The Recall Desk

Archive

September 2015 recalls

1,186 recalls were announced in September 2015.

What the numbers show

Critical
119
Severe
561
High
378
Moderate
103
Low
25

Of the 1,186 recalls this month scored against our rubric, 10% are Critical, 47% are Severe.

1101–1186 of 1186

  • SevereFDA (Drugs)·D-1363-2015·2015-09-02

    Mucinex Fast-Max Recalled for Missing Drug Facts Labeling

    Reckitt Benckiser is recalling Mucinex Fast-Max liquid bottles because the back label is missing active ingredients and safety warnings.

    Product
    MUCINEX FAST-MAX — MUCINEX FAST-MAX (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1399-2015·2015-09-02

    Methadone Injection Recalled Due to Sterility Assurance Concerns

    Liberty Drug & Surgical is recalling Methadone 10 mg/mL Injection vials because process deficiencies could have compromised sterility.

    Product
    Methadone 10 mg/mL Injection, 10 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1360-2015·2015-09-02

    Bactroban Ointment Recalled for Penicillin Contamination and Foreign Substances

    GlaxoSmithKline is recalling Bactroban Ointment due to penicillin cross-contamination and foreign substances found during manufacturing.

    Product
    Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. NDC 0029-1525-44
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1401-2015·2015-09-02

    Liberty Drug Recalls Doxycycline IV Bags Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 30 bags of Doxycycline/0.9% NaCl IV due to process deficiencies that could have compromised sterility.

    Product
    Doxycycline/0.9% NaCl 300 mg/500 mL IV, 500 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1383-2015·2015-09-02

    Liberty Drug Recalls Injectable Due to Sterility Process Deficiencies

    Liberty Drug & Surgical is recalling Papaverine/Phentolamine/Atropine/PGE-1 Injectable vials because process deficiencies may have compromised the product's sterility.

    Product
    Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 9 mg/1 mg/0.1 mg/10 mcg/mL, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1361-2015·2015-09-02

    GlaxoSmithKline Recalls Bactroban Cream Due to Penicillin Contamination

    GlaxoSmithKline is recalling Bactroban Cream (mupirocin calcium) 2% because the product was contaminated with penicillin and foreign substances during manufacturing.

    Product
    Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (NDC 0029-1527-25), Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1404-2015·2015-09-02

    Liberty Drug Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 6 vials of Methylcobalamin 1,000 mcg/mL Injectable due to process deficiencies that could have compromised sterility.

    Product
    Methylcobalamin 1,000 mcg/mL Injectable, 1.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1364-2015·2015-09-02

    Mucinex Fast Max Liquid Recalled for Missing Drug Facts Labeling

    Reckitt Benckiser is recalling Mucinex Fast Max Night Time Cold & Flu liquid bottles because the back label is missing active ingredients and safety warnings.

    Product
    Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Diphenhydramine HCl Antihistamine/Cough Suppressant, Phenylephrine HCl Nasal Decongestant, 6 fl oz. (180 mL) Bottle, For Ages 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1353-2015·2015-09-02

    Pharmedium Recalls Oxytocin Injection Bags Due to Particulate Matter

    Pharmedium Services, LLC is recalling 72 bags of oxyTOCIN 15 Units in 5% Dextrose Injection due to the presence of particulate matter.

    Product
    oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP, packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K2677, NDC# 61553-777-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1394-2015·2015-09-02

    Liberty Drug Recalls Doxycycline IV Bags Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 112 bags of Doxycycline IV solution because process deficiencies may have compromised sterility.

    Product
    Doxycycline/0.9% NaCl 150 mg/250 mL IV, 250 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1393-2015·2015-09-02

    Liberty Drug Recalls Papervine Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling Papervine/Phentolamine/PGE-1 Injectable vials because process deficiencies may have compromised sterility.

    Product
    Papervine/Phentolamine/PGE-1 Injectable, 30 mg/0.5 mg/30 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1368-2015·2015-09-02

    Mucinex Fast Max Liquid Recalled for Missing Drug Facts Labeling

    Reckitt Benckiser is recalling Mucinex Fast Max liquid bottles because the back label is missing active ingredients and safety warnings.

