The Recall Desk

Archive

January 2020 recalls

534 recalls were announced in January 2020.

What the numbers show

Critical
40
Severe
215
High
178
Moderate
85
Low
16

Of the 534 recalls this month scored against our rubric, 7% are Critical, 40% are Severe.

401–500 of 534

  • ModerateFDA (Food)·F-0464-2020·2020-01-15

    Wayfare Vanilla Pudding Recalled for Package Bloating and Off Flavors

    Wayfare Health Foods LLC is recalling Plant Based Vanilla Pudding due to consumer complaints about package bloating, sourness, and textural issues.

    Product
    Plant Based WayFare Vanilla Pudding Organic Dairy Free, Item #1221. Net wt. 4 oz. There are 4/4 oz. cups per pack with cardboard overwrap. UPC 845681000358.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0474-2020·2020-01-15

    Nestle Toll House Chocolate Chip Tub Recalled for Rubber Pieces

    Gerber Products Company is recalling Nestle Toll House Chocolate Chip Tubs due to the potential presence of food-grade rubber pieces.

    Product
    Nestle Toll House Chocolate Chip Tub (36oz), UPC 050000622641
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0638-2020·2020-01-15

    Lupin Recalls Blisovi Fe 1.5/30 Tablets Due to Crumbling

    Lupin Pharmaceuticals is recalling Blisovi Fe 1.5/30 tablets because they crumble when removed from the blister pack.

    Product
    Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only, Distributed by: Lupin Pharmaceuticals Inc Baltimore, MD 21202, Manufactured for: Lupin Limited Pithampur 454775 INDIA 240875, NDC 68180-866-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0463-2020·2020-01-15

    Wayfare Chocolate Pudding Recalled for Packaging and Flavor Issues

    Wayfare Health Foods LLC is recalling Plant Based WayFare Chocolate Pudding due to consumer complaints about bloated packaging, off flavors, and textural changes.

    Product
    Plant Based WayFare Chocolate Pudding Organic Dairy Free, Item #1222. Net wt. 4 oz. There are 4/4 oz. cups per pack with cardboard overwrap. UPC 845681000365.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0478-2020·2020-01-15

    Nestle Toll House Sprinkles Recalled for Potential Rubber Contamination

    Gerber Products Company is recalling Nestle Toll House Holiday Chocolate Chip Tree Sprinkles due to the potential presence of food-grade rubber pieces.

    Product
    Nestle Toll House Holiday Chocolate Chip Tree Sprinkles (16oz), UPC 050000279852
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0786-2020·2020-01-15

    Idelle Labs Recalls SURE 48hr Anti-Perspirant Due to Labeling Error

    Idelle Labs is recalling SURE 48hr Confidence Unscented Anti-Perspirant because the label lists an active ingredient that is not actually in the product.

    Product
    SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5513-2 UPC 8 83484 71794 3 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0651-2020·2020-01-15

    Enovachem Recalls Estriol USP Micronized Due to Impurity Test Failures

    Asclemed USA Inc. dba Enovachem Pharmaceuticals is recalling specific lots of Estriol, USP, (Micronized), 0.12 g, because additional testing found Out of Specification impurity test results.

    Product
    Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0783-2020·2020-01-15

    Abbott Fast-Cath Trio Hemostasis Introducer Recalled for Incorrect Size

    Abbott Medical is recalling 814 Fast-Cath Trio Hemostasis Introducer devices because they contain 12F components instead of the expected 14F size.

    Product
    Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0776-2020·2020-01-15

    Nextremity Solutions Recalls Stratum MDS Screws Due to Length Discrepancy

    Nextremity Solutions is recalling 87 Stratum MDS Screws because they are 2mm shorter than the length indicated on the package label.

    Product
    Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0792-2020·2020-01-15

    Cochlear Baha 5 Sound Processor Battery Door Recall

    Cochlear Americas Inc. is recalling 50 units of Baha 5 Sound Processor Tamper Proof Battery Doors packaged with the incorrect component.

    Product
    Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.)
    Category
    Medical Device
    Distribution
    10 states
  • LowFDA (Drugs)·D-0784-2020·2020-01-15

    Idelle Labs Recalls SURE Antiperspirant for Undeclared Active Ingredient

    Idelle Labs is recalling SURE 48hr Confidence Nourishing Coconut Antiperspirant & Deodorant because the label lists an active ingredient that is not actually in the product.

