The Recall Desk

Archive

February 2014 recalls

473 recalls were announced in February 2014.

What the numbers show

Critical
14
Severe
98
High
222
Moderate
120
Low
19

Of the 473 recalls this month scored against our rubric, 3% are Critical, 21% are Severe.

Which agencies issued them

401–473 of 473

  • HighFDA (Devices)·Z-0887-2014·2014-02-05

    Synergetics Recalls 27ga Endo Illuminator Due to Faulty Sterile Seals

    Synergetics Inc. is recalling 96 units of 27ga ONE-STEP Endo Illuminator devices because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.27P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0851-2014·2014-02-05

    Siemens Dimension Vista 500 and 1500 Systems Recalled for Flex Assignment Error

    Siemens is recalling Dimension Vista 500 and 1500 systems with software version 3.5.1 or lower because the system may assign the wrong Flex cartridge to user-defined methods.

    Product
    User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with software version 3.5.1 or lower User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System is an in vitro diagnostic device intended to dupli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0846-2014·2014-02-05

    Focus Diagnostics Recalls Simplexa Flu A/B & RSV Direct Assay Kits

    Focus Diagnostics is recalling 1,052 Simplexa Flu A/B & RSV Direct assay kits due to sporadic false positive RSV signals that may lead to incorrect diagnostic results.

    Product
    Simplexa Flu A/B & RSV Direct assay, Model MOL2650. The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and resp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0891-2014·2014-02-05

    Synergetics Recalls Two-Port Vitrectomy End Irrigators Due to Seal Failure

    Synergetics is recalling specific lots of Two-Port Vitrectomy End Irrigators because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    Two-Port Vitrectomy (TPV (tm)) Wide Field High Flow End Irrigator, Synergetics, inc., 19ga, length 7.0 ft, sterile / EO, 56.14. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0828-2014·2014-02-05

    Accuray CyberKnife Robotic Radiosurgery System Recall for Mounting Assembly Issue

    Accuray is recalling 302 CyberKnife systems worldwide due to a potential safety issue where the Synchrony Boom Arm Mounting Assembly may detach.

    Product
    Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0824-2014·2014-02-05

    Siemens ACUSON SC2000 Ultrasound System Recalled for Loose User Interface

    Siemens Medical Solutions is recalling 843 ACUSON SC2000 ultrasound systems because the user interface assembly may become loose and fall off.

    Product
    ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 Hz. Manufacturer: Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 SC2000 ultrasound imaging system is intended for Cardiac, neo-natal and fetal cardiac, Pedi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0889-2014·2014-02-05

    Synergetics Recalls 23ga Wide Field Corona Endo Illuminator Due to Seal Failure

    Synergetics Inc is recalling 108 units of 23ga Wide Field Corona Endo Illuminators because faulty seals on the outer pouch could result in seal failure.

    Product
    23ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0869-2014·2014-02-05

    BD BACTEC FX Diagnostic Instrument Recalled for False Negative Results

    Becton Dickinson & Co. is recalling 198 BD BACTEC FX instruments because a component may fail, causing false negative results in clinical specimens.

    Product
    BD BACTEC FX- Top Unit instrument, catalog number 441385, and Bottom Unit instrument, catalog 441386, available as a single or a stack configuration; Manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The BD BACTEC FX instrument is designed for the rapi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0858-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff is recalling 1,460 Certas Programmable Valves used for hydrocephalus because they may not operate properly.

    Product
    Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocepha
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1428-2014·2014-02-05

    Lambs Farm Shortbread Almond Crescent Cookies Recalled for Undeclared Allergens

    The Lambs Farm, Inc. is recalling Shortbread Almond Crescent cookies because the labels fail to declare milk, soy, and wheat allergens.

    Product
    Shortbread Almond Crescent cookies sold under the Lambs Farm brand and packaged in a plastic bag with a net weight of 10 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1464-2014·2014-02-05

    Walmart Great Value Tex Mex Trail Mix Recalled for Undeclared Milk

    Ann's House of Nuts, Inc. is recalling Walmart Great Value Tex Mex Trail Mix because it contains undeclared milk, a major food allergen.

