The Recall Desk

Archive

September 2018 recalls

633 recalls were announced in September 2018.

What the numbers show

Critical
19
Severe
188
High
305
Moderate
102
Low
19

Of the 633 recalls this month scored against our rubric, 3% are Critical, 30% are Severe.

1–100 of 633

  • SevereNHTSA·18V680000·2018-09-28

    BMW Recalls 2019 X6 and X6 M for Rear Suspension Defect

    BMW is recalling 2019 X6 and X6 M vehicles because improperly hardened rear suspension bolts may break, increasing crash risk.

    Product
    BMW — BMW X6, X6 M
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V681000·2018-09-28

    KZRV Sonic Travel Trailer Recall for Propane Manifold Fire Risk

    KZRV is recalling 2017-2019 Sonic 190VRB travel trailers because the liquid propane manifold may be located close to the axle tube, posing a fire risk.

    Product
    KZRV — KZRV SONIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18234·2018-09-28

    Boy Story Recalls Mason and Billy Action Dolls Due to Choking Hazard

    Boy Story is recalling Mason and Billy action dolls because the vinyl joints can break, creating pieces that pose a choking hazard to young children.

    Product
    Mason & Billy action dolls and Mason & Billy HeForShe special edition action dolls
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalNHTSA·18V662000·2018-09-27

    Honda Recalls 2010-2014 Vehicles for Air Bag Inflator Explosion Risk

    Honda is recalling 2010-2014 Ridgeline, Element, and Acura RL vehicles because the passenger air bag inflator may explode, posing a risk of serious injury or death.

    Product
    HONDA — HONDA, ACURA RIDGELINE, ELEMENT, RL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V661000·2018-09-27

    Honda Recalls Vehicles for Frontal Air Bag Inflator Explosion Risk

    Honda is recalling specific 2010-2015 models because the passenger frontal air bag inflator may explode, potentially causing serious injury or death.

    Product
    HONDA — HONDA, ACURA CIVIC, INSIGHT, CROSSTOUR, PILOT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V678000·2018-09-27

    Forest River Recalls 2019 Flagstaff and Rockwood Trailers for Brake Defect

    Forest River is recalling 2019 Flagstaff and Rockwood recreational trailers because incorrectly oriented brake mounting flanges may cause premature brake failure, increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER FLAGSTAFF, ROCKWOOD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·18235·2018-09-27

    Life Fitness Recalls PowerMill Climbers Due to Fire Hazard

    Life Fitness is recalling about 11,800 PowerMill climbers because liquid entering the power receptacle can cause electrical arcing, sparking, and fire.

    Product
    PowerMill climbers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V664000·2018-09-27

    Honda Recalls 2019 Insight, Odyssey, and Ridgeline for Air Bag Defect

    Honda is recalling 2019 Insight, Odyssey, and Ridgeline vehicles because a manufacturing error in the SRS control unit may prevent air bags or seatbelt pretensioners from deploying in a crash.

    Product
    HONDA — HONDA RIDGELINE, ODYSSEY, INSIGHT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V663000·2018-09-27

    Honda Recalls 2017-2018 Civic and CR-V for Steering Defect

    Honda is recalling 2017-2018 Civic and CR-V vehicles because a loose magnet in the electric power steering system may cause unintended steering input, increasing crash risk.

    Product
    HONDA — HONDA CIVIC, CR-V
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18240·2018-09-27

    IKEA Recalls CALYPSO Ceiling Lamps Due to Falling Glass Shade Hazard

    IKEA is recalling CALYPSO ceiling lamps because the glass shade can detach and fall, posing impact and laceration hazards. Consumers should stop using the lamps and return them for a refund or replacement.

    Product
    CALYPSO Ceiling Lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-3012-2018·2018-09-26

    Ventana Recalls CINtec p16 Histology Reagent Due to Dispenser Defects

    Ventana Medical Systems is recalling 468 units of CINtec p16 Histology reagent because leaking dispensers may cause false negative test results.

