The Recall Desk

Archive

February 2015 recalls

651 recalls were announced in February 2015.

What the numbers show

Critical
223
Severe
214
High
145
Moderate
59
Low
10

Of the 651 recalls this month scored against our rubric, 34% are Critical, 33% are Severe.

Which agencies issued them

601–651 of 651

  • SevereFDA (Food)·F-0930-2015·2015-02-04

    Groove Gluten-Free Ice Cream Sandwich Recalled for Listeria Risk

    Great Feeling Foods is recalling Groove Gluten-Free Ice Cream Sandwiches due to potential Listeria monocytogenes contamination from an ice cream ingredient.

    Product
    Groove Gluten-Free Peanut Butter Cookie & French Vanilla Ice Cream Sandwich. The product is sold in 3 fl. oz. single packs and 6 fl. oz. 2-packs and labeled as Groove. The UPC codes are 8 52692 00407 7 and 8 52692 00401 5.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0927-2015·2015-02-04

    Groove Gluten-Free Ice Cream Sandwich Recalled for Listeria Risk

    Great Feeling Foods is recalling Groove Gluten-Free Ice Cream Sandwiches due to potential Listeria monocytogenes contamination from an ice cream base ingredient.

    Product
    Groove Gluten-Free Chocolate Chip Cookie & French Vanilla Ice Cream Sandwich. The product is sold in 3 fl. oz. single packs and 6 fl. oz. 2-packs and labeled as Groove. The UPC codes are 8 52692 00404 6 and 8 52692 00400 8.
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·15V063000·2015-02-04

    Utility Recalls 2014-2015 Trailers Due to Brake Actuator Defect

    Utility Trailer Manufacturing Company is recalling 2014-2015 trailers because a brake actuator defect may cause overheating and fire.

    Product
    UTILITY — UTILITY, UTILITY TRAILER VS1RA, VS1DC, VS2DX, VS2RA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0812-2015·2015-02-04

    SunBurst Foods Recalls Twin Ham Biscuits Due to Listeria Risk

    SunBurst Foods is recalling Twin Ham Biscuits because they may be contaminated with Listeria monocytogenes. The affected products were distributed in North Carolina, New Jersey, and South Carolina.

    Product
    Twin Ham Biscuits, Net Wt. 2.50 oz. and 3.00 oz., UPC 7-01248-00124-7, MFG Code 125
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1013-2015·2015-02-04

    Siemens Syngo RT Therapist Software Recall Due to Mistreatment Risk

    Siemens is recalling Syngo RT Therapist software because a combination with CTVision may cause wrong offset calculations, leading to patient mistreatment.

    Product
    Syngo RT Therapist: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer
    Category
    Medical Device
    Distribution
    3 states
  • SevereNHTSA·15V064000·2015-02-04

    GM Recalls 2006-2007 Chevrolet and Pontiac Vehicles for Steering Defect

    General Motors is recalling specific 2006-2007 Chevrolet Malibu, Malibu Maxx, and Pontiac G6 vehicles because the electric power steering assist may suddenly fail, increasing crash risk.

    Product
    CHEVROLET — CHEVROLET, PONTIAC MALIBU, G6, MALIBU MAXX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0818-2015·2015-02-04

    SunBurst Foods Recalls Double Cheese Dogs Due to Listeria Risk

    SunBurst Foods is recalling specific lots of Double Cheese Dogs because they may be contaminated with Listeria monocytogenes.

    Product
    Double Cheese Dogs, Net WT., 6.40 oz., UPC 7-01248-00802-4, MFG Code 650
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0859-2015·2015-02-04

    SunBurst Foods Recalls Fried Bologna Sandwiches for Listeria Risk

    SunBurst Foods is recalling specific lots of Fried Bologna Sandwiches due to a potential Listeria monocytogenes contamination.

