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.

1001–1100 of 1186

  • ModerateFDA (Devices)·Z-2609-2015·2015-09-09

    Customed Minor Laceration Tray Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling Minor Laceration Trays because the sterilization processes and package integrity were not adequately validated.

    Product
    MINOR LACERATION TRAY CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2487-2015·2015-09-09

    Pointe Scientific Recalls G6PD Controls Due to Reduced Stability

    Pointe Scientific is recalling G6PD Controls due to reduced reconstituted stability that may cause out-of-specification results.

    Product
    Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). Also sold as individual vials Bottle: Clear glass vials Cap: Rubber seal with colored aluminum seals Glucose-6-phosphate dehydrogenase (G6PD) controls can be
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2543-2015·2015-09-09

    Roche Recalls cobas Liat Analyzers Due to Incorrect LED Components

    Roche Molecular Systems is recalling five cobas Liat Analyzers because incorrect LED components were used in the printed circuit board assemblies.

    Product
    cobas Liat Analyzer, for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-3075-2015·2015-09-09

    think Thin Oatmeal Recalled for Incorrect Honey Peanut Butter Labeling

    Interpac Technologies is recalling think Thin oatmeal cups that have the correct lid but an incorrect Honey Peanut Butter label. The product contains visible nuts.

    Product
    think Thin Protein & Fiber Oatmeal, Madagascar Vanilla, Almonds, Pecans; 10 g Protein, 5 g Fiber, 190 calories; Net wt 1.76 oz. (50g); (Nuts are visible in product when lid is opened. Tray - 12 x 1.76 oz cups UPC 753656711881: Individual cup UPC 753656 711874 Ingredients:
    Category
    Food
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2727-2015·2015-09-09

    Transonic Flow Probe Recalled Due to Software Defect

    Transonic Systems Inc is recalling 3 mm Flow Probes due to software defects causing incorrect readings on flow meters.

    Product
    Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2729-2015·2015-09-09

    Transonic Flow Probe Recalled Due to Software Defect

    Transonic Systems Inc is recalling 6 mm Flow Probes due to programming errors causing incorrect meter readings.

    Product
    Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2553-2015·2015-09-09

    Customed Universal Drainage Trays Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 960 Universal Drainage Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    UNIVERSAL DRAINAGE TRAY CUSTOMED 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2539-2015·2015-09-09

    Limacorporate Recalls SMR Shoulder Trial Humeral Heads Due to Assembly Issues

    Limacorporate is recalling specific SMR Shoulder Trial Humeral Heads because their dimensions are out of specification, making them difficult to assemble.

    Product
    SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2482-2015·2015-09-09

    Bayer Recalls Contour Next Control Solution for Potential Test Errors

    Bayer is recalling 5 million bottles of Contour Next Control Solution because improper shaking may cause inaccurate blood glucose meter readings.

    Product
    Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic bottle, 2.5mL. Indicated for use with fresh fingertip capillary whole blood samples.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2721-2015·2015-09-09

    Transonic Flow Probe Recalled Due to Software Defect

    Transonic Systems Inc is recalling 36 Transonic Flow Probes due to programming errors that cause incorrect meter readings.

    Product
    Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2726-2015·2015-09-09

    Transonic Flow Probe Recall Due to Software Defect in EPROM

    Transonic Systems Inc is recalling 2 mm Flow Probes due to programming errors causing incorrect meter readings.

    Product
    Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2540-2015·2015-09-09

    Limacorporate Recalls SMR Shoulder Trial Heads Due to Assembly Issues

    Limacorporate S.p.A is recalling 93 units of SMR Shoulder Trial Heads because dimensions are out of specification, making assembly difficult.

    Product
    SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2720-2015·2015-09-09

    Transonic Flow Probe Recalled Due to Software Defect in EPROM

    Transonic Systems Inc is recalling 2 mm Flow Probes due to programming errors causing incorrect meter readings.

    Product
    Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2667-2015·2015-09-09

    Customed Laparoscopy Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 32 laparoscopy packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    LAPAROSCOPY PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2483-2015·2015-09-09

    Biomet Vision RingLoc Hip Prosthesis Recalled for Missing Screw Hole Plugs

    Biomet, Inc. is recalling five units of the Vision RingLoc Shell 50 mm hip prosthesis because they were assembled without screw hole plugs.