    Product
    CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Food)·F-1973-2018·2018-09-26

    Market of Choice Recalls Sesame Noodle Salad Vegan for Undeclared Egg

    Market of Choice Inc is recalling Sesame Noodle Salad Vegan in 8 oz. and 16 oz. containers due to undeclared egg. The product was distributed in Oregon.

    Product
    Sesame Noodle Salad Vegan, packaged in 8 oz. or 16 oz. plastic container. UPC of 8 oz. container: 0 211630 203994. UPC of 16 oz. container: 0 211637 807492. The label is read in parts: "***SESAME NOODLE SALAD VEGAN***Soba Noodles (wheat, our, buckwheat, tapioca starch, s
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-0003-2019·2018-09-26

    QuVa Pharma Recalls Subpotent Norepinephrine IV Bags Nationwide

    QuVa Pharma is recalling 528 bags of Norepinephrine 4 mg in 5% Dextrose because the active ingredient may be missing. The product was distributed to hospitals nationwide.

    Product
    Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 08804, UPC 70092103417.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3194-2018·2018-09-26

    Fresenius 2008T Hemodialysis Systems Recalled for Disinfectant Exposure Risk

    Fresenius Medical Care is recalling 80 hemodialysis systems because a power failure during cleaning may allow disinfectant to remain in the machine and be delivered to patients.

    Product
    2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1193-2018·2018-09-26

    Beaumont Bio-Med Recalls Sinus Response Homeopathic Formula Due to CGMP Deviations

    Beaumont Bio-Med, Inc. is recalling 90 bottles of Sinus Response Homeopathic Formula due to manufacturing deviations that could result in microbial contamination.

    Product
    Sinus Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7013-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2999-2018·2018-09-26

    Ventana Medical Systems Recalls ultraView SISH DNP Detection Kit Due to Leaking

    Ventana Medical Systems is recalling 96 units of the ultraView SISH DNP Detection Kit because leaking and sticking dispensers may cause false negative IHC results.

    Product
    ultraView SISH DNP Detection Kit US, Catalog Number 05572037001, model 760-098 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2970-2018·2018-09-26

    Pro-Med DORO LUCENT Headrest System Recalled for Malfunction Risk

    Pro-Med Instruments is recalling 30 DORO LUCENT Headrest Systems because mixing design revisions may cause malfunction during surgery.

    Product
    DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Food)·F-1968-2018·2018-09-26

    Campomex USA Fresh Cilantro Recalled Due to Cyclospora Contamination

    Campomex USA is recalling fresh cilantro found positive for Cyclospora. The product was distributed in California after being mistakenly released from import hold.

    Product
    Campomex USA fresh cilantro: 5 dozens (60) per box.
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·18V670000·2018-09-26

    Nova Bus Recalls 2017 LFS Hybrid Buses for Transmission Defect

    Nova Bus is recalling 2017 LFS Hybrid and LFS Arctic Hybrid buses because pressure switches may fail, causing a loss of drive and increasing crash risk.

    Product
    NOVA BUS — NOVA BUS LFS, LFS ARTIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3006-2018·2018-09-26

    Ventana CONFIRM anti-Progesterone Receptor Antibody Recalled for Dispenser Defects

    Ventana Medical Systems is recalling CONFIRM anti-Progesterone Receptor antibodies due to leaking and sticking dispensers that may cause false negative IHC results.

    Product
    CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody, Catalog Number 05278392001, model 790-4296 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2972-2018·2018-09-26

    Pro-Med DORO LUCENT Transitional Member Recall for Potential Malfunction

    Pro-Med Instruments is recalling 31 DORO LUCENT Transitional Members because mixing design revisions may cause the headrest system to malfunction.

