromise sterility.

    Product
    Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0537-2019·2018-12-12

    Zimmer Biomet Recalls Smooth Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling Smooth Guide Wires because creases in the sealing area may compromise product sterility. The recall affects 48,320 units distributed worldwide.

    Product
    Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2255-008-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0551-2019·2018-12-12

    Capintec Recalls Captus 700 Thyroid Uptake Systems Due to Spring Arm Failure

    Capintec Inc is recalling 65 Captus 700 Thyroid Uptake Systems because a broken tension rod can cause the spring arm to fail and the collimator to fall.

    Product
    Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0542-2019·2018-12-12

    Zimmer Biomet Recalls Pressure Sentinel Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling 1,676 Pressure Sentinel Guide Wires because creases in the packaging seal may compromise sterility. The defect could increase the risk of infection during orthopaedic surgery.

    Product
    Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0525-2019·2018-12-12

    ASO Recalls Family Wellness Sterile Gauze Pads Due to Sterilization Concerns

    ASO, LLC is recalling Family Wellness First Aid Sterile Gauze Pads because they may not be fully sterilized. The affected units were distributed nationwide to ten states.

    Product
    Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard box
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0535-2019·2018-12-12

    Zimmer Biomet Recalls Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires because creases in the sealing area may compromise product sterility.

    Product
    Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-038-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0547-2019·2018-12-12

    Philips Brilliance 10 Slice CT Scanner Recalled for Gantry Cover Failure Risk

    Philips is recalling Brilliance 10 Slice CT scanners because fiberglass resin may separate, causing the gantry front cover and metal support to fail or fall.

    Product
    Brilliance 10 Slice (Air), Model 728251 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analyst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0546-2019·2018-12-12

    Philips Brilliance 16 Slice CT Scanner Recall for Cover Separation

    Philips is recalling Brilliance 16 Slice CT scanners because fiberglass resin may separate, causing the gantry front cover to fail or fall.

    Product
    Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analyst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0553-2019·2018-12-12

    Zimmer Biomet Recalls 20mm Compress Device Short Anchor Plug

    Zimmer Biomet is recalling 6 units of the 20mm Compress Device Short Anchor Plug due to potential metal burrs that may prevent proper insertion of drill and transverse pins.

    Product
    Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant Item number: 178562 Product Usage: 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously fai
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0531-2019·2018-12-12

    Zimmer Biomet Recalls Humeral Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling specific lots of M/DN Intramedullary Fixation Humeral Guide Wires because creases in the packaging may compromise sterility.

    Product
    Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-025-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0534-2019·2018-12-12

    Zimmer Biomet Recalls Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling 9,387 units of ZMS Intramedullary Fixation Smooth Guide Wires because creases in the sealing area compromise product sterility.

    Product
    Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-037-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0540-2019·2018-12-12

    Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterility Concerns

    Zimmer Biomet is recalling 12,724 units of Natural Nail System Tear Drop Guide Wires because creases in the packaging may compromise sterility.

    Product
    Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 70 cm Length Item Number: 47-2490-098-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0541-2019·2018-12-12

    Zimmer Biomet Recalls Natural Nail System Tear Drop Guide Wires

    Zimmer Biomet is recalling Natural Nail System Tear Drop Guide Wires due to creases in the sealing area that compromise sterility.

    Product
    Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 70 cm Length Item Number: 47-2490-098-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0557-2019·2018-12-12

    Stephanix D2RS Digital Dynamic Remote System Recalled for Table Movement Risk

    Stephanix is recalling 17 D2RS Digital Dynamic Remote Systems because the table may continue moving after a command is released.

    Product
    STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional proc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0545-2019·2018-12-12

    Philips Brilliance 16 Slice CT Scanner Recalled for Gantry Cover Separation Risk

    Philips Medical Systems is recalling 6,343 Brilliance 16 Slice CT scanners nationwide due to a potential fiberglass resin separation that could cause the gantry front cover to fall.

    Product
    Brilliance 16 Slice (Power), Model 728240 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0683-2019·2018-12-12

    Smartypants Kids Complete Gummy Vitamins Recalled for Foreign Objects

    Smartypants Vitamins is recalling 60,726 bottles of Kids Complete gummy vitamins due to consumer complaints of finding foreign objects in the bottles.