    Product
    Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-3070-2015·2015-09-09

    HoneyCombs Formula E Recalled for Excessive Coliform Bacteria

    HoneyCombs Industries is recalling Formula E droppers due to coliform counts exceeding specifications. The product was distributed nationwide.

    Product
    Formula E packaged in 1 FL OZ (29mL) droppers. HoneyCombs Industries, 10671 6075 Road, Montrose, CO 81403.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3068-2015·2015-09-09

    HoneyCombs Formula C&F Recalled for Excessive Coliform Bacteria

    HoneyCombs Industries is recalling 161 bottles of Formula C&F droppers because the powdered golden seal ingredient contained coliform bacteria levels exceeding specifications.

    Product
    Formula C&F packaged in 1 FL OZ (29mL) droppers. HoneyCombs Industries, 10671 6075 Road, Montrose, CO 81403.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3071-2015·2015-09-09

    HoneyCombs Formula KB Recalled for Excessive Coliform Bacteria

    HoneyCombs Industries is recalling 133 units of Formula KB droppers because the powdered golden seal ingredient contained coliform bacteria levels above the specified limit.

    Product
    Formula KB packaged in 1 FL OZ (29mL) droppers. HoneyCombs Industries, 10671 6075 Road, Montrose, CO 81403.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3072-2015·2015-09-09

    HoneyCombs Formula L Recalled for Excessive Coliform Bacteria

    HoneyCombs Industries is recalling 68 units of Formula L droppers due to coliform counts exceeding specifications.

    Product
    Formula L packaged in 1 FL OZ (29mL) droppers. HoneyCombs Industries, 10671 6075 Road, Montrose, CO 81403.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3077-2015·2015-09-09

    Big Train Vanilla Chai Tea Mix Recalled for Mislabeling Sugar Content

    Big Train Inc. is recalling one lot of Vanilla Chai Tea Latte mix because it is labeled 'No Sugar Added' but actually contains sugar.

    Product
    Big Train Chai Tea Vanilla Chai, Naturally and Artificially Flavored Drink Mix, No Sugar Added, NET WT 56 oz (3 LB 8 OZ) 1.59kg lb), UPC 6 42628 10359 8. Case UPC code: 10642628103526 Soft sided 3.5 lb. pouch style package. Each case has 4 pouches.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0417-2015·2015-09-09

    Diagnostic Hybrids Recalls MicroVue Bb Plus EIA Kits Due to Inaccurate Results

    Diagnostic Hybrids Inc is recalling 171 MicroVue Bb Plus EIA kits because they produce concentration values approximately 50% higher than expected.

    Product
    MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Food)·F-3067-2015·2015-09-09

    HoneyCombs Recalls Golden Seal Extract Due to High Coliform Count

    HoneyCombs Industries is recalling 432 bottles of Golden Seal Extract because the product contained higher levels of coliform bacteria than allowed by specifications.

    Product
    Golden Seal Extract packaged in 1 FL OZ (29mL) droppers. HoneyCombs Industries, 10671 6075 Road, Montrose, CO 81403.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2722-2015·2015-09-09

    Transonic Flow Probe Recalled Due to Software Defect in EPROM

    Transonic Systems Inc is recalling a 6 mm Transonic Flow Probe due to a software defect causing incorrect meter readings.

    Product
    Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3073-2015·2015-09-09

    HoneyCombs Industries Recalls Expello-C Due to High Coliform Counts

    HoneyCombs Industries is recalling 262 bottles of Expello-C because the powdered golden seal ingredient contained coliform bacteria levels exceeding specifications.

    Product
    Expello-C packaged in 1 FL OZ (29mL) droppers. HoneyCombs Industries, 10671 6075 Road, Montrose, CO 81403.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1406-2015·2015-09-09

    Qualitest Recalls Lisinopril Tablets for Failed Dissolution Specifications

    Vintage Pharmaceuticals is recalling 8,705 bottles of Lisinopril 40 mg tablets because they failed dissolution specifications. The affected lots were distributed nationwide and in Puerto Rico.

