The Recall Desk

Archive

December 2014 recalls

1,028 recalls were announced in December 2014.

What the numbers show

Critical
72
Severe
272
High
309
Moderate
311
Low
64

Of the 1,028 recalls this month scored against our rubric, 7% are Critical, 26% are Severe.

Which agencies issued them

1001–1028 of 1028

  • ModerateFDA (Devices)·Z-0449-2015·2014-12-03

    Remel TB Potassium Permanganate Stain Recalled for Performance Issues

    Remel Inc is recalling TB Potassium Permanganate stain due to potential cloudiness or discoloration that may affect mycobacterial diagnosis.

    Product
    Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycobacteria.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0420-2015·2014-12-03

    Siemens Hemoglobin A1c Reagent Cartridges Recalled for Positive Bias

    Siemens is recalling certain lots of Dimension HB1C Flex reagent cartridges because they show a positive bias in hemoglobin A1c measurements.

    Product
    Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Meas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0435-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Resano Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 8mm Resano Forceps instruments because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0448-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Tip-Up Fenestrated Graspers for Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Tip-Up Fenestrated Graspers because deviations in reprocessing steps can cause surface degradation and mechanical wear.

    Product
    8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0436-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Permanent Cautery Hooks Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 8mm Permanent Cautery Hooks because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM PERMANENT CAUTERY HOOK,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0258-2015·2014-12-03

    Actavis Recalls Diclofenac Sodium and Misoprostol Tablets Due to Split Tablets

    Actavis Laboratories is recalling 5,451 bottles of Diclofenac Sodium and Misoprostol tablets because some contain split or broken tablets.

    Product
    DICLOFENAC SODIUM AND MISOPROSTOL — DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0467-2015·2014-12-03

    Biomerica Recalls Calcitonin ELISA Kits Due to Potential False High Values

    Biomerica is recalling Calcitonin ELISA Kits because they may produce false high values. The recall covers 1,062 units distributed worldwide.

    Product
    Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0431-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Micro Bipolar Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Micro Bipolar Forceps because deviations in reprocessing steps can cause surface degradation and mechanical wear.

    Product
    8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0444-2015·2014-12-03

    Intuitive Surgical Recalls 8mm MEGA SUTURECUT ND Instruments

    Intuitive Surgical is recalling 509 units of 8mm MEGA SUTURECUT ND instruments due to potential surface degradation and accelerated mechanical wear.

    Product
    8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0484-2015·2014-12-03

    CooperSurgical LEEP Loop Electrode Recalled for Outer Box Mislabeling

    CooperSurgical is recalling LEEP Radius Loop Electrodes because the outer box is mislabeled with the wrong part number.

    Product
    CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0425-2015·2014-12-03

    Discus Dental Recalls Relief ACP Oral Care Gel Due to Filling Error

    Discus Dental LLC is recalling Relief ACP Oral Care Gel because some units were filled with hydrogen peroxide instead of phosphate gel, potentially causing increased sensitivity.

    Product
    Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0477-2015·2014-12-03

    ZOLL Recalls NeuroFlo Catheter Due to Missing Regulatory Filing

    ZOLL Circulation is recalling one lot of NeuroFlo Catheters because a required regulatory supplement was not filed after the company acquired the product's assets.

    Product
    7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage. The NeuroFlo Catheter is und
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0466-2015·2014-12-03

    Remel Recalls Oxoid Legionella Latex Test Due to False Negative Results

    Remel Inc is recalling Oxoid Legionella Latex Test kits because a reagent may produce false negative results. The recall covers 59 boxes distributed nationwide.

    Product
    Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Latex Reagent, DR0802, Lot 1301912. The responsible firm on the label is Oxoid Ltd.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0463-2015·2014-12-03

    Abbott m2000sp Software Incompatibility Recall for Nucleic Acid Testing

    Abbott Molecular is recalling m2000sp CD-ROMs because some Application Specifications are incompatible with software versions 6.0 and 7.0, causing error code 9000.

    Product
    Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0257-2015·2014-12-03

    Zydus Recalls Amlodipine Besylate Tablets Due to Discoloration

    Zydus Pharmaceuticals is recalling Amlodipine Besylate 10 mg tablets due to brown spots embedded in the product.

    Product
    AMLODIPINE BESYLATE — AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0469-2015·2014-12-03

    Novadaq LUNA Chest Recalled for Sterile Labeling Error

    Novadaq Technologies is recalling 828 LUNA Chest units because non-sterile drapes were inadvertently mislabeled as sterile.

    Product
    LUNA Chest, Model No. LU4006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0470-2015·2014-12-03

    Novadaq Non-Sterile Drape Recalled for Incorrect Sterile Labeling

    Novadaq Technologies is recalling 324 non-sterile LUNA drapes that were inadvertently mislabeled with an additional contents sterile label.

    Product
    Non-sterile drape
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0226-2015·2014-12-03

    Synthes Recalls Titanium Polyaxial Reduction Heads for Spine Screws

    Synthes (USA) Products LLC is recalling 24 Titanium Polyaxial Reduction Heads for Matrix Spine Screws because the inner diameter may not have been machined to the correct specification.

    Product
    Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System. Intended for posterior pedicle screw fixation (Tl OS2- ilium), posterior hook fixation (Tl-L5), or anterolateral fixation (T
    Category
    Medical Device
    Distribution
    3 states
  • HighCPSC·15039·2014-12-02

    Daikin Streamer Air Purifiers Recalled for Fire Hazard

    Daikin is recalling Streamer air purifiers because the circuit board can overheat and cause a fire. No injuries have been reported.

    Product
    Daikin Streamer air purifiers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15710·2014-12-02

    Eaton Recalls Electrical Meter Breakers Due to Shock Hazard

    Eaton is recalling about 1,100 MBED 3042 series residential meter breakers because their electrical components can be easily accessed, posing a shock hazard.

    Product
    Electrical Meter Breakers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V763000·2014-12-01

    Subaru Recalls 2003-2005 Models for Air Bag Inflator Rupture Risk

    Subaru is recalling 2003-2005 Legacy, Outback, and Baja vehicles in high-humidity areas because the passenger air bag inflator may rupture during deployment.

    Product
    SUBARU — SUBARU OUTBACK, LEGACY, BAJA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V764000·2014-12-01

    Mercedes-Benz Recalls 2014-2015 Sprinter Vehicles Due to Oil Leak Fire Risk

    Mercedes-Benz is recalling 2014-2015 Sprinter 2500 and 3500 vans because oil may leak from the chain tensioner gasket, posing a fire and road hazard risk.

    Product
    MERCEDES BENZ — MERCEDES BENZ, MERCEDES-BENZ SPRINTER 2500, SPRINTER 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V762000·2014-12-01

    Mercedes-Benz Recalls 2014-2015 Models Due to Oil Leak Fire Risk

    Mercedes-Benz is recalling 4,871 vehicles because oil may leak from the chain tensioner gasket, posing a fire and road hazard risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLK250, ML250, E250
    Category
    Vehicle
    Distribution
    Distributed nationwide

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