The Recall Desk

Archive

October 2018 recalls

865 recalls were announced in October 2018.

What the numbers show

Critical
24
Severe
129
High
473
Moderate
213
Low
26

Of the 865 recalls this month scored against our rubric, 3% are Critical, 15% are Severe.

Which agencies issued them

401–500 of 865

  • LowFDA (Drugs)·D-0025-2019·2018-10-24

    Mylan Recalls Levonorgestrel and Ethinyl Estradiol Tablets Due to Labeling Errors

    Mylan Pharmaceuticals is recalling specific lots of levonorgestrel and ethinyl estradiol tablets because the blister packs display incorrect NDC and product name information.

    Product
    Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91 tablets each, Made in India, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7281-53.
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0070-2019·2018-10-24

    Cicatricure Scar Cream Recalled for Low Active Ingredient Levels

    Product Quest Manufacturing LLC is recalling Cicatricure Scar Cream + Sunscreen SPF 30 because the octocrylene and avobenzone levels were found to be lower than required.

    Product
    Cicatricure, Scar Cream + Sunscreen SPF 30 (avobenzone 3%, octocrylene 10%, oxybenzone 6%), 0.7 oz. (19.8 g) tube, Distributed by: Genomma Lab USA Inc., Houston, TX 77027, UPC 6 50067 00018 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V750000·2018-10-23

    Proterra Recalls 2016-2017 Catalyst Buses Due to Brake Caliper Defect

    Proterra is recalling 2016-2017 Catalyst transit buses because a defect in the brake calipers may cause the guide pin support bolt to break, potentially leading to loss of braking ability or tire pressure.

    Product
    PROTERRA — PROTERRA CATALYST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19018·2018-10-23

    Zeagle Sport Buoyancy Control Devices Recalled Due to Drowning Hazard

    Huish Outdoors is recalling Zeagle Sport buoyancy control devices because inflator buttons can break, causing rapid air loss or auto-inflation that poses a drowning risk to scuba divers.

    Product
    Zeagle Sport buoyancy control devices (BCDs)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V748000·2018-10-22

    E-One Recalls 2016-2018 Typhoon and Cyclone II Aerial Devices

    E-One is recalling 2016-2018 Typhoon and Cyclone II aerial devices because a torque rod tower may crack, potentially affecting vehicle handling and increasing crash risk.

    Product
    E-ONE — E-ONE TYPHOON, CYCLONE II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V747000·2018-10-22

    E-One Recalls 2012-2015 Emergency Vehicles Due to Fire Risk

    E-One is recalling 2012-2015 Typhoon, Cyclone II, and Cyclone III emergency vehicles because a melting relay in the HVAC system can increase the risk of a fire.

    Product
    E-ONE — E-ONE TYPHOON, CYCLONE III, CYCLONE II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V735000·2018-10-22

    Ford Recalls 2012-2018 Focus Models Due to Fuel System Defect

    Ford is recalling 2012-2018 Focus vehicles with 2.0L engines because a malfunctioning valve may cause the engine to stall while driving, increasing crash risk.

    Product
    FORD — FORD FOCUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V749000·2018-10-22

    E-One Recalls 2017 Classic Fire Vehicles Due to Pump Wiring Defect

    E-One is recalling 2017 Classic Fire emergency vehicles equipped with specific Kubota pumps that may be improperly wired, preventing warning lamps from illuminating.

    Product
    E-ONE — E-ONE CLASSIC FIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V746000·2018-10-22

    KME Commercial Skid Recall for Improperly Wired Pump Warning Lamps

    Kovatch Mobile Equipment is recalling 2015 and 2017 KME Commercial Skids because improperly wired pumps may fail to display oil pressure and temperature warnings.

    Product
    KME — KME COMMERCIAL SKID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V745000·2018-10-22

    Altec Recalls 2014-2018 Digger Derrick Vehicles for Software Defect

    Altec is recalling 2014-2018 Digger Derrick vehicles because the Zone Rating System may fail to alert operators to excessive loads, increasing injury risk.

    Product
    ALTEC — ALTEC DIGGER DERRICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·103-2018·2018-10-21

    Bakkavor Recalls Meat and Poultry Products Due to Possible Salmonella and Listeria

    Bakkavor Foods USA is recalling approximately 795,261 pounds of ready-to-eat meat and poultry products containing onions that may be contaminated with Salmonella and Listeria monocytogenes.