    Product
    Lisinopril Tablets, USP, 40 mg, a) 45-count bottle (NDC 0603-4214-60), b) 500-count bottle (NDC 0603-4214-28), Rx Only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2723-2015·2015-09-09

    Transonic Flow Probe Recalled Due to Software Defect

    Transonic Systems Inc is recalling 8 mm Flow Probes due to a software defect that causes flow meters to display incorrect error messages.

    Product
    Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2642-2015·2015-09-09

    Customed Surgical Gowns Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling surgical gowns due to inadequate validation of sterilization processes and package integrity.

    Product
    GOWN SURG. POLY REINF. XL XLONG 40/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2728-2015·2015-09-09

    Transonic Flow Probe Recalled Due to Software Defect

    Transonic Systems Inc is recalling 4 mm Flow Probes due to software defects causing incorrect meter readings.

    Product
    Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2733-2015·2015-09-09

    Beckman Coulter Recalls Access Thyroglobulin Assay Reagent Packs

    Beckman Coulter is recalling Access Thyroglobulin Assay reagent packs because some may exhibit greater than 10% imprecision at low concentrations.

    Product
    Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2730-2015·2015-09-09

    Neuro Kinetics I-Portal NOTC System Recalled for Incorrect Investigational Labeling

    Neuro Kinetics is recalling 45 I-Portal NOTC systems because the OVAR research test was sold with an incorrect investigational label.

    Product
    Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2725-2015·2015-09-09

    Transonic Flow Probe Recalled Due to Software Defect

    Transonic Systems Inc is recalling 3 mm Flow Probes due to a software defect that causes flow meters to display incorrect status messages.

    Product
    Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2491-2015·2015-09-09

    Philips Ingenuity TF PET/MR Systems Recalled for Potential Database Lockup

    Philips is recalling 11 Ingenuity TF PET/MR systems because the PET Reconstruction Server database may lock up between scans, though no field issues have been reported.

    Product
    Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2663-2015·2015-09-09

    Customed Breast Packs Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 24 units of Breast Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    BREAST PACK-BOD 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2544-2015·2015-09-09

    Ortho VITROS 5,1 FS Chemistry System Software Recall

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems because a software anomaly may reset user-configured parameters to defaults during installation.

    Product
    VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644, IVD --- Ortho Clinical Diagnostics I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2486-2015·2015-09-09

    FDA Recalls Bright Embrace Bili Light Due to Incorrect Temperature Labeling

    Physician Engineered Products, Inc. is recalling 97 Bright Embrace Single Bili Lights because the upper limit for ambient temperature was printed incorrectly in the instructions.

    Product
    Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-2724-2015·2015-09-09

    Transonic Flow Probe Recalled Due to Software Defect in EPROM

    Transonic Systems Inc is recalling 2 mm Flow Probes due to programming errors causing incorrect meter readings.

    Product
    Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow intra-operatively.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1416-2015·2015-09-09

    Silarx Lamivudine Oral Solution Recalled for Mismatched Expiration Dates

    Silarx Pharmaceuticals is recalling 576 bottles of Lamivudine Oral Solution because the expiration date on the carton does not match the bottle label.

    Product
    Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc. Carmel, NY 10512, NDC 54838-0566-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2478-2015·2015-09-09

    Abbott FIRMap 60mm Catheter Recalled for Incorrect Expiration Date Labeling

    Abbott Electrophysiology is recalling 86 units of FIRMap 60mm Catheters because the expiration date was incorrectly printed on the labels.

    Product
    FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Sterile, Rx only Cardiovascular: For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to
    Category
    Medical Device
    Distribution
    19 states
  • SevereUSDA FSIS·120-2015·2015-09-08

    Olli Salumeria Americana Recalls Pork Salami Due to Misbranding

    Olli Salumeria Americana is recalling pork salami products because the packaging lacks an ingredient list, failing to disclose the presence of sulfites from wine.

    Product
    OLLI SALUMERIA AMERICANA — Olli Salumeria Americana, LLC Recalls Pork Products Due To Misbranding
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·15E073000·2015-09-08

    Cummins Recalls ISB, ISL, and ISX Engines Due to Stalling Risk

    Cummins is recalling certain ISB6.7, ISL9, ISX12, and ISX15 engines because a faulty Engine Control Module may cause the engine to stall without warning, increasing crash risk.