    Product
    Walmart Great Value Tex Mex Trail Mix, Net Wt 28 oz (793g), Distributed by Wal Mart Stores, Inc., Bentonville, AR, packed in rigid clear plastic jars.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-0896-2014·2014-02-05

    Synergetics Recalls 23ga Mid-Field Endo Illuminator Due to Seal Failure

    Synergetics Inc is recalling 26 units of 23ga Mid-Field Endo Illuminator devices because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    23ga Mid-Field Endo Illuminator, Synergetics length 7.5 ft, sterile / EO, 56.22.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1463-2014·2014-02-05

    NatureBox Picante Ranch Mix Recalled for Missing Wheat Allergen Labeling

    NatureBox is recalling Picante Ranch Mix because the ingredient list failed to disclose unbleached wheat flour and bulgur wheat.

    Product
    NatureBox Picante Ranch Mix Spicy Snack Mix with Corn Nuts and Masa Chips; Net. WT: 4 oz. (113 g), Stand up Pouch, Vegan Ingredients: Corn Nuts (corn, canola oil, soybean oil, salt), Sugar, Flax Chips (Yellow corn masa, flax seeds, soybean oil, salt) Snack Seasoning(sour cr
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1433-2014·2014-02-05

    Lambs Farm Cookie Combo Recalled for Undeclared Milk and Wheat Allergens

    The Lambs Farm, Inc. is recalling Cheerful Cookie Combo tins because the labels fail to declare milk and wheat allergens.

    Product
    Cheerful Cookie Combo containing an assortment of Lemon Butter Cookies and Famous Butter Cookies sold under the Lambs Farm brand and packaged in a white metal tin with a net weight of 1 lb.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0870-2014·2014-02-05

    BD BACTEC FX 40 Diagnostic Instrument Recalled for False Negative Results

    Becton Dickinson is recalling two BD BACTEC FX 40 instruments because a defective component may cause false negative results in clinical specimens.

    Product
    BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnostic Systems, 7 Loveton Circle, Sparks, MD 21152. The instrument is designed for the rapid detection of bacteria and fungi in clinical specimens. Samples are drawn from patients and injected directly i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0898-2014·2014-02-05

    Synergetics Recalls 23ga Aspirating Endo Illuminator Due to Seal Failure

    Synergetics is recalling 43 units of 23ga Aspirating Endo Illuminators because faulty seals on the outer pouch could result in seal failure.

    Product
    23ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0883-2014·2014-02-05

    Synergetics Recalls 72 Sterile Ophthalmic Endo Illuminators Due to Seal Failure

    Synergetics Inc. is recalling 72 sterile ophthalmic Endo Illuminators because faulty seals on the outer pouch could fail, potentially compromising sterility.

    Product
    Endo Illuminator, Synergetics, inc., 20ga, length 7.0 ft, sterile / EO, 56.02. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0879-2014·2014-02-05

    Synergetics Recalls 25ga Awh Chandelier Ophthalmic Devices Due to Seal Failure

    Synergetics Inc is recalling 36 units of 25ga Awh Chandelier ophthalmic devices because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    25ga Awh Chandelier, Synergetics, inc., B&L Cannula Compatible, length 8.0 ft, sterile / EO, 56.52.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0857-2014·2014-02-05

    Sorin CP5 Centrifugal Pump System Recalled for Control Knob Failures

    Sorin Group is recalling 75 CP5 centrifugal pump systems due to reports of pump speed control knob failures that result in no response.

    Product
    CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0884-2014·2014-02-05

    Synergetics Recalls 23ga Endo Illuminator Due to Faulty Seals

    Synergetics Inc. is recalling 102 units of 23ga Endo Illuminator devices because faulty seals on the outer pouch could result in seal failure.

    Product
    23ga Endo Illuminator (Eckardt Trocar Compatible), Synergetics, inc., length 8.0 ft, sterile / EO, 56.02.23P Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0872-2014·2014-02-05

    Synergetics Recalls Sterile Ophthalmic Tubing Sets Due to Seal Failure Risk

    Synergetics Inc. is recalling 12 units of sterile ophthalmic tubing sets because faulty seals could fail, potentially compromising sterility.

    Product
    Standard tubing set, Synergetics, Inc., length 10 ft, sterile / EO, 17570. Packed 6 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0791-2014·2014-02-05

    Philips Brilliance CT Systems Recalled for Dose Calculation Issue

    Philips is recalling 23 Brilliance CT systems because the DoseRight feature may suggest higher radiation doses for large children than expected.

    Product
    Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0855-2014·2014-02-05

    Orthofix Firebird Modular Screw Driver Recalled for Collet Malfunction

    Orthofix is recalling 443 Modular Screw Drivers because the collet may malfunction, preventing effective screw placement and delaying surgery.

