The Recall Desk

Archive

November 2013 recalls

588 recalls were announced in November 2013.

What the numbers show

Critical
11
Severe
126
High
224
Moderate
219
Low
8

Of the 588 recalls this month scored against our rubric, 2% are Critical, 21% are Severe.

Which agencies issued them

401–500 of 588

  • SevereFDA (Drugs)·D-66403-003·2013-11-13

    Mylan Recalls Lamotrigine Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling 28,140 bottles of 200 mg Lamotrigine tablets because they were not manufactured according to Good Manufacturing Practices.

    Product
    Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and b) 500-count bottles (NDC 0378-4254-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66318-001·2013-11-13

    Amgen Recalls Prolia Injection Due to Visible Cellulose Fibers

    Amgen is recalling 4,163 Prolia (denosumab) prefilled syringes because visible cellulose fibers were found during routine quality checks.

    Product
    PROLIA — PROLIA (DENOSUMAB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66447-001·2013-11-13

    Irinotecan Hydrochloride Injection Recalled for Incorrect Formulation Calculation

    West-Ward Pharmaceutical Corp. is recalling Irinotecan Hydrochloride Injection because a calculation error resulted in drug levels higher than labeled.

    Product
    IRINOTECAN HYDROCHLORIDE — IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0163-2014·2013-11-13

    Smiths Medical Recalls Portex Spinal Trays Due to Visual Particulates

    Smiths Medical is recalling Portex Spinal Anaesthesia Trays because visual particulates were found in the included Lidocaine and Dextrose ampules.

    Product
    Portex¿ Saddleblock Tray with Drugs 22g Quincke (Without Introducer); 4792-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0138-2014·2013-11-13

    Elekta Recalls Stereotactic Circular Collimators Due to Potential Clinical Errors

    Elekta, Inc. is recalling 89 Stereotactic Circular Collimators used in radiotherapy for head tumors due to a potential for clinical errors.

    Product
    Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0124-2014·2013-11-13

    Safeway Recalls Angel Food Cups Due to Missing Milk and Soy Allergen Labels

    Safeway is recalling 448 packages of Angel Food Cups because the labels failed to list milk and soy as ingredients.

    Product
    Angel Food Cups 4 Count; labeled for retail sale in the following stores: Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons. Angel Food Cups 4 Count  0 lb. 3 oz. (85g); Individual cake cups sold in package of 4 items.
    Category
    Food
    Distribution
    21 states
  • HighFDA (Food)·F-0112-2014·2013-11-13

    Martha White Corn Meal Recalled for Aflatoxin Levels Exceeding FDA Limits

    J M Smucker Co is recalling specific lots of Martha White Corn Meal because independent testing found aflatoxin levels above FDA specifications.

    Product
    Martha White Corn Meal Plain, White, Enriched NET WT 32 OZ (2 LB) 907g Paper Bag Mfg Code 3193 511 BEST IF USED BY: 12-Mar-14 Product labeled in part, INGREDIENTS: WHITE CORN MEAL, NIACIN, IRON, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC ACID*** MAY CONTAIN MILK AND WHEAT…
    Category
    Food
    Distribution
    33 states
  • HighFDA (Devices)·Z-0148-2014·2013-11-13

    Fresenius Liberty Cycler Recalled for Fluid Leak and Contamination Risk

    Fresenius Medical Care is recalling Liberty Cyclers because fluid leaks may contaminate dialysate, potentially causing peritonitis.

    Product
    Fresenius Liberty¿ Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0126-2014·2013-11-13

    Safeway Angel Food Cake Recalled for Missing Soy Flour Labeling

    Safeway is recalling Angel Food Cake Fruit Topped because the ingredient label omitted soy flour, a major allergen.

    Product
    Angel Food Cake Fruit Topped; labeled for retail sale in the following stores: Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons. Angel Food Cake Fruit Topped  3 lb. 12 oz. (1701 g); Angel Food Cake Fruit Topped  Black or White…
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-0141-2014·2013-11-13

    Steris Harmony Equipment Management System Recalled for Drive Screw Failure Risk

    Steris Corporation is recalling 127 Harmony Equipment Management Systems because a drive screw in the ceiling supply unit may break, causing the adjustable arm to drop.