    Product
    ELECTRICAL SYSTEM:IGNITION:MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·121-2015·2015-09-08

    Schrader Farms Recalls Ground Beef Due To Possible Non-O157 E. Coli Contamination

    Schrader Farms is recalling approximately 20 pounds of ground beef sold in Seneca County, New York, due to possible non-O157 E. coli contamination.

    Product
    Schrader Farms, LLC — Schrader Farms Meat Market Recalls Beef Product Due To Possible Non-O157 E. Coli Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·15235·2015-09-08

    IKEA Recalls VYSSA SPELEVINK Crib Mattresses for Fire Hazard

    IKEA is recalling VYSSA SPELEVINK crib mattresses because they fail to meet federal flammability standards, posing a fire hazard. No injuries have been reported.

    Product
    VYSSA SPELEVINK crib mattresses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V566000·2015-09-08

    Hyundai Recalls 2009-2011 Accent Vehicles for Brake Light Switch Defect

    Hyundai is recalling approximately 99,500 2009-2011 Accent vehicles because a malfunctioning brake light switch may prevent brake lights from illuminating or disable cruise control.

    Product
    HYUNDAI — HYUNDAI ACCENT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15751·2015-09-08

    Nestlé Recalls Water Dispensers Due to Fire Hazard

    Nestlé Waters North America is recalling about 190 water dispensers because screws holding the heat band can break, causing the unit to overheat and posing a fire hazard.

    Product
    Water dispensers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V562000·2015-09-04

    New Flyer Transit Buses Recalled for Potential Steering Loss

    New Flyer is recalling 432 transit buses from 2013-2015 because a tie rod clamp may be improperly torqued, risking a loss of steering.

    Product
    NEW FLYER — NEW FLYER XN40, XN35, XD40, XD60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V561000·2015-09-04

    Keystone Recalls 2008-2009 Travel Trailers Due to Fire Risk

    Keystone is recalling 2008-2009 travel trailers and fifth wheels because a transfer switch may overheat and cause a fire.

    Product
    KEYSTONE — KEYSTONE CHALLENGER, RAPTOR, BIG SKY, EVEREST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V565000·2015-09-04

    Thomas Built Buses Recall Wheelchair Lifts with Potential Bearing Failure

    Daimler Trucks North America is recalling 4,334 Thomas Built Buses equipped with specific Ricon wheelchair lifts due to a defect that could cause the platform to fall.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2, SAF-T-LINER FS65, SAF-T-LINER HDX, MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V564000·2015-09-04

    Thomas Built Buses Recall Wheelchair Lifts Due to Bearing Defect

    Daimler Trucks North America is recalling 2006-2015 Thomas Built Buses equipped with certain Ricon wheelchair lifts. Defective pivot holes may allow bearings to move, risking platform failure and injury.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX, SAF-T-LINER HDX, SAF-T-LINER EF, MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V557000·2015-09-03

    Fontaine Recalls 2015 Traverse HT Trailers Due to Suspension Defect

    Fontaine Trailer Company is recalling 2015 Traverse HT trailers because a suspension member may separate from the trailer, increasing the risk of a crash.

    Product
    FONTAINE — FONTAINE TRAVERSE HT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15231·2015-09-03

    Cannondale Mountain Bicycles Recalled for Stem Failure and Fall Risk

    Cycling Sports Group is recalling about 23,000 Cannondale mountain bicycles because the OPI stem/steering tube can fail, posing a risk of injury from a fall.

    Product
    Cannondale mountain bicycles with OPI stem/steering tube
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15232·2015-09-03

    Prestone Windshield De-Icer and Ice & Frost Shield Recalled for Child Safety

    Prestone is recalling about 4.1 million bottles of windshield de-icer and frost shield because the trigger sprays can be removed, allowing children access to toxic chemicals.

    Product
    Prestone® Windshield De-Icer and Prestone® Ice & Frost Shield
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1357-2015·2015-09-02

    PharMEDium Recalls Heparin Sodium Injection Bags Due to Particulate Matter

    PharMEDium Services, LLC is recalling 240 bags of Heparin Sodium Injection USP 25,000 Units in 250 mL bags due to the presence of particulate matter.