    Product
    Fried Bologna Sandwich (on bun), Net Wt. 3.80 oz., UPC 7-01248-00329-6, MFG Code 275
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0814-2015·2015-02-04

    SunBurst Foods Recalls Cheese Cubes with Crackers Due to Listeria Risk

    SunBurst Foods, Inc. is recalling specific lots of Cheese Cubes with Crackers due to a potential Listeria monocytogenes contamination.

    Product
    Cheese Cubes with Crackers (Vac Pack), Net Wt. 3.50 oz., UPC 7-01248-00160-5, MFG Code 1049
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1022-2015·2015-02-04

    Innokas Medical VC150 Vital Signs Monitor Recalled for Alarm Failure

    Innokas Medical is recalling 20 VC150 Vital Signs Monitors because they may fail to issue visual and audible alarms when SpO2 or RRa values violate limits during mode switching.

    Product
    VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medical Oy. Catalog numbers 2067980-002, 2067980-006, 2067980-010, and 2067980-014.
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·15V065000·2015-02-04

    Morgan Olson Recalls 2014 Service Body Trucks for Lighting Defects

    Morgan Olson is recalling 11 model year 2014 Service Body trucks because rear identification and license plate lamps may be mounted incorrectly, reducing visibility.

    Product
    MORGAN OLSON — MORGAN OLSON SERVICE BODY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V066000·2015-02-04

    Piaggio Recalls Vespa and Piaggio Motorcycles Due to Fuel Pump Defect

    Piaggio is recalling specific Vespa and Piaggio motorcycles because a defective fuel pump may cause the vehicle to stall or fail to restart, increasing crash risk.

    Product
    VESPA — VESPA, PIAGGIO LX 150, GTS SUPER 250, GTV 250, BV 250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1011-2015·2015-02-04

    Philips BrightView MRI Systems Recalled for Unintended Movement

    Philips is recalling 1,064 BrightView MRI systems worldwide due to software issues causing unintended detector and gantry movement.

    Product
    BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1014-2015·2015-02-04

    Clinical Innovations Recalls Ebb Complete Tamponade System Due to Balloon Leak Risk

    Clinical Innovations, LLC is recalling 827 units of the Ebb Complete Tamponade System because of a potential for balloon leaks in lots manufactured since August 2014.

    Product
    Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1016-2015·2015-02-04

    Mobius Airo Mobile Intraoperative CT System Recalled for Data Transfer Errors

    Mobius Imaging is recalling 21 Airo Mobile Intraoperative CT systems because a software error may cause incorrect or missing navigation data to transfer to the Brainlab Curve system.

    Product
    Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1031-2015·2015-02-04

    Baxter HomeChoice Peritoneal Dialysis Cycler Recalled for Keypad Malfunction

    Baxter Healthcare is recalling HomeChoice and HomeChoice Pro automated peritoneal dialysis cyclers because the keypad buttons may activate without being pressed.

    Product
    HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-1020-2015·2015-02-04

    Sunrise Medical Recalls Six Quickie Q7 Adult Rigid Wheelchairs

    Sunrise Medical is recalling six Quickie Q7 Adult Rigid Wheelchairs because the height-adjustable handle may dislodge due to failing locking mechanisms.

    Product
    Quickie Q7 Adult Rigid Wheelchair Model EIR4.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1023-2015·2015-02-04

    Beckman Coulter Lipase Assay Recalled Due to NAC Interference

    Beckman Coulter is recalling Lipase Assay kits because N-acetyl cysteine can cause falsely low results.

    Product
    Beckman Coulter, Lipase Assay, Catalog No. OSR6X30
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1012-2015·2015-02-04

    Aesculap Miethke Shunt System Accessories Recalled for Incorrect MR Safety Labeling

    Aesculap, Inc. is recalling Miethke Shunt System accessories because the shelf box labels incorrectly display an MR conditional symbol. The product is actually MR unsafe, and the correct information is only provided in the Instructions for Use.