    Product
    Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 fl oz (180 mL) bottles Total - 12 fl oz (360 mL), For Ages 12+, Dist. by Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-528-22-01, NDC 63824-528-22-00, UPC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1366-2015·2015-09-02

    Mucinex Fast-Max Liquid Recalled for Missing Drug Facts Labeling

    Reckitt Benckiser is recalling Mucinex Fast-Max liquid bottles because the back label is missing active ingredients and safety warnings.

    Product
    Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two - 6 fl oz (180 mL) bottles Total -12 fl oz (360 mL), For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-526-22
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1352-2015·2015-09-02

    Unichem Recalls Hydrochlorothiazide Tablets Due to Foreign Tablet Presence

    Unichem Pharmaceuticals is recalling 4,776 bottles of hydrochlorothiazide 25 mg tablets because a pharmacist found a clopidogrel tablet in one bottle.

    Product
    HYDROCHLOROTHIAZIDE — HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2455-2015·2015-09-02

    Omnilife Recalls Offset Femoral Alignment Guides Due to Incorrect Markings

    Omnilife Science Inc. is recalling 15 Offset Femoral Alignment Guides because the markings are reversed, which may prevent proper alignment during surgery.

    Product
    Offset Femoral Alignment Guide 4mm x 6¿; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems. Product Usage: The instrumentation has been designed to facilitate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2454-2015·2015-09-02

    Omnilife Recalls Offset Femoral Alignment Guides Due to Incorrect Markings

    Omnilife Science Inc. is recalling 15 Offset Femoral Alignment Guides because the markings are reversed, which may prevent proper alignment during surgery.

    Product
    Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2466-2015·2015-09-02

    Sunrise Medical Recalls Quickie and Zippie IRIS Wheelchairs with MONO Backrest

    Sunrise Medical is recalling 64 Quickie and Zippie IRIS wheelchairs because the MONO Backrest System may break, posing a risk of falls or injury to the occupant.

    Product
    Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2458-2015·2015-09-02

    Medline Recalls Central Line Kits Due to Incorrect Age Labeling

    Medline Industries is recalling Central Line kits due to a printing error that mislabels the intended patient age. The error could lead to use on the wrong patient population.

    Product
    Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called a central line, is a long, thin, flexible tube used to give medicines, fluids, n
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2467-2015·2015-09-02

    Sunrise Medical Recalls Quickie IRIS Wheelchairs with Dynamic Backrest

    Sunrise Medical is recalling 64 Quickie IRIS wheelchairs because the backrest system may break, posing a risk of falls or injury to the occupant.

    Product
    Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2470-2015·2015-09-02

    GE Healthcare Recalls Centricity Universal Viewer Software Due to Image Loss

    GE Healthcare is recalling 26 Centricity Universal Viewer Version 6.0 systems because medical images may be missing when a specific system parameter is set to a value greater than 1.

    Product
    Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2450-2015·2015-09-02

    Siemens Recalls Dimension Vista B2-Microglobulin Reagent Cartridges

    Siemens Healthcare Diagnostics is recalling 1,655 Dimension Vista B2-Microglobulin Flex Reagent Cartridges due to potential reagent contamination that may cause falsely low test results.

    Product
    Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B¿2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Mea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3050-2015·2015-09-02

    Veggie Evolution Vegetable Crisps Recalled for Undeclared Milk Allergen

    It Takes A Village Foods, LLC is recalling Vegetable Crisps Lemon Parmesan because the label declares Parmesan cheese but fails to declare milk as an allergen.

    Product
    Vegetable Crisps Lemon Parmesan sold under brand Veggie Evolution, each poly pouch has a net weight 2 oz. There are 6 packages per case. UPC is 7 36211 15015 8. The product's label is read in part: "***VEGGIE EVOLUTION***VEGETABLE CRISPS***LEMON PARMESAN***INGREDIENTS: CARROTS
    Category
    Food
    Distribution
    22 states
  • HighFDA (Devices)·Z-2443-2015·2015-09-02

    Recall of Infant Heel Warmers Due to Potential Breakage and Spillage

    The FDA is recalling 68,800 units of Infant Heel Warmers because they may break during activation, causing spillage of contents that could irritate skin or eyes.

