The Recall Desk

Archive

February 2019 recalls

610 recalls were announced in February 2019.

What the numbers show

Critical
67
Severe
179
High
200
Moderate
148
Low
16

Of the 610 recalls this month scored against our rubric, 11% are Critical, 29% are Severe.

Which agencies issued them

501–600 of 610

  • ModerateFDA (Devices)·Z-0773-2019·2019-02-13

    NeuViz 128 CT Scanner Recalled for Potential Image Field of View Error

    Neusoft Medical Systems is recalling three NeuViz 128 CT scanners because a software defect may cause incorrect image field of view, potentially leading to misaligned clinical scans.

    Product
    NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY tran
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-0807-2019·2019-02-13

    Wisconsin Cheese Group Recalls Sabor Brasil Queijo Minas Frescal Cheese

    Wisconsin Cheese Group is recalling Sabor Brasil Queijo Minas Frescal Cheese because it was transported at elevated temperatures.

    Product
    Sabor Brasil Queijo Minas Frescal Cheese Net Wt. 17.6 oz (498g) UPC 19753-00049 Keep Refrigerated.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0805-2019·2019-02-13

    Wisconsin Cheese Group Recalls La Campina Fresh Frying Cheese

    Wisconsin Cheese Group is recalling La Campina Queso De Freir Fresh Frying Cheese because it was transported at elevated temperatures.

    Product
    La Campina Queso De Freir Fresh Frying Cheese. Net Wt. 10 oz (283g) UPC 19753-00073 Keep Refrigerated.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0804-2019·2019-02-13

    Wisconsin Cheese Group Recalls Sabor Brasil Minas Cheese Due to Temperature Issues

    Wisconsin Cheese Group is recalling Sabor Brasil Minas Farmer's Cheese because it was transported at elevated temperatures. The product was distributed in New Jersey and New York.

    Product
    Sabor Brasil Queijo Minas / Minas Farmer's Cheese. Net Wt. 3 lbs / 1.36kg UPC 19753-00075 Keep Refrigerated.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0819-2019·2019-02-13

    Bone Marrow Biopsy Needle Recall Due to Sterile Seal Manufacturing Issue

    Angiotech is recalling 2,502 bone marrow biopsy needles due to a manufacturing issue affecting the sterile seal on blister trays.

    Product
    Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0796-2019·2019-02-13

    Medtronic CareLink Encore 29901 Programmer Recalled for Usage Restrictions

    Medtronic is recalling CareLink Encore 29901 programmers to ensure they are used only for Medtronic or Vitatron implantable devices by trained personnel.

    Product
    MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0426-2019·2019-02-13

    US Pharmaceuticals Recalls Hydrocortisone Cream Due to Microbial Contamination

    US Pharmaceuticals is recalling Hydrocortisone Cream Intensive Healing due to out-of-specification microbial counts in purified water.

    Product
    HYDROCORTISONE CREAM INTENSIVE HEALING — HYDROCORTISONE CREAM INTENSIVE HEALING (HYDROCORTISONE CREAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0809-2019·2019-02-13

    Wisconsin Cheese Group Recalls Taino Queso de Hoja Due to Temperature Issues

    Wisconsin Cheese Group is recalling Taino Queso de Hoja cheese because it was transported at elevated temperatures. The recall affects 25 cases distributed in New Jersey and New York.

    Product
    Taino Queso de Hoja, Puerto Rico Style Cheese. Net Wt. 17.6 oz (498g) UPC 19753-0094 Keep Refrigerated.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0810-2019·2019-02-13

    Mimoso Queijo Minas Frescal Cheese Recalled for Temperature Violation

    Wisconsin Cheese Group is recalling Mimoso Queijo Minas Frescal cheese because it was transported at elevated temperatures. The product was distributed in New Jersey and New York.

    Product
    Mimoso Queijo Minas Frescal. Net Wt. 28 oz (793g) UPC 19753-0050 Keep Refrigerated.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0427-2019·2019-02-13

    Medline Remedy Barrier Ointment Recalled for Microbial Contamination

    US Pharmaceuticals is recalling Medline Remedy Barrier Skin Protectant Ointment due to out-of-specification microbial counts in purified water.