    Product
    HEPARIN Sodium Injection USP 25,000 USP Units added to 250 mL 5% Dextrose Injection USP (100 units per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K0419, NDC# 61553-419-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-3045-2015·2015-09-02

    Kroger Black Pepper Recalled Due to Salmonella Contamination

    Kroger is recalling Black Pepper Coarse Ground because a related product tested positive for Salmonella. The recall covers items produced on the same filling line.

    Product
    Kroger Black Pepper Coarse Ground UPC 11110 70041 NET WT 17.1 oz plastic container
    Category
    Food
    Distribution
    31 states
  • CriticalFDA (Food)·F-3043-2015·2015-09-02

    Kroger Ground Cinnamon Recalled Due to Salmonella Risk on Filling Line

    The Kroger Co is recalling specific lots of Ground Cinnamon because a related product on the same line tested positive for Salmonella.

    Product
    Kroger Ground Cinnamon UPC 11110 70034 NEW WT. 18.3 oz Plastic container
    Category
    Food
    Distribution
    31 states
  • CriticalFDA (Food)·F-3047-2015·2015-09-02

    Fisher Brand Chopped Walnuts Recalled Due to Salmonella Contamination

    John B. Sanfilippo & Son Inc. is recalling Fisher Brand chopped walnuts after FDA testing found Salmonella. Consumers should stop using the product.

    Product
    Fisher Brand chopped walnuts, packaged in 10 ounce, polyethylene stand-up bag with zipper. The bag is blue with white lettering.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-3046-2015·2015-09-02

    Kroger Artificial Bacon Flavored Chips Recalled Due to Salmonella Risk

    The Kroger Co is recalling specific lots of Kroger Bac'n Buds Artificial Bacon Flavored Chips because a related product tested positive for Salmonella.

    Product
    Kroger Bac'n Buds ARTIFICIAL BACON FLAVORED CHIPS 14.1oz plastic container UPC 0 11110 70025 4
    Category
    Food
    Distribution
    31 states
  • CriticalFDA (Drugs)·D-1358-2015·2015-09-02

    PharMEDium Recalls Epinephrine Injection Bags Due to Particulate Matter

    PharMEDium Services, LLC is recalling 264 bags of Epinephrine HCl injection due to the presence of particulate matter in the saline solution.

    Product
    EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP (16 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6119, NDC# 61553-119-61.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1356-2015·2015-09-02

    PharMEDium Recalls Epinephrine Injection Bags Due to Particulate Matter

    PharMEDium Services, LLC is recalling 48 bags of Epinephrine HCl injection due to the presence of particulate matter in the solution.

    Product
    EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP (64 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6618, NDC# 61553-618-61.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1351-2015·2015-09-02

    Teva Recalls ADRUCIL Fluorouracil Injection Due to Particulate Matter

    Teva Pharmaceuticals USA is recalling ADRUCIL (fluorouracil injection) vials due to the presence of silicone rubber and fluorouracil crystals in the solution.

    Product
    ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by Teva Parenteral Medicines, Inc., Irvine, CA. NDC 073-3019-11 (individual vial), NDC 0703-3019-12 (carton of five).
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1354-2015·2015-09-02

    PharMEDium Recalls Epinephrine Injection Bags Due to Particulate Matter

    PharMEDium Services is recalling 36 bags of Epinephrine HCl injection due to the presence of particulate matter in the solution.

    Product
    EPINEPHrine HCl 1 mg added to 250 mL 0.9% Sodium Chloride Injection USP (4 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6244, NDC# 61553-244-61.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1389-2015·2015-09-02

    Liberty Drug Recalls Tobramycin Ophthalmic Solution Due to Sterility Concerns

    Liberty Drug & Surgical is recalling Tobramycin 14 mg/mL Ophthalmic Solution because process deficiencies may have compromised the product's sterility.

    Product
    Tobramycin 14 mg/mL Ophthalmic Solution, 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1362-2015·2015-09-02

    GlaxoSmithKline Recalls Mupirocin Calcium Cream Due to Penicillin Contamination

    GlaxoSmithKline is recalling Mupirocin Calcium Cream, 2%, because the product was contaminated with penicillin and foreign substances during manufacturing.