    Product
    Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment Management Systems (EMS) are used in hospital facilities to provide ready access to medical gasses, electrical power and audio/visual data services, in addition to managing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V565000·2013-11-13

    Sutphen Fire Apparatus Recall for Ladder Bearing Defect

    Sutphen is recalling specific fire apparatus models because ladder extension bearings may seize, causing cables to fail and the aerial to retract unexpectedly.

    Product
    SUTPHEN — SUTPHEN SPH 100, SP 110, SPI 112, SAI 110
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0170-2014·2013-11-13

    Hamilton Medical Recalls HAMILTON-C2 Ventilators Due to Loudspeaker Defects

    Hamilton Medical is recalling 316 HAMILTON-C2 ventilators because the alarm system loudspeakers exceeded manufacturer-defined limits for improper functioning.

    Product
    HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0135-2014·2013-11-13

    Edwards Lifesciences Recalls Aortic Perfusion Cannulas Due to Cracks

    Edwards Lifesciences is recalling two lots of aortic perfusion cannulas because cracks were found in the t-connectors during product evaluation.

    Product
    Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For Single Use Only, Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V567000·2013-11-13

    GM Recalls 2014 Chevrolet Malibu for Defroster Software Defect

    General Motors is recalling 2014 Chevrolet Malibus because the HVAC control may fail, preventing the windshield defroster from working and reducing visibility.

    Product
    CHEVROLET — CHEVROLET MALIBU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0151-2014·2013-11-13

    Ethicon Adjustable Gastric Band Recalled for Force to Lock Failure

    Ethicon Endo-Surgery Inc is recalling 1,248 units of Adjustable Gastric Bands because they failed to meet Force to Lock requirements during aging studies.

    Product
    Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical treatment of morbid obesity
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0168-2014·2013-11-13

    Roche COBAS INTEGRA 800 Analyzer Recalled for Software Maintenance Defect

    Roche Diagnostics is recalling 527 COBAS INTEGRA 800 Analyzers with software version 9864.C2 because the system fails to perform necessary ISE service actions and maintenance requests.

    Product
    COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling accessory A fully automated system for clinical chemistry analysis intended for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0167-2014·2013-11-13

    Invacare Aquatec Ocean Mobile Shower and Toilet Commode Recall

    Invacare is recalling Aquatec Ocean mobile shower and toilet commodes because backrest cushion fixtures may unlatch in reclined or tilted positions.

    Product
    Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower and toilet commode with tilting function. Mobile shower and toilet commode with tilting function
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0143-2014·2013-11-13

    Baxter Recalls Dual Luer Lock Caps Due to Loose Particulate Matter

    Baxter Healthcare is recalling specific lots of Dual Luer Lock Caps because loose particulate matter was found in the packaging, posing a risk of embolic events.

    Product
    Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0114-2014·2013-11-13

    Martha White Cornbread Recalled for Aflatoxin Contamination

    J M Smucker Co is recalling specific lots of Martha White Cotton Country Cornbread because aflatoxin levels exceeded FDA specifications.

    Product
    Martha White Cotton Country Cornbread, NET WT 6 OZ (170g) Paper Bag Mfg Code 3107 501 BEST IF USED BY: 17-Apr-14 Product labeled in part, INGREDIENTS: ENRICHED DEGERMINATED WHITE CORN MEAL, ENRICHED BLEACHED FLOUR***PARTIALLY HYDROGENATED SOYBEAN OIL, DEXTROSE, BAKING POWDER***…
    Category
    Food
    Distribution
    33 states
  • HighFDA (Food)·F-0110-2014·2013-11-13

    White Lily Cornmeal Mix Recalled for Aflatoxin Contamination

    J M Smucker Co is recalling White Lily Enriched White Cornmeal Mix because aflatoxin levels exceeded FDA specifications.

    Product
    WHITE LILY¿ ENRICHED WHITE Cornmeal MIX SELF-RISING NET WT 32 OZ (2 LB) 907g Paper Bag Mfg Code 3135 511 BEST IF USED BY: 15-JAN-14 Product labeled in part, INGREDIENTS: ENRICHED WHITE CORN MEAL, WHEAT FLOUR AND DEGERMINATED WHITE CORN MEAL***BAKING POWDER***SALT***CONTAINS…
    Category
    Food
    Distribution
    33 states
  • HighFDA (Devices)·Z-0139-2014·2013-11-13

    Intuitive Surgical Recalls da Vinci Patient Carts Due to Fluid Complaints

    Intuitive Surgical is recalling 1,754 da Vinci S and SI Patient Carts worldwide due to increased complaints about fluid entering the cart base.