    Product
    Smartypants Kids Complete, Non GMO Multi and omega 3's vitamin D3 for bones, vitamin B12 for Energy: 90 gummies. UPC 8 5136 00425 5 Distributed by SmartyPants Inc., Marina del Rey, CA 90292
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0527-2019·2018-12-12

    Barco Front Cover Attachment Kit Recalled for Potential Falling Hazard

    Barco N.V. is recalling 2,087 MDRC-1119 Front Cover Attachment Kits because metal strips may deform, causing the protective cover to fall.

    Product
    Optional MDRC-1119 Front Cover Attachment Kit for review display monitors. Product Usage: The product is an optional kit, intended to be attached in front of the LCD panel of a review display (MDRC-1119).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0532-2019·2018-12-12

    Zimmer Biomet Recalls Humeral Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling 780 Humeral Guide Wires because creases in the packaging may compromise sterility. The product is a single-use surgical instrument.

    Product
    Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-026-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0681-2019·2018-12-12

    Schnucks Crescent Rolls Recalled for Undeclared Milk Allergen

    English Bay Batter L.P. is recalling Schnucks BIG & FLAKY CRESCENT ROLLS due to undeclared milk in the ingredient list and contains statement.

    Product
    Schnucks BIG & FLAKY CRESCENT ROLLS, 6 ROLLS, NET WT 11.25 OZ UPC 0 41318 57046 5
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0543-2019·2018-12-12

    Philips Brilliance 64 CT Scanner Recall for Gantry Cover Separation Risk

    Philips Medical Systems is recalling Brilliance 64 CT scanners due to a potential fiberglass resin separation that could cause the gantry front cover to fail and fall.

    Product
    Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and displ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0530-2019·2018-12-12

    Zimmer Biomet Recalls Pressure Sentinel Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling Pressure Sentinel Guide Wires because creases in the sealing area compromise product sterility. The recall affects 48,320 units distributed worldwide.

    Product
    Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0550-2019·2018-12-12

    Capintec Recalls Captus 3000 Thyroid Uptake Systems Due to Spring Arm Failure

    Capintec Inc is recalling 385 Captus 3000 Thyroid Uptake Systems because a broken tension rod can cause the spring arm to fail and the collimator to fall.

    Product
    Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·19046·2018-12-12

    Stanley Commercial Hardware Locksets Recalled Due to Entrapment Risk

    dormakaba USA is recalling Stanley Commercial Hardware locksets because they may fail to open, posing an entrapment hazard in emergencies. No injuries have been reported.

    Product
    Door locksets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19047·2018-12-12

    White-Rodgers Recalls Emerson Sensi WiFi Thermostats Due to Fire Hazard

    White-Rodgers is recalling Emerson branded Sensi WiFi thermostats because contact between wires and household voltage can cause fire. No injuries have been reported.

    Product
    Emerson Branded Sensi WiFi thermostats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0691-2019·2018-12-12

    First Source Chocolate and Nut Tray Recalled for Undeclared Nuts

    First Source, LLC is recalling Chocolate and Nut Trays because they contain undeclared pecans and cashews. The product was distributed in six states.

    Product
    Chocolate and Nut Tray. The product comes in a four-quadrant plastic tray, NET WT 37 OZ (2 LBS 5 OZ) 1.05KG, with UPC: 0 23637 43369 0.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0555-2019·2018-12-12

    Pfizer Recalls Thermacare HeatWraps Menstrual Due to Material Leakage

    Pfizer is recalling Thermacare HeatWraps Menstrual because the wraps may come apart and leak granular material.

    Product
    Thermacare HeatWraps Menstrual a) UPC 0573302002 b) UPC 0573302044 Product Usage: Provides heat therapy for temporary relief of minor menstrual cramp pain and associated back aches.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0687-2019·2018-12-12

    Frutarom Recalls Sugar-Free Syrup Containing Sugar

    Frutarom USA Inc. is recalling 1,018 bottles of Sebastiano's French Vanilla syrup because the product contains sugar despite being labeled 'Naturally Sugar Free.'