    Product
    Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0818-2019·2019-02-13

    Bone Marrow Biopsy Needle Recall Due to Sterile Seal Manufacturing Issue

    Angiotech is recalling 1,404 Bone Marrow Biopsy Needles due to a manufacturing defect in the sterile seal on blister trays.

    Product
    Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0804-2019·2019-02-13

    Richard Wolf Bronchoscope Tubes Recalled for Potential Bonding Defects

    Richard Wolf GmbH is recalling 873 Bronchoscope Tubes, Model Texas, because non-functional bonding points may loosen. The devices are used for respiratory tract investigation and therapy.

    Product
    Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscopes are intended for investigation, diagnosis and therapy of pathological changes and removal of foreign bodies in the area of the tracheobronchi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0799-2019·2019-02-13

    Abbott Recalls ARCHITECT Total T3 Reagent Kits Due to Carryover

    Abbott Ireland Diagnostics Division is recalling ARCHITECT Total T3 Reagent Kits because reagent carryover may cause depressed test results on specific platforms.

    Product
    ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0795-2019·2019-02-13

    Medtronic CareLink 2090 Programmer Recalled for Longevity Display Error

    Medtronic is recalling CareLink 2090 programmers because they may incorrectly display the remaining longevity value for up to two years before the device reaches its Recommended Replacement Time.

    Product
    MEDTRONIC CARELINK 2090 programmer
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0800-2019·2019-02-13

    Bard SureStep Foley Tray System Recalled for Potential Sample Port Leaks

    Bard Medical Division is recalling 450 units of SureStep Foley Tray Systems because the sample ports may leak urine.

    Product
    BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. Intended for use in the drainage and/or collection and/or measurement of urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0429-2019·2019-02-13

    Lupin Recalls Bimatoprost Ophthalmic Solution Due to Impurity Failures

    Lupin Pharmaceuticals is recalling Bimatoprost Ophthalmic Solution 0.03% because out-of-specification results were observed for individual and total impurities.

    Product
    Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles, Rx only, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0794-2019·2019-02-13

    Ascension Radial Head Implant Recalled for Incorrect Instructions for Use

    Ascension Orthopedics is recalling specific Radial Head Implants because they were packaged with instructions for a different product.

    Product
    Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Food)·F-0817-2019·2019-02-13

    La Canasta Flour Tortillas Recalled Due to Packaging Ink Contamination

    La Canasta Mexican Food Products is recalling specific lots of flour tortillas because packaging ink is contaminating the product.

    Product
    My Nanas Best Tasting Home Style-Estilo Casero Flour Tortillas Bakery Fresh. 24 oz (680g). Plastic bag
    Category
    Food
    Distribution
    1 state
  • LowFDA (Devices)·Z-0792-2019·2019-02-13

    BD FACSLyric Flow Cytometer Recalled Due to Unsupported Operating System Configuration

    Becton, Dickinson and Company is recalling three BD FACSLyric flow cytometers because they were installed with an unsupported Windows 10 operating system configuration.

    Product
    BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1, catalog number 662878 BD FACSLyric is a high-performance flow cytometer designed to support both routine clinical analysis and research for the identification, quantification, and characterization of cells in support
    Category
    Medical Device
    Distribution
    1 state
  • SevereNHTSA·19V093000·2019-02-12

    Freightliner Cascadia Recall for Tie-Rod Failure Risk

    Daimler Trucks North America is recalling 2013-2016 Freightliner Cascadia trucks because brake vibrations may cause tie-rod failure, leading to loss of steering.

    Product
    FREIGHTLINER — FREIGHTLINER CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19062·2019-02-12

    Target Recalls Toddler Unicorn Boots Due to Choking Hazard

    Target is recalling Cat & Jack toddler boots because the unicorn horn can detach, posing a choking hazard to children.

    Product
    Cat & Jack Unicorn "Chiara" Boots
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·015-2019·2019-02-11

    Panola County Processing Recalls Sausage Products Due to Processing Deviation

    Panola County Processing LLC is voluntarily recalling approximately 59 pounds of smoked sausage products due to a processing deviation that may have led to underprocessing.