    Product
    Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Patient Side Cart (PSC) is a robotic platform used for da Vinci Surgery. It is the operative component for both da Vinci systems and…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0105-2014·2013-11-13

    Martha White Self-Rising Corn Meal Recalled for Aflatoxin Contamination

    J M Smucker Co is recalling specific lots of Martha White Self-Rising Corn Meal because aflatoxin levels exceeded FDA specifications.

    Product
    Martha White¿ SELF-RISING Corn Meal Bolted White Enriched Hot Rize Net Wt 5 lb (2.26 kg) Paper bag, Mfg Code 3127 511 BEST IF USED BY: 7-Jan-14, Product labeled in part, INGREDIENTS: ENRICHED BOLTED WHITE CORN MEAL***BAKING POWDER***SALT***DISTRIBUTED BY: MARTHA WHITE FOODS…
    Category
    Food
    Distribution
    33 states
  • HighFDA (Devices)·Z-0149-2014·2013-11-13

    Ethicon Endo-Surgery Recalls Adjustable Gastric Bands Due to Locking Failure

    Ethicon Endo-Surgery Inc is recalling adjustable gastric bands because they failed to meet force-to-lock requirements during aging studies.

    Product
    Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids, or in various kit configurations with one band per kit. Product Usage: Intended for use in surgical treatment of morbid obesity
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0107-2014·2013-11-13

    Martha White Cornbread Mix Recalled for Aflatoxin Contamination

    J M Smucker Co is recalling specific lots of Martha White Buttermilk Cornbread & Muffin Mix because aflatoxin levels exceeded FDA specifications.

    Product
    Martha White¿ Buttermilk Cornbread & Muffin Mix NET WT 6 OZ (170g) Laminated Pouch Mfg Code 3105 501 BEST IF USED BY: 15 APR 14 Product labeled in part INGREDIENTS: ENRICHED DEGERMINATED WHITE CORN MEAL, WHEAT FLOUR*** PARTIALLY DEHYDROGENATED SOYBEAN OIL, DEXTROSE, BAKING…
    Category
    Food
    Distribution
    33 states
  • HighFDA (Food)·F-0108-2014·2013-11-13

    Martha White Cornbread Mix Recalled for Aflatoxin Contamination

    J M Smucker Co is recalling specific lots of Martha White Cotton Country Cornbread Mix because independent testing found aflatoxin levels exceeding FDA specifications.

    Product
    Martha White¿¿ COTTON COUNTRY CORNBREAD BUTTERMILK CORNBREAD MIX NET WT 6 OZ (170g) Laminated Pouch Mfg Code 3106 501 BEST IF USED BY: 16 APR 14 & Mfg Code 3107 501 BEST IF USED BY: 17 APR 14 Product labeled in part, ¿¿SINGREDIENTS: ENRICHED DEGERMINATED WHITE CORN MEAL, AND…
    Category
    Food
    Distribution
    33 states
  • HighFDA (Devices)·Z-0169-2014·2013-11-13

    Vital Images Recalls VitreaCore Software Due to Image Orientation Defect

    Vital Images, Inc. is recalling VitreaCore software versions 6.0 through 6.5 due to a potential for incorrect or reversed image orientation in certain snapshots.

    Product
    VitreaCore¿ software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5. The VitreaCore (ViTALConnect) system is a medical diagnostic software system intended to process, analyze…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0103-2014·2013-11-13

    Jim Dandy Iron Fortified Quick Grits Recalled for Aflatoxin Contamination

    J M Smucker Co is recalling Jim Dandy Iron Fortified Quick Grits because independent testing found aflatoxin levels exceeding FDA specifications.