    Product
    Sebastiano s Naturally Flavored Gourmet Syrups French Vanilla Naturally Sugar Free, Sweetened with Stevia; 25.4 fl. oz. (750 ml)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0528-2019·2018-12-12

    Becton Dickinson Recalls Trypticase Soy Agar Plates Due to Growth Inhibition

    Becton Dickinson is recalling 54,300 plates of Trypticase Soy Agar with 5% Sheep Blood because a manufacturing error inhibited the growth of Gram-negative organisms.

    Product
    BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0688-2019·2018-12-12

    Frozen Peach Dices Recalled for Foreign Plastic Material

    Titan Farms is recalling 192 cases of Tickled PEACHES Freestone Dices due to the presence of foreign plastic material.

    Product
    Tickled PEACHES Freestone Dices; Net wt 4.4 oz. (125g) sealed plastic cups; KEEP FROZEN; Palmetto Processing Solutions 5 RW Dubose Road Ridge Spring, SC 29129 UPC 0110817134020432
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0556-2019·2018-12-12

    Pfizer Recalls Thermacare Heatwraps Due to Material Leakage

    Pfizer is recalling specific lots of Thermacare Heatwraps because the wraps may come apart and leak granular material.

    Product
    Thermacare HEATWRAPS JOINT PAIN THERAPY, 8 HEATWRAPS; MUSCLE PAIN THERAPY, 3 HEATWRAPS a) UPC 0573301311 b) UPC 0573301311 Product Usage: Provides heat therapy for temporary relief of minor muscular and joint aches and pains associated with overexertion, sprains, and arthr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0695-2019·2018-12-12

    Tillamook Udderly Chocolate Ice Cream Recalled for Undeclared Color Additives

    Tillamook is recalling Udderly Chocolate ice cream because it contains trace amounts of undeclared color additives Amaranth and Yellow No. 6.

    Product
    Udderly Chocolate ice cream (item #67045), packaged in 1.75 qt. container. UPC 0 72830 07045 4. The label is read in parts: "***Tillamook*** ICE CREAM*** UDDERLY CHOCOLATE *** CONTAINS: MILK, TREE NUTS (COCONUT), SOY, EGG. IT IS MADE WITH EQUIPMENT THAT ALSO MAKES PRODUCTS CO
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-0682-2019·2018-12-12

    NOW Foods Recalls Mislabeled Vitamin B-50 Complex Vegetable Capsules

    NOW Foods is voluntarily recalling 61 bottles of Vitamin B-50 Complex with C 100 Veg Caps because they are mislabeled as Vitamin B-50 mg 100 Veg Caps.

    Product
    NOW Vitamin B-50 Complex with C 100 Veg Caps
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0559-2019·2018-12-12

    Tosoh AIA-360 Analyzer Recalled for Labeling Clarifications on Maintenance Requirements

    Tosoh Bioscience is recalling 1,228 AIA-360 Analyzers to update labeling and training materials regarding maintenance and reagent requirements.

    Product
    AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diagnostic to provide testing for a broad menu of assays in a unique patented dry reagent format.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0554-2019·2018-12-12

    Pfizer Recalls Thermacare HeatWraps Due to Leaking Granular Material

    Pfizer is recalling Thermacare Muscle Pain Therapy HeatWraps because the wraps may come apart and leak granular material.

    Product
    Thermacare Muscle Pain Therapy HeatWraps: a) UPC 0573301314 b) UPC 0573301303 Product Usage: Provides heat therapy for temporary relief of minor muscular and joint aches and pains associated with overexertion, sprains, and arthritis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0299-2019·2018-12-12

    Fresenius Kabi Recalls Sodium Chloride Vials Due to Incorrect Latex Labeling

    Fresenius Kabi is recalling 1,312,350 vials of Sodium Chloride Injection because labels incorrectly state the stoppers do not contain natural rubber latex.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0686-2019·2018-12-12

    Black River Industries Recalls Italian Spice Blend Due to Plastic Contamination

    Black River Industries is recalling Italian Spice Blend Salt Free because it may contain plastic foreign material. The product was distributed to Wisconsin correctional facilities.