    Product
    Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal fixation procedure. It is a reusable instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0871-2014·2014-02-05

    Spacelabs AriaTelemetry Transmitters Recalled for SpO2 Display Errors

    Spacelabs is recalling AriaTelemetry transmitters because they may display SpO2 values when sensors are disconnected or failed.

    Product
    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0881-2014·2014-02-05

    Synergetics Recalls 27ga Ophthalmic Chandelier Due to Faulty Sterile Seals

    Synergetics is recalling 24 units of 27ga ONE-STEP Awh/Tano Vivid Chandeliers because faulty seals on the outer pouch could fail, compromising the sterile status of the ophthalmic devices.

    Product
    27ga ONE-STEP (tm) Awh/Tano Vivid Chandelier, Synergetics, length 8.0 ft, sterile / EO, 56.55.27P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0886-2014·2014-02-05

    Synergetics Recalls Stiff 25ga Endo Illuminator Due to Faulty Seals

    Synergetics Inc is recalling 48 units of Stiff 25ga Endo Illuminators because faulty seals on the outer pouch could result in seal failure.

    Product
    Stiff 25ga Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0893-2014·2014-02-05

    Synergetics Recalls Vivid Endo Illuminator Due to Faulty Seals

    Synergetics Inc. is recalling Vivid Endo Illuminators because faulty seals on the outer pouch could fail, potentially compromising the sterile status of the device.

    Product
    Wide Field Endo Illuminator, Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.21P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0878-2014·2014-02-05

    Synergetics Recalls 29ga Ophthalmic Chandeliers Due to Faulty Seals

    Synergetics Inc. is recalling 233 units of 29ga Oshima Dual Chandeliers because faulty seals on the outer pouch could fail, compromising the sterile status of the devices.

    Product
    29ga Oshima Dual Chandelier, Synergetics, inc., length 7.5 ft, sterile / EO, 56.50.29P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0863-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff, Inc. is recalling 409 units of Codman Certas Programmable Valves because they may not operate properly.

    Product
    Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and Accessories Product Code: 82-8806 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cereb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1042-2014·2014-02-05

    Wockhardt Recalls Pantaprazole Sodium Tablets Due to Dissolution Failure

    Wockhardt USA is recalling 1,129 bottles of Pantaprazole Sodium 40 mg tablets because they failed dissolution specifications.

    Product
    Pantaprazole Sodium Delayed Release Tablets , USP 40 mg, 1000 tablets bottle, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd Parsippany, NJ 07054 USA. NDC: 64679-0434-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1446-2014·2014-02-05

    Hnos. Perez Cactus Pads Recalled for Unpermitted Pesticides

    West Coast Produce is recalling Hnos. Perez brand cactus pads found to contain unpermitted pesticides in California.

    Product
    Hnos. Perez brand cactus leaves (pads): distributed by: West Coast Produce 300 Franklin St. Oakland, CA 94607
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1448-2014·2014-02-05

    Marquez Produce Recalls Fresh Cactus Due to Unapproved Pesticides

    Marquez Produce is recalling Fresh Cactus ("Nopal") because it contains unapproved pesticides. The recall affects 352 units distributed in California.

    Product
    Fresh Cactus ("Nopal"), 40lbs/bx
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1447-2014·2014-02-05

    Mexpogroup Cactus Recalled for Unapproved Pesticide Residues in California

    Shasta Produce is recalling Mexpogroup Cactus in California due to the presence of pesticides without established US tolerance levels.

    Product
    Mexpogroup Cactus Grown in Mexico; 44 lbs, 20 KG; Calle El Rosario #20581 Col Buenos Aires Norte C.P. 22700 Tijuana, Mexico.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0829-2014·2014-02-05

    Anspach Recalls Single-Use Sterile Bone Cutting Burs Due to Length Discrepancy

    The Anspach Effort, Inc. is recalling 599 single-use sterile bone cutting burs because the cutters were longer than stated on the label.

    Product
    AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0901-2014·2014-02-05

    Merit Medical Systems Recalls RAD BOARD Devices Due to Missing Labels

    Merit Medical Systems is voluntarily recalling one lot of RAD BOARD devices because missing labels may allow incorrect orientation, potentially obscuring patient anatomy during fluoroscopy.