    Product
    Bakkavor Foods USA, Inc. Recalls Meat and Poultry Products due to Possible Salmonella and Listeria monocytogenes Contamination In Onions
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·098-2018·2018-10-19

    Ruiz Food Products Recalls Taquitos Due to Salmonella and Listeria Concerns

    Ruiz Food Products is recalling approximately 2.5 million pounds of ready-to-eat beef and poultry taquitos due to possible Salmonella and Listeria contamination in onion ingredients.

    Product
    Ruiz Food Products, Inc. — Ruiz Food Products, Inc. Recalls Beef and Poultry Products due to Possible Salmonella and Listeria monocytogenes Contamination in Onion Ingredient
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·102-2018·2018-10-19

    SK Food Group Recalls Chicken Wraps Due to Salmonella and Listeria Concerns

    SK Food Group is recalling approximately 174,207 pounds of frozen chicken wrap products because the vegetables used may be contaminated with Salmonella and Listeria monocytogenes.

    Product
    SK Food Group — SK Food Group Recalls Chicken Products due to Possible Salmonella and Listeria monocytogenes Contamination in Vegetables
    Category
    Food
    Distribution
    13 states
  • SevereNHTSA·18V740000·2018-10-19

    Chrysler Recalls Pacifica Plug-in Hybrids for Engine Restart and Fire Risk

    Chrysler is recalling 2017-2018 Pacifica Plug-in Hybrids because the engine may fail to restart, causing unburned fuel to enter the exhaust and increasing crash or fire risks.

    Product
    CHRYSLER — CHRYSLER PACIFICA PLUG-IN HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·099-2018·2018-10-19

    Caito Foods Recalls Chicken Salads and Bowls Due to Salmonella and Listeria

    Caito Foods is recalling ready-to-eat chicken salads and bowls because a corn ingredient may be contaminated with Salmonella and Listeria monocytogenes.

    Product
    Caito Foods, LLC — Caito Foods, LLC Recalls Salad And Bowl Products Made With Chicken Due To Possible Salmonella and Listeria monocytogenes Contamination In Corn
    Category
    Food
    Distribution
    5 states
  • SevereNHTSA·18V741000·2018-10-19

    Thor Motor Coach Recalls 2018-2019 Models Due to Propane Leak Risk

    Thor Motor Coach is recalling 2018-2019 Four Winds, Chateau, and Freedom Elite vehicles because a liquid propane hose may be damaged, creating a leak and fire risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH FREEDOM ELITE, CHATEAU, FOUR WINDS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·19017·2018-10-19

    Brookstone Wireless Speakers Recalled Due to Fire Hazard

    Brookstone is recalling Big Blue Party wireless speakers because their lithium-ion batteries can overheat and catch fire, posing a fire hazard.

    Product
    Wireless speakers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·097-2018·2018-10-19

    GHSW LLC Recalls Chicken Salads Due to Salmonella and Listeria Concerns

    GHSW, LLC is recalling approximately 1,786 pounds of ready-to-eat chicken salads sold in six states because a corn ingredient may be contaminated with Salmonella and Listeria monocytogenes.

    Product
    F&S Fresh Foods — GHSW, LLC Recalls Salad Products Due To Possible Salmonella And Listeria monocytogenes Contamination In Corn
    Category
    Food
    Distribution
    6 states
  • SevereUSDA FSIS·101-2018·2018-10-19

    Buddy's Kitchen Recalls Pork and Chicken Products Due to Contamination

    Buddy's Kitchen is recalling ready-to-eat pork and chicken products containing vegetables potentially contaminated with Salmonella and Listeria monocytogenes.

    Product
    Buddy's Kitchen, Inc. — Buddy's Kitchen, Inc. Recalls Pork and Chicken Products due to Possible Salmonella and Listeria monocytogenes Contamination in Vegetables
    Category
    Food
    Distribution
    7 states
  • SevereUSDA FSIS·100-2018·2018-10-19

    Envolve Foods Recalls Chicken and Beef Products Due to Contamination Concerns

    Envolve Foods is recalling approximately 292,764 pounds of ready-to-eat chicken and beef products due to possible Salmonella and Listeria monocytogenes contamination in vegetable ingredients.

    Product
    Envolve Foods Recalls Chicken and Beef Products due to Possible Salmonella and Listeria monocytogenes Contamination in Vegetables
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·18V739000·2018-10-19

    2019 Jeep Cherokee Recall for Transmission Stall Risk

    Chrysler is recalling 2019 Jeep Cherokee vehicles with 2.4L engines because improper transmission calibration may cause a stall, increasing crash risk.

