The Recall Desk

Archive

January 2013 recalls

322 recalls were announced in January 2013.

What the numbers show

Critical
24
Severe
105
High
118
Moderate
50
Low
25

Of the 322 recalls this month scored against our rubric, 7% are Critical, 33% are Severe.

Which agencies issued them

201–300 of 322

  • HighFDA (Devices)·Z-0655-2013·2013-01-16

    Concentric Medical Recalls FlowGate Balloon Guide Catheters Due to Tip Collapse

    Concentric Medical is recalling 13 FlowGate Balloon Guide Catheters after reports of resistance and possible distal tip collapse during use.

    Product
    FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate" Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters with a radiopaque marker on the distal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0873-2013·2013-01-16

    Pastry Food Products Recalls Trigel Pizza Turnovers for Undeclared Milk

    Pastry Food Products Inc. is recalling Trigel Empanadillas de Pizza due to undeclared milk. The product was distributed in Puerto Rico.

    Product
    &TRIGAL***Empanadillas de Pizza (Pizza turnovers)***12 ct***Pastry Foods Inc., Rio Piedras, PR&
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0652-2013·2013-01-16

    TissueNet Recalls UltraFill DBM Putty Due to Stainless Steel Particulates

    Surgical Tissue Network Inc. is recalling UltraFill DBM Putty-Porcine because the products may contain trace amounts of 316L Stainless Steel particulates.

    Product
    UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 5cc Product Code: RT53005 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0644-2013·2013-01-16

    Applied Medical Recalls Kii Shielded Bladed Access Systems Due to Blade Exposure Risk

    Applied Medical is voluntarily recalling 72 units of Kii shielded bladed access systems because the blade may remain exposed after shield deployment.

    Product
    Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0876-2013·2013-01-16

    Lifevantage Recalls Protandim Dietary Supplement Due to Metal Fragments

    Lifevantage Corp is recalling Protandim dietary supplements because tablets may contain small metal fragments. The recall affects 247,896 bottles sold in the US, Japan, Australia, Mexico, and Canada.

    Product
    Protandim is packaged in a 90cc cylindrical blue bottle with a silver cap and contains thirty caplets per bottle. Label has a blue background with multi-colored print and pictorial stating in part: Lifevantage PROTANDIM *the Nrf2 Synergizer Dietary Supplement I 30…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0658-2013·2013-01-16

    Zoll AutoPulse Resuscitation System Recalled for Unexpected Compression Stops

    Zoll Circulation is recalling AutoPulse Model 100 systems because they may stop compressions unexpectedly during use.

    Product
    AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0653-2013·2013-01-16

    TissueNet Recalls UltraFill DBM Putty Due to Stainless Steel Particulates

    Surgical Tissue Network, Inc. recalled UltraFill DBM Putty-Porcine because products may contain trace amounts of 316L Stainless Steel particulates.

    Product
    UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 10cc Product Code: RT53010 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0662-2013·2013-01-16

    Maquet Cardiosave Intra-Aortic Balloon Pump Recall for Cord Failure Risk

    Maquet is recalling 29 Cardiosave Intra-Aortic Balloon Pumps because the coiled cord assembly may fail if mishandled.

    Product
    CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0663-2013·2013-01-16

    Merit Medical Recalls Custom Procedural Trays Due to Particulate Matter

    Merit Medical Systems is recalling 422 Custom Procedural Trays and Kits because of particulate matter found in the 0.9% Sodium Chloride Injection.

    Product
    Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0660-2013·2013-01-16

    Biomet Recalls PT Hybrid Glenoid Post Due to Oversized Thread

    Biomet is recalling PT Hybrid Glenoid Posts because an oversized male thread may prevent the post from seating fully, potentially creating a gap in the implant.

    Product
    PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0643-2013·2013-01-16

    Philips HeartStart HS1 Defibrillators Recalled for Manual Clarification

    Philips is recalling HeartStart HS1 defibrillators to clarify maintenance information in the Owner's Manual.

    Product
    Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0664-2013·2013-01-16

    Siemens Healthcare Recalls Phenobarbital Assay Kits Due to Imprecision

    Siemens Healthcare Diagnostics is recalling specific lots of Emit 2000 and Syva Emit Phenobarbital Assays due to higher imprecision and outliers on Beckman Coulter AU Systems.