    Product
    Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1024-2015·2015-02-04

    Beckman Coulter Uric Acid Assay Recalled Due to NAC Interference

    Beckman Coulter is recalling Uric Acid Assay kits because N-acetyl cysteine administration can cause falsely low test results.

    Product
    Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0380-2015·2015-02-04

    Baxter Recalls Fluconazole Injection Bags Due to Seal Defects

    Baxter Healthcare is recalling 31,130 bags of Fluconazole Injection due to potential leaks from incomplete seals, which may compromise sterility.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1026-2015·2015-02-04

    Beckman Coulter Lactate Assay Recalled Due to NAC Interference

    Beckman Coulter is recalling Lactate Assay kits because N-acetyl cysteine (NAC) administration can cause falsely low test results.

    Product
    Beckman Coulter, Lactate Assay, Catalog No. OSR6X93
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1021-2015·2015-02-04

    Synthes 2.0 Mandible Locking Plate Bender Recall for Tip Breakage

    Synthes, Inc. is recalling 973 units of the 2.0 Mandible Locking Plate Bender/Cutter because the tips may break during use, potentially delaying surgery.

    Product
    2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1009-2015·2015-02-04

    Synthes Mandible External Fixator Recalled for Incorrect MR Safe Labeling

    Synthes, Inc. is recalling Mandible External Fixators because updated testing protocols mean the devices can no longer be designated MR Safe, despite previous labeling.

    Product
    The Synthes Mandible External Fixator; all lots of part nos.: 04.305.003 04.305.004 04.305.005 04.305.010 04.305.011 04.305.012 03.305.006 04.305.100 04.305.101 04.305.102 04.305.103 04.305.128 04.305.130 04.305.134 04.305.138 04.305.140 04.305.142…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1015-2015·2015-02-04

    Fresenius Medical Care Recalls Unqualified Hemodialysis Power Supply Assemblies

    Fresenius Medical Care is recalling 10 unqualified power supply assemblies for specific hemodialysis machines. The components were distributed in Oklahoma and Florida.

    Product
    ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Delivery System
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1025-2015·2015-02-04

    Beckman Coulter Cholesterol Assay Recalled Due to NAC Interference

    Beckman Coulter is recalling Cholesterol Assay kits because N-acetyl cysteine administration can cause falsely low results.

    Product
    Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0926-2015·2015-02-04

    LaBree's Bakery Recalls Chocolate Chip Mini Muffins for Foreign Material

    LaBree's Bakery is recalling 205 cases of Chocolate Chip Mini Muffins due to the presence of foreign material. The product was distributed in Michigan and New York.

    Product
    LaBree's Bakery Chocolate Chip Mini Muffins, 12 pack. Net wt. 10 oz. packaged in plastic clamshell. Frozen Product Code: 7778
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1027-2015·2015-02-04

    Siemens Syngo.plaza PACS Recalled for Potential Image Loss During System Crashes

    Siemens Medical Solutions is recalling 50 Syngo.plaza PACS systems because images may be lost if the system crashes before saving data to the hard disk.

    Product
    Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1010-2015·2015-02-04

    Baxter Recalls Four Lead TUR Irrigation Sets Due to Seal Failure Risk

    Baxter Healthcare is recalling 26,028 units of Four Lead TUR Irrigation Sets because the pouch packaging seal may fail at high altitudes.

    Product
    Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.2 m)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0955-2015·2015-02-04

    GE Healthcare Recalls Revolution CT Scanners Due to Missing Quality Control Test

    GE Healthcare is recalling 13 Revolution CT scanners because a required quality control test was not performed during installation.

    Product
    The Revolution CT is a multi-slice (256 detector row) CT scanner consisting of a gantry, patient table, scanner desktop (operator console), system cabinet, power distribution unit (POU). and interconnecting cables.The system includes image acquisition hardware, image acquisition…
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1032-2015·2015-02-04

    Fresenius Kabi Recalls HEPFLUSH-10 Heparin Lock Flush Solution Due to pH Failure

    Fresenius Kabi is recalling HEPFLUSH-10 heparin lock flush solution because a specific lot failed pH specifications. The recall covers 69,725 units distributed nationwide.