    Product
    JEEP — JEEP CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V737000·2018-10-19

    Forest River Recalls Motorhomes With Damaged Rear Lighting Modules

    Forest River is recalling specific 2017-2019 motorhomes because a damaged rear module may cause marker, brake, or turn signal lights to stop working.

    Product
    FOREST RIVER — FOREST RIVER, COACHMEN BERKSHIRE, CROSS COUNTRY, SPORTSCOACH, LEGACY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V734000·2018-10-18

    Harley-Davidson Recalls 2017-2018 Motorcycles Due to Clutch Actuator Leak

    Harley-Davidson is recalling 177,636 motorcycles because a leaking clutch actuator may prevent disengagement, increasing crash risk.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON FLTRXSE, FLSTFBS, FLHRXS, FLHTCU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19016·2018-10-18

    Hydrolevel Recalls Slant/Fin Boiler Controllers Due to Fire Hazard

    Hydrolevel is recalling HydroStat Model 3000 boiler controllers for Slant/Fin boilers because a malfunction can cause overheating and fire. No injuries or property damage have been reported.

    Product
    HydroStat Model 3000 boiler controllers for Slant/Fin boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19014·2018-10-18

    Vista Railing Systems Recalls ProBuilt Aluminum Posts Due to Fall Hazard

    Vista Railing Systems is recalling ProBuilt aluminum deck railing posts because they can separate from the base, posing a fall hazard. No injuries have been reported.

    Product
    Aluminum deck railing posts
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V727000·2018-10-18

    Charles Machine Recalls 2018 Ditch Witch Trailers Due to Jib Boom Defect

    Charles Machine is recalling 2018 Ditch Witch trailers with vacuum excavators because the jib boom can become loose and swing outside the trailer while being towed.

    Product
    CHARLES MACHINE — CHARLES MACHINE DITCH WITCH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·096-2018·2018-10-17

    GHSE Recalls Ready-to-Eat Salads Due to Salmonella and Listeria Contamination

    GHSE, LLC is recalling approximately 738 pounds of ready-to-eat salads with steak due to possible Salmonella and Listeria monocytogenes contamination in the corn ingredient.

    Product
    GHSE, LLC — GHSE, LLC Recalls Salads Containing Meat Products due to Possible Salmonella and Listeria monocytogenes Contamination In Corn
    Category
    Food
    Distribution
    3 states
  • CriticalUSDA FSIS·094-2018·2018-10-17

    Mary's Harvest Recalls Wrap and Salad Meat Products Due to Contamination

    Mary's Harvest Fresh Foods is recalling ready-to-eat wrap and salad products in Idaho, Oregon, and Washington due to possible Salmonella and Listeria contamination in a corn ingredient.

    Product
    Mary's Harvest Fresh Foods, Inc. — Mary's Harvest Fresh Foods, Inc. Recalls Wrap and Salad Meat Products due to Possible Salmonella and Listeria monocytogenes Contamination In Corn
    Category
    Food
    Distribution
    3 states
  • CriticalUSDA FSIS·095-2018·2018-10-17

    Taylor Farms Recalls Pork Carnitas Bowls Due to Salmonella and Listeria

    Taylor Farms Northwest LLC is recalling pork carnitas bowls due to possible Salmonella and Listeria contamination in tomatillos. No illnesses have been reported.

    Product
    Taylor Farms Northwest LLC — Taylor Farms Northwest LLC Recalls Pork Carnitas Bowl Products due to Possible Salmonella and Listeria monocytogenes Contamination In Tomatillos
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·18V732000·2018-10-17

    BMW Recalls 2019 X5 xDrive40i Vehicles for Fire Risk

    BMW is recalling 2019 X5 xDrive40i vehicles because a short circuit in the Body Domain Controller may cause overheating and increase the risk of a fire.

    Product
    BMW — BMW X5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0015-2019·2018-10-17

    Magnesium Sulfate Injection Recalled Due to Mispackaged Heparin Unit

    Pfizer is recalling 94,752 bags of Magnesium Sulfate in Water for Injection because a single unit of Heparin was found inside a case.

    Product
    MAGNESIUM SULFATE IN WATER — MAGNESIUM SULFATE IN WATER (MAGNESIUM SULFATE IN WATER)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·093-2018·2018-10-17

    GH Foods Recalls Chicken Salads Due to Salmonella and Listeria Concerns

    GH Foods CA, LLC is recalling approximately 987 pounds of ready-to-eat chicken salads in California due to possible Salmonella and Listeria monocytogenes contamination in corn ingredients.