    Product
    Radial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for a medical procedure. The Merit RAD BOARD is a rigid and stiff body board intended for use for various medical purposes. RAD BOARD was specifically designed to support the weight of a patie
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0825-2014·2014-02-05

    Siemens ACUSON SC2000 Ultrasound System Recalled for Control Panel Lock Failure

    Siemens is recalling 271 ACUSON SC2000 ultrasound systems because the control panel locking mechanism can fail, making the device difficult to steer during transport.

    Product
    ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mountain View, CA 94043 Ultrasound imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0868-2014·2014-02-05

    Siemens Free T3 Assay Kits Recalled for Positive Bias in Results

    Siemens Healthcare Diagnostics is recalling Free T3 Assay kits due to a positive bias that may cause normal thyroid patients to appear abnormal.

    Product
    T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and REF/Catalog Number L2KF36 (600 Tests), SMN 10381682; an IVD Immunoassay kit for use with the IMMULITE 2000/IMMULITE 200 XPi Analyzers --- Origin: UK Siemens Healthcare Diagnost
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0847-2014·2014-02-05

    Zimmer Dental Recalls Tapered Screw-Vent Implant Lot Due to Labeling Error

    Zimmer Dental is voluntarily recalling a specific lot of Tapered Screw-Vent Implants because some packages may display incorrect size information on the cap label.

    Product
    Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0840-2014·2014-02-05

    GE Optima CT Systems Recalled for Manual Film Composer Data Mismatch

    GE Healthcare is recalling 272 Optima CT520 and CT540 systems because the Manual Film Composer feature may display or print images with incorrect patient names or mismatched image previews.

    Product
    GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0832-2014·2014-02-05

    Philips Brilliance iCT Computed Tomography Systems Recalled for Image Artifacts

    Philips is recalling seven Brilliance iCT and iCT SP CT scanners because patient images exhibited ring artifacts.

    Product
    Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH The Brilliance iCT and iCT SP are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray tr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1450-2014·2014-02-05

    Washington Vegetable Co Recalls Cactus Pads Due to Unapproved Pesticides

    Washington Vegetable Co is recalling Cactus Pads (Nopal) from Mexico because unapproved pesticides were found during sampling by the CA Department of Pesticide Regulation.

    Product
    Cactus Pads (Nopal) Mexpogroup: Product of Mexico
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0842-2014·2014-02-05

    Biomerieux Recalls API Listeria Kits Due to ZYM B Reagent Defect

    Biomerieux is recalling API Listeria kits because a defect in the ZYM B reagent may cause false negative results in biochemical tests.

    Product
    API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as a database. The ZYM B reagent is including in API Listeria kit and it is used as an additional reagent for revealing the result of DIM mi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0892-2014·2014-02-05

    Synergetics Vivid Endo Illuminator Recalled for Faulty Sterile Seals

    Synergetics Inc. is recalling Vivid Endo Illuminators because faulty seals on the outer pouch could fail, compromising the sterile status of the single-use ophthalmic devices.

    Product
    Vivid (tm) Endo Illuminator, 20ga, Synergetics, inc., length 7.5 ft, sterile / EO, 56.20P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0843-2014·2014-02-05

    BioMérieux Recalls API NH Kits Due to ZYM B Reagent Defect

    BioMérieux is recalling API NH kits because a defect in the ZYM B reagent may cause false negative results in biochemical tests.

    Product
    API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catharrhalis (Branhamella catarrhalis), which uses miniaturized tests, as well as a specially adapted database. API NH also enables the biotyp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0830-2014·2014-02-05

    Anspach Twist Drill Recall Due to Incorrect Length Labeling

    The Anspach Effort, Inc. is recalling 29 single-use sterile twist drills because the cutters were longer than stated on the label.

    Product
    Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0900-2014·2014-02-05

    Boston Scientific Recalls 1068 Peripheral Imaging Catheters Due to Guidewire Issues

    Boston Scientific is recalling 1,068 units of the Atlantis PV 8.5F Peripheral Imaging Catheter because physicians reported an inability to pass a guidewire through the device.

    Product
    Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Sterilized using irradiation. Product Usage: This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an 8.5F-introducer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0867-2014·2014-02-05

    Siemens Free T3 Assay Kits Recalled for Positive Bias in Results

    Siemens Healthcare Diagnostics is recalling Free T3 Assay kits due to a positive bias that may cause normal thyroid patients to appear abnormal.