    Product
    Jim Dandy¿ Iron Fortified Quick Grits, 1lb paper box, Labeled in part "INGREDIENTS: IRON, WHITE CORN GRITS, NIACIN, THIAMIN, MONONITRATE, RIBOFLAVIN, FOLIC ACID. DISTRIBUTED BY: MARTHA WHITE FOODS, INC., P. O. BOX 751030 MEMPHIS, TN 38175***0 13300 11501 5***3067 511 Best If…
    Category
    Food
    Distribution
    33 states
  • HighNHTSA·13V566000·2013-11-13

    GM Recalls 2013 Chevrolet Malibu for Power Seat Wiring Fire Risk

    General Motors is recalling 2013 Chevrolet Malibus with 8-way power seats because the wiring harness may chafe, potentially causing a short circuit or fire.

    Product
    CHEVROLET — CHEVROLET MALIBU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0104-2014·2013-11-13

    Jim Dandy Enriched Quick Grits Recalled for Aflatoxin Contamination

    J M Smucker Co is recalling Jim Dandy Enriched Quick Grits because independent testing found aflatoxin levels exceeding FDA specifications.

    Product
    Jim Dandy¿ Enriched Quick Grits, 1lb paper box, Labeled in part INGREDIENTS: WHITE CORN GRITS***NACIN, THIAMIN, MONONITRATE, RIBOFLAVIN, FOLIC ACID. DISTRIBUTED BY: MARTHA WHITE FOODS, INC., P. O. BOX 751030 MEMPHIS, TN 38175***0 13300 12107 8***3143 511 BEST IF USED BY…
    Category
    Food
    Distribution
    33 states
  • HighFDA (Devices)·Z-0181-2014·2013-11-13

    Siemens Healthcare Recalls Emit 2000 Phenobarbital Assay Due to Imprecision

    Siemens Healthcare Diagnostics is recalling specific lots of the Emit 2000 Phenobarbital Assay because they may produce imprecise results. The recall covers units distributed in the US and Mexico.

    Product
    Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0175-2014·2013-11-13

    Mesa Laboratories Recalls pH 7.0 Buffer Solution Due to Mold Growth

    Mesa Laboratories is recalling specific lots of pH 7.0 Buffer Solution bottles because of mold growth. The product is used to calibrate pH meters in hemodialysis settings.

    Product
    pH 7.0 Buffer Solution Pint and Quart Bottles, Part Number 02.0030 for Pints and 02.0031 for Quarts. Packaged in Plastic Bottles. Can be sold individually or in cartons with 6 bottles per box (for quart bottles only). Used in the hemodialysis setting to calibrate pH meters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0127-2014·2013-11-13

    Stryker Recalls Dekompressor Percutaneous Discectomy Probes Due to Fracture Risk

    Stryker is recalling Dekompressor Percutaneous Discectomy Probes because the auger or cannula may fracture if the device is manually bent, potentially requiring additional medical intervention.

    Product
    Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus material.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0164-2014·2013-11-13

    Smiths Medical Recalls Portex Spinal Trays with Particulate Contamination

    Smiths Medical is recalling Portex Spinal Anaesthesia Trays because visual particulate was found in the included Lidocaine and Dextrose ampules.

    Product
    Portex¿ Saddleblock Tray with Drugs  25g Quincke; 4795-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0142-2014·2013-11-13

    Sorin Recalls S5 Heart-Lung Machines Due to Cardioplegia Control Malfunction

    Sorin Group is recalling 84 S5 Heart-Lung Machines because of a malfunction in the cardioplegia control system.

    Product
    S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-0119-2014·2013-11-13

    Irwin Naturals Recalls Dual Action Cleanse Due to Chloramphenicol Contamination

    Irwin Naturals is recalling Dual Action Cleanse and Daily Digestive Enzymes because they may be contaminated with chloramphenicol.

    Product
    Dual Action Cleanse by Cellular Research Formulas with Green Tea Bonus 60 ct, Item AN056906E, UPC Code: 7 10363 56906 8
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0106-2014·2013-11-13

    Gladiola White Cornbread Mix Recalled for Aflatoxin Contamination

    JM Smucker is recalling Gladiola White Cornbread Mix because independent testing found aflatoxin levels exceeding FDA specifications.

    Product
    Gladiola¿ White Cornbread Mix, Net Wt 6 oz (170g) Laminated Pouch Mfg Code 3101 501 BEST IF USED BY: 11 APR 14 Product labeled in part, INGREDIENTS: ENRICHED DEGERMINATED WHITE CORN MEAL, AND ENRICHED BLEACHED FLOUR***PARTIALLY DEHYDROGENATED SOYBEAN OIL, DEXTROSE, BAKING…
    Category
    Food
    Distribution
    33 states
  • HighFDA (Food)·F-0109-2014·2013-11-13

    Martha White Corn Meal Mix Recalled for Aflatoxin Levels

    J M Smucker Co is recalling Martha White Self-Rising Buttermilk Corn Meal Mix because independent testing found aflatoxin levels exceeding FDA specifications.