    Product
    Italian Spice Blend Salt Free in 2 Lb. plastic bottles and 20 Lb. bulk boxes. Ingredients; Basil, Rosemary, Oregano, Marjoram & Spices. Not labeled for Resale.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0692-2019·2018-12-12

    Tillamook Mudslide Ice Cream Recalled for Undeclared Color Additives

    Tillamook Mudslide ice cream is recalled because it contains trace amounts of undeclared color additives Amaranth and Yellow No. 6.

    Product
    Tillamook Mudslide ice cream (item #63006), packaged in 3 gallon tub. UPC 0 72830 63006 1. The label is read in parts: "***TILLAMOOK MUDSLIDE ICE CREAM*** ALLERGEN INFORMATION: This product contains milk, peanut, soy, tree nut (coconut), egg. It is made with equipment that al
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Food)·F-0694-2019·2018-12-12

    Tillamook Vanilla Chocolate Chip Ice Cream Recalled for Undeclared Color Additives

    Tillamook is recalling Vanilla Chocolate Chip ice cream because it contains undeclared color additives Amaranth and Yellow No. 6.

    Product
    Vanilla Chocolate Chip ice cream (item #67017), packaged in 1.75 qt. container. UPC 0 72830 07017 1. The label is read in parts: "***Tillamook*** ICE CREAM*** VANILLA CHOCOLATE CHIP *** CONTAINS: MILK, TREE NUTS (COCONUT), EGG. IT IS MADE WITH EQUIPMENT THAT ALSO MAKES PRODUC
    Category
    Food
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0561-2019·2018-12-12

    Helena Laboratories Recalls Cascade Abrazo c-ACT-LR Test Cards

    Helena Laboratories is recalling 27 kits of Cascade Abrazo c-ACT-LR Test Cards due to reported variations in test results.

    Product
    Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0684-2019·2018-12-12

    Black River Industries Recalls Parsley Flakes Due to Plastic Foreign Material

    Black River Industries is recalling Parsley Flakes because they may contain plastic foreign material. The recall also includes Basil Leaf Sweet and Italian Spice Blend No Salt.

    Product
    Parsley Flakes in 6 oz. and 24 oz. plastic bottles and 20 lb boxes
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0693-2019·2018-12-12

    Tillamook Ice Cream Recalled for Undeclared Color Additives

    Tillamook County Creamery is recalling Chocolaty Chip Cookie Dough ice cream because it contains undeclared color additives Amaranth and Yellow No. 6.

    Product
    Chocolaty Chip Cookie Dough ice cream (item #67016), packaged in 1.75 qt. container. UPC 0 72830 07016 4. The label is read in parts: "***Tillamook ***ICE CREAM *** CHOCOLATY CHIP COOKIE DOUGH *** CONTAINS: MILK, WHEAT, SOY, TREE NUTS (COCONUT), EGG. IT IS MADE WITH EQUIPMENT
    Category
    Food
    Distribution
    11 states
  • LowFDA (Devices)·Z-0529-2019·2018-12-12

    Helena Laboratories Recalls Gel Alkaline Phosphatase Isoenzyme Control Kits

    Helena Laboratories is recalling 43 Gel Alkaline Phosphatase Isoenzyme Control Kits due to customer complaints of lower enzyme activity.

    Product
    Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE Gel Alkaline Phosphatase Isoenzyme Control 20mL 001831 Alkaline Phosphatase Isoenzyme Control is to be used as a qualitative
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0289-2019·2018-12-12

    Aurobindo Recalls Amlodipine and Olmesartan Medoxomil Tablets Due to Discoloration

    Aurobindo Pharma USA Inc. is recalling Amlodipine and Olmesartan Medoxomil tablets because they were found to be pink instead of the expected cream color.

    Product
    AMLODIPINE AND OLMESARTAN MEDOXOMIL — AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0526-2019·2018-12-12

    Neomed NeoConnect Enteral Extension Sets Recalled for Incorrect Expiration Date

    Neomed Inc is recalling NeoConnect Enteral Extension Sets because the sterile pouch labels display an incorrect expiration date of 2016-11-19 instead of 2019-11-09.