    Product
    Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended for use in the quantitative analysis of Phenobarbital in human serum or plasma.
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-0640-2013·2013-01-16

    Siemens Chek-Stix Control Strips Recalled for Potential Inaccurate Leukocyte Results

    Siemens Healthcare Diagnostics Inc is recalling Chek-Stix Combo Pak control strips because the leukocyte result may become negative if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0636-2013·2013-01-16

    Siemens CLINITEK Atlas Control Strips Recalled for Potential Leukocyte Result Errors

    Siemens is recalling CLINITEK Atlas Positive and Negative Control Strips because leukocyte results may become negative if the solution is held above 25°C for more than two hours.

    Product
    Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019 When used with the CLINITEK ATLAS¿ Automated urine Chemistry Analyzer and CLINITEK ATLAS¿ 10 reagent Pak, CLINITEK ATLAS¿ Positive and Negative Control Strips provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateNHTSA·13V013000·2013-01-16

    Entegra Aspire Motorhomes Recalled for Incorrect Tire Certification Label

    Entegra Coach is recalling 2013 Aspire motorhomes because the certification label incorrectly identifies rear axle tire sizes, potentially leading to improper tire installation.

    Product
    ENTEGRA — ENTEGRA ASPIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0661-2013·2013-01-16

    Advanced Sterilization Products Recalls STERRAD NX Cassettes Due to Shelf-Life Data

    Advanced Sterilization Products is recalling 12,280 STERRAD NX Cassettes because it lacks adequate data to support the product's labeled shelf-life.

    Product
    STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0648-2013·2013-01-16

    Siemens Healthcare Recalls TSH Calibrator Vials Due to Dose Recovery Issues

    Siemens Healthcare Diagnostics is recalling specific lots of TSH calibrator vials because they showed under-recovery of dose values.

    Product
    Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Food)·F-0870-2013·2013-01-16

    Asian Boy Tapioca Stick Recalled for Undeclared Sulfites

    New B.C.N. Trading Inc. is recalling Asian Boy Tapioca Sticks because they contain undeclared sulfites. The product was distributed in six states.

    Product
    Asian Boy (EBQ) Tapioca Stick 3.5 oz (100g) New B.C.N. Trading Inc. 701 Hadky South Plainfield, NJ 07080 MINH NGUYET TRADING CO., LTD. BIN CHANH -HOCHIMINH CITY VIETNAM UPC 627404021822
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0637-2013·2013-01-16

    Siemens Chek-Stix Control Strips Recalled for Potential Leukocyte Result Errors

    Siemens Healthcare Diagnostics is recalling Chek-Stix Combo Pak control strips because the leukocyte result may become negative if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results for glucose…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0656-2013·2013-01-16

    Stryker Recalls Accolade Hip Stems Due to Packaging Mix-Up

    Stryker is recalling specific Accolade hip stems because size 3.5 stems were mistakenly packaged as size 2.5 stems, creating a risk of product mix-up.

    Product
    Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0642-2013·2013-01-16

    Philips HeartStart FRx AED Recall for Maintenance Manual Clarification

    Philips is recalling HeartStart FRx AEDs to clarify maintenance instructions in the Owner's Manual.

    Product
    Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0862-2013·2013-01-16

    Sam's Club Artisan Fresh Miniature Candy Cookie Recall for Labeling Error

    Dawn Food Products is recalling Sam's Club Artisan Fresh Miniature Candy Cookies due to a labeling discrepancy involving White Chocolate Macadamia Nut Cookies.

    Product
    Sam's Club Artisan Fresh Miniature Candy Cookie Carton 504 Count , 28.35 lb (12.89 kg)
    Category
    Food
    Distribution
    4 states
  • LowFDA (Devices)·Z-0646-2013·2013-01-16

    Siemens Healthcare Recalls TSH Calibrator Vials Due to Dose Recovery Issues

    Siemens Healthcare Diagnostics is recalling specific lots of Coat-A-Consta IRMA TSH calibrators due to confirmed under-recovery of dose values.