    Product
    Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC 66993-942-31), 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-1380-2015·2015-09-02

    Liberty Drug Recalls Cyanocobalamin Syringes Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 6 syringes of Cyanocobalamin 500 mcg/mL Injectable due to process deficiencies that could have compromised sterility.

    Product
    Cyanocobalamin 500 mcg/mL Injectable, 1 mL pre-filled syringe, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1397-2015·2015-09-02

    Liberty Drug Recalls Glycerin Injection Due to Sterility Concerns

    Liberty Drug & Surgical is recalling Glycerin 72% Injection vials because process deficiencies may have compromised sterility. The product was distributed to physicians and facilities in NJ and NY.

    Product
    Glycerin (v/v) 72% Injection, 25 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-1381-2015·2015-09-02

    Liberty Drug Recalls Papaverine Injectable Due to Sterility Concerns

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

    Product
    Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/1 mg/10 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-1395-2015·2015-09-02

    Liberty Drug Recalls Dexamethasone Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 22 vials of Dexamethasone 24 mg/mL Injectable due to process deficiencies that could have compromised sterility.

    Product
    Dexamethasone 24 mg/mL Injectable, 1 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-1388-2015·2015-09-02

    Liberty Drug Recalls Doxycycline IV Bags Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 88 bags of Doxycycline IV solution because process deficiencies may have compromised sterility.

    Product
    Doxcycline/0.9% NaCl 150 mg/150 mL IV, 150 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-1365-2015·2015-09-02

    Mucinex Fast-Max Cold & Sinus Recalled for Missing Drug Facts Labeling

    Reckitt Benckiser is recalling Mucinex Fast-Max Cold & Sinus liquid because the back of the bottle is missing active ingredients and safety warnings.

    Product
    Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. by: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-016-66,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1367-2015·2015-09-02

    Mucinex Fast Max Liquid Recalled for Missing Drug Facts Labeling

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

    Product
    Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 638
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1400-2015·2015-09-02

    Liberty Drug Recalls Papaverine Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling specific lots of Papaverine/Phentolamine/Atropine/PGE-1 Injectable due to process deficiencies that could compromise sterility.

    Product
    Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 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-1391-2015·2015-09-02

    Liberty Drug Recalls 17-Hydroxyprogesterone Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 85 vials of 17-Hydroxyprogesterone injectable because process deficiencies may have compromised sterility.

    Product
    17-Hydroxyprogesterone 250 mg/mL Injectable, 5 mL multi-dose vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1385-2015·2015-09-02

    Liberty Drug Recalls Papaverine Injectable Due to Sterility Concerns

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

    Product
    Papaverine/Phentolamine/PGE-1 Injectable, 10 mg/0.6 mg/10 mcg/mL, 2.5 mL vials, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1386-2015·2015-09-02

    Liberty Drug Recalls Papaverine Injectable Due to Sterility Concerns

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

    Product
    Papaverine/Phentolamine/PGE-1 Injectable, 20.8 mg/1.4 mg/14 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-1403-2015·2015-09-02

    Liberty Drug Recalls Lidocaine Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling Lidocaine/Sodium Chloride injectable vials because process deficiencies may have compromised sterility.

    Product
    Lidocaine/Sodium Chloride 0.4%/20% Injectable, 5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereUSDA FSIS·119-2015·2015-09-02

    Kenosha Beef Recalls Pork Sausage Patties Due to Metal Contamination

    Kenosha Beef International is recalling approximately 89,235 pounds of Johnsonville pork sausage patties that may contain small pieces of metal.

    Product
    Kenosha Beef International Ltd — Kenosha Beef Recalls Pork Sausage Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Drugs)·D-1387-2015·2015-09-02

    Liberty Drug Recalls Vancomycin Ophthalmic Solution Due to Sterility Concerns

    Liberty Drug & Surgical is recalling Vancomycin 25 mg/mL Ophthalmic Solution because process deficiencies may have compromised the product's sterility.