    Product
    SURE 48hr Confidence Nourishing Coconut invisible solid Antiperspirant & Deodorant Net Wt 2.6 oz (73g) NDC# 41595-5547-1 UPC 8 83484 31020 5 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·20056·2020-01-14

    Thompson's WaterSeal Aerosol Protectors Recalled for Fire Hazard

    The Thompson's Company is recalling about 852,000 aerosol cans of WaterSeal wood and masonry protectors because leaking propellant poses a fire hazard.

    Product
    Thompson's® WaterSeal® Waterproofing Wood Protector and Masonry Protector in Aerosol Cans
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V012000·2020-01-13

    Toyota and Lexus Recall Vehicles for Fuel Pump Failure Risk

    Toyota is recalling approximately 1.8 million vehicles because a fuel pump failure could cause the engine to stall while driving, increasing crash risk.

    Product
    LEXUS — LEXUS, TOYOTA RC 350, CAMRY, ES350, RC 300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V010000·2020-01-10

    Genuine Scooter Recalls 2020 Royal Alloy GT150 Due to Brake Rotor Defect

    Genuine Scooters is recalling 2020 Royal Alloy GT150 scooters because the front brake rotor may become uncentered, potentially causing a loss of braking and increasing crash risk.

    Product
    GENUINE SCOOTER — GENUINE SCOOTER ROYAL ALLOY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V011000·2020-01-10

    GM Recalls 2007-2008 Trucks for Air Bag Inflator Defect

    General Motors is recalling 2007-2008 Chevrolet Silverado and GMC Sierra trucks because front passenger air bag inflators may explode.

    Product
    GMC — GMC, CHEVROLET SIERRA 2500, SIERRA 3500, SILVERADO 2500, SILVERADO 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·002-2020·2020-01-10

    Culinary International Recalls Chicken Burritos Due to Undeclared Egg Allergen

    Culinary International is recalling approximately 626 pounds of frozen chicken burritos that actually contain eggs, an undeclared allergen. No illnesses have been reported.

    Product
    Ruiz Food Products, Inc. — Culinary International, LLC Recalls Chicken Burrito Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalNHTSA·20V008000·2020-01-09

    Nissan and Infiniti Recall Vehicles for Air Bag Inflator Defect

    Nissan is recalling specific 2001-2011 Nissan and Infiniti vehicles because front passenger air bag inflators may explode due to propellant degradation.

    Product
    NISSAN — NISSAN, INFINITI MAXIMA, FX45, VERSA, M35
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalNHTSA·20V007000·2020-01-09

    Ferrari Recalls 458 Italia and California for Air Bag Defect

    Ferrari is recalling 982 vehicles because front passenger air bag inflators may explode, posing a risk of serious injury or death.

    Product
    FERRARI — FERRARI CALIFORNIA, 458 ITALIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20050·2020-01-09

    Holiday Travel Mugs Recalled Due to Fire Hazard in Microwaves

    Boston Warehouse Trading Corp. is recalling Holiday Travel Mugs sold at Meijer because metallic print can spark in microwaves, posing a fire hazard.

    Product
    Holiday Travel Mugs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·20712·2020-01-09

    Little Bambino Tricycles Recalled for Lead Paint Violation and Poisoning Risk

    Thesaurus Global Marketing is recalling Little Bambino tricycles because lead levels in the paint and components exceed federal bans, posing a poisoning risk to young children.

    Product
    Little Bambino 4 in 1 canopy children's tricycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-01092020-01·2020-01-09

    Carso's Swedish Meatballs Recalled for Undeclared Anchovy Allergen

    Carso's Pasta Company issued a public health alert for Swedish meatballs containing undeclared anchovies. No illnesses have been reported.

    Product
    Carso's Pasta Company — FSIS Issues Public Health Alert for Swedish Meatball Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0633-2020·2020-01-08

    FDA Recalls Silver Bullet Male Enhancement Capsules for Undeclared Active Ingredient

    The FDA is recalling Silver Bullet male enhancement capsules because they contain an undeclared active ingredient (Sildenafil) and were marketed without an approved NDA/ANDA.

    Product
    Silver Bullet, Get Bigger and Harder, Works in Minutes, Lasts for Days, 10 male enhancement capsules in blister foil package, 725mg per capsule, Distributed by Silver Bullet Ltd, Golden Springs, CO, USA, UPC: 610877392698.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0631-2020·2020-01-08

    American Health Packaging Recalls Ranitidine Syrup Due to NDMA Impurity

    American Health Packaging is recalling specific lots of Ranitidine Syrup because the presence of the NDMA impurity was detected in the product.