    Product
    Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status.
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Food)·F-0861-2013·2013-01-16

    Meijer Redskin Peanuts Recalled for Incorrect Sodium Labeling

    Meijer Distribution is recalling 16oz Redskin Peanuts because sodium content was not correctly stated on the label. No illnesses have been reported.

    Product
    Markets of Meijer 16oz Redskin Peanuts
    Category
    Food
    Distribution
    5 states
  • LowFDA (Devices)·Z-0641-2013·2013-01-16

    Siemens Chek-Stix Control Strips Recalled for Potential Leukocyte Result Failure

    Siemens Healthcare Diagnostics is recalling Chek-Stix Combo Pak control strips because the leukocyte result may become negative if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0635-2013·2013-01-16

    Siemens Chek-Stix Urine Control Strips Recalled for Temperature Sensitivity

    Siemens Healthcare Diagnostics is recalling Chek-Stix Positive and Negative Control Strips for Urine Chemistry because the leukocyte result may become inaccurate if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0639-2013·2013-01-16

    Siemens Chek-Stix Control Strips Recalled for Potential Leukocyte Result Errors

    Siemens Healthcare Diagnostics is recalling specific lots of Chek-Stix control strips because the leukocyte result may become negative if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0665-2013·2013-01-16

    Siemens Emit Tox Serum Calibrators Recalled for Incorrect Expiration Date

    Siemens Healthcare Diagnostics is recalling 1,998 cartons of Emit Tox Serum Calibrators because an incorrect expiration date was assigned to Lot D1.

    Product
    Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(R) tox(TM) Serum Barbiturate and Benzodiazepine Assays as a reference for the semi-quantitative analis of barbiturates and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0638-2013·2013-01-16

    Siemens Chek-Stix Control Strips Recalled for Potential Leukocyte Result Errors

    Siemens Healthcare Diagnostics is recalling Chek-Stix control strips because the leukocyte result may become negative if the solution is held above 25°C for more than two hours.

    Product
    Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) Catalog Number: 1360L Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·13092·2013-01-15

    Bugaboo Recalls Strollers Due to Fall and Choking Hazards

    Bugaboo is recalling Cameleon and Donkey strollers because a button on the carry handle can disengage, causing the handle to detach and posing fall and choking hazards to young children.

    Product
    Bugaboo Cameleon and Bugaboo Donkey Model Strollers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13095·2013-01-15

    Target Recalls Circo Girls' Fleece Pajamas for Flammability Violation

    Target is recalling Circo girls' fleece pajamas because they fail to meet federal flammability standards, posing a risk of burn injuries to children.

    Product
    Girls' Circo Fleece Blanket Sleepers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·13E001000·2013-01-14

    Ricon Recalls Wheelchair Lifts Due to Fire Risk from Cable

    Ricon is recalling S and K Series wheelchair lifts equipped with an optional armored pendant cable that may cause a short circuit and fire.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V010000·2013-01-14

    GM Recalls 2013 Chevrolet Express and GMC Savana for Ignition Key Defect

    General Motors is recalling specific 2013 Chevrolet Express and GMC Savana vans because the ignition key can be removed while the vehicle is running or not in Park.

    Product
    CHEVROLET — CHEVROLET, GMC EXPRESS, SAVANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V011000·2013-01-11

    Blue Bird Recalls 2007-2009 L4RE Buses for Steering Gear Defect

    North American Bus Industries is recalling 53 Blue Bird L4RE transit buses from 2007-2009 due to a defective steering gear attachment that could cause loss of steering control.

    Product
    BLUE BIRD — BLUE BIRD L4RE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13090·2013-01-10

    A-Plus Marine Recalls Scuba Diving Air Hoses Due to Drowning Hazard

    A-Plus Marine is recalling high-pressure scuba diving air hoses because they can separate from the regulator, reducing air supply and posing a drowning hazard.

    Product
    High-pressure scuba diving air hoses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13718·2013-01-10

    BRP Recalls Can-Am Commander Side-By-Side Vehicles Due to Steering Hazard

    BRP is recalling about 3,400 Can-Am Commander side-by-side vehicles because improper steering assembly can cause loss of control, posing a risk of serious injury.