    Product
    Vancomycin 25 mg/mL Opthalmic Solution, packaged in a) 10 mL bottle and b) 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1384-2015·2015-09-02

    Liberty Drug Recalls Papaverine/Phentolamine/PGE-1 Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 2 vials of Papaverine/Phentolamine/PGE-1 Injectable because process deficiencies may have compromised sterility.

    Product
    Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/2 mg/20 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-1390-2015·2015-09-02

    Liberty Drug Recalls Doxycycline IV Bags Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 58 bags of Doxycycline IV solution because process deficiencies may have compromised sterility.

    Product
    Doxycycline/0.9 % NaCl 100 mg/100 mL IV, 100 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-1396-2015·2015-09-02

    Morphine IV Bags Recalled Due to Sterility Assurance Concerns

    Liberty Drug & Surgical is recalling four bags of Morphine/0.9% NaCl IV solution because process deficiencies may have compromised sterility.

    Product
    Morphine/0.9 % NaCl 1 mg/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
  • SevereNHTSA·15V551000·2015-09-02

    Foretravel Recalls 2012-2014 Motorhomes Due to Loose Front Ball Joints

    Foretravel is recalling 2012-2014 Nimbus, Phenix, and IH45 motorhomes because loose front ball joints may separate, causing loss of steering control and increasing crash risk.

    Product
    FORETRAVEL — FORETRAVEL NIMBUS, IH45, PHENIX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2451-2015·2015-09-02

    Synthes Trauma Ex-Fix System Recalled for MR Labeling Corrections

    Synthes (USA) Products LLC is recalling the Trauma Ex-Fix System to correct MRI safety labeling. The recall identifies additional part numbers as MR Conditional and notes one serious injury.

    Product
    Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle; (M) for the construction of an external fixation frame for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1392-2015·2015-09-02

    Liberty Drug Recalls Hydroxocobalamin Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 15 vials of Hydroxocobalamin Injectable due to process deficiencies that could have compromised sterility.

    Product
    Hydroxocobalamin (Preserved) 10,000 mcg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-3053-2015·2015-09-02

    Fresh Unlimited Recalls Kale Caesar Pasta Salad Due to Undeclared Eggs

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

    Product
    Kale Caesar Pasta Recovery Salad, 3.375# (1530g) INGREDIENTS: COOKED TRI-ROTINI PASTA***CAESAR DRESSING (Soybean Oil, Water, Distilled Vinegar, Romano Cheese*** ALLERGENS: FISH, MILK, WHEAT
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-1359-2015·2015-09-02

    Bactroban Nasal Ointment Recalled for Penicillin Contamination

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

    Product
    Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. NDC 0029-1526-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2462-2015·2015-09-02

    Arrow International Recalls PICC Kits with Potential Peel-Away Sheath Defect

    Arrow International is recalling 52,109 PICC kits because the peel-away sheath hub tabs may prematurely detach. One injury has been reported.

    Product
    PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1355-2015·2015-09-02

    PharMEDium Recalls Heparin Sodium Injection Bags Due to Particulate Matter

    PharMEDium Services is recalling 480 bags of Heparin Sodium Injection USP due to the presence of particulate matter. The product was distributed nationwide.

    Product
    HEPARIN Sodium Injection USP, 12,500 USP Units added to 250 mL 5% Dextrose Injection USP (50 units per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K0418, NDC# 61553-418-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1382-2015·2015-09-02

    Liberty Drug Recalls Methylcobalamin Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling Methylcobalamin 5000 mcg/mL Injectable vials due to process deficiencies that could have compromised sterility.

    Product
    Methylcobalamin 5000 mcg/mL Injectable, 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-1398-2015·2015-09-02

    Liberty Drug Recalls Phenol 6% Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling Phenol 6% Injectable vials because process deficiencies may have compromised the product's sterility.

    Product
    Phenol 6% Injectable, 30 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-1402-2015·2015-09-02

    Liberty Drug Recalls Hydroxocobalamin Injectable Due to Sterility Concerns

    Liberty Drug & Surgical is recalling 6 vials of Hydroxocobalamin Injectable due to process deficiencies that could have compromised sterility.

    Product
    Hydroxocobalamin (Preserved) 1,000 mcg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.
    Category
    Drug
    Distribution
    2 states

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