    Product
    Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0746-2020·2020-01-08

    Thoratec HeartMate 3 Mobile Power Unit Recalled for Static Electricity Risk

    Thoratec Corp. is recalling HeartMate 3 Mobile Power Units because excessive static electricity can cause unrecoverable power loss, potentially reducing blood flow from the left ventricular assist system.

    Product
    HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, REF 106524US, UDI or GTIN: 00813024013297, and 106524, UDI or GTIN: 00813024011712 - Product Usage: P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0632-2020·2020-01-08

    Ranitidine Tablets Recalled Due to NDMA Impurity

    Granules India Limited is recalling Ranitidine tablets because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    RANITIDINE — RANITIDINE (RANITIDINE)
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-0766-2020·2020-01-08

    Villa Sistemi Medicali Recalls Apollo EZ X-Ray Table Due to Chain Failure

    Villa Sistemi Medicali is recalling one Apollo EZ X-ray table because the angulation chain may fail early due to metal fatigue.

    Product
    Apollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-controlled table is X-ray equipment that can be used to perform general radiographic and fluoroscopic examinations. The system is a fixed position type. The movements of the table and tube support are motori
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0765-2020·2020-01-08

    Villa Sistemi Medicali Recalls Apollo DRF X-ray Tables Due to Chain Failure

    Villa Sistemi Medicali is recalling seven Apollo DRF X-ray tables because the angulation chain may fail early due to metal fatigue.

    Product
    Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an X-ray equipment that allows to perform general radiographic and fluoroscopic examinations. The system is a fixed position type. The movements of the table and tube support are motori
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0748-2020·2020-01-08

    Roche Recalls Accu-Chek Guide Blood Glucose Monitoring Systems Due to Power Issues

    Roche Diabetes Care is recalling Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues that may affect device performance.

    Product
    Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RETAIL KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0747-2020·2020-01-08

    Roche Recalls Accu-Chek Guide Blood Glucose Monitoring System Due to Power Issues

    Roche Diabetes Care is recalling Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues. The recall affects 318,678 units distributed in the US and 35 other countries.

    Product
    Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPLE KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0752-2020·2020-01-08

    Roche Recalls Accu-Chek Guide Blood Glucose Monitoring Systems Due to Power Issues

    Roche Diabetes Care is recalling Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues. The recall affects 452,392 units distributed in the US and internationally.

    Product
    Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0449-2020·2020-01-08

    Mrs. Condies Salad Company Recalls Honey Bear Platter for Undeclared Milk

    Mrs. Condies Salad Company is recalling Honey Bear Small Party Platters containing Ranch Dressing dip because the product contains undeclared milk.

    Product
    Mrs. Condies Salad Company's Honey Bear Small Party Platter containing Ranch Dressing dip,3.5 lbs.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0681-2020·2020-01-08

    DeWALT and Stanley Laser Distance Measurers Recalled for Excessive Radiation

    Stanley Black & Decker is recalling specific DeWALT and Stanley laser distance measurers because they may emit laser radiation exceeding Class II safety limits.

    Product
    The products involved are DeWALT laser distance measurers, model numbers DW0165, DW0165S, DW0330S and Stanley Fatmax FMHT77506. These products were produced for DeWALT and Stanley by a contract manufacturer.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0772-2020·2020-01-08

    Nucletron Flexitron Brachytherapy Afterloader Recalled for Cable Guide Failure

    Nucletron BV is recalling 383 Flexitron brachytherapy afterloader systems due to a component failure that may cause treatment interruption or incorrect source positioning.

    Product
    There is a complaint regarding internal check cable guide mechanism failure for the Nucletron Flexitron brachytherapy afterloader system. Due to an obstruction during the check cable out drive, the internal guiding tube became displaced and the check cable became damaged. This is
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0770-2020·2020-01-08

    Carl Zeiss PLEX Elite 9000 Recalled for Electrical Shock Hazard

    Carl Zeiss Meditec is recalling 151 PLEX Elite 9000 Swept-Source OCT devices because a design fault may expose operators to hazardous voltage when contacting the metal enclosure.

    Product
    The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dime
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0764-2020·2020-01-08

    Villa Sistemi Medicali Recalls Apollo X-ray Tables Due to Chain Failure Risk

    Villa Sistemi Medicali is recalling three Apollo X-ray tables because the angulation chain may fail early due to metal fatigue.