    Product
    Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2456-2015·2015-09-02

    Trilliant Surgical Reamer Heads Recalled for Guide Pin Fit Issues

    Trilliant Surgical Ltd. is recalling 638 Concave and Convex Reamer Heads because the cannulation may be too small to allow the Guide Pin to pass through freely.

    Product
    Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm; Convex Reamer Head, 18 mm; Convex Reamer Head 20 mm; Convex Reamer Head 22 mm, used with Gridlock Plating system, for use in trauma and recons
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2439-2015·2015-09-02

    PTW UNIDOS webline Dosimeters Recalled for Potential Radiation Over-Exposure

    PTW-Freiburg is recalling PTW UNIDOS webline dosimeters because measurement errors at high dose rates could display too-low doses, potentially leading to radiation over-exposure.

    Product
    PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2447-2015·2015-09-02

    Roche cobas b 123 Fluid Pack Recall for Low PO2 Results

    Roche is recalling 82 cobas b 123 Fluid Packs due to a calibration issue that may cause erroneously low PO2 results in patient samples.

    Product
    cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total hemoglob
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3056-2015·2015-09-02

    Bruce Foods Chicken Fry Mix Recalled for Peanut Contamination

    Bruce Foods is recalling 147 cases of Chicken Fry Mix because the product may be contaminated with peanut protein.

    Product
    THE ORIGINAL CHICKEN FRY MIX FROM THE MAKERS OF LOUISIANA BRAND HOT SAUCE, NET WT. 9 oz. (255g), BRUCE FOODS CORPORATION, EL PASO, TEXAS, UPC 1760002733
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-3057-2015·2015-09-02

    Bruce Foods Recalls Louisiana Chicken Wing Seasoning for Peanut Contamination

    Bruce Foods Corporation is recalling 22 cases of Louisiana Chicken Wing Seasoning because the product may be contaminated with peanut protein.

    Product
    LOUISIANA CHICKEN WING SEASONING, HERBS AND SPICES, ADD FLAVOR TO CHICKEN, NET 3.0 OZ (85g), BRUCE FOODS CORPORATION, UPC 1760002153
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-3051-2015·2015-09-02

    Fresh Unlimited Caesar Salad Recalled for Undeclared Egg Allergen

    Fresh Unlimited Inc is recalling Caesar Salad kits because the labels failed to declare the presence of eggs, a major food allergen.

    Product
    Caesar Salad, #5.56 (2,522g) "INGREDIENTS: Romaine Lettuce, Caesar Dressing (Soybean oil, water, distilled vinegar, Romano cheese (pasteurized part skim milk, cheese culture, salt, enzymes),*****" *ALLERGENS** Fish, Milk, Wheat
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-3049-2015·2015-09-02

    Veggie Evolution Kale Crisps Recalled for Undeclared Milk Allergen

    It Takes A Village Foods is recalling Veggie Evolution Kale Crisps Lemon Parmesan because the label lists Parmesan cheese but fails to declare milk as an allergen.

    Product
    Kale Crisps Lemon Parmesan sold under brand Veggie Evolution, each plastic package has a net weight 1.5 oz. There are six packages per case. UPC is 7 94504 69431 4. The product's label is read in part: "***VEGGIE EVOLUTION***KALE CRISPS***LEMON PARMESAN***INGREDIENTS: KALE,
    Category
    Food
    Distribution
    22 states
  • HighNHTSA·15E072000·2015-09-02

    Peter Paul Nitrous Oxide Solenoid Valve Recall for Potential Breakage

    Peter Paul Electronics is recalling specific nitrous oxide solenoid valves because end stops may break under pressure, posing an injury risk to nearby individuals.

    Product
    FUEL SYSTEM, OTHER:DELIVERY:HOSES, LINES/PIPING, AND FITTINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V555000·2015-09-02

    Volvo Recalls 2016 Models Due to Starter Motor Fuse Failure Risk

    Volvo is recalling 7,855 model year 2016 vehicles because a starter motor fuse may blow, preventing the car from restarting in traffic and increasing crash risk.

    Product
    VOLVO — VOLVO S60, V60, XC60, XC70
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2444-2015·2015-09-02

    FDA Recalls Covidien Infant Heel Warmers Due to Breakage Risk

    The FDA is recalling 164,749 units of Covidien Infant Heel Warmers because they may break during activation, causing spillage and potential skin or eye irritation.