    Product
    NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the
    Category
    Medical Device
    Distribution
    8 states
  • SevereNHTSA·18V880000·2018-12-11

    Blue Bird Recalls 2019 School Buses for Parking Brake Cable Defect

    Blue Bird is recalling 2019 All American and Vision school buses because the parking brake cable may disengage, allowing the bus to move unintentionally.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V881000·2018-12-11

    Blue Bird Recalls 2019 Transit Buses Due to Parking Brake Defect

    Blue Bird is recalling 2019 All American and Vision transit buses because the parking brake cable may disengage, allowing the bus to move unintentionally.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18E113000·2018-12-11

    Gillig Recalls Fire Extinguishers Due to Actuator Malfunction

    Gillig LLC is recalling specific fire extinguishers sold as aftermarket parts because the actuator may fail to discharge the suppression agent, increasing injury risk during a fire.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V877000·2018-12-10

    Thomas Built Buses Recalls Saf-T-Liner C2 School Buses for Roof Adhesive Defect

    Daimler Trucks North America is recalling 2017-2019 Thomas Built Buses Saf-T-Liner C2 school buses because improperly applied roof adhesive may reduce roof header strength during a rollover crash.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·120-2018·2018-12-10

    CTI Foods Recalls Pork and Poultry Sausage Due to Metal Contamination

    CTI Foods is recalling frozen Jimmy Dean sausage links that may contain metal pieces. No illnesses have been reported, but consumers should discard the product.

    Product
    CTI Foods LLC. — CTI Foods LLC, Recalls Ready-To-Eat Pork and Poultry Sausage Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·18V878000·2018-12-10

    Thomas Built Buses Saf-T-Liner C2 Recalled for Roof Adhesive Defect

    Daimler Trucks North America is recalling 2017-2019 Thomas Built Buses Saf-T-Liner C2 transit buses because improperly applied roof adhesive may increase injury risk in rollover crashes.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·119-2018·2018-12-09

    3-D Meats Recalls Beef Snack Sticks for Undeclared Milk Allergen

    3-D Meats, LLC is recalling approximately 47 pounds of ready-to-eat beef snack sticks because they are misbranded and may contain undeclared milk, a known allergen.

    Product
    3-D Meats, LLC Recalls Ready-To-Eat Beef Snack Stick Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·118-2018·2018-12-07

    Amboy Group Recalls Poultry Products for Undeclared Allergens

    Amboy Group, LLC is recalling raw boneless and skinless poultry products because they are misbranded and may contain undeclared milk, egg, and soy.

    Product
    Amboy Group, LLC Recalls Poultry Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·18V872000·2018-12-07

    Mercedes-Benz Recalls 2018 C 300 and E 400 for Steering Defect

    Mercedes-Benz is recalling two 2018 vehicles because the steering coupling may not be locked, which could reduce steering ability and increase crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ C 300, E 400
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V875000·2018-12-07

    Micro Bird Recalls CT-Series Buses for Seat Lock Defect

    Micro Bird is recalling 2015-2018 CT-Series buses because foldaway seats may not stay locked during a crash, increasing injury risk.

    Product
    MICRO BIRD — MICRO BIRD CT-SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V870000·2018-12-07

    PACCAR Recalls 2018 Kenworth and Peterbilt Trucks for Seat Belt Defect

    PACCAR is recalling 2018 Kenworth and Peterbilt trucks because seat belt buckles may be glued instead of sewn, risking separation in a crash.

    Product
    KENWORTH — KENWORTH, PETERBILT T880, T680, 579, 567
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V873000·2018-12-07

    Altec Recalls 2017-2018 Vehicles Due to Brake Light Wiring Defect

    Altec is recalling 2017-2018 Aerial Devices, Service Bodies, and Digger Derricks because Whelen accessory brake lights may illuminate without the brake pedal being pressed.

    Product
    ALTEC — ALTEC AERIAL DEVICE, SERVICE BODY, DIGGER DERRICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V874000·2018-12-07

    Rosenbauer Fire Apparatus Recalled for Brake Light Wiring Defect

    Rosenbauer America is recalling 2017-2018 Fire Apparatus vehicles because Whelen accessory brake lights may illuminate without the brake pedal being pressed, potentially confusing other drivers.

    Product
    ROSENBAUER — ROSENBAUER FIRE APPARATUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V871000·2018-12-07

    Keystone Recalls 2018-2019 Raptor Trailers Due to Propane Line Routing

    Keystone RV Company is recalling 2018-2019 Raptor recreational trailers because an incorrectly routed propane line allows the grill to be stored while lit, increasing fire risk.