    Product
    Panola County Processing LLC — Panola County Processing, LLC Recalls Sausage Products Due to Possible Processing Deviation
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·19V078000·2019-02-11

    Forest River Recalls 2019 Columbus Trailers Due to Hitch Bolt Issue

    Forest River is recalling 2019 Columbus recreational trailers because insufficiently tightened pin box mounting bolts could cause the trailer to separate from the tow vehicle.

    Product
    FOREST RIVER — FOREST RIVER COLUMBUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V081000·2019-02-11

    Blue Bird Recalls One 2019 Vision Bus for Wheelchair Lift Defect

    Blue Bird is recalling one 2019 Vision bus because a wheelchair lift component may fail, allowing the platform to rise too high and increasing injury risk.

    Product
    BLUE BIRD — BLUE BIRD VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V080000·2019-02-11

    Lakota Recalls 2018-2019 Trailers Due to Incorrect Tire Placard Data

    Lakota is recalling 2018-2019 Bighorn, Charger, Colt, and Livestock Edition trailers because incorrect tire data on the Federal Placard could lead to tire overload and failure.

    Product
    LAKOTA — LAKOTA CHARGER, COLT, LIVESTOCK EDITION, BIGHORN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V082000·2019-02-11

    Blue Bird Recalls School Buses with Defective Wheelchair Lifts

    Blue Bird is recalling 2015-2019 Vision and All American school buses because a wheelchair lift component may fail, causing the platform to rise too high and increasing the risk of injury.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN, VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·014-2019·2019-02-10

    VICS Acquisition Recalls Chicken Products Due to Undeclared Egg Allergen

    VICS Acquisition, LLC is recalling approximately 99,975 pounds of frozen chicken products because they contain eggs, a known allergen, that is not declared on the label.

    Product
    VICS Acquisition, LLC — VICS Acquisition, LLC Recalls Chicken Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    7 states
  • HighNHTSA·19V064000·2019-02-08

    Isuzu and Chevrolet Trucks Recalled for Odometer Unit Display Error

    Isuzu is recalling 2019 NPR and Chevrolet 4500/5500 trucks because the odometer may display kilometers instead of miles, potentially delaying critical maintenance.

    Product
    CHEVROLET — CHEVROLET, ISUZU LOW CAB FORWARD 4500, NRR, LOW CAB FORWARD 5500, NPR HD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V085000·2019-02-08

    Forest River Cherokee Recalled for Incorrect Federal Tire Placard Information

    Forest River is recalling 2019 Cherokee recreational trailers because the Federal Placards list incorrect tire size information, which may lead to the installation of insufficient tires.

    Product
    FOREST RIVER — FOREST RIVER CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V088000·2019-02-07

    GM Recalls 2016-2018 Silverado and Sierra 3500 Trucks for Fuel Tank Fire Risk

    General Motors is recalling 2016-2018 Chevrolet Silverado 3500 and GMC Sierra 3500 trucks because a fuel sensor defect may cause the front tank to overfill, potentially leading to a fuel leak and fire.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO 3500, SIERRA 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V066000·2019-02-07

    Freightliner Recalls Cascadia Trucks Due to Air Bag Deployment Risk

    Daimler Trucks is recalling 2018-2020 Freightliner Cascadia trucks because the driver's frontal air bag may deploy unexpectedly, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V086000·2019-02-07

    GM Recalls 2016-2018 Cadillac and Chevrolet Vehicles for Steering Defect

    General Motors is recalling specific 2016-2018 Cadillac and Chevrolet vehicles because the electric power steering system may fail, increasing crash risk.

    Product
    CADILLAC — CADILLAC, CHEVROLET CTS, CAMARO, CORVETTE, ATS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0764-2019·2019-02-06

    Edwards Lifesciences Recalls Swan Ganz Catheters Due to Lumen Assembly Error

    Edwards Lifesciences is recalling 9 units of Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings.

    Product
    Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Food)·F-1053-2019·2019-02-06

    ALDI Rio Duero Plums Recalled for Listeria Contamination Risk

    Jac Vandenberg Inc. is recalling Rio Duero plums sold at ALDI due to potential Listeria monocytogenes contamination.