    Product
    Martha White¿ SELF-RISING BUTTERMILK CORN MEAL MIX White-Enriched Hot Rize NET WT 32 OZ (2 LB) 907g Paper Bag Mfg Code 3151 511 BEST IF USED BY: 31 JAN 14 Product labeled in part, INGREDIENTS: ENRICHED WHITE CORN MEAL, WHEAT FLOUR AND DEGERMINATED WHITE CORN MEAL***BAKING…
    Category
    Food
    Distribution
    33 states
  • HighFDA (Devices)·Z-0171-2014·2013-11-13

    Handicare Bath Bliss Handset Recall for Inoperable Lifts

    Handicare Accessibility is recalling 3,301 handsets for Minivator Bath Bliss Reclining Bath Lifts because two units became inoperable while users were in the tub.

    Product
    Handset component of the Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), Part Number BP300-100/BP300-400RSUS (handset) - Model Numbers BBR0311USAB (blue) and BBR0311USSS (silver) Handset component devices operate the Minivator Bath Bliss Reclining Bath…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0157-2014·2013-11-13

    Portex Spinal Trays Recalled Due to Visual Particulate in Lidocaine Ampules

    Smiths Medical ASD is recalling 73 Portex Spinal Trays because visual particulate was found in the included Lidocaine HCL ampules.

    Product
    Portex¿ Spinal Tray with Drugs 22g/25g Quincke; 15249-21 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0147-2014·2013-11-13

    Beckman Coulter Recalls UniCel DxH 800 and DxH 600 Hematology Analyzers

    Beckman Coulter is recalling 1,025 UniCel DxH 800 and DxH 600 hematology analyzers because specific check valves may fail, potentially causing air or liquid leaks.

    Product
    UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0016-2014·2013-11-13

    Siemens Fluoroscopic X-Ray Systems Recalled for Potential Radiation Malfunction

    Siemens is recalling 23 fluoroscopic X-ray systems due to a potential malfunction that may cause radiation to continue longer than expected, resulting in unnecessary dose.

    Product
    Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0158-2014·2013-11-13

    Smiths Medical Recalls Portex Spinal Trays with Particulate Contamination

    Smiths Medical ASD, Inc. is recalling Portex Spinal Trays because visual particulate was found in the included Lidocaine and Dextrose ampules.

    Product
    Portex¿ Spinal Tray with Drugs 25g Whitacre; 15545C-21 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0150-2014·2013-11-13

    Ethicon Adjustable Gastric Band Recalled for Force to Lock Failure

    Ethicon Endo-Surgery Inc is recalling 2,475 Adjustable Gastric Bands because aging studies showed they failed to meet Force to Lock test requirements.

    Product
    Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical treatment of morbid obesity
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0134-2014·2013-11-13

    Edwards Lifesciences Recalls Fem-Flex Femoral Arterial Cannulas Due to Cracks

    Edwards Lifesciences is recalling two lots of Fem-Flex Femoral Arterial Cannulas because cracks were found in the t-connectors during product evaluation.

    Product
    Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usage: Edwards Lifesciences femoral access cannulae are intended for use in situations which require rapid femoral venous and arterial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0154-2014·2013-11-13

    Medtronic Resolute Integrity Coronary Stent Recall for Incorrect Compliance Chart Labeling

    Medtronic is recalling 201 units of Resolute Integrity Zotarolimus-eluting Coronary Stents because the compliance chart may incorrectly reference a 2.25 mm diameter instead of the correct 3.0 mm.

    Product
    Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in Medtronic Ireland, Galaway, Ireland. Distributed by: Medtronic Inc. Minneapolis, MN. Indicated for improving coronary luminal diameters in patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0179-2014·2013-11-13

    Carestream DRX-Revolution Mobile X-Ray Systems Software Patch Recall

    Carestream Health is voluntarily installing a software patch on DRX-Revolution mobile X-ray systems to address reports of non-diagnostic images during normal exposure exams.