    Product
    Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2445-2015·2015-09-02

    FDA Recalls Omnilife Apex Interface Acetabular Shells Due to Design Defect

    Omnilife Science Inc. is recalling 112 Apex Interface Hemi 54X and Flared 56X acetabular shells because improper screw hole placement may occur due to inaccurate index line location.

    Product
    APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3048-2015·2015-09-02

    Veggie Evolution Kale Crisps Recalled for Undeclared Soy

    It Takes A Village Foods is recalling Veggie Evolution Kale Crisps Zen Nori because the product contains soy, which is not declared on the label.

    Product
    Kale Crisps Zen Nori product is seaweed flavored dehydrated kale chip, sold under brand Veggie Evolution, each poly pouch has a net weight 1.5 oz. There are six packages per case. UPC is 7 13757 57480 8. The product's label is read in part: "***VEGGIE EVOLUTION***KALE CRISPS*
    Category
    Food
    Distribution
    22 states
  • HighFDA (Food)·F-3044-2015·2015-09-02

    Kroger Garlic Powder Recalled Due to Salmonella Contamination

    The Kroger Co is recalling specific containers of Kroger Garlic Powder because a sample tested positive for Salmonella. The recall covers items produced on the filling line between sanitation cycles.

    Product
    Kroger Garlic Powder UPC 11110 70039 NEW WT 24.7 OZ Plastic Container
    Category
    Food
    Distribution
    31 states
  • HighFDA (Devices)·Z-2461-2015·2015-09-02

    Ferno iNX Wheeled Stretcher Wheel Caster Set Screw Recall

    Ferno-Washington Inc is recalling 26 Ferno iNX Wheeled Stretchers due to improperly installed wheel caster set screws that may allow bearing cups to back out.

    Product
    Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Food)·F-3055-2015·2015-09-02

    Vic's Original White Popcorn Recalled for Undeclared Milk Allergen

    Barrel O' Fun Snack Foods is recalling one lot of Vic's Original White Popcorn because it contains an undeclared milk allergen.

    Product
    Vic's All Natural Original White Popcorn, Net Wt. 1-1/8 oz (32g), UPC 46555-00062
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2383-2015·2015-09-02

    Philips DigitalDiagnost X-ray Systems Recalled for Missing Exposure Beep Signal

    Philips is recalling 62 DigitalDiagnost X-ray systems because a software defect prevents the exposure termination beep from sounding after 12 hours of operation.

    Product
    Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctors or technicians.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3052-2015·2015-09-02

    Fresh Unlimited Recalls Kale Chicken Caesar Pasta Salad for Undeclared Eggs

    Fresh Unlimited Inc is recalling Kale Chicken Caesar Pasta Salad because the product labels failed to declare the allergen eggs.

    Product
    Kale Chicken Caesar Pasta Salad, 3.87# (1.757g) INGREDIENTS: COOKED TRI-ROTINI PASTA***CAESAR DRESSING (Soybean Oil, Water, Distilled Vinegar, Romano Cheese*** ALLERGENS: FISH, MILK, SOY, WHEAT
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2438-2015·2015-09-02

    Otto Bock Genium X3 Knee Joint Prosthesis Recalled for Hydraulic Failure

    Otto Bock Healthcare Products GmbH is recalling the Genium X3 knee joint prosthesis because its hydraulic resistance control may fail under certain conditions.

    Product
    Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH. Intended to be used solely for lower limb prosthetic fittings.
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·15230·2015-09-02

    Tadpoles Moses Basket and Stand Recalled for Fall Hazard

    Sleeping Partners is recalling Tadpoles Moses baskets and stands because the basket can slide off inclined surfaces and the stand can tip, posing a fall hazard to infants.

    Product
    Tadpoles Baby and Kids Moses Basket and Stand
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3058-2015·2015-09-02

    Bruce Foods Recalls Louisiana Wing Kit for Peanut Contamination

    Bruce Foods Corporation is recalling 'Louisiana' Wing Kits due to potential peanut protein contamination. The product was distributed in nine states.