    Product
    F&S Produce West LLC dba F&S Fresh Foods — GH Foods CA, LLC Recalls Salads Containing Chicken Products due to Possible Salmonella and Listeria monocytogenes Contamination In Corn
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0083-2019·2018-10-17

    OrthoSensor VERASENSE Sensors Recalled Due to Post-Surgical Fluid Presence

    Orthosensor, Inc. is recalling 37 VERASENSE sensors for Zimmer Biomet Persona CR E-F/3-11 Right knees because fluid was reported inside the posterior lateral corner post-surgery.

    Product
    OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-0025-2019·2018-10-17

    Sarap Asian Fusion Recalls Matcha Chocolate Cookies for Undeclared Allergens

    Sarap Asian Fusion is recalling Matcha Chocolate cookies because they contain undeclared wheat and soy lecithin. The cookies were sold online to customers in multiple states.

    Product
    Matcha Chocolate (cookies); A Sarap Asian Fusion Product; NET WT. 70 G/Cookie; Contains: Flour, eggs, Baking Soda, Baking Powder, Milk Powder, White Sugar, Brown Sugar, Salt, Butter, Matcha, Vanilla extract, milk chocolate. MFG at 12042 West St. Garden Grove, CA 92840
    Category
    Food
    Distribution
    44 states
  • HighFDA (Devices)·Z-0090-2019·2018-10-17

    Sterilmed Recalls Reprocessed Agilis Steerable Introducers Due to Endotoxin Concerns

    Sterilmed, Inc. is recalling 218 reprocessed Agilis Steerable Introducers because they may not meet endotoxin requirements. The devices were distributed in California, Colorado, Minnesota, and Washington.

    Product
    Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V736000·2018-10-17

    Great Dane Recalls 2019 Trailers for Insufficient Reflective Tape

    Great Dane is recalling 2019 Champion Composite Plate dry freight trailers because they may have insufficient reflective tape, reducing visibility and increasing crash risk.

    Product
    GREAT DANE — GREAT DANE CHAMPION COMPOSITE DRY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0019-2019·2018-10-17

    Albertsons Bourbon Maple Blondie Ice Cream Recalled for Undeclared Tree Nuts

    Albertsons Inc is recalling Signature Reserve Bourbon Maple Blondie Ice Cream due to undeclared tree nuts. The product was distributed in Oregon and Washington.

    Product
    Signature Reserve Bourbon Maple Blondie Ice Cream 14 FL OZ UPC 2113009912
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0082-2019·2018-10-17

    OrthoSensor VERASENSE Sensors Recalled Due to Fluid Inside Posterior Lateral Corner

    Orthosensor, Inc. is recalling 41 VERASENSE sensors for Zimmer Biomet Persona CR E-F/3-11 Left knees because fluid was reported inside the posterior lateral corner after surgery.

    Product
    OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0088-2019·2018-10-17

    Medline Recalls Unna Boot Compression Wraps Due to Mold Contamination

    Medline Industries is recalling Unna Boot Compression Wraps because sporadic reports identified common mold on certain lots.

    Product
    Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers: a) NONUNNA3 and b) NONUNNA4 Product is packaged in a foil pouch, which is inserted in a box carton. There are 12 cartons in each case.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0097-2019·2018-10-17

    Bayer Recalls Codan Filters Due to Potential Particulate Contamination

    Bayer is recalling Codan Filters used in IV administration sets because the dust cap may generate particulate that enters the fluid path.

    Product
    Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product Usage: 1.2 micron filter for use with Intravenous Administration Sets
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0093-2019·2018-10-17

    NeoMed Enteral Feeding Tubes Recalled for Tethered Plug Defect

    Neomed Inc is recalling NeoMed Enteral Feeding Tubes because the tethered plug may inadvertently open after closure, potentially compromising the device's seal.

    Product
    NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and lengths 40cm, 60cm, 90cm. The product consists of a polyurethane feeding tube with an attached hub and tethered plug to close the hub when the feeding tube is not in use.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0008-2019·2018-10-17

    Alkano Chemicals Recalls Thyroid Powder Due to Inconsistent Active Ingredient Levels

    Alkano Chemicals, Inc. is recalling 8 kg of Thyroid Powder, Lot # 170501, due to inconsistent levels of active ingredients levothyroxine and liothyronine.

    Product
    Thyroid powder, 4.5 kg foil bag, 5x1 kg foil bags packed in 25 Kg Fiber Drum, Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongpai Road, Dongxing District, Neijiang City Sichuan, China Tel:+886 832…
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-0024-2019·2018-10-17

    Sarap Asian Fusion Recalls Black Sesame White Chocolate Cookies

    Sarap Asian Fusion is recalling Black Sesame White Chocolate cookies due to undeclared wheat, soy lecithin, and milk.