    Product
    KEYSTONE — KEYSTONE RAPTOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19044·2018-12-06

    Meijer Recalls Falls Creek Kids Hoodies Due to Choking Hazard

    Meijer is recalling about 25,000 Falls Creek Kids infant and toddler hoodies because the zipper slider can detach, posing a choking hazard to young children.

    Product
    Falls Creek Kids infant and toddler hoodies
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V868000·2018-12-06

    GM Recalls 2019 Silverado and Sierra Crew Cab for Air Bag Defect

    General Motors is recalling 2019 Chevrolet Silverado 1500 and GMC Sierra 1500 Crew Cab vehicles because the passenger-side air bag may not inflate properly in a crash.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO 1500, SIERRA 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19042·2018-12-06

    Skip Hop Recalls Tuo Convertible High Chairs Due to Fall Hazards

    Skip Hop is recalling Tuo convertible high chairs because the legs can detach from the seat, posing fall and injury hazards to children.

    Product
    Tuo convertible high chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0722-2019·2018-12-05

    Chukar Cherries Ultra Dark Chocolate Cocoa Pecans Recalled for Unlabeled Milk

    Chukar Cherry Company is recalling 569 pouches of Ultra Dark Chocolate Cocoa Pecans because the product contains milk, which is not listed on the label.

    Product
    Ultra Dark Chocolate Cocoa Pecans, Chukar Cherries brand, packaged in 7.5 oz. plastic pouches. UPC 0 11261 22507 1. The label is read in parts: "***ULTRA DARK CHOCOLATE COCOA PECANS***Ingredients: Bittersweet Chocolate (Cacao Beans, Pure Cane Sugar, Unsweetened Chocolate, Coco
    Category
    Food
    Distribution
    22 states
  • CriticalFDA (Food)·F-0664-2019·2018-12-05

    Imported Mexican Cheese Recalled Due to Salmonella Contamination

    Alebrije Imports Inc. is recalling Queseria "La Milagrosa" cheese due to Salmonella contamination found by the California Department of Food and Agriculture.

    Product
    Queseria "La Milagrosa" La Delicia al Paladar. 1/2 kg and 1 kg sizes. Packaged in a plastic bag with a yellow label.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0678-2019·2018-12-05

    New Forest LLC Recalls Organic Cardamom Due to Salmonella Risk

    New Forest LLC is recalling 2,723 kgs of Organic Cardamom Green Whole from Guatemala due to potential Salmonella contamination. The product was distributed in Wisconsin and Nevada.

    Product
    Organic Cardamom Green Whole. Product of Guatemala. Product is labeled with a paper label son onto each 25-kg poly-lined, poly-weave "double bag". The label reads - Certified Organic Cardamom Pod Mixed Grade, Certified Organic by Mayacert, Product of Guatemala, Net Weight 25.00
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0506-2019·2018-12-05

    NxStage PureFlow B Solution Recalled Due to Bag Bursting Risk

    NxStage Medical is recalling 7,275 units of PureFlow B Solution because the bag's smaller chamber may burst, releasing electrolyte fluid that can injure eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0437-2019·2018-12-05

    Maquet Cardiovascular Recalls QUADROX-i Neonatal Membrane Oxygenators

    Maquet Cardiovascular is recalling QUADROX-i Neonatal membrane oxygenators due to a potential for blood leakage at the blood inlet connector when using a specific reducing screw adapter.

    Product
    QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V862000·2018-12-05

    Audi Recalls 2015-2016 A6 and A7 Models for Fire Risk

    Volkswagen is recalling 2015-2016 Audi A6 and 2015 A7 vehicles because an incorrectly inserted auxiliary heater connector may overheat and cause a fire.

    Product
    AUDI — AUDI A7, A6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V863000·2018-12-05

    Volkswagen Recalls 2018 Audi Models for Fuel Hose Fire Risk

    Volkswagen is recalling 2018 Audi A3 and TT models because a fuel hose connector may detach, causing a leak that increases fire risk.