    Product
    Can-Am® Commander side-by-side off-road vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-109-2013·2013-01-09

    FDA Recalls Methylprednisolone Acetate Injection Due to Non-Sterility

    New England Compounding Center is recalling 9,062 vials of Methylprednisolone Acetate Injection because they may not be sterile. The recall is nationwide.

    Product
    Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-111-2013·2013-01-09

    FDA Recalls Methylprednisolone Acetate Injection Due to Non-Sterility

    New England Compounding Center is recalling 3,822 vials of Methylprednisolone Acetate 80 mg/mL Injection nationwide due to non-sterility concerns.

    Product
    Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-110-2013·2013-01-09

    FDA Recalls Methylprednisolone Acetate Injection Due to Non-Sterility

    New England Compounding Center is recalling 5,130 vials of Methylprednisolone Acetate Injection nationwide due to non-sterility concerns.

    Product
    Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-108-2013·2013-01-09

    FDA Recalls Methylprednisolone Acetate Injection Due to Non-Sterility

    New England Compounding Center is recalling 23,897 vials of Methylprednisolone Acetate Injection nationwide due to non-sterility concerns.

    Product
    Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-121-2013·2013-01-09

    New England Compounding Center Recalls Lidocaine Vials Due to Sterility Concerns

    New England Compounding Center is recalling Lidocaine vials because the FDA determined there is a lack of assurance of sterility.

    Product
    Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-119-2013·2013-01-09

    New England Compounding Center Recalls Isovue Vials Due to Sterility Concerns

    New England Compounding Center is recalling Isovue 200 mg/mL and 300 mg/mL vials nationwide due to a lack of assurance of sterility.

    Product
    Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-117-2013·2013-01-09

    New England Compounding Center Recalls Glycerin 100% Vials for Sterility Concerns

    New England Compounding Center is recalling 165 vials of Glycerin 100% PF due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0620-2013·2013-01-09

    SynCardia Recalls Companion External Batteries Due to Thermal Event Risk

    SynCardia Systems is recalling Companion External Batteries used with the Companion 2 Driver System because they may be at risk of thermal events or physical damage.

    Product
    Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-112-2013·2013-01-09

    New England Compounding Center Recalls Betamethasone Repository Injections

    New England Compounding Center is recalling Betamethasone Repository injections due to a lack of assurance of sterility. The recall covers all lot codes distributed nationwide.

    Product
    Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-118-2013·2013-01-09

    New England Compounding Center Recalls Hyaluronidase Vials Due to Sterility Concerns

    New England Compounding Center is recalling Hyaluronidase 150 u/ml PF vials nationwide because the FDA determined there is a lack of assurance of sterility.

    Product
    Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-114-2013·2013-01-09

    New England Compounding Center Recalls Bupivacaine Products Due to Sterility Concerns

    New England Compounding Center is recalling Bupivacaine 0.25%, 0.5%, and 0.75% PF products because the agency cannot assure the sterility of the medication.

    Product
    Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V006000·2013-01-09

    Autocar Recalls 2012 Xpert Vehicles Due to Seat Belt Anchorage Defect

    Autocar is recalling 80 model year 2012 Xpert vehicles because seat belt anchorages may fail to meet federal safety standards, increasing injury risk in crashes.

    Product
    AUTOCAR — AUTOCAR XPERT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0622-2013·2013-01-09

    Hill-Rom Recalls Liko Standard Slingbar 450 Due to Injury Reports

    Hill-Rom is recalling 261 Liko Standard Slingbar 450 units after receiving reports of serious injuries. The device is used with ceiling and mobile patient lifts.

    Product
    Liko Standard Slingbar 450. The Standard Slingbar 450 is a versatile sling bar which can be used for most lifting situations. It can be used with different Liko ceiling and mobile lifts.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0628-2013·2013-01-09

    Stryker Medical Surgical Beds Recalled for Brake Ring Defect

    Stryker is recalling 9 Model 3002SEX and 3005S3EX medical surgical beds because brake rings may not meet specifications, negatively impacting holding force.