    Product
    DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
    Category
    Medical Device
    Distribution
    7 states
  • SevereNHTSA·18V677000·2018-09-26

    Daimler FCCC MC Motorhome Chassis Recall for Air Gauge Line Misconnection

    Daimler Trucks North America is recalling 2017-2019 FCCC MC motorhome chassis because primary and secondary air lines were incorrectly connected to the pressure gauges, increasing crash risk.

    Product
    FCCC — FCCC MC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1966-2018·2018-09-26

    Shearer's White Corn Tortilla Chips Recalled for Metal Contamination

    Shearer's Foods is recalling specific lots of white corn tortilla chips due to possible metal contamination. The products were distributed in 17 US states and Canada.

    Product
    White Corn Tortilla Chips packaged under the following brand names and sizes: 1. Shearer's White Restaurant Style Bulk, 12 ct. 16 oz., #203540212; 2. Shearer's White Round Tortilla Bulk, 12 ct. 16 oz., #210230212; 3. Shurfine Tortilla Chips, Net Wt. 30 oz (1 lb 14 o
    Category
    Food
    Distribution
    17 states
  • HighFDA (Devices)·Z-2996-2018·2018-09-26

    Ventana OptiView DAB IHC Detection Kit Recalled for Leaking Dispensers

    Ventana Medical Systems is recalling OptiView DAB IHC Detection Kits because leaking dispensers may cause false negative test results.

    Product
    OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3211-2018·2018-09-26

    Accuray Recalls CyberKnife Calibration Film Due to Dimensional Inaccuracy

    Accuray is recalling 259 units of Ashland Box Film Ball Cube II calibration film because manufacturing defects may cause up to 0.5 mm of positional inaccuracy in CyberKnife systems.

    Product
    Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2997-2018·2018-09-26

    Ventana ultraView Universal DAB Detection Kit Recalled for Dispenser Defects

    Ventana Medical Systems is recalling ultraView Universal DAB Detection Kits due to leaking and sticking reagent dispensers that may cause false negative IHC results.

    Product
    ultraView Universal DAB Detection Kit, Catalog Number 05269806001, model 760-500 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3188-2018·2018-09-26

    EOS Imaging Recalls sterEOS Workstation Due to 3D Projection Errors

    EOS Imaging is recalling 17 sterEOS workstations because 3D projections may be incorrect when using specific secondary image captures, potentially leading to clinical errors.

    Product
    sterEOS workstation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3015-2018·2018-09-26

    Ventana NEXES VEN IVIEW DAB Detection Kit Recall for Leaking Dispensers

    Ventana Medical Systems is recalling NEXES VEN IVIEW DAB Detection Kits due to leaking and sticking reagent dispensers that may cause false negative IHC results.

    Product
    NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1967-2018·2018-09-26

    Shearers Foods Recalls Yellow Corn Tortilla Chips Due to Metal Contamination

    Shearers Foods is recalling specific lots of yellow corn tortilla chips sold under multiple brands due to possible metal contamination.

    Product
    Yellow Corn Tortilla Chips packaged under the following brand names and sizes: 1. Shearer's Restaurant Rounds Tortilla Chips, Net Wt. 3 oz. (85g), UPC 37578-61920; 2. Uno Grande Yellow Round Tortilla Chips, 6 ct 16 oz, #903040112; 3. Wendy's, Net Wt. 1.5 oz. (42.5g)
    Category
    Food
    Distribution
    17 states
  • HighFDA (Devices)·Z-2998-2018·2018-09-26

    Ventana iView DAB Detection Kit Recalled for Leaking and Sticking Dispensers

    Ventana Medical Systems is recalling iView DAB Detection Kits due to leaking and sticking reagent dispensers that may cause false negative immunohistochemistry results.

    Product
    iView DAB Detection Kit, Catalog Number 05266157001, model 760-091 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3010-2018·2018-09-26

    Ventana anti-Helicobacter Pylori Reagent Recall Due to Dispenser Leaks

    Ventana Medical Systems is recalling anti-Helicobacter Pylori reagents because leaking dispensers may cause false negative test results.