    Product
    Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled X-ray system suitable for radiography and fluoroscopy examinations. The system is stationary mounted. The movements of the table and the tube stand are motorized and remo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0767-2020·2020-01-08

    Medtronic Recalls O-arm O2 Imaging Systems Due to Belt Loosening

    Medtronic is recalling 90 O-arm O2 Imaging Systems because a manufacturing issue may cause the gantry tractor motor drive belt to loosen, potentially rotating 3D images relative to the patient's physical position.

    Product
    O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0753-2020·2020-01-08

    Medicrea Polyaxial Pedicle Screws Recalled Due to Incorrect Length

    Medicrea International is recalling 210 polyaxial pedicle screws that are 50mm long instead of the labeled 45mm, posing a risk of nerve contact and postoperative pain.

    Product
    Medicrea Pass LP, REF B02217545, Non Sterile, Material: Ti-6Al-4V ELI, VIS PEDICULAIRE POLYAXIALE 7.5MM x 45MM, POLYAXIAL PEDICLE SCREW 7.5MM x 45 MM, POLYAXIAL PEDIKELSCHRAUBE 7.5MM X 45MM, TORNILLO PEDICULAR POLIAXIAL 7.5MM x 45MM VITE POLIASSIALE PEDUNCOLARE 7.5MM x 45MM, PAR
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0763-2020·2020-01-08

    Villa Sistemi Medicali Recalls Juno DRF X-Ray Systems Due to Chain Failure

    Villa Sistemi Medicali is recalling 46 Juno DRF x-ray systems because the angulation chain may fail early due to metal fatigue.

    Product
    Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0749-2020·2020-01-08

    Roche Recalls Accu-Chek Guide Blood Glucose Meters Due to Power Issues

    Roche Diabetes Care is recalling 21,094 Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues. The recall covers units distributed in the US and 34 other countries.

    Product
    Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER ONLY MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0750-2020·2020-01-08

    Roche Recalls Accu-Chek Guide Blood Glucose Monitoring Systems

    Roche Diabetes Care is recalling specific Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues.

    Product
    Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RETAIL KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0443-2020·2020-01-08

    Frito-Lay Recalls Classic Lays Potato Chips Due to Potential Water Contamination

    Frito-Lay is recalling specific bags of Classic Lays potato chips because water from a roof leak may have dripped on the product prior to packaging.

    Product
    Classic Lays potato chips 2 3/4 oz. UPC 28400 42054; Classic Lays potato chips 8 oz. UPC 28400 19914; Classic Lays potato chips 10 oz. UPC 28400 64549; Classic Lays potato chips 15 1/4 oz. UPC 28400 64474; Classic Lays potato chips 15 7/8 oz. UPC 28400 11087 all packaged in flexi
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Food)·F-0448-2020·2020-01-08

    Sara Lee Frozen Pumpkin Spice Latte Pie Recalled for Undeclared Red Dye

    Sara Lee Frozen Foods is recalling Chef Pierre Pumpkin Spice Latte Pies because they contain undeclared FD & C Red 40 dye.

    Product
    Chef Pierre 37 Ounce Pumpkin Spice Latte Pie, in foil pie pan with dome lid, frozen, 4 pies per wholesale case, with SKU number 09368 and UPC number 032100093682
    Category
    Food
    Distribution
    16 states
  • ModerateFDA (Food)·F-0450-2020·2020-01-08

    Great Value Macadamia Nuts Recalled for Pine Nut Mislabeling

    Texas Star Nut and Food Co. is recalling Great Value Macadamia Nuts because one case was found to contain pine nuts instead of macadamia nuts.

    Product
    Great Value Macadamia Nuts 4 oz. pouch with UPC CODE: 078742309422 packaged in a cello bag, 6 per case
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0751-2020·2020-01-08

    Roche Recalls Accu-Chek Guide Blood Glucose Monitoring Systems Due to Power Issues

    Roche Diabetes Care is recalling 355,400 Accu-Chek Guide Blood Glucose Monitoring Systems due to potential power issues. The recall covers units distributed in the US and 33 other countries.

    Product
    Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SAMPLE KIT FCN MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0773-2020·2020-01-08

    Medela Invia Foam Dressing Kit Recalled for Packaging Defects

    Medela Inc is recalling Invia Foam Dressing Kits with FitPad because holes in the sterile packaging may compromise sterility.

    Product
    Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam Dressing Kit with FitPad consists of a foam pad, a section interface (Invia FitPad) and Transparent Film (one or more pieces depending on the kit size).
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0762-2020·2020-01-08

    Deerfield iMRX MRI and Angiography System Recalled for Hardware Error

    Deerfield Imaging is recalling six iMRX MRI and Angiography Systems due to a potential hardware error in the generator A100 power supply that may prevent X-ray operation.