    Product
    "LOUISIANA" WING KIT containing CHICKEN WING SEASONING, HERBS AND SPICES, ADD FLAVOR TO CHICKEN, NET 3.0 OZ (85g), BRUCE FOODS CORPORATION, UPC 1760002153 (wing seasoning)
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2446-2015·2015-09-02

    Roche cobas b 123 Fluid Pack Recall for Low PO2 Results

    Roche is recalling 82 cobas b 123 Fluid Packs due to a calibration issue that may cause erroneously low PO2 results in patient samples.

    Product
    cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total hemoglob
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2457-2015·2015-09-02

    RayStation 4.7.1 Radiation Therapy Software Recalled for Algorithm Error

    RaySearch Laboratories is recalling RayStation 4.7.1 software due to an algorithm error that reverses contraction distances in radiation therapy planning.

    Product
    RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2440-2015·2015-09-02

    Brainlab ExacTrac 6.0 Patient Positioning System Recalled for Display Error

    Brainlab AG is recalling ExacTrac 6.0.x software due to a potential display error in Digitally Reconstructed Radiographs used for x-ray correction.

    Product
    ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
    Category
    Medical Device
    Distribution
    32 states
  • ModerateFDA (Devices)·Z-2459-2015·2015-09-02

    Advanced Sterilization Products Recalls CIDEX Activated Dialdehyde Solution

    Advanced Sterilization Products is recalling CIDEX Activated Dialdehyde Solution because it may lack adequate data to support its 24-month shelf life.

    Product
    CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2460-2015·2015-09-02

    ASO Recalls Carepak Bandages Due to Unlabeled Benzalkonium Chloride

    ASO, LLC is recalling Carepak Sheer Adhesive Bandages because 5/8 bandages contain 0.1% Benzalkonium Chloride, which is not listed on the label.

    Product
    Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2476-2015·2015-09-02

    AMUSA Recalls 0.9% Sodium Chloride Injection Due to Process Control Issues

    MRP, LLC dba AMUSA is recalling 0.9% Sodium Chloride Injection because procedures for product acceptance and control were not adequately established.

    Product
    0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-1373-2015·2015-09-02

    Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

    Dr. Reddy's Laboratories is recalling 1,056 bottles of Amlodipine Besylate and Atorvastatin Calcium tablets because the atorvastatin component is subpotent.

    Product
    AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2469-2015·2015-09-02

    GE Healthcare Recalls Centricity PACS-IW Systems Due to Missing Images

    GE Healthcare is recalling 82 Centricity PACS-IW systems because medical images may be missing when a specific system parameter is set to a value greater than 1.

    Product
    Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2477-2015·2015-09-02

    Nidek OPD-Scan III Recall for Software Aberration Calculation Error

    Nidek Inc is recalling 3,836 OPD-Scan III Refractive Power/Corneal Analyzers due to a software bug that incorrectly calculates high-order aberrations.

    Product
    OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01. Opthalmic: The OPD-Scan III is a diagnostic instrument that is indicated for use f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2474-2015·2015-09-02

    Baxter Recalls CAPD Solution Transfer Sets for Labeling Revisions

    Baxter Healthcare Corp. is recalling 35,460 units of CAPD Solution Transfer Sets to update labeling with additional safety instructions and warnings.

    Product
    CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. intended for use with containers of DIANEAL peritoneal dialysis solution.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2468-2015·2015-09-02

    Stryker recalls mislabeled 5mm trocar sleeves due to length discrepancy

    Stryker Sustainability Solutions is recalling 90 reprocessed trocar sleeves labeled as 100mm but containing 75mm models.

    Product
    Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve 5mm x 100mm Reprocessed by Stryker Sustainability Solutions Product Usage: The Reprocessed Ethicon ENDOPATH¿ XCEL Universal Trocar Stability Sleeve is a sterile si
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1369-2015·2015-09-02

    Mucinex Fast-Max DM Max Recalled for Missing Drug Facts Labeling

    Reckitt Benckiser is recalling Mucinex Fast-Max DM Max bottles because the back label is missing active ingredients and safety warnings.

    Product
    MUCINEX FAST-MAX DM MAX AND MUCINEX NIGHTTIME COLD AND FLU — MUCINEX FAST-MAX DM MAX AND MUCINEX NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2441-2015·2015-09-02

    Iris Diagnostics Recalls iChemVELOCITY Urine Chemistry Systems for Labeling Error

    Iris Diagnostics is recalling iChemVELOCITY Automated Urine Chemistry systems because they do not maintain the claimed 5-day strip stability under specified conditions.