    Product
    Plums sold at ALDI, packaged in a 2-pound bag with the brand Rio Duero, EAN# 7804650090304.
    Category
    Food
    Distribution
    18 states
  • CriticalFDA (Food)·F-0936-2019·2019-02-06

    Dakota Specialty Milling Enhanced Flax Flour Blend Recalled for Salmonella Risk

    Dakota Specialty Milling is recalling Enhanced Flax Flour Blend because an ingredient may be contaminated with Salmonella. The product was distributed in California, Ohio, and Texas.

    Product
    Dakota Specialty Milling Enhanced Flax Flour Blend, 42205, Net Wt 50 lbs. Ground Flax, Calcium Sulfate, inulin, VM 112 (vitamin mix flour enrichment containing Niacin, Iron, Vitamin B-1, Vitamin B-2, Folic Acid, Wheat Starch)
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-1051-2019·2019-02-06

    Jac Vandenberg Recalls Chilean Peaches Due to Listeria Contamination Risk

    Jac Vandenberg Inc. is recalling bulk peaches from Chile and Rio Duero brand peaches sold at Aldi due to potential Listeria monocytogenes contamination.

    Product
    Peaches, sold as a bulk retail item, with PLU 4044, and country of origin of Chile. The peaches sold at Aldi are packaged in a two pound bag with the brand Rio Duero, EAN# 7804650090281.
    Category
    Food
    Distribution
    18 states
  • CriticalFDA (Devices)·Z-0765-2019·2019-02-06

    Edwards Lifesciences Recalls Swan Ganz Catheters Due to Lumen Reversal

    Edwards Lifesciences is recalling 459 Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings, potentially leading to misdiagnosis.

    Product
    Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0410-2019·2019-02-06

    Prinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Prinston Pharmaceutical Inc. is recalling Irbesartan and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA) above acceptable levels.

    Product
    IRBESARTAN AND HYDROCHLOROTHIAZIDE — IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V065000·2019-02-06

    Subaru Recalls 2019 Forester and Crosstrek for Steering Defect

    Subaru is recalling 2019 Forester and Crosstrek vehicles because a steering connector may short circuit, causing a loss of power steering assistance.

    Product
    SUBARU — SUBARU CROSSTREK, FORESTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0413-2019·2019-02-06

    Prinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Prinston Pharmaceutical Inc is recalling Irbesartan and Hydrochlorothiazide tablets because FDA labs found the impurity NDEA above acceptable levels.

    Product
    IRBESARTAN AND HYDROCHLOROTHIAZIDE — IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0423-2019·2019-02-06

    Lupin Recalls Cephalexin Oral Suspension Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling 14,400 bottles of Cephalexin for Oral Suspension due to CGMP deviations and the presence of extraneous material in sucrose excipients.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0411-2019·2019-02-06

    Prinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Prinston Pharmaceutical Inc. is recalling Irbesartan and Hydrochlorothiazide tablets because FDA testing found N-nitrosodimethylamine (NDEA) above the acceptable daily intake level.

    Product
    IRBESARTAN AND HYDROCHLOROTHIAZIDE — IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0763-2019·2019-02-06

    Edwards Lifesciences Recalls Swan Ganz Catheters Due to Lumen Reversal

    Edwards Lifesciences is recalling 875 units of Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings.

    Product
    Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac o
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·19E008000·2019-02-06

    Aisin Transmission Control Module Recall for Mazda and Fiat Vehicles

    Aisin World Corp. of America is recalling Transmission Control Modules for 2016-2019 Mazda Miata MX-5 and 2017-2019 Fiat 124 vehicles. Incorrect programming may cause unexpected downshifting and abrupt deceleration.

    Product
    POWER TRAIN:AUTOMATIC TRANSMISSION:CONTROL MODULE (TCM/PCM/TECM) recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0409-2019·2019-02-06

    Prinston Recalls Irbesartan Tablets Due to NDEA Impurity

    Prinston Pharmaceutical Inc. is recalling Irbesartan 300 mg tablets because FDA testing found N-nitrosodimethylamine (NDEA) levels above the interim acceptable daily intake.

    Product
    IRBESARTAN — IRBESARTAN (IRBESARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0412-2019·2019-02-06

    Prinston Recalls Irbesartan and Hydrochlorothiazide Tablets Due to NDEA Impurity

    Prinston Pharmaceutical Inc. is recalling Irbesartan and Hydrochlorothiazide tablets because FDA testing found the impurity NDEA above acceptable limits.