    Product
    iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiography. The IMRIS iMRX system is the integration of a Siemens Artis zee family (biplane or floor or ceiling mounted single plane) and the IMRI
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0647-2020·2020-01-08

    Akorn Recalls Myorisan 20mg Capsules Due to Mispackaging Error

    Akorn, Inc. is recalling Myorisan (isotretinoin) 20mg capsules because some cartons contained 40mg blister cards. The error was found in a customer complaint.

    Product
    MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box, Rx only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forset, IL 60045; NDC 61748-302-13.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0444-2020·2020-01-08

    Chicken of the Sea Sardines Recalled for Incorrect Labeling

    Chicken of the Sea is recalling specific cans of sardines because they were labeled as 'in Water' but actually contain tomato sauce.

    Product
    Chicken of the Sea Sardines in Water; Net Wt. 3.75 oz. (106g) UPC 0 48000 00707 0 18 Individual items per case Ingredient: Sardines, water, salt. Distributed by Chicken of the Sea International, San Diego, CA Product of Poland.
    Category
    Food
    Distribution
    9 states
  • LowFDA (Devices)·Z-0771-2020·2020-01-08

    Nidek Specular Microscope Recalled for Electromagnetic Noise Exceeding Standards

    Nidek, Inc. is recalling 13 Specular Microscopes, Model CEM-530, because their electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard.

    Product
    NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0634-2020·2020-01-08

    PCA Skin Blemish Control Bar Recalled for High Salicylic Acid Content

    Island Kinetics is recalling PCA Skin Blemish Control Bar because the salicylic acid content exceeds the firm's specifications.

    Product
    PCA Skin Blemish Control Bar, 3.2 oz/90g, Salicylic acid 2% - Acne cleanser, For external use only, Distributed by PCA Skin, 6210 E. Thomas Rd., Ste. 200, Scottsdale, AZ 85251; UPC 812025010397.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0635-2020·2020-01-08

    Lupin Recalls Bimatoprost Ophthalmic Solution Due to Impurity Specifications

    Lupin Pharmaceuticals is recalling 2,130 bottles of Bimatoprost Ophthalmic Solution because an out-of-specification impurity was detected.

    Product
    Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·20V004000·2020-01-06

    Micro Bird Recalls CT-Series Shuttle Buses Due to Fire Risk

    Micro Bird is recalling 2015-2019 CT-Series shuttle buses because an oversized breaker may cause wire overheating and fire. Owners should contact the manufacturer for a free replacement.

    Product
    MICRO BIRD — MICRO BIRD CT-SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V005000·2020-01-06

    Micro Bird Recalls 2015-2019 T-Series Buses for Fire Risk

    Micro Bird is recalling 2015-2019 T-Series school buses because an oversized circuit breaker may cause wire overheating and fire.

    Product
    MICRO BIRD — MICRO BIRD T-SERIES TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·001-2020·2020-01-03

    Kettle Cuisine Recalls Lentil and Beef Soup for Undeclared Allergens

    Kettle Cuisine Midco, LLC is recalling ready-to-eat lentil and beef soup products because they contain undeclared egg and wheat allergens.

    Product
    Kettle Cuisine Midco, LLC — Kettle Cuisine Midco, LLC, Recalls Ready-To-Eat Soup Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    6 states
  • CriticalNHTSA·20V001000·2020-01-02

    Subaru and Saab Vehicles Recalled for Air Bag Inflator Defect

    Subaru is recalling specific 2003-2014 models and Saab 9-2X vehicles because passenger air bag inflators may explode due to humidity, posing a risk of serious injury or death.

    Product
    SUBARU — SUBARU, SAAB OUTBACK, BAJA, IMPREZA, LEGACY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V003000·2020-01-02

    Subaru and Saab Recall Vehicles Due to Air Bag Inflator Defect

    Subaru is recalling specific 2003-2014 models and Saab 9-2X vehicles because passenger air bag inflators may explode, posing a risk of serious injury or death.

    Product
    SUBARU — SUBARU, SAAB OUTBACK, BAJA, IMPREZA, LEGACY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20E001000·2020-01-02

    Takata Frontal Air Bag Inflators Recalled for Explosion Risk

    Takata is recalling specific non-desiccated frontal air bag inflators used as interim remedies. These inflators may explode due to propellant degradation, posing a risk of serious injury or death.