    Product
    Black Sesame White Chocolate (cookies); A Sarap Asian Fusion Product; Net WT. 65 G/Cookie; Contains: Flour, eggs, Baking Soda, Baking Powder, Milk Powder, White Sugar, Brown Sugar, Salt, Butter, Black Sesame, Vanilla extract, white chocolate. MFG at 12042 West St. Garden…
    Category
    Food
    Distribution
    44 states
  • HighFDA (Devices)·Z-0087-2019·2018-10-17

    OrthoSensor VERASENSE Sensors Recalled Due to Fluid Inside Posterior Corner

    Orthosensor, Inc. is recalling 68 VERASENSE sensors for Zimmer Biomet Persona CR G-H/7-12 Right because fluid was reported inside the posterior lateral corner post-surgery.

    Product
    OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0079-2019·2018-10-17

    Ortho-Clinical VITROS 5600 System Recalled for Sample Dispensing Defect

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because they may dispense insufficient sample volume without suppressing potentially incorrect results.

    Product
    VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802413
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0085-2019·2018-10-17

    OrthoSensor VERASENSE Sensors Recalled Due to Post-Surgical Fluid Presence

    Orthosensor, Inc. is recalling 36 VERASENSE sensors for Zimmer Biomet Persona CR C-D/3-9 Right knees because fluid was reported inside the posterior lateral corner post-surgery.

    Product
    OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-0023-2019·2018-10-17

    Sarap Asian Fusion Recalls Miso Milo Chocolate Cookies Due to Undeclared Allergens

    Sarap Asian Fusion is recalling Miso Milo Chocolate cookies because they contain undeclared wheat and soy lecithin. The cookies were sold online to customers in multiple states.

    Product
    Miso Milo Chocolate (cookies); A Sarap Asian Fusion Product; Net Wt. 70 G/Cookie; Contains: Flour, eggs, Baking Soda, Baking Powder, Milk Powder, White Sugar, Brown Sugar, Salt, Butter, Miso, Milo cacao, vanilla extract, milk chocolate. MFG at 12042 West St. Garden…
    Category
    Food
    Distribution
    44 states
  • HighFDA (Devices)·Z-0086-2019·2018-10-17

    OrthoSensor VERASENSE Sensors Recalled Due to Post-Surgical Fluid Presence

    Orthosensor, Inc. is recalling 84 VERASENSE sensors for Zimmer Biomet Persona CR G-H/7-12 Left because fluid was reported inside the posterior lateral corner post-surgery.

    Product
    OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0084-2019·2018-10-17

    OrthoSensor VERASENSE Sensors Recalled Due to Post-Surgical Fluid Presence

    Orthosensor, Inc. is recalling 56 VERASENSE sensors for Zimmer Biomet Persona CR C-D/3-9 Left because some were reported to have fluid inside the posterior lateral corner post-surgery.

    Product
    OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-0026-2019·2018-10-17

    Sarap Asian Fusion Recalls Ube Cookies & Cream for Undeclared Allergens

    Sarap Asian Fusion is recalling Ube Cookies & Cream because the product contains undeclared wheat, soy lecithin, and milk.

    Product
    Ube Cookies & Cream (cookies); A Sarap Asian Fusion Product; NET WT. 65 G/Cookie; Contains: Flour, eggs, Baking Soda, Baking Powder, Milk Powder, White Sugar, Brown Sugar, Salt, Butter, Ube, Vanilla extract, cookies & cream chocolate. MFG at 12042 West St. Garden Grove…
    Category
    Food
    Distribution
    44 states
  • HighFDA (Food)·F-0022-2019·2018-10-17

    Whole Foods Recalls 365 Everyday Value White Corn Chips for Undeclared Milk

    Whole Foods Market is recalling 365 Everyday Value White Corn Chips because they may contain undeclared milk. The affected products were distributed nationwide in the US and Canada.

    Product
    365 Everyday Value Brand White Corn Chips, Salted NET WT 20 oz. (1 LB 4 OZ) 567 g packaged in a plastic bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0091-2019·2018-10-17

    Durex Synthetic Polyisoprene Condoms Recalled for Burst Pressure Concerns

    Reckitt Benckiser LLC is recalling Durex Synthetic polyisoprene condoms in New York due to insufficient data ensuring they meet internal burst pressure specifications at the end of their 5-year shelf life.