    Product
    VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3011-2018·2018-09-26

    Ventana Recalls CINtec Histology Reagents Due to Dispenser Defects

    Ventana Medical Systems is recalling 120 units of CINtec Histology reagents worldwide because leaking dispensers may cause false negative test results.

    Product
    CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·18233·2018-09-26

    CFMOTO Recalls CFORCE ATVs Due to Fuel Hose Fire Hazard

    CFMOTO is recalling about 5,300 CFORCE all-terrain vehicles because a fuel hose can crack and leak, posing a fire hazard. No injuries have been reported.

    Product
    CFORCE all-terrain off-highway vehicles (ATVs)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2766-2018·2018-09-26

    Degania Foley Catheters Recalled Due to Defective Temperature Sensors

    Degania Silicone is recalling Foley catheters with temperature sensors because defective units may display lower body temperatures than actual.

    Product
    Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3003-2018·2018-09-26

    Ventana Anti-Pan Keratin Antibody Recalled for Leaking and Sticking Dispensers

    Ventana Medical Systems is recalling 354 units of Anti-Pan Keratin Primary Antibody due to leaking and sticking dispensers that may cause false negative IHC results.

    Product
    ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2785-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors

    Degania Silicone, Ltd. is recalling 1,000 temperature sensing Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Temperature sensing catheter 16FR, Catalogue Number 102201101663NU Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3186-2018·2018-09-26

    Polymedco PATHFAST NTproBNP Cartridges Recalled for Measurement Bias

    Polymedco is recalling 272 PATHFAST NTproBNP cartridges due to a manufacturing defect that may cause measurement values to be 12% to 20% higher than actual.

    Product
    PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST¿ for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-3014-2018·2018-09-26

    Ventana Medical Systems Recalls Leaking HPV III Probe Dispensers

    Ventana Medical Systems is recalling 195 units of the INFORM HPV III Fam 16 Probe due to leaking and sticking dispensers that may cause false negative test results.

    Product
    INFORM HPV III Fam 16 Probe - US Export, Catalog Number 05278856001, model 800-4295 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2761-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensor Catheters Due to Defective Sensors

    Degania Silicone is recalling 16,133 temperature sensor catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Temperature Sensor Catheter 16FR, Catalogue Number 102201101663BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2757-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensor Catheters Due to Defective Sensors

    Degania Silicone, Ltd. is recalling 1,588 Temperature Sensor Catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2754-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 153 temperature sensor Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Temperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary blad
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2772-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors

    Degania Silicone, Ltd. is recalling 1,000 temperature sensing Foley catheters because defective sensors may display lower body temperatures than actual.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201100880MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1969-2018·2018-09-26

    CedarLane Organic Couscous Salad Recalled for Undeclared Wheat Allergen

    CedarLane Organic Couscous, Veggies & Chickpeas with Citrus Dressing is being recalled because it is labeled gluten-free but contains undeclared wheat.

    Product
    CedarLane Organic Salads; Couscous, Veggies & Chickpeas with Citrus Dressing. NET WT 9 oz. -Gluten Free -Vegetarian Perishable, Keep Refrigerated. UPC: 38794 99904 Manufactured and Distributed by: CedarLane Foods, Carson, CA 90746
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2768-2018·2018-09-26

    Degania Foley Temperature Sensor Catheters Recalled for Defective Sensors

    Degania Silicone is recalling 250 Foley Temperature Sensor Catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Foley Temperature Sensor Catheter 8FR, Catalogue Number 102201100880JP Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladd
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3005-2018·2018-09-26

    Ventana ISH Protease 3 Reagent Recall for Leaking and Sticking Dispensers

    Ventana Medical Systems is recalling ISH Protease 3 reagents due to leaking and sticking dispensers that may cause false negative IHC results.