    Product
    iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1377-2015·2015-09-02

    Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

    Dr. Reddy's Laboratories is recalling Amlodipine Besylate and Atorvastatin Calcium tablets because the atorvastatin component is subpotent.

    Product
    AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2452-2015·2015-09-02

    Trilliant Surgical Recalls 3.0/4.0 Cannulated Drill Bits Due to Sizing Issue

    Trilliant Surgical Ltd. is recalling 121 units of 3.0/4.0 Cannulated Drill Bits because the inner diameter is too small for the guide wire to pass through.

    Product
    3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wire
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2448-2015·2015-09-02

    Alcon Recalls LX3 Microscope Floor Stands Due to Cabling Issues

    Alcon is voluntarily recalling LX3 Microscope Floor Stands because cabling issues may cause loss of functionality or illumination failure.

    Product
    LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. Product Usage: The LX3 Microscope Floor Stand is an accessory to the LuxOR Opthalmic Microscope and the LuxOR Opthalmic Microscope with Q-VUE 3-D Assistant Visualization and provides a portable sus
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2374-2015·2015-09-02

    Ethicon Recalls SEDASYS Sedation Systems Due to Plastic Degradation

    Ethicon is recalling 14 SEDASYS Computer-Assisted Personalized Sedation Systems because unspecified disinfecting methods caused the plastic material of the Control Unit to degrade.

    Product
    SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3054-2015·2015-09-02

    Nepali Finger Chips Recalled for Undeclared Tartrazine

    Balajee Trade Link LLC is recalling Rato Bhale Nepali Finger Chips because the product contains undeclared tartrazine (yellow #5).

    Product
    Rato Bhale Nepali Finger Chips Product of Nepal Weight: 200g (7.05 OZ) Imported by: Balajee Trade Link, LLC, PA USA Batch No. 01-15
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2471-2015·2015-09-02

    Baxter Recalls MiniCap Peritoneal Dialysis Transfer Sets for Labeling Updates

    Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets to update labeling with new safety instructions and warnings.

    Product
    MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C4483. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnect
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2472-2015·2015-09-02

    Baxter MiniCap Peritoneal Dialysis Transfer Set Labeling Recall

    Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets to update labeling with safety instructions and warnings.

    Product
    MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5C4482. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are perf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2464-2015·2015-09-02

    Trilliant Surgical Recalls Tiger Cannulated Screw System Tray Lids

    Trilliant Surgical Ltd. is recalling 71 units of Tiger Cannulated Tray Lids because they are occasionally difficult to remove from sterilization trays.

    Product
    Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are components of the Tiger Cannulated Screw System and the Tiger Headless Cannulated Screw System The Tiger Cannulated Screw Fixation System and the Tig
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2465-2015·2015-09-02

    Tornier Recalls Salto Talaris Tibial Guide Due to Assembly Defect

    Tornier is voluntarily recalling five units of the Salto Talaris Tibial Guide because they cannot be assembled to the Talar Pin Setting guide.

    Product
    Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2442-2015·2015-09-02

    Medtronic Guardian Real-Time Monitor Recalled for Finnish Translation Error

    Medtronic MiniMed is recalling 254 Guardian Real-Time Monitors distributed in Finland due to a language translation error that reverses the on-screen labels for LOW and HIGH glucose alerts.

    Product
    Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2453-2015·2015-09-02

    BD CD56 PE Cy 7 Reagent Recalled for Unexpected Staining Patterns

    Becton, Dickinson and Company is recalling three lots of CD56 PE Cy 7 reagent because they contain a low amount of HLA-DR PE antibody, which could result in an unexpected staining pattern.

    Product
    BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen promotes homophilic adhesion in neurons and may be involved in homophilic adhesion of NK cells.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2473-2015·2015-09-02

    Baxter MiniCap Extended Life PD Transfer Set Labeling Recall

    Baxter Healthcare Corp. is recalling 33,474 units of MiniCap Extended Life PD Transfer Sets to update labeling with additional safety instructions and warnings.