    Product
    Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease).
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0080-2019·2018-10-17

    Ortho-Clinical Diagnostics Recalls VITROS 5600 Integrated Systems

    Ortho-Clinical Diagnostics is recalling refurbished VITROS 5600 Integrated Systems because they may dispense insufficient sample volumes without suppressing potentially incorrect results.

    Product
    VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802915
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0094-2019·2018-10-17

    Widex BABY Hearing Aids Recalled for Non-Tamper-Resistant Battery Drawers

    Widex A/S is recalling two BABY440 hearing aids because they were fitted with non-tamper-resistant battery drawers. The devices were distributed in Georgia and New York.

    Product
    Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification devices in everyday listening environments.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0014-2019·2018-10-17

    Syntec Pharma Recalls Thyroid Powder Due to Inconsistent Active Ingredient Levels

    Syntec Pharma Corp is recalling 486 kg of Thyroid Powder USP because the active ingredients levothyroxine and liothyronine have inconsistent levels.

    Product
    THYROID POWDER USP (Levothyroxine labeled range of 34.2-41.8mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 8.1-9.9mcg/grain) active pharmaceutical ingredient; 25 KG bag, Rx Compounding only, Manu By: Sichuan Friendly Pharmaceutical Co., Ltd., No. 680…
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Food)·F-0021-2019·2018-10-17

    Hodgson Mill Gluten Free Cookie Mix Recalled for Ingredient Labeling Errors

    Hodgson Mill is recalling 707 cases of Gluten Free Cookie Mix because the packaging lists incorrect ingredients, omitting amaranth flour and baking soda while including baking powder and vanilla.

    Product
    Hodgson Mill Cookie Mix Gluten Free 12oz. cardboard carton retail unit; 6 retail units per case. UPC Code 0 71518 02125 2
    Category
    Food
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0076-2019·2018-10-17

    AngioDynamics BioFlo Port Recall Due to Incorrect Sterile Assembly

    AngioDynamics is recalling BioFlo Ports that were partially manufactured with the wrong sterile port assembly. The devices were distributed in Indiana.

    Product
    BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port - Product Usage - Long-term access to the central venous system for administration of fluids including but not limited…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0013-2019·2018-10-17

    Syntec Pharma Recalls Thyroid Powder Due to Inconsistent Active Ingredient Levels

    Syntec Pharma Corp is recalling 5 KG bags of Thyroid Powder USP because the active ingredients levothyroxine and liothyronine have inconsistent levels.

    Product
    THYROID POWDER USP, Full Strength (Levothyroxine labeled range of 103-125mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 24.3-29.7mcg/grain) active pharmaceutical ingredient; 5 KG bag, Rx Compounding only, Manu By: Sichuan Friendly Pharmaceutical Co.…
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0010-2019·2018-10-17

    Pfizer Recalls Glipizide XL Tablets Due to Manufacturing Deviations

    Pfizer is recalling 7,777 bottles of Glipizide XL 5 mg tablets because rejected product was used in manufacturing, violating CGMP standards.

    Product
    Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distributed by: Greenstone LLC. Peapack, NJ 07977 --- NDC 59762-0541-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0077-2019·2018-10-17

    Instrumentation Laboratory Recalls HemosIL ReadiPlasTin Diagnostic Reagent

    Instrumentation Laboratory is recalling 9,751 kits of HemosIL ReadiPlasTin due to potential imprecision and out-of-range quality controls.

    Product
    Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0026-2019·2018-10-17

    Takeda Recalls Actoplus met XR Tablets Due to Defective Delivery System

    Takeda is recalling Actoplus met XR tablets because the laser-drilled holes on the metformin core may be missing, potentially affecting drug delivery.

    Product
    Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000 mg, Rx Only, 30 tablet bottle, Distributed by: Takeda Pharmaceuticals America, Inc, Deerfield, IL 60015. NDC: 64764-510-30
    Category
    Drug
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0092-2019·2018-10-17

    Stryker Spine AVS Aria Cage Recalled for Incorrect Marker Placement

    Stryker Spine is recalling five AVS Aria Cage units because the anterior and posterior markers were placed on the incorrect sides of the device.

    Product
    AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0089-2019·2018-10-17

    Implant Direct Legacy Implant Closed-Tray Transfer Mislabeled Cap Recall

    Implant Direct is recalling 217 units of Legacy Implant Closed-Tray Transfer components due to potential cap mislabeling. The correct part number is on the main vial label.

    Product
    Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0101-2019·2018-10-17

    Agfa Healthcare Recalls Enterprise Imaging Desktops Due to Sorting Error

    Agfa Healthcare is recalling 17 Enterprise Imaging Desktops because adding a comparison study may disrupt the chronological sorting of images in the Clinical Side Bar.