    Product
    ISH Protease 3, Catalog Number 05273331001, model 780-4149 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2971-2018·2018-09-26

    Pro-Med Instruments Recalls DORO LUCENT Locking Transitional Member

    Pro-Med Instruments is recalling 31 DORO LUCENT Locking Transitional Members because mixing design revisions may cause the headrest system to malfunction.

    Product
    DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2762-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 1,025 Temperature Sensor Catheters because defective sensors may display lower body temperatures than actual patient readings.

    Product
    Temperature Sensor Catheter 18FR, Catalogue Number 102201101863BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3002-2018·2018-09-26

    Ventana iVIEW Blue Plus Detection Kit Recalled for Dispenser Leaks

    Ventana Medical Systems is recalling iVIEW Blue Plus Detection Kits because leaking dispensers may cause false negative IHC results.

    Product
    ISH iVIEW Blue Plus Detection Kit, Catalog Number 05266181001, model 760-097 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2783-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 2,461 temperature sensing Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Temperature sensing catheter 18FR, Catalogue Number 102203101863DO Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2778-2018·2018-09-26

    Degania Silicone Recalls Thermistor Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 14,326 Thermistor Foley catheters because defective sensors may display inaccurate, lower body temperature readings.

    Product
    Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladd
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2758-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 475 Temperature Sensor Foley Catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2759-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensor Catheters Due to Defective Sensors

    Degania Silicone is recalling 1,028 temperature sensor catheters because defective sensors may display lower body temperatures than actual.

    Product
    Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2782-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 34,627 temperature sensing Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Temperature sensing catheter 16FR, Catalogue Number 102203101663DO Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2784-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors

    Degania Silicone, Ltd. is recalling 1,000 temperature sensing Foley catheters because defective sensors may display lower body temperatures than actual.

    Product
    Temperature sensing catheter 14FR, Catalogue Number 102201101463NU Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3009-2018·2018-09-26

    Ventana Basal Cell IHC Reagent Recall Due to Dispenser Defects

    Ventana Medical Systems is recalling 75 units of Basal Cell IHC reagents due to leaking and sticking dispensers that may cause false negative results.

    Product
    VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·18V671000·2018-09-26

    Volkswagen Recalls 2019 Jetta Vehicles Due to Misaligned Headlights

    Volkswagen is recalling 2019 Jetta vehicles with LED headlights because the passenger-side light may be misaligned, reducing visibility and increasing crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN JETTA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3209-2018·2018-09-26

    Exactech Recalls Optetrak Logic CC Stem Extension Due to Thread Defects

    Exactech is recalling one unit of the Optetrak Logic CC Stem Extension because it may have non-conforming internal threads.

    Product
    Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic d
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-3181-2018·2018-09-26

    Stryker Recalls IsoFlex LAL Support Surfaces Due to Fire Barrier Defect

    Stryker is recalling 243 IsoFlex LAL support surfaces because they were assembled with a non-conforming fire barrier. The units were distributed in five US states.

    Product
    IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support surface assists in the prevention and treatment of all pressure injuries (including stages 1,2,3,4, unstageable injury, and deep tissue injury) and is recommended to be implemented in c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2991-2018·2018-09-26

    Mobius AIRO Mobile CT System Recalled for Software Fault

    Mobius Imaging is recalling 147 AIRO Mobile CT Systems because a software fault prevents the tube current modulation feature from working.

    Product
    AIRO Mobile CT System Model # MobiCT-32
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3007-2018·2018-09-26

    Ventana CONFIRM anti-Estrogen Receptor Antibody Recalled for Dispenser Defects

    Ventana Medical Systems is recalling CONFIRM anti-Estrogen Receptor antibodies due to leaking and sticking dispensers that may cause false negative IHC results.

    Product
    CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody, Catalog Number 05278414001, Model 790-4325 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2760-2018·2018-09-26

    Degania Temperature Sensor Catheters Recalled for Defective Sensors

    Degania Silicone is recalling 16,350 temperature sensor catheters because defective sensors may display lower body temperatures than actual.