    Product
    IRBESARTAN AND HYDROCHLOROTHIAZIDE — IRBESARTAN AND HYDROCHLOROTHIAZIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0767-2019·2019-02-06

    West Pharma Vial2BAG DC 13mm Recalled for Adverse Events

    West Pharma Services IL, Ltd. is recalling Vial2BAG DC 13mm devices due to reported adverse events and potential inadequate drug admixing.

    Product
    Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0812-2019·2019-02-06

    Grand Strand Sandwich Company Recalls Ham and Cheese Croissant Lunch Box Sandwiches

    Grand Strand Sandwich Company is recalling 140 cases of Ham & Cheese Croissant Lunch Box Sandwiches due to potential Listeria monocytogenes contamination. The product was distributed in North Carolina and South Carolina.

    Product
    LUNCH BOX SANDWICHES HAM & CHEESE CROISSANT; NET WT 5OZ (142G); MADE BY: GS Sandwich Co. Longs, SC 29568 843.399.2999; UPC 0 67062 21217 2
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0790-2019·2019-02-06

    XTant Medical Recalls Calix Lumbar Spinal Implants for Sterilization Concerns

    XTant Medical is recalling 632 Calix Lumbar Spinal Implant System units due to a change in packaging and sterilization method to address potential risks of compromised sterilization.

    Product
    Calix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22mm x 10mm x 8mm PLIF ASSY PC, REF X034-0173PC 26mm x 10mm x 6mm PLIF ASSY PC, REF X034-0240PC 26mm x 10mm x 8mm PLIF ASSY PC, REF X034-0241PC 26mm x 10mm x 10mm PLIF ASSY PC, REF X034-0242P
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Food)·F-0813-2019·2019-02-06

    Grand Strand Sandwich Company Recalls Italian Sub Sandwiches for Listeria Risk

    Grand Strand Sandwich Company is recalling 28 cases of Italian Sub Lunch Box Sandwiches due to potential Listeria monocytogenes contamination. The product was distributed in North Carolina and South Carolina.

    Product
    LUNCH BOX SANDWICHES ITALIAN SUB; NET WT 7OZ (198G); MADE BY: GS Sandwich Co. Longs, SC 29568 843.399.2999; UPC 0 67068 12222 8
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0768-2019·2019-02-06

    FDA Recalls Vial2BAG Transfer Device Due to Reported Adverse Events

    West Pharma Services is recalling Vial2BAG Transfer Devices because adverse events were reported when used with oxytocin in pregnant women.

    Product
    Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0784-2019·2019-02-06

    Roche Anti-HAV IgM Test System Recalled for Erroneous Results

    Roche Diagnostics is recalling Anti-HAV IgM test systems due to potential erroneous result messages on the cobas e 602 module.

    Product
    Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium or sodium hepar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0761-2019·2019-02-06

    Glass Onion Catering Recalls Hummus and Quinoa Wraps Due to Undeclared Soy

    Atherstone Foods, Inc. dba Glass Onion Catering is recalling 114 units of Hummus & Quinoa Tabouleh Wraps because mayonnaise containing soy was used in error, and the product label does not declare soy as an allergen.

    Product
    greens & Grains Hummus & Quinoa Tabouleh Wrap with lemon tahini dressing: Perishable: Keep Refrigerated Plastic container with tamper proof hinged lid Use by 12/19/18 Incorrect dressing was used: Label states: Dressing: Tahini (ground sesame seeds), Lemon Juice, Water,
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0937-2019·2019-02-06

    Dakota Specialty Milling Recalls MG Premix for Salmonella Risk

    Dakota Specialty Milling is recalling 92,150 lbs of MG Premix because an ingredient may be contaminated with Salmonella.

    Product
    Dakota Specialty Milling Milton's MG Premix w Enrichment 94503860, 41820, Net Wt 50 lbs. Yellow Corn, Wheat Bran, Oat Fiber, Enrichment Blend (Contains: Vitamins B1, B2, B3, B6, B12; Pantothenic Acid; Zinc; Wheat Starch), Bread Softener, (contains Wheat Flour, Enzymes), Ferrous
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0780-2019·2019-02-06

    Siemens Recalls Atellica IM 1300 Analyzer Software Due to Multiple Issues

    Siemens Healthcare Diagnostics is recalling 217 Atellica IM 1300 Analyzers worldwide due to multiple issues identified in software version 1.14.2 and lower.