    Product
    T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 10381626; an IVD Immunoassay kit for use with the IMMULITE/IMMULITE 1000 Analyzers --- Shipping or unit package: 100, 200, 500 and 600 test kits --- Origin: UK Siemens Healthcare Diagnostics Products Lt
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0850-2014·2014-02-05

    Kimberly-Clark Radiofrequency Cannula Recalled for Incorrect Active Tip Length

    Kimberly-Clark is recalling Radiofrequency Cannulas where the active tip may be 5mm instead of the labeled 10mm, potentially affecting lesion creation in nervous tissue.

    Product
    Kimberly-Clark RadiOpaque Radiofrequency Cannula, Gauge 22, Length 100 mm, Active Tip 10 mm, Distributed in the US by Kimberly-Clark,Product code PMF22-100-10 The product is used to create lesions in nervous tissue when used with the Kimberly-Clark radiofrequency generator and
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0853-2014·2014-02-05

    GE Healthcare Recalls Innova IGS 630 Biplane Imaging Systems

    GE Healthcare is recalling 28 Innova IGS 630 biplane imaging systems because a specific user action may cause the X-ray function to lock up.

    Product
    GE Healthcare Innova IGS 630. Biplane Cardiovascular and Interventional Imaging System. Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0841-2014·2014-02-05

    BioMérieux Recalls ZYM B Reagent Due to Visual Defect and False Negatives

    BioMérieux is recalling ZYM B Reagent (REF 70493) because a visual defect and activity issue can cause false negative results in API biochemical tests.

    Product
    ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1053-2014·2014-02-05

    Watson Recalls Hydrocodone and Acetaminophen Tablets Due to Broken Tablets

    Watson Laboratories is recalling 717 bottles of Hydrocodone Bitartrate and Acetaminophen tablets because the product contains broken tablets.

    Product
    Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 count bottles, Rx only. Manufactured by Watson Laboratories, Inc., Corona, CA 92880. Distributed by: Watson Pharma, Inc. NDC: 00591-0517-01.
    Category
    Drug
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0848-2014·2014-02-05

    Maquet Compressor Mini Recalled for Excessive Compressed Air Temperature

    Maquet is recalling 237 Compressor Mini units because they may deliver compressed air at a temperature higher than specified.

    Product
    Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the specifications of the compressor mini. compressor mini is intended to be operated by healthcare providers, physicians, nurses, and tech
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1442-2014·2014-02-05

    LSG Food World Recalls Fu Zhou Vermicelli for Filth and Misbranding

    LSG Food World Inc. is recalling Fu Zhou Vermicelli due to filth and missing English translations. The product was distributed in New York.

    Product
    Lam Sheng Kee Fu Zhou Vermicell, Net Wt. 4.4 LB (2000 g), product is packaged in plastic bag with twelve (12) bags per carton. UPC 6949682 803360; Manufactured by LAM SHENG KEE (HK) INTERNATIONAL LIMITED RM3. 8/F, YUEXIU BLDG., 160-174 LOCKHART ROAD, WAN CHAI HK; Distributed by
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1451-2014·2014-02-05

    Mars Recalls Uncle Ben's Mexican Flavor Rice Due to Flushing Reports

    Mars Food US is recalling Uncle Ben's Infused Rice Mexican Flavor due to reports of flushing reactions after consumption.

    Product
    Uncle Ben's (R), Infused(R) Rice Mexican Flavor rice, NET WT 5 LB (2.27 kg), distributed by MARS Foodservices US, P.O. Box 5059, Rancho Dominguez, CA 90224-5059
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-1439-2014·2014-02-05

    Atlapac Recalls Swollen California Girl Canned Peach Halves

    Atlapac Trading Company is recalling California Girl canned Peach Halves in Juice because the cans were reported to be swollen.

    Product
    California Girl canned Peach Halves in Juice, 6 cans per case. UPC 52391 72992
    Category
    Food
    Distribution
    1 state
  • LowFDA (Devices)·Z-0865-2014·2014-02-05

    GE Centricity Laboratory System Software Recall for Calculation Errors

    GE Healthcare is recalling Centricity Laboratory System software due to a defect that may report calculated results as 0 or truncate them.

    Product
    The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical res
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1440-2014·2014-02-05

    LSG Food World Recalls Bean Paste Bread for Labeling Defect

    LSG Food World Inc. is recalling Bean Paste Bread because the product label lacks an English translation. The recall covers 1,050 cartons distributed in New York.