    Product
    Temperature Sensor Catheter 14FR, Catalogue Number 102201101463BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2780-2018·2018-09-26

    Degania Silicone Recalls Thermistor Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling Thermistor Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Thermistor Foley catheter, nonsterile, Catalogue Number 102201101463MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladd
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3000-2018·2018-09-26

    Ventana OptiView Amplification Kit Recalled for Leaking Dispensers

    Ventana Medical Systems is recalling OptiView Amplification Kits due to leaking dispensers that may cause false negative IHC results.

    Product
    OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3201-2018·2018-09-26

    Medtronic Recalls Contour Plus Link 2.4 Meters with Incorrect Units

    Medtronic is recalling two Contour Plus Link 2.4 meters distributed in Slovakia that display glucose in mg/dL instead of mmol/L.

    Product
    Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system Contour Plus LINK 2.4 wireless blood glucose monitoring system (glucometer, test strips and control solution) is designed for self-testing by persons with diabetes and the moni
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2755-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 11,488 temperature sensor Foley catheters because defective sensors may display lower body temperatures than actual.

    Product
    Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladd
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3202-2018·2018-09-26

    ShinChang Recalls Disposable Insulin Syringes Due to Barrel Cracks

    ShinChang Medical Co., Ltd. is recalling 6,570,800 disposable insulin syringes because a small crack was found in the top end of the barrel near the needle.

    Product
    Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16. (10 syringes are packaged in a flexible plastic (poly bag) and 10 flexible plastic (poly bag) are packaged in one in box. Finally, pack the inboxes in the carton case.)
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-3206-2018·2018-09-26

    Coviden Temperature Sensing Foley Catheters Recalled for Inaccurate Readings

    Coviden is recalling temperature sensing Foley catheters because they may display lower body temperature readings than the patient's actual temperature.

    Product
    400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16TSD
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-3180-2018·2018-09-26

    bioMerieux Recalls VITEK 2 AST-P655 Cards Due to Gentamicin Error

    bioMerieux is recalling VITEK 2 AST-P655 cards because six lots were manufactured with insufficient gentamicin, potentially affecting high-level resistance screening results.

    Product
    VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 421913 Product Usage: VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3183-2018·2018-09-26

    Med-Mizer Recalls PR1000 Pivot Rehab Beds Due to Cable Pinching Risk

    Med-Mizer is recalling 230 PR1000 Pivot Rehab Beds because wires may become pinched during extreme left pivoting, requiring patient transfer until repaired.

    Product
    PR1000 Pivot Rehab Bed AC powered adjustable bed.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-2756-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 500 units of temperature sensor Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Temperature sensor Foley catheter 10FR, Catalogue Number 102205101080AB Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary blad
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3210-2018·2018-09-26

    Medline Recalls Endoscopic Cleaning Brushes Due to Detachment Risk

    Medline Industries is recalling single-use endoscopic cleaning brushes because they may detach during cleaning, potentially leaving parts inside the scope.

    Product
    Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED, W/ HANDLE - 300 EA/CS, 50EA/BX, 6BX/CS; b. Item Number DYK1002DBDE, BRUSH, CLEANING, DBL, DIF ENDS - 500 EA/CS, 50 EA/BX, 10 BX/CS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3004-2018·2018-09-26

    Ventana ultraView Universal Alkaline Phosphatase Red Detection Kit Recalled

    Ventana Medical Systems is recalling 8,211 units of the ultraView Universal Alkaline Phosphatase Red Detection Kit due to leaking and sticking dispensers that may cause false negative IHC results.

    Product
    ultraView Universal Alkaline Phosphatase Red Detection Kit, Catalog Number 05269814001, model 760-501 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3016-2018·2018-09-26

    Ventana ultraView SISH DNP Detection Kit Recalled for Leaking Dispensers

    Ventana Medical Systems is recalling 342 units of the ultraView SISH DNP Detection Kit because leaking dispensers may cause false negative IHC results.