    Product
    Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing…
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0095-2019·2018-10-17

    GE Healthcare CARESCAPE Monitor B450 Recalled for Network-Related Restart Issues

    GE Healthcare is recalling CARESCAPE Monitor B450 units because they may restart simultaneously and fail to complete the process if connected to an overloaded network.

    Product
    GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0096-2019·2018-10-17

    GE Healthcare CARESCAPE Monitor B850 Recalled for Network-Related Restart Issues

    GE Healthcare is recalling CARESCAPE Monitor B850 units because they may simultaneously restart during prolonged network overload, preventing the restart from completing until the network issue is corrected.

    Product
    GE Healthcare CARESCAPE Monitor B850 Product Usage: Intended uses of CARESCAPE B850 V2 in 510(k) countries [UR_CRSCP-1046]: The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0012-2019·2018-10-17

    InvaGen Recalls Amlodipine Besylate Tablets Due to Subpotency

    InvaGen Pharmaceuticals is recalling one lot of Amlodipine Besylate 10 mg tablets because the product failed to meet assay specifications at 3-month stability conditions.

    Product
    AMLODIPINE BESYLATE — AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0088-2019·2018-10-17

    GSK Recalls Prevacid 24HR Capsules Due to Manufacturing Deviations

    GSK is voluntarily recalling Prevacid 24HR capsules nationwide due to Current Good Manufacturing Practice (CGMP) deviations. No illnesses have been reported.

    Product
    Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per bottle in a carton containing 1 bottle (NDC: 0067-6286-14), 2 bottles (NDC: 0067-6286-28) or 3 bottles (NDC: 0067-6286-42), Over-the-counter, Distributed By: GSK Consumer Healthcare, Warren, NJ 07059.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0011-2019·2018-10-17

    Jubilant Cadista Recalls Pantoprazole Tablets Due to Dark Discoloration

    Jubilant Cadista Pharmaceuticals is recalling 158,466 bottles of 40 mg pantoprazole sodium delayed-release tablets due to dark discoloration or brown spots on the edges.

    Product
    Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0016-2019·2018-10-17

    Xiromed Recalls Altavera Tablets Due to Generic Name Mislabeling

    Xiromed LLC is recalling Altavera tablets because the generic name on the packaging may cause confusion. The FDA classifies this as a Class III recall.

    Product
    ALTAVERA — ALTAVERA (LEVONORGESTREL AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0081-2019·2018-10-17

    BD FocalPoint Slide Profiler Recalled for Temperature Limit Labeling Error

    Becton Dickinson is recalling BD FocalPoint Slide Profiler and GS Review Station units because they may not function below 15°C. The agency states this issue has no potential to cause harm.

    Product
    BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·092-2018·2018-10-16

    Prime Deli Recalls Salads with Bacon Due to Salmonella and Listeria

    Prime Deli Corporation is recalling ready-to-eat salads with bacon sold in Texas due to possible Salmonella and Listeria contamination in corn.

    Product
    Prime Deli Corporation Recalls Salads Containing Meat Products due to Possible Salmonella and Listeria monocytogenes Contamination in Corn
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·18V728000·2018-10-16

    Altec Recalls 2015-2017 Aerial Devices Due to Fire Risk

    Altec is recalling 2015-2017 TA45M and AM50/55 aerial devices because a faulty DC-DC converter can cause a fire.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E096000·2018-10-16

    Streetcar Recalls Aftermarket Suspension Kits for RAM Trucks

    Streetcar ORV LLC is recalling aftermarket suspension kits for 2013-2018 RAM 2500 and 3500 trucks because improper installation may weaken the steering connection, increasing crash risk.

    Product
    RAM — RAM 3500, 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V729000·2018-10-16

    Grand Design Recalls 2019 Reflection Travel Trailers Due to Wiring Defect

    Grand Design is recalling 2019 Reflection travel trailers because incorrect wiring on the 50-amp mini-breaker may leave the circuit unprotected, increasing fire risk.

    Product
    GRAND DESIGN — GRAND DESIGN REFLECTION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V730000·2018-10-16

    Yamaha Recalls SR400 Motorcycles Due to Engine Oil Leak Risk

    Yamaha is recalling 2015-2018 SR400 motorcycles because an engine oil line nut may be loose, causing oil to leak onto the rear tire and increasing crash risk.