    Product
    Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg Bed, is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital facilities. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-106-2013·2013-01-09

    Hospira Recalls Epinephrine Injection Due to Potential Glass Particulates

    Hospira is recalling specific lots of Epinephrine Injection USP because they may contain glass particles.

    Product
    Epinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM, Hospira, Inc., Lake Forest, IL --- NDC 0409-7241-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-113-2013·2013-01-09

    Betamethasone Sodium Phosphate Injection Recalled for Sterility Concerns

    New England Compounding Center is recalling Betamethasone Sodium Phosphate injections due to a lack of assurance of sterility.

    Product
    Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection, Betamethasone Sodium Phosphate 8 mg/mL PF Injection, Betamethasone Sodium Phosphate 12 mg/mL PF Injection, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0855-2013·2013-01-09

    Sanh Yuan Preserved Plum Candy Recalled for Lead Contamination

    Cho Fuku Group is recalling Sanh Yuan Preserved Plum Candy due to unacceptable levels of lead. The product was distributed in California and Washington.

    Product
    Sanh Yuan Preserved Plum Candy (Sweet and Sour Prune), 5 oz (142g)
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0624-2013·2013-01-09

    Hospira Recalls Plum A+ Infusion Pumps Due to Door Roller Defect

    Hospira is recalling 297,833 Plum A+ infusion pumps because a door roller assembly may break, causing unrestricted flow or over-delivery of IV fluids.

    Product
    Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971; b) list 11973 - software version 10.3; c) list 12391 - software version 11.3; d) list 20679 - Hospira MedNet Software e) list 20792…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-116-2013·2013-01-09

    New England Compounding Center Recalls Dexamethasone Sodium Phosphate Vials

    New England Compounding Center is recalling Dexamethasone Sodium Phosphate vials due to a lack of assurance of sterility.

    Product
    Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0621-2013·2013-01-09

    Fisher & Paykel Healthcare Recalls Reusable Breathing Circuits Due to Hole Damage

    Fisher & Paykel Healthcare is recalling specific lots of reusable breathing circuits because tube hole damage could cause gas leaks and loss of pressure during oxygen therapy.

    Product
    Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Drugs)·D-115-2013·2013-01-09

    New England Compounding Center Recalls Clonidine Vials Due to Sterility Concerns

    New England Compounding Center is recalling Clonidine 100 mcg/mL vials nationwide due to a lack of assurance of sterility.

    Product
    Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0856-2013·2013-01-09

    Cocoa~Latte Hot Drink Maker Recalled Due to Lead Leaching Risk

    Focus Products Group is recalling Cocoa~Latte Hot Drink Makers because a brass bushing may leach lead into beverages.

    Product
    Cocoa~Latte Hot Drink Maker; an electric hot drink mixer and dispenser with a 32 fl.oz. heating and mixing jar, twist and lock lid, "perfect temperature" feature, mixing paddle, and dripless faucet; Focus Electrics, LLC, West Bend, WI 53095
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0625-2013·2013-01-09

    Hospira Recalls Plum A+3 Infusion Pumps Due to Door Roller Defect

    Hospira is recalling 28,599 Plum A+3 infusion pumps worldwide because a door roller assembly may break, potentially causing unrestricted flow or over-delivery of IV medication.

    Product
    Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software; Product Usage: The Plum…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-122-2013·2013-01-09

    New England Compounding Center Recalls Omnipaque Vials Due to Sterility Concerns

    New England Compounding Center is recalling Omnipaque vials nationwide because the company cannot ensure the product is sterile.

    Product
    Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0623-2013·2013-01-09

    B. Braun Recalls Infusomat Space Pump Pole Clamps Due to Breakage Risk

    B. Braun Medical is recalling 13,078 Infusomat Space Pump Pole Clamps because the locking grids may break.

    Product
    Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0858-2013·2013-01-09

    Nature's Path Recalls Granola Due to Undeclared Almond Allergen

    Nature's Path Foods is recalling 25 lb. containers of Hemp Plus Granola because the product contains almonds that are not declared on the label.