    Product
    ultraView SISH DNP Detection Kit, Catalog Number 05907136001, model 800-098 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2775-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 500 sterile Foley catheters with defective temperature sensors that may display inaccurate readings.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101680MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2765-2018·2018-09-26

    Degania Silicone Recalls Foley Catheters with Defective Temperature Sensors

    Degania Silicone is recalling 89,122 Foley catheters with temperature sensors because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101480TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2770-2018·2018-09-26

    Degania Foley Temperature Sensor Catheters Recalled for Defective Sensors

    Degania Silicone is recalling 250 Foley Temperature Sensor Catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary blad
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2763-2018·2018-09-26

    Degania Silicone Recalls Foley Catheters with Defective Temperature Sensors

    Degania Silicone is recalling 4,332 Foley catheters with temperature sensors because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Foley Catheter with temperature sensor 400TM 8FR, Catalogue Number 102201100880TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the ur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2771-2018·2018-09-26

    Degania Foley Temperature Sensor Catheters Recalled for Defective Sensors

    Degania Silicone is recalling Foley Temperature Sensor Catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary blad
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2781-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors

    Degania Silicone, Ltd. is recalling 4,372 temperature sensing Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Temperature sensing catheter 14FR, Catalogue Number 102203101463DO Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2776-2018·2018-09-26

    Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors

    Degania Silicone, Ltd. is recalling 100 units of temperature sensing Foley catheters because defective sensors may display lower body temperatures than actual.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101080MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V676000·2018-09-26

    Midwest Fire Recalls All-Poly Series Emergency Vehicles Due to Software Defect

    Midwest Fire is recalling 2014-2019 All-Poly Series emergency vehicles because touchscreen software may cause accessories to turn on or off unexpectedly, increasing crash risk.

    Product
    MIDWEST FIRE — MIDWEST FIRE ALL-POLY SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2779-2018·2018-09-26

    Degania Silicone Recalls Thermistor Foley Catheters Due to Defective Sensors

    Degania Silicone is recalling 330 Thermistor Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.

    Product
    Thermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V674000·2018-09-26

    BMW Recalls 2013-2015 760Li Vehicles for Engine Stall Risk

    BMW is recalling 2013-2015 760Li vehicles because incompatible software in the Engine Control Unit may cause the engine to stall, increasing crash risk.

    Product
    BMW — BMW 760LI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2774-2018·2018-09-26

    Degania Silicone Foley Catheters Recalled for Defective Temperature Sensors

    Degania Silicone is recalling 500 units of temperature-sensing Foley catheters because defective sensors may display inaccurate, lower body temperature readings.

    Product
    Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101880MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3195-2018·2018-09-26

    Fresenius 2008T Hemodialysis System Recalled for Disinfectant Exposure Risk

    Fresenius Medical Care is recalling 40 units of the 2008T Hemodialysis System because a power failure during cleaning could leave disinfectant in the dialysate delivered to patients.

    Product
    2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3203-2018·2018-09-26

    Coviden Recalls Defective Temperature Sensing Foley Catheters

    Coviden is recalling specific sterile Foley catheter trays because the temperature sensors may display lower body temperature readings than the patient's actual temperature.

    Product
    400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-3013-2018·2018-09-26

    Ventana Medical Systems Recalls Leaking CINtec p16 Histology Reagent Dispensers

    Ventana Medical Systems is recalling 240 units of CINtec p16 Histology reagent dispensers due to leaking and sticking issues that may cause false negative test results.

    Product
    CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3192-2018·2018-09-26

    Invivo Xper Flex Cardio Physiomonitoring System Recalled for Firmware Error

    Invivo Corporation is recalling 38 Xper Flex Cardio Physiomonitoring Systems distributed in the Netherlands due to incorrect firmware that may cause inaccurate ECG and heart rate displays.

    Product
    Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
    Category
    Medical Device
    Distribution
    0 states

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