    Product
    AIR BAGS:FRONTAL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V002000·2020-01-02

    Subaru and Saab Recall Vehicles Due to Air Bag Inflator Defect

    Subaru and Saab are recalling specific model years because passenger air bag inflators may explode due to humidity, posing a risk of serious injury.

    Product
    SUBARU — SUBARU, SAAB OUTBACK, BAJA, IMPREZA, LEGACY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-01022020·2020-01-02

    USDA Alerts on Sun Foods Egg Products Linked to Listeria Outbreak

    USDA issued a public health alert for Sun Foods egg products containing ingredients from an FDA recall due to possible Listeria monocytogenes contamination.

    Product
    Sun Foods — FSIS Issues Public Health Alert for Products Associated with the FDA Almark Foods Recall Due to Possible Listeria Monocytogenes Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0417-2020·2020-01-01

    FDA Recalls Okami California Rolls for Listeria Contamination Risk

    Fuji Food Products is recalling Okami brand 8pc California Rolls due to potential Listeria monocytogenes contamination. Consumers should not eat the product.

    Product
    Okami brand 8pc California Roll, SKU 28101
    Category
    Food
    Distribution
    31 states
  • CriticalFDA (Food)·F-0425-2020·2020-01-01

    Okami Sushi Platter Recalled for Potential Listeria Contamination

    Fuji Food Products is recalling Okami brand 25pcs Sushi Platters due to potential Listeria monocytogenes contamination. Consumers should not consume the product.

    Product
    Okami brand 25pcs Sushi Platter, SKU 28200
    Category
    Food
    Distribution
    31 states
  • CriticalFDA (Food)·F-0418-2020·2020-01-01

    Fuji Food Products Recalls Okami Supreme California Rolls for Listeria Risk

    Fuji Food Products is recalling Okami brand 8pc Supreme California Rolls due to potential Listeria monocytogenes contamination. Consumers should not eat the product.

    Product
    Okami brand 8pc Supreme California Roll, SKU 28103
    Category
    Food
    Distribution
    31 states
  • CriticalFDA (Food)·F-0414-2020·2020-01-01

    Trader Joe's Tempura Shrimp Crunch Roll Recalled for Listeria Risk

    Fuji Food Products is recalling Trader Joe's 8pc Tempura Shrimp Crunch Roll due to potential Listeria monocytogenes contamination.

    Product
    Trader Joe's 8pc Tempura Shrimp Crunch Roll, 8.5oz, SKU 513289
    Category
    Food
    Distribution
    31 states
  • CriticalFDA (Food)·F-0413-2020·2020-01-01

    Trader Joe's California Rolls Recalled for Listeria Risk

    Fuji Food Products is recalling Trader Joe's 8pcs Regular California Rolls due to potential Listeria monocytogenes contamination.

    Product
    Trader Joe's 8pcs Regular California Roll, 8oz, SKU 00348997T
    Category
    Food
    Distribution
    31 states
  • CriticalFDA (Devices)·Z-0022-2020·2020-01-01

    Galemed Babi.Plus Pressure Relief Manifold Recalled for Low Venting Pressure

    Galemed is recalling Babi.Plus 12.5 cm H2O Pressure Relief Manifolds because they may vent gas below standard pressure. The recall covers 14,964 units distributed in North Carolina and Nevada.

    Product
    Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
    Category
    Medical Device
    Distribution
    2 states
  • CriticalFDA (Food)·F-0424-2020·2020-01-01

    Okami Brown Rice California Rolls Recalled for Listeria Risk

    Fuji Food Products is recalling Okami brand 8pc Brown Rice Classic California Rolls due to potential Listeria monocytogenes contamination.

    Product
    Okami brand 8pc Brown Rice Classic California Roll, SKU 28122
    Category
    Food
    Distribution
    31 states
  • CriticalFDA (Food)·F-0416-2020·2020-01-01

    Trader Joe's Brown Rice California Rolls Recalled for Listeria Risk

    Fuji Food Products is recalling Trader Joe's Brown Rice California Rolls due to potential Listeria monocytogenes contamination.

    Product
    Trader Joe's 8pcs Brown Rice California Roll, 8oz, SKU 909822
    Category
    Food
    Distribution
    31 states
  • CriticalFDA (Food)·F-0429-2020·2020-01-01

    FDA Recalls Okami Salmon Philly Rolls Due to Listeria Risk

    Fuji Food Products is recalling Okami brand 8pc Salmon Philly Rolls because they may be contaminated with Listeria monocytogenes.