    Product
    Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Number (SMN): 1066001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0786-2019·2019-02-06

    Medtronic Recalls Suction and Anticoagulation Assemblies Due to Connector Defects

    Medtronic is recalling 7,587 Suction and Anticoagulation Assemblies because Y-connectors may tear or crack, potentially causing leaks and blood loss.

    Product
    SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0780-2019·2019-02-06

    Sysco Classic Liquid Margarine Recalled for Mislabeled Soy Lecithin

    Ventura Foods LLC is recalling Sysco Classic Liquid Margarine because the interior packaging misidentifies the product as canola oil, failing to declare soy lecithin.

    Product
    Sysco Classic Liquid Margarine; 2 x 17.5 lb. plastic containers; 99961WFS
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0794-2019·2019-02-06

    Fine Land Corp Recalls Meiqili Durian Candy for Undeclared Milk

    Fine Land Corp is recalling Meiqili Durian Candy because it contains undeclared milk. The product was distributed in six states.

    Product
    Meiqili Durian Candy in plastic bag with clear window, Net Wt: 12 ounce (340 g). It is a labeled as a product of P.R.C. and has a UPC code of 4-897055-795465-0. Sole Agent of U.S.A.: Fine Land Corp.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0782-2019·2019-02-06

    Siemens Atellica Analyzer Software Recall for Multiple System Issues

    Siemens Healthcare Diagnostics is recalling Atellica analyzer software versions 1.14.2 and lower due to multiple identified issues affecting in vitro diagnostic testing.

    Product
    Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number (SMN): 1 067000 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0769-2019·2019-02-06

    West Pharma Services Recalls Vial2BAG DC 20mm Medical Devices

    West Pharma Services is recalling Vial2BAG DC 20mm devices because adverse events were reported with the similar 13mm model used with oxytocin in pregnant women.

    Product
    Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0422-2019·2019-02-06

    BromSite Ophthalmic Solution Recalled for Lack of Sterility Assurance

    Sun Pharmaceutical is recalling BromSite (bromfenac) 0.075% ophthalmic solution due to a lack of sterility assurance. The recall affects 69,840 bottles distributed nationwide.

    Product
    BROMSITE — BROMSITE (BROMFENAC)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0814-2019·2019-02-06

    Grand Strand Ham and Cheese Lunch Box Sandwiches Recalled for Listeria

    Grand Strand Sandwich Company is recalling 420 cases of Ham & Cheese Lunch Box Sandwiches due to potential Listeria monocytogenes contamination.

    Product
    LUNCH BOX SANDWICHES HAM & CHEESE; NET WT 4.5 OZ (127G); MADE BY: GS Sandwich Co. Longs, SC 29568 843.399.2999; UPC 0 67068 12110 8
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1052-2019·2019-02-06

    Jac Vandenberg Recalls Chilean Nectarines for Listeria Contamination

    Jac Vandenberg Inc. is recalling nectarines from Chile sold at Aldi and Costco due to potential Listeria monocytogenes contamination.

    Product
    Nectarines sold as a bulk retail item, with PLU 3035 (white flesh nectarine) and 4378 (yellow flesh nectarine), and country of origin of Chile. The nectarines sold at Aldi are packaged in a two pound bag with EAN 7804650090298. The nectarines sold at Costco are packaged in a 4-po
    Category
    Food
    Distribution
    18 states
  • HighFDA (Food)·F-0779-2019·2019-02-06

    Pennant Ingredients Recalls Donut Glaze Due to Salmonella Contamination Risk

    Pennant Ingredients is recalling specific lots of RTU Donut Glaze because the product may be contaminated with Salmonella.

    Product
    New & Improved RTU Donut Glaze, NET WEIGHT 2800 lb. (1270 Kg) tote, UPC Codes: 608002213109, Product Code: 4110531
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0791-2019·2019-02-06

    3M Surgical Clipper Recalled for Overheating Risk During Charging

    3M is recalling 19,860 Surgical Clippers due to reports of overheating when charging from modified sine wave power inverters in mobile EMS settings.