    Product
    DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0132-2014·2013-11-13

    Carestream DRX Revolution Mobile X-Ray System Column Cover Recall

    Carestream Health is recalling DRX Revolution mobile x-ray systems because the column end cover may dislodge from the column.

    Product
    DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0136-2014·2013-11-13

    Bayer A1CNow+ Test Kits Recalled for Potential Inaccurate Results

    Bayer is recalling A1CNow+ test kits because they may produce high-bias readings if stored at room temperature for 4 to 5 months.

    Product
    Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by Bayer HealthCare LLC, Sunnyvale, CA The A1CNow+ test provides quantitative measurement of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-66403-001·2013-11-13

    Mylan Recalls Amlodipine Besylate Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling Amlodipine Besylate Tablets, 2.5 mg, because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (NDC 0378-5208-77) and b) 500-count bottles (NDC 0378-5208-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0137-2014·2013-11-13

    ITC Surgicutt Bleeding Time Device Recalled for Loose Blades

    ITC-Nexus Dx is recalling Surgicutt bleeding time devices because the blades may be loose. The recall affects Lot AK301M distributed nationwide.

    Product
    Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0130-2014·2013-11-13

    Smith & Nephew Recalls Mispackaged Genesis II Tibial Base Components

    Smith & Nephew is recalling four units of Genesis II tibial base components due to size and side mislabeling.

    Product
    GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0145-2014·2013-11-13

    Richard Wolf Recalls S(a)line Resectoscope Vaporization Electrodes Due to Packaging Error

    Richard Wolf Medical Instruments Corp. is recalling S(a)line resectoscope vaporization electrodes because a different model was found packaged in the wrong pouch.

    Product
    Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: only for continuous irrigation sheath 24,5 Fr.; LOT 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF; Cartons of 3 units labeled in part: REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0180-2014·2013-11-13

    Carestream DRX Mobile X-Ray Systems Recalled for Software Defect

    Carestream Health is voluntarily patching DRX Mobile X-Ray systems to fix a software issue causing non-diagnostic images.

    Product
    CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0165-2014·2013-11-13

    Insulet Recalls OmniPod Insulin Starter Kits Due to Mislabeling

    Insulet Corporation is recalling 1,719 OmniPod Insulin Management System Starter Kits because the included alcohol prep pads are not properly labeled.

    Product
    OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit) Product Usage: The Starter Kit (SKT-UST400) is provided to users as an introduction to the OmniPod Insulin Management System prior to initiating care. It includes the Personal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0093-2014·2013-11-13

    American Laboratories Recalls Plant Enzyme Powder Due to Chloramphenicol Contamination

    American Laboratories Inc is recalling NUT 14-500 plant enzyme powder because it may be contaminated with Chloramphenicol. The product was distributed to five states.

    Product
    NUT 14-500, powder, plant enzyme blend, packaged in 15 kg and 23 kg double poly bags inside fiber box. Product 98A
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-66403-006·2013-11-13

    Mylan Recalls Amlodipine and Benazepril Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling Amlodipine Besylate and Benazepril HCl capsules because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 100-count bottles (NDC 0378-6896-01) and b) 500-count bottles (NDC 0378-6896-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0159-2014·2013-11-13

    Smiths Medical Recalls Portex Regional Anesthesia Trays with Visual Particulates

    Smiths Medical is recalling Portex Regional Anesthesia Trays because visual particulates were found in the included Lidocaine and Dextrose ampules.

    Product
    Portex¿ Regional Anesthesia Tray with Drugs; 15548-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-66403-007·2013-11-13

    Mylan Recalls Amlodipine and Benazepril Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling Amlodipine Besylate and Benazepril HCl capsules because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg, packaged in a) 100-count bottles (NDC 0378-6897-01) and b) 500-count bottles (NDC 0378-6897-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0177-2014·2013-11-13

    Pinook Micro Massager Recalled for Lack of FDA Approval

    Pinook-Usa is recalling 28,994 Pinook Micro Massagers because the company failed to submit a premarket submission and gain FDA approval for the device.

    Product
    Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0101-2014·2013-11-13

    Vitalab Recalls Beet Plant Juice Tablets Due to Foreign Object

    Vitalab Co Inc is recalling specific lots of whole beet plant juice tablets because a customer found a foreign object in the product.