    Product
    AUDI — AUDI A3 CABRIOLET, TT ROADSTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0514-2019·2018-12-05

    Eurotrol HemoTrol Level 2 Recalled Due to Microbial Contamination

    Eurotrol Inc. is recalling HemoTrol Level 2 hematology quality control mixtures because microbial contamination causes incorrect measurement results.

    Product
    HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Catalogue number: 171.002.002 Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue¿ Hb 201 systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0502-2019·2018-12-05

    NxStage PureFlow B Solution Recalled for Potential Bag Bursting and Injury

    NxStage Medical is recalling specific lots of PureFlow B Solution because the smaller chamber of the two-chamber bag can burst, releasing electrolyte fluid that may cause injury if it contacts eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0359-2019·2018-12-05

    Sandoz Losartan Potassium and Hydrochlorothiazide Tablets Recalled for NDEA Impurity

    Sandoz is recalling Losartan Potassium and Hydrochlorothiazide tablets because FDA testing found the impurity NDEA above acceptable levels.

    Product
    Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufactured by: Lek Pharmaceuticals d.d. SI-1526 Ljubljana,Sovenia for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5207-10.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0507-2019·2018-12-05

    NxStage PureFlow B Solution Recalled for Potential Bag Bursting Hazard

    NxStage Medical is recalling PureFlow B Solution because the smaller chamber of the bag can burst, releasing electrolyte fluid that may cause injury if it contacts eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V864000·2018-12-05

    Volkswagen Recalls 2018 Golf R Vehicles Due to Fuel Hose Defect

    Volkswagen is recalling 2018 Golf R vehicles because a fuel hose connector may detach, causing a leak that increases fire risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN GOLF R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0470-2019·2018-12-05

    Synaptive Medical Recalls BrightMatter Guide Software Due to Defect

    Synaptive Medical Inc is recalling 37 units of BrightMatter Guide software due to a defect that occurs when switching between specific port trajectories during surgery.

    Product
    BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0505-2019·2018-12-05

    NxStage PureFlow B Solution Recalled for Potential Bag Bursting

    NxStage Medical is recalling PureFlow B Solution because the bag's smaller chamber may burst, releasing electrolyte fluid that can injure eyes or skin.

    Product
    NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0674-2019·2018-12-05

    Duncan Hines Classic White Cake Mix Recalled for Salmonella

    ConAgra Foods is recalling Duncan Hines Classic White cake mix after a positive finding of Salmonella in a retail sample.

    Product
    Duncan Hines Classic Classic White cake mix 15.25oz. 12 retail units per case 644209307500
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0515-2019·2018-12-05

    Eurotrol HemoTrol Level 3 Recalled Due to Microbial Contamination

    Eurotrol Inc. is recalling HemoTrol Level 3 hematology quality control mixtures because microbial contamination causes incorrect, lower-than-assigned measurement results.

    Product
    HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture. Catalogue number: 171.003.002 Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue¿ Hb 201 systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0518-2019·2018-12-05

    Fresenius Granuflo Dry Acid Concentrate Recalled for Foreign Substance

    Fresenius Medical Care is recalling Granuflo Dry Acid Concentrate for hemodialysis due to confirmed foreign substance contamination.

    Product
    Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0723-2019·2018-12-05

    Chukar Cherry Company Recalls Organic Chocolate Rainier Cherries for Unlabeled Milk

    Chukar Cherry Company is recalling 502 pouches of Organic Ultra Dark Vanilla Chocolate Rainier Cherries because the product contains milk, which is not listed on the label.

    Product
    Organic Ultra Dark Vanilla Chocolate Rainier Cherries, Chukar Cherries brand, packaged in 7.5 oz. plastic pouches. UPC 0 11261 27207 5. The label is read in parts: "***ORGANIC ULTRA DARK VANILLA CHOCOLATE RAINIER CHERRIES *** Ingredients: Organic Bittersweet Chocolate (Organic
    Category
    Food
    Distribution
    22 states
  • HighFDA (Devices)·Z-0523-2019·2018-12-05

    GE Healthcare Recalls Solar 8000M Patient Monitoring Systems

    GE Healthcare is recalling Solar 8000M patient monitors because they may restart simultaneously during network overload, potentially disrupting patient monitoring.

    Product
    Solar 8000M Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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