    Product
    3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper Classic, 9602, is intended to remove body hair and head hair from patients in preparation for any medical procedure requiring hair removal.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0788-2019·2019-02-06

    GE Healthcare Recalls LOGIQ P6 Ultrasound Scanners Due to Probe Heating

    GE Healthcare is recalling 1,897 LOGIQ P6 ultrasound scanners (Models BT07 and BT09) because the probe-head surface can reach increased temperatures during specific scans.

    Product
    GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model BT09 (b) Model BT07 Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cepha
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0781-2019·2019-02-06

    Siemens Atellica Analyzer Software Recall for Multiple System Issues

    Siemens Healthcare Diagnostics is recalling Atellica analyzer software versions 1.14.2 and lower due to multiple identified issues affecting in vitro diagnostic testing systems.

    Product
    Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0778-2019·2019-02-06

    Haemonetics Recalls Cell Saver 5/5+ Bowl Sets Due to Leakage

    Haemonetics is recalling 11,208 units of Cell Saver 5/5+ Bowl Sets because the 70ml centrifuge bowls may leak during cell salvage processing.

    Product
    Cell Saver 5/5+ Bowl Set, 70ml, Product ID: 0291E-00, 0291A-00 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a re
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0779-2019·2019-02-06

    Haemonetics Recalls Cell Saver Elite Processing Kits Due to Leakage Risk

    Haemonetics is recalling 4,576 Cell Saver Elite Processing Kits because the 70ml centrifuge bowl may leak during cell salvage processing.

    Product
    Cell Saver Elite Processing Kit, 70 ml, Product ID: CSE-P-70 Indications for Use: The Haemonetics Cell Saver 5/5+ System and its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a resu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0785-2019·2019-02-06

    Medtronic Recalls Reservoir Y Adapters Due to Tearing and Cracking

    Medtronic is recalling 1,100 Reservoir Y Adapters because the Y-connectors may tear or crack, potentially causing blood loss and circuit breaches during autotransfusion.

    Product
    RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0421-2019·2019-02-06

    Domperidone 10 mg Capsules Recalled for Lack of Processing Controls

    Duren Health Mart Pharmacy is recalling 840 capsules of Domperidone 10 mg due to a lack of processing controls. The product was distributed in Tennessee.

    Product
    Domperidone 10 mg capsules, 100-count per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00507-2011-00
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0414-2019·2019-02-06

    Akorn Recalls Gentamicin Sulfate Ophthalmic Solution Due to Particulate Matter

    Akorn, Inc. is recalling specific lots of Gentamicin Sulfate Ophthalmic Solution because crystalline particles were detected during clarity testing.

    Product
    Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0789-2019·2019-02-06

    Abbott Recalls Alinity i Processing Modules Due to Gear Pump Assembly Issue

    Abbott is recalling Alinity i Processing Modules because a gear pump assembly issue causes foaming and dried residue in the wash buffer reservoir.

    Product
    Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c) Part Number A-30109694-01 Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and auto
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0416-2019·2019-02-06

    Duren Health Mart Pharmacy Recalls Omeprazole Suspension Due to Processing Controls

    Duren Health Mart Pharmacy is recalling Omeprazole 4 mg/mL Suspension because of a lack of processing controls. The recall is limited to Tennessee.

    Product
    Omeprazole 4 mg/mL Suspension, 150cc to 300 cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00000-0001-07
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0428-2019·2019-02-06

    Mylan Recalls Fexofenadine Tablets Due to Elevated Impurities

    Mylan Pharmaceuticals is recalling specific lots of Fexofenadine HCl 180 mg tablets because routine stability testing showed slightly elevated related compounds.

    Product
    Fexofenadine HCl Tablets, USP, 180 mg, packaged in a) 30-count bottles (NDC 0378-0782-93) and b) 500-count bottles (NDC 0378-0782-05); Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0775-2019·2019-02-06

    Wilson-Cook Medical Recalls Mislabeled Captura Serrated Forceps

    Wilson-Cook Medical is recalling 6 units of Captura Serrated Forceps due to mislabeling that swapped spike and no-spike models.