    Product
    MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2449-2015·2015-09-02

    Carestream DRX-Evolution X-Ray System Recalled for Image Stitching Defect

    Carestream Health is recalling DRX-Evolution X-ray systems due to a software defect that may cause undetected image stitching inconsistencies.

    Product
    CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2463-2015·2015-09-02

    Hardy Diagnostics Recalls HardyCHROM MRSA In Vitro Diagnostic Plates

    Hardy Diagnostics is recalling HardyCHROM MRSA plates due to a potential quality control issue involving the MSSA strain.

    Product
    HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2475-2015·2015-09-02

    Synthes Sternal ZIPFIX Application Instrument Recalled Due to Detaching End Cap

    Synthes (USA) Products LLC is recalling 451 Sternal ZIPFIX Application Instruments because the end cap may loosen and detach, rendering the instrument non-functional.

    Product
    Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1375-2015·2015-09-02

    Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

    Dr. Reddy's Laboratories is recalling 984 bottles of Amlodipine Besylate and Atorvastatin Calcium tablets because the atorvastatin component is subpotent.

    Product
    AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1379-2015·2015-09-02

    Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

    Dr. Reddy's is recalling Amlodipine Besylate and Atorvastatin Calcium tablets because the atorvastatin component was found to be subpotent.

    Product
    AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1376-2015·2015-09-02

    Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

    Dr. Reddy's Laboratories is recalling specific lots of Amlodipine Besylate and Atorvastatin Calcium tablets because they contain subpotent atorvastatin.

    Product
    AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1378-2015·2015-09-02

    Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

    Dr. Reddy's is recalling specific lots of Amlodipine Besylate and Atorvastatin Calcium tablets because they contain subpotent atorvastatin.

    Product
    AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1374-2015·2015-09-02

    Dr. Reddy's Recalls Subpotent Amlodipine and Atorvastatin Tablets

    Dr. Reddy's Laboratories is recalling 576 bottles of Amlodipine Besylate and Atorvastatin Calcium tablets because the atorvastatin component is subpotent.

    Product
    AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM — AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM (AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1371-2015·2015-09-02

    KVK-Tech Recalls Phentermine Hydrochloride Capsules Due to Impurity Failures

    KVK-Tech is recalling specific lots of Phentermine Hydrochloride Capsules because they failed impurity specifications during stability testing.

    Product
    Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1370-2015·2015-09-02

    Taro Recalls Topicort Topical Spray Due to Impurity Test Failures

    Taro Pharmaceuticals is recalling Topicort topical spray because impurity testing failed at 6 and 9 months. The recall covers 16,320 bottles distributed nationwide.

    Product
    TOPICORT — TOPICORT (DESOXIMETASONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·15E071000·2015-09-01

    Specialty Products Company Recalls Aftermarket Suspension Alignment Hardware Kits

    Specialty Products Company is recalling aftermarket alignment hardware kits for certain Mercedes-Benz and Chrysler/Dodge vehicles because the suspension bolts may fracture, potentially causing loss of vehicle control.

    Product
    SUSPENSION recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V549000·2015-09-01

    Spartan Motorhomes Recalled for Potential Engine Cooling Fan Separation

    Spartan Motors USA is recalling 2004-2008 K2, K3, and MM motorhomes because the engine cooling fan may separate from the drive, posing an injury risk to nearby individuals.

    Product
    SPARTAN — SPARTAN MM, K3, K2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15228·2015-09-01

    MiWorld Recalls iPhone Wall Chargers Due to Fire Hazard

    MiWorld Accessories is recalling iPhone 5/5S wall chargers sold at Charlotte Russe because they can overheat and catch fire. One fire incident was reported.

    Product
    USB Cord & Wall Chargers for iPhone 5/5S
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V550000·2015-09-01

    Kawasaki Recalls Vulcan 1700 Motorcycles for Ignition Wire Chafing Risk

    Kawasaki is recalling specific Vulcan 1700 Voyager and Vaquero motorcycles because an ignition wire may chafe against the fuel tank, causing a short circuit and potential engine stall.

    Product
    KAWASAKI — KAWASAKI VULCAN 1700 VOYAGER, VULCAN 1700 VAQUERO
    Category
    Vehicle
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2015.