    Product
    Bean Paste Bread, Net Wt. 420 g, product is packaged within a plastic bag with twelve (12) bags per carton.
    Category
    Food
    Distribution
    1 state
  • LowFDA (Food)·F-1441-2014·2014-02-05

    LSG Food World Recalls Jam-Filled Bread for Missing English Label Translation

    LSG Food World Inc. is recalling Bread Filled with Jam and Bean Paste Bread because the product labels lack English translations.

    Product
    Bread Filled with Jam, Net Wt. 420 g, product is packaged within a plastic bag with twelve (12) bags per carton.
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·011-2014·2014-02-04

    ConAgra Recalls Chicken Noodle Soup for Undeclared Wheat and Egg Allergens

    ConAgra Foods is recalling 54,673 pounds of chicken noodle soup mislabeled as chicken with rice, failing to declare wheat and egg allergens.

    Product
    Pennsylvania Firm Recalls Chicken Noodle Soup Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·14V035000·2014-02-04

    Schwing Recalls 2012-2013 Concrete Pump Trucks Due to Fire Risk

    Schwing America is recalling 2012-2013 concrete pump trucks because a specific potting compound in DC-DC converters can conduct electricity and cause fires.

    Product
    SCHWING — SCHWING S58SX, S61SX, S39SX, S43SX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V031000·2014-02-04

    Mitsubishi Recalls 2013 Outlander Sport for Air Bag Wiring Defect

    Mitsubishi is recalling 2013 Outlander Sport vehicles with leather seats because improperly routed air bag wiring may prevent the driver's air bag from deploying in a crash.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V034000·2014-02-04

    Chrysler Recalls 2014 Ram ProMaster Vehicles for Brake Hose Defect

    Chrysler is recalling 2014 Ram ProMaster vehicles because a manufacturing tool may have damaged a brake hose, potentially causing fluid leakage and reduced braking performance.

    Product
    RAM — RAM PROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V037000·2014-02-04

    Kaffenbarger Recalls International Trucks with Fire-Prone DC-DC Converters

    Kaffenbarger is recalling certain 2006-2013 International trucks because a specific DC-DC converter potting compound can conduct electricity and cause a fire.

    Product
    INTERNATIONAL — INTERNATIONAL 9900I SFA 6X4, 4300 SBA 4X2, 7600 SFA 6X4, 4300M7 SBA 4X2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V033000·2014-02-04

    Heartland Recalls Fifth Wheel Travel Trailers Due to Incorrect Certification Label

    Heartland is recalling 2014 fifth wheel travel trailers equipped with optional 17.5-inch wheels because the Federal Certification Label contains incorrect wheel specifications.

    Product
    HEARTLAND — HEARTLAND GRAND CANYON, MONTEREY, SAN ANTONIO, SAVANNAH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·010-2014·2014-02-04

    Texas Firm Recalls Beef Products Due To Possible E. Coli Contamination

    PFP Enterprises is recalling approximately 15,865 pounds of beef products distributed in four states and Puerto Rico due to possible contamination with multiple non-O157 E. coli strains.

    Product
    Texas Firm Recalls Beef Products Due To Possible E. Coli Contamination
    Category
    Food
    Distribution
    4 states
  • HighCPSC·14099·2014-02-04

    3T Design Recalls Cervélo P5 Bicycles with Aduro Handlebars

    3T Design is recalling Cervélo P5 bicycles with Aduro aero handlebars because the forward extension mounts can detach while riding, posing a risk of injury.

    Product
    Cervélo P5 bicycles with 3T Aduro aero handlebars
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V030000·2014-02-04

    Eldorado Buses Recalled for Fire Risk in Electrical Components

    Eldorado is recalling specific E-Z Rider II, Axess, and Passport buses because a potting compound in electrical components may conduct electricity and cause a fire.

    Product
    ELDORADO — ELDORADO E-Z RIDER II, AXESS, PASSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14100·2014-02-04

    Lion Force Boys' Puffer Coats Recalled for Strangulation Hazard

    Lion Force is recalling boys' puffer coats sold at Burlington Coat Factory because the hood drawstrings pose a strangulation hazard to children.

    Product
    Lion Force Boys' Puffer Coats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·009-2014·2014-02-01

    House of Smoke Recalls Meat Products Due to Undeclared Soy Lecithin

    House of Smoke, Inc. is recalling approximately 144,000 pounds of meat and poultry products because they contain soy lecithin, a known allergen not declared on the label.

    Product
    House Of Smoke, Inc. — Colorado Firm Recalls Various Meat Products Due To Soy Lecithin
    Category
    Food
    Distribution
    Distributed nationwide

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