    Product
    COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0774-2019·2019-02-06

    Wilson-Cook Medical Recalls Mislabelled Captura Serrated Biopsy Forceps

    Wilson-Cook Medical is recalling 8 units of Captura Serrated Biopsy Forceps in France, Ireland, and Japan due to mislabeling.

    Product
    COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0415-2019·2019-02-06

    Gentamicin Ophthalmic Solution Recalled for Crystalline Particulate Matter

    H J Harkins Company is recalling Gentamicin Ophthalmic Solution due to crystalline particles found during clarity testing.

    Product
    GENTAMICIN OPTH-SOL 5ml Compare: Garamycin. 5-mL plastic dropper bottle, Mfg: AKORN 17478-0283-10. NDC 52959-0103-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0417-2019·2019-02-06

    Progesterone Cream Recalled for Lack of Processing Controls

    Duren Health Mart Pharmacy is recalling Progesterone 10% cream due to a lack of processing controls. The product was distributed in Tennessee.

    Product
    Progesterone 10% cream, 12gm to 30gm per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00000-0002-99
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0418-2019·2019-02-06

    Testosterone Cream Recalled for Lack of Processing Controls

    Duren Health Mart Pharmacy is recalling Testosterone 0.1% cream due to a lack of processing controls. The product was distributed in Tennessee.

    Product
    Testosterone 0.1% cream, 30 grams, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00000-0000-98
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0419-2019·2019-02-06

    Promethazine Gel Recalled by Duren Health Mart Pharmacy for Processing Control Issues

    Duren Health Mart Pharmacy is recalling Promethazine Gel 50 mg/mL due to a lack of processing controls. The affected product was distributed in Tennessee.

    Product
    Promethazine Gel 50 mg/mL, 1cc to 10cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00002-1901-03
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0783-2019·2019-02-06

    Siemens Recalls Atellica Sample Handler Prime Due to Software Issues

    Siemens Healthcare Diagnostics is recalling 410 Atellica Sample Handler Prime units because software version 1.14.2 and lower contain multiple issues.

    Product
    Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material Number (SMN): 11069001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0420-2019·2019-02-06

    Progesterone 100 mg SR Capsules Recalled for Lack of Processing Controls

    Duren Health Mart Pharmacy is recalling 1,306 capsules of Progesterone 100 mg SR due to a lack of processing controls.

    Product
    Progesterone 100 mg SR capsules, 30-180 capsules per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00311-2003-01
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-0762-2019·2019-02-06

    Edwards Lifesciences Recalls Swan Ganz Catheters Due to Lumen Assembly Error

    Edwards Lifesciences is recalling 277 Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings.

    Product
    Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0777-2019·2019-02-06

    Riverpoint Medical Recalls 18G Brachy Grids for Incorrect CE Labeling

    Riverpoint Medical is recalling 443 units of 18G Brachy Grids because they are labeled with a CE mark despite not being approved in the European Union.

    Product
    RP RIVERPOINT MEDICAL 18G Brachy Grid B&K(TM) style, REF RPG-18 Product Usage: The Riverpoint Brachytherapy Grid is used during Brachytherapy procedures to assist with the precise insertion of the needle or other probes. The Riverpoint Brachytherapy Grid is placed against the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·013-2019·2019-02-05

    Richwell Group Recalls Frozen Sheat Fish Products for Import Violation

    Richwell Group is recalling approximately 73,360 pounds of frozen Sheat fish products that were imported from Vietnam without the required benefit of import inspection.

    Product
    Richwell Group, Inc. Recalls Siluriformes Products Produced Without Benefit of Import Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V068000·2019-02-05

    Fiat 124 Spider Recall for Transmission Software Defect

    Chrysler is recalling 2017-2019 Fiat 124 Spider vehicles with automatic transmissions due to a software defect that may cause unexpected downshifting and sudden deceleration.

    Product
    FIAT — FIAT 124 SPIDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V067000·2019-02-05

    RAM Recalls 2019 Ram 1500 Trucks Due to Brake Pedal Defect

    Chrysler is recalling 2019 Ram 1500 trucks with adjustable pedals because the brake pedal may separate from the assembly, increasing crash risk.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2019.