    Product
    Okami brand 8pc Salmon Philly Roll, SKU 28113
    Category
    Food
    Distribution
    31 states
  • CriticalFDA (Food)·F-0422-2020·2020-01-01

    FDA Recalls Okami Spicy Supreme California Rolls for Listeria Risk

    Fuji Food Products is recalling Okami brand 8pc Spicy Supreme California Rolls due to potential Listeria monocytogenes contamination.

    Product
    Okami brand 8pc Spicy Supreme California Roll, SKU 28104
    Category
    Food
    Distribution
    31 states
  • CriticalFDA (Food)·F-0420-2020·2020-01-01

    Fuji Food Products Recalls Okami Spicy California Rolls for Listeria Risk

    Fuji Food Products is recalling Okami brand 8pc Spicy California Rolls due to potential Listeria monocytogenes contamination. Consumers should discard or return the product.

    Product
    Okami brand 8pc Spicy California Roll, SKU 28102
    Category
    Food
    Distribution
    31 states
  • CriticalFDA (Food)·F-0430-2020·2020-01-01

    Trader Joe's Smoked Salmon Poke Bowl Recalled for Listeria Risk

    Fuji Food Products is recalling Trader Joe's 8.4oz Smoked Salmon Poke Bowls due to potential Listeria monocytogenes contamination.

    Product
    Trader Joe's 8.4oz Smoked Salmon Poke Bowl, SKU 603751
    Category
    Food
    Distribution
    31 states
  • SevereFDA (Food)·F-0410-2020·2020-01-01

    Lin's Waha International Recalls Suantianyangmei Waxberry for Undeclared Sulfites

    Lin's Waha International Corp. is recalling Suantianyangmei Waxberry because the product contains undeclared sulfites and cyclamates.

    Product
    Suantianyangmei Waxberry, 8.11 OZ (230g) clear plastic containers, UPC 6948576407226 and 3.12.2020 stamped on the box
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-0428-2020·2020-01-01

    Fuji Food Products Recalls Okami Tempura Shrimp Rolls Due to Listeria Risk

    Fuji Food Products is recalling Okami OK Tempura Shrimp Roll products because they may be contaminated with Listeria monocytogenes. The recall covers units distributed in multiple states.

    Product
    Okami OK Tempura Shrimp Roll, 6pc w/ Sweet and Dynamite Sauce, SKU 28114
    Category
    Food
    Distribution
    31 states
  • SevereFDA (Food)·F-0412-2020·2020-01-01

    Trader Joe's Spicy California Rolls Recalled for Listeria Risk

    Fuji Food Products is recalling Trader Joe's Spicy California Rolls due to potential Listeria monocytogenes contamination.

    Product
    Trader Joe's 8pcs Spicy California Roll, 8oz, SKU 00348966T
    Category
    Food
    Distribution
    31 states
  • SevereFDA (Devices)·Z-0021-2020·2020-01-01

    Galemed Babi.Plus Bubble PAP Valve Recalled for Pressure Relief Defect

    Galemed Corporation is recalling Babi.Plus Bubble PAP Valves because the pressure relief manifold may vent gas below standard pressure.

    Product
    Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Food)·F-0432-2020·2020-01-01

    Trader Joe's Shrimp Spring Rolls Recalled for Listeria Risk

    Fuji Food Products is recalling Trader Joe's Shrimp Spring Rolls due to potential Listeria monocytogenes contamination.

    Product
    Trader Joe's Shrimp Spring Rolls 7oz, SKU 908795
    Category
    Food
    Distribution
    31 states
  • SevereFDA (Food)·F-0415-2020·2020-01-01

    Trader Joe's Smoked Salmon Philly Rolls Recalled for Listeria Risk

    Fuji Food Products is recalling Trader Joe's Smoked Salmon Philly Rolls due to potential Listeria monocytogenes contamination.

    Product
    Trader Joe's 8pcs Smoked Salmon Philly Roll, SKU 603775
    Category
    Food
    Distribution
    31 states
  • SevereFDA (Food)·F-0460-2020·2020-01-01

    Northern Fisheries Recalls Frozen Yellowfin Tuna Ground Meat Due to Histamine

    Northern Fisheries Ltd. is recalling 1,251 cases of frozen yellowfin tuna ground meat because it may contain increased levels of histamine, posing a risk of scombrotoxin fish poisoning.