    Product
    YAMAHA — YAMAHA SR400
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19010·2018-10-16

    Gold Recalls Eddie Bauer Infant Carriers Due to Fall Hazard

    Gold Inc. is recalling Eddie Bauer fabric infant carriers because buckles can break, posing a fall hazard to children. No injuries have been reported.

    Product
    Eddie Bauer fabric infant carriers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V723000·2018-10-15

    Keystone Recalls 2019 Fifth Wheels and Travel Trailers for Axle Bearing Defect

    Keystone RV Company is recalling 2019 Dutchmen, Keystone, and Crossroads fifth wheels and travel trailers because axles may be missing inner bearing races, which can cause bearing failure and affect vehicle handling.

    Product
    DUTCHMEN — DUTCHMEN, KEYSTONE, CROSSROADS AEROLITE, BULLET, COUGAR, PASSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·091-2018·2018-10-15

    A La Carte Foods Recalls Frozen Meat and Poultry Sausage Products

    A La Carte Foods Properties, LLC is recalling approximately 30,438 pounds of frozen meat and poultry sausage products because they contain meat produced without federal inspection.

    Product
    A La Carte Foods Properties, LLC — A La Carte Foods Properties, LLC Recalls Meat and Poultry Products Containing Meat Produced without Benefit of Inspection
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·18V722000·2018-10-15

    Forest River Recalls School Buses Due to Seat Foam Impact Defect

    Forest River is recalling certain Starcraft and StarTrans school buses because the seat foam may not absorb enough impact in a crash, increasing injury risk.

    Product
    STARCRAFT BUS — STARCRAFT BUS, STARTRANS QUEST, PRODIGY, SENATOR II, QUEST XL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V726000·2018-10-15

    Keystone Recalls 2019 Crossroads Fifth Wheels Due to Awning Switch Defect

    Keystone is recalling 2019 Crossroads Cruiser and Volante fifth wheels because defective awning switches may allow the awning to unroll while the vehicle is moving.

    Product
    CROSSROADS — CROSSROADS VOLANTE, CRUISER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V724000·2018-10-15

    Mercedes-Benz Recalls 2018 AMG GT Models for Air Bag Software Issue

    Mercedes-Benz is recalling 2018 AMG GT and AMG GT C Cabrio vehicles because a software error may cause both stages of the frontal air bags to deploy in a low-speed crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GT, AMG GT C
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V721000·2018-10-12

    Great Dane Recalls 2019 Everest Trailers for Missing Brake Rollers

    Great Dane is recalling 2019 Everest CL reefer trailers that may lack brake rollers, reducing braking effectiveness and increasing crash risk.

    Product
    GREAT DANE — GREAT DANE EVEREST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V717000·2018-10-12

    Mazda Recalls CX-7, CX-9, and Mazda6 for Air Bag Inflator Defect

    Mazda is recalling 2010-2015 CX-7, CX-9, and Mazda6 vehicles because the front passenger air bag inflator may explode during deployment, posing a risk of serious injury or death.

    Product
    MAZDA — MAZDA CX-7, CX-9, MAZDA6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V718000·2018-10-12

    Riverside Dream Trailer Recall for Awning Deployment Risk

    Riverside is recalling one 2018 Dream trailer because the awning may deploy while moving, increasing crash risk. Dealers will replace the awning controller free of charge.

    Product
    RIVERSIDE — RIVERSIDE DREAM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·089-2018·2018-10-11

    Jerky Boyz Recalls Chicken Jerky Due to Possible Underprocessing

    Jerky Boyz Chicken Jerky is recalling approximately 23 pounds of ready-to-eat chicken jerky products due to a processing deviation that may have led to underprocessing.

    Product
    Jerky Boyz Chicken Jerky Recalls Chicken Jerky Products due to Possible Processing Deviation
    Category
    Food
    Distribution
    1 state
  • SevereCPSC·19009·2018-10-11

    Cooper Lighting Recalls Solar-Powered Outdoor LED Fixtures Due to Fire Hazard

    Cooper Lighting is recalling specific All-Pro and Defiant solar-powered outdoor LED light fixtures because the batteries can overheat and cause a fire.

    Product
    All-Pro and Defiant solar-powered outdoor LED light fixtures
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V715000·2018-10-11

    Hyundai Recalls 2019 Santa Fe Vehicles Due to Air Bag Bolt Interference

    Hyundai is recalling 2019 Santa Fe vehicles because side curtain air bag mounting bolts may damage the air bags during deployment, increasing injury risk in a crash.

    Product
    HYUNDAI — HYUNDAI SANTA FE
    Category
    Vehicle
    Distribution
    Distributed nationwide

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