    Product
    HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1029-2015·2015-02-04

    Orthosensor Recalls Verasense Knee System Due to Inoperable Sensor Pad

    Orthosensor, Inc. is recalling 22 Verasense Knee System devices because one sensor pad is inoperable. The devices were distributed to six U.S. states.

    Product
    Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery.
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Devices)·Z-1028-2015·2015-02-04

    Smiths Medical Recalls Arterial Blood Sampling Kits Due to Labeling Error

    Smiths Medical ASD, Inc. is recalling 900 units of Portex Anaerobic Pulsator Arterial Blood Sampling Kits because the inner unit label displays an expiration date one year later than the actual date.

    Product
    Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Number: G1392 Product Usage: The Arterial Blood Sampling Kit is intended for sampling arterial blood for the measurement of blood gasses, Cooximetry…
    Category
    Medical Device
    Distribution
    1 state
  • LowUSDA FSIS·028-2015·2015-02-04

    Krehbiels Specialty Meats Recalls Pork Bratwurst Due to Misbranding

    Krehbiels Specialty Meats is recalling approximately 29 pounds of pork bratwurst because the label failed to list all ingredients due to a printing error.

    Product
    Krehbiels Specialty Meats Inc — Recall Notification Report 028-2015 (Bratwurst)
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1030-2015·2015-02-04

    Arrow Medical Kits Recalled for Incorrect Biopatch Dressing Size

    Arrow International Inc. is recalling specific medical kits because they were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.

    Product
    Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V057000·2015-02-03

    Mack Pinnacle Trucks Recalled for Brake Reservoir Defect

    Mack is recalling 2014-2015 Pinnacle trucks because a smaller air reservoir may increase stopping distance, raising crash risk.

    Product
    MACK — MACK PINNACLE (CXU)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V061000·2015-02-03

    Newmar Recalls 2014-2015 King Aire and Essex Vans for Brake Valve Defect

    Newmar is recalling 98 model year 2014-2015 King Aire and Essex vehicles because a damaged valve diaphragm may reduce air pressure, potentially compromising braking performance.

    Product
    NEWMAR — NEWMAR KING AIRE, ESSEX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V060000·2015-02-03

    Blue Bird Recalls 2011-2016 All American Buses for Exhaust Hanger Failure

    Blue Bird is recalling 2011-2016 All American rear engine transit buses because exhaust system hangers may fail, potentially causing housings to fall onto the roadway.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V055000·2015-02-02

    Husqvarna FE 350 S and FE 501 S Recalled for Front Fork Defect

    KTM is recalling 2015 Husqvarna FE 350 S and FE 501 S motorcycles because the front fork piston rod may not be tightened correctly, increasing crash risk.

    Product
    HUSQVARNA — HUSQVARNA FE 501 S, FE 350 S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V054000·2015-02-02

    Nissan Recalls Infiniti and GT-R Vehicles for Steering Column Defect

    Nissan is recalling specific 2008-2009 Infiniti and Nissan GT-R vehicles because a steering column defect may cause loss of steering, increasing crash risk.

    Product
    INFINITI — INFINITI, NISSAN EX35, GT-R, FX35, FX45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V056000·2015-02-02

    Mack Recalls 2015 LEU Trucks Due to Door Latch Defect

    Mack is recalling 2015 LEU trucks because a short door component may prevent opening from inside, hindering emergency egress.

    Product
    MACK — MACK LEU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V053000·2015-02-02

    Brammo Recalls 2013-2014 Empulse Motorcycles Due to Oil Leak Hazard

    Brammo is recalling 2013-2014 Empulse and Empulse R motorcycles because oil may leak from the transmission onto the rear tire, increasing crash risk.

    Product
    BRAMMO — BRAMMO EMPULSE, EMPULSE R
    Category
    Vehicle
    Distribution
    Distributed nationwide

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