    Product
    Frozen Yellowfin Tuna Ground Meat, Keep Frozen, Imported/Distributed: Mical Seafood Inc., 10400 Griffin Rd, Suite #209, Cooper City, Florida 33328
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0434-2020·2020-01-01

    Trader Joes Queso Fundido 16oz Recalled for Listeria Contamination

    Trader Joes Queso Fundido 16oz is recalled due to potential Listeria monocytogenes contamination. The product was distributed in multiple states.

    Product
    Trader Joes Queso Fundido 16oz, SKU 646574
    Category
    Food
    Distribution
    31 states
  • SevereFDA (Food)·F-0433-2020·2020-01-01

    Trader Joe's Tofu Spring Rolls Recalled for Listeria Risk

    Fuji Food Products is recalling Trader Joe's Tofu Spring Rolls due to potential Listeria monocytogenes contamination.

    Product
    Trader Joe's Tofu Spring Rolls 7oz, SKU 921510
    Category
    Food
    Distribution
    31 states
  • SevereFDA (Food)·F-0419-2020·2020-01-01

    FDA Recalls Okami California Rolls Due to Listeria Risk

    Fuji Food Products is recalling Okami brand 8pc Supreme California Rolls because they may be contaminated with Listeria monocytogenes.

    Product
    Okami brand 8pc Supreme California Roll, SKU 28103
    Category
    Food
    Distribution
    31 states
  • SevereFDA (Food)·F-0427-2020·2020-01-01

    Fuji Food Products Recalls Seafood Combo for Listeria Risk

    Fuji Food Products is recalling Okami 8pc Seafood Combo products due to potential Listeria monocytogenes contamination.

    Product
    Okami 8pc SEAFOOD COMBO 6 SURIMI 2 EBI SHRIMP, SKU 28262
    Category
    Food
    Distribution
    31 states
  • HighFDA (Devices)·Z-0733-2020·2020-01-01

    Medtronic Lamicel Cervical Dilators Recalled for Sterilization Defect

    Medtronic Xomed is recalling Lamicel 20PK 3MM INTL Cervical Dilators because the sterilization dose did not meet the required Sterility Assurance Level.

    Product
    Lamicel 20PK 3MM INTL Cervical dilator
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0435-2020·2020-01-01

    Ardent Mills Recalls Wild Harvest Organic Flour for E. coli Risk

    Ardent Mills LLC is recalling Wild Harvest Organic Unbleached All Purpose Flour due to potential E. coli (STEC) contamination. Consumers should stop using the product.

    Product
    Wild Harvest Organic Unbleached All Purpose Flour, Net Wt 5 lb. (2.26 kg) in paper bags, UPC 7 11535 50915 8, 8 bags per case.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0724-2020·2020-01-01

    Bard Max-Core Biopsy Instrument Recalled for Firing Failures

    Bard Peripheral Vascular Inc is recalling 727,034 units of the Bard Max-Core Disposable Core Biopsy Instrument due to complaints of failure to fire and failure to obtain samples.

    Product
    BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0719-2020·2020-01-01

    3M Recalls Durapore Advanced Surgical Tape Due to Bond Failure Risk

    3M is recalling Durapore Advanced Surgical Tape because long-term exposure to high moisture may cause bond failure and fiber fraying, posing a risk of accidental ingestion or aspiration.

    Product
    3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0725-2020·2020-01-01

    GE Healthcare ApexPro Telemetry System Recalled for Cybersecurity Vulnerabilities

    GE Healthcare is recalling 11,347 ApexPro Telemetry Systems worldwide due to cybersecurity vulnerabilities in specific server versions connected to hospital networks.

    Product
    ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0441-2020·2020-01-01

    Ferris Coffee and Nut Company Recalls R.H. Macy's Roasted Salted Cherries

    Ferris Coffee and Nut Company is recalling R.H. Macy's Roasted Salted Cherries due to undeclared cashew, pecan, milk, and soy allergens.

    Product
    R.H. Macys & Co. Roasted Salted Cherries Berries and Nuts with Dark Chocolate, in 10oz metal tin, UPC - 788709600362
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-0440-2020·2020-01-01

    White Castle Jalapeno Cheese Sliders Recalled for Listeria Risk

    White Castle is recalling Jalapeno Cheese Sliders due to possible Listeria monocytogenes contamination. The product was distributed to 52 centers in 24 states.

    Product
    White Castle Sliders - Jalapeno Cheese Sliders - Jalapeno Cheeseburgers, UPC 8298801106 (6pk Jalapeno Cheeseburger)
    Category
    Food
    Distribution
    0 states

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