    Product
    Hemp Plus Granola. The product is packaged in a 25 lb. container. The UPC is 0 58449 88001 1. The product is labeled in parts: "***HempPlus Granola***INGREDIENTS: Organic rolled oats, organic evaporated cane juice, organic soybean oil, organic brown rice flour, organic flax…
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-0629-2013·2013-01-09

    Stryker Medical Surgical Beds Recalled for Brake Ring Defect

    Stryker is recalling Model 3002S3EX and 3005S3EX medical surgical beds because brake rings may not meet specifications, negatively impacting holding force.

    Product
    Medical Surgical Bed, Model 3005S3EX Medical Surgical Bed The S3" MedSurg Bed, Model 3005 is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-124-2013·2013-01-09

    New England Compounding Center Recalls Triamcinolone Vials Due to Sterility Concerns

    New England Compounding Center is recalling specific Triamcinolone vials nationwide because the company cannot guarantee the products are sterile.

    Product
    Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0860-2013·2013-01-09

    Nature's Plus Spiru-tein Energy Meal Recalled for Gluten Mislabeling

    Natural Organics is recalling Nature's Plus Spiru-tein High Protein Energy Meal, S'mores flavor, because it is labeled gluten-free but contains gluten.

    Product
    Nature's Plus GLUTEN Free SPIRU-TEIN HIGH PROTEIN ENERGY MEAL, S'mores (Flavor), 1.2 OZ. (34g) Packet, Display Box Product No. 95903, Individual Packet Product No. 45905, UPC Code 097467459052. There are 8 foil packets per corrugated display box. --- Serving Size - 1 packet…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0633-2013·2013-01-09

    Horiba Medical Recalls Pentra C200 Automated Chemistry Analyzer

    Horiba Medical is recalling 384 Pentra C200 analyzers because they may record incorrect AST values without triggering an alarm.

    Product
    PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0630-2013·2013-01-09

    Mindray DPM Central Station Recalled for Patient Data Anomaly

    Mindray is recalling two DPM Central Station units due to a software anomaly that may replace one patient's trend data with another's.

    Product
    DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0618-2013·2013-01-09

    Medtronic Intersept Custom Tubing Packs Recalled for Packaging Damage

    Medtronic is recalling Intersept Custom Tubing Packs because packaging trays may be damaged, compromising product sterility.

    Product
    Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the following Model numbers: 0E27R16, 1A30R6, 2493R24, 2493R25, 5D56R5, 5Z93R4, 5Z93R5, 7E64R2, 7J53R2…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0627-2013·2013-01-09

    Maquet Yuno Extension Table Device Recalled for Screw Tension Issue

    Maquet Inc. is recalling 63 Yuno Extension Table Devices due to a potential issue with the screw tension of the extension device.

    Product
    Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt,Germany Used to support the lower extremities immediately before during and after surgery. The extension device is mounted to the YUNO operating table. The product…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0632-2013·2013-01-09

    Horiba Medical Recalls ABX PENTRA AST CP Diagnostic Reagent

    Horiba Medical is recalling ABX PENTRA AST CP reagent because it recorded incorrect low values for high AST levels without triggering an alarm.

    Product
    ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0626-2013·2013-01-09

    Hospira Recalls Plum A+ Hyperbaric Infusion Pumps Due to Door Roller Defect

    Hospira is recalling 180 Plum A+ Hyperbaric Infusion Pumps because a door roller assembly may break, potentially causing unrestricted flow or over-delivery of medication.

    Product
    Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-123-2013·2013-01-09

    Saline 10% and 3% vials are recalled for sterility assurance concern

    New England Compounding Center is recalling 54 vials of Saline 10% and 3% in 5 mL and 10 mL sizes because sterility could not be assured. The vials were distributed nationwide, and all lot codes are included.

    Product
    Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0634-2013·2013-01-09

    Abbott m2000sp Instrument Software Recall for Data Saving Error

    Abbott Molecular is recalling m2000sp Instruments due to a software issue where changes to control or calibrator information are not saved.

    Product
    Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0631-2013·2013-01-09

    Cooper Vision Recalls AVAIRA Toric Contact Lenses for Silicone Oil Residue

    Cooper Vision is recalling 246 units of AVAIRA Toric Contact Lenses because they exceeded the acceptance limit for silicone oil residual.

    Product
    AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-107-2013·2013-01-09

    Abbott Recalls Synthroid Tablets Due to Incorrect Strength Labeling

    Abbott Laboratories is recalling specific lots of Synthroid (levothyroxine sodium) tablets because bottles labeled as 150 mcg actually contained 75 mcg tablets.

    Product
    SYNTHROID — SYNTHROID (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0619-2013·2013-01-09

    HemoCue Urine Analyzer Recall for Missing Documentation

    HemoCue AB is recalling 48 urine analyzers because they were shipped with the wrong Quick Reference Guide and a missing warranty statement.

    Product
    Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capillary action. The filled cuvette is inserted into the device where the contents…
    Category
    Medical Device
    Distribution
    17 states
  • LowFDA (Devices)·Z-0617-2013·2013-01-09

    St. Jude Medical Recalls Fast-Cath Transseptal Guiding Introducers Due to Packaging Error

    St. Jude Medical is recalling 26 units of Fast-Cath Transseptal Guiding Introducers because they were packaged with a 180-degree curve instead of the labeled 90-degree curve.

    Product
    Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial…
    Category
    Medical Device
    Distribution
    3 states
  • HighCPSC·13088·2013-01-08

    HEICO Neon Sign Power Supply Transformers Recalled Due To Fire Hazard

    HEICO lighting is recalling specific neon sign power supply transformers because they do not meet UL standards and pose a fire risk. No injuries have been reported.

    Product
    Power Supply Transformers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13087·2013-01-08

    Fisher-Price Recalls Rock 'n Play Infant Sleepers Due to Mold Risk

    Fisher-Price is recalling about 800,000 Rock 'n Play infant sleepers because mold can develop between the cushion and frame, posing a respiratory risk to infants.

    Product
    Newborn Rock 'n Play Sleeper™
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V005000·2013-01-07

    Forest River Recalls 2010-2012 Berkshire and Charleston Motorhomes

    Forest River is recalling 2010-2012 Berkshire and Charleston diesel motorhomes because loose diode jumpers may prevent brake lights from working or cruise control from disengaging.

    Product
    FOREST RIVER — FOREST RIVER CHARLESTON, BERKSHIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V003000·2013-01-04

    Polaris Recalls GEM Electric Vehicles Due to Parking Brake Defect

    Polaris is recalling 2010-2013 GEM electric vehicles because the parking brake may fail to engage, increasing the risk of the vehicle rolling away.

    Product
    GEM — GEM E2 XLD, E6S, E4S, E2S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13715·2013-01-04

    Amana Heating and Cooling Units Recalled for Fire Hazard

    Goodman Company is recalling Amana packaged heating and cooling units because inaccurate serial plates could lead to undersized wiring and fire.

    Product
    Amana Packaged Gas/Electric Heating and Cooling units
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0525-2013·2013-01-02

    Praxair Vantage Grab n Go Gas Cylinder Pressure Regulator Recall

    Praxair Inc. is recalling Vantage Grab n Go gas cylinder pressure regulators due to isolated incidents of ignition inside cylinders subjected to significant physical impact.

    Product
    Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG Usage: Regulator reduces pressure in oxygen-containing cylinder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V001000·2013-01-02

    GM Recalls 2013 Trucks and SUVs for Transmission Shift Defect

    General Motors is recalling 54,686 model year 2013 vehicles due to a transmission defect that may allow the vehicle to roll away.

    Product
    CHEVROLET — CHEVROLET, GMC, CADILLAC SILVERADO, AVALANCHE 1500, SIERRA, EXPRESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-100-2013·2013-01-02

    Lloyd Inc. Recalls Subpotent Thyro-Tab 0.050 mg. Tablets

    Lloyd Inc. of Iowa is recalling specific lots of Thyro-Tab 0.050 mg. tablets because they are subpotent and have a 9-month stability interval.

    Product
    Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0594-2013·2013-01-02

    Zimmer Spine Ardis Inserter Recalled for Potential Spacer Fragmentation

    Zimmer, Inc. is recalling the Spine Ardis Inserter because excessive force can break the PEEK spacer, causing sharp fragments that may damage adjacent structures.

    Product
    Zimmer Spine Ardis Inserter, Rx, non-sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide

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