    Product
    VIT-RA-TOX Whole Beet Plant Juice, dietary supplement, dry, 400 mg tablet, packaged in 150 tablets glass, amber bottles. No. 48. National Distributors: V.E. Irons, Inc, N. Kansas City, MO. Springreen Whole Beet Plant Juice, dietary supplement, dry, 400 mg tablet, packaged…
    Category
    Food
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-0162-2014·2013-11-13

    Smiths Medical Recalls Portex Spinal Trays with Particulate Contamination

    Smiths Medical is recalling Portex Spinal Anaesthesia Trays because some included glass ampules contain visual particulate matter.

    Product
    Portex¿ Saddleblock Tray with Drugs 26g Quincke, 4745-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0155-2014·2013-11-13

    Trumpf Medical Systems Recalls ORBIT PT Patient Transport Device

    Trumpf Medical Systems is recalling one ORBIT PT unit due to a power supply defect that caused smoke and odor.

    Product
    ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0153-2014·2013-11-13

    Beckman Coulter ISE REF Valve Recall for Chemistry Analyzers

    Beckman Coulter is recalling ISE REF Valves for AU480, AU680, and AU5800 analyzers due to premature valve failure that may affect test accuracy.

    Product
    ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0100-2014·2013-11-13

    Source Naturals GABA Supplement Recalled for Metal Fragment

    Source Naturals is recalling GABA dietary supplements because a metal fragment was found in a tablet during inspection.

    Product
    Serene Science/Source Naturals brand GABA (Gamma-Aminobutyric Acid), CALM MIND, A dietary supplement, 45 Tablets, Item #: SN0237; 90 Tablets, Item #: SN0240; 180 Tablets, Item #: SN0268; Product label states, "manufactured for Source Naturals, Inc., P.O. Box 2118, Santa…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0129-2014·2013-11-13

    Zimmer Recalls Ti-Magna Fx Washers Due to Sterile Barrier Integrity Testing

    Zimmer, Inc. is recalling 2,632 Ti-Magna Fx Washers distributed in Japan to ensure sterile barrier integrity after a review of historic packaging validations.

    Product
    Ti-Magna Fx Washer Ti-Versa-FX¿II Femoral Fixation System S/C Plates The compression tube/plates of this trauma system are used with Ti-Versa-Fx¿ II Femoral Fixation System lag screws for the internal fixation of proximal femoral and supracondylar fractures. The Ti-Magna…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0156-2014·2013-11-13

    Smiths Medical Recalls Portex Spinal Trays Due to Visual Particulate

    Smiths Medical ASD, Inc. is recalling 140 Portex Spinal Trays because visual particulate was found in the included Lidocaine and Dextrose ampules.

    Product
    Portex¿ Spinal Tray with Drugs 22g Whitacre/25g Whitacre; 15248C-22/25 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0152-2014·2013-11-13

    Beckman Coulter Recalls ISE REF Valves for Chemistry Analyzers

    Beckman Coulter is recalling ISE REF Valves for AU series chemistry analyzers because premature valve failure may affect test accuracy.

    Product
    ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0166-2014·2013-11-13

    Insulet Recalls OmniPod Demonstration Kits Due to Mislabeling

    Insulet Corporation is recalling 5,050 OmniPod Insulin Management Product Demonstration Kits because the included alcohol prep pads are not properly labeled.

    Product
    OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) Product Usage: The Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by healthcare professionals for patients to experience what wearing a Pod may feel…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0161-2014·2013-11-13

    Smiths Medical Recalls Portex Spinal Trays with Particulate Contamination

    Smiths Medical is recalling Portex Spinal Trays because visual particulate was found in the lidocaine and dextrose ampules.

    Product
    Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597C-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0176-2014·2013-11-13

    Pinook Mini Massager Recalled for Failure to Submit Premarket Approval

    Pinook-Usa is recalling 28,994 Pinook Mini Massagers because the company failed to submit a premarket submission and gain approval for the medical device.

    Product
    Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthen the abdominal muscles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0131-2014·2013-11-13

    Smith & Nephew Recalls Swapped Genesis II Tibial Base Implants

    Smith & Nephew is recalling four units of Genesis II tibial base implants due to packaging errors where size 5 left and size 6 right components were swapped.

    Product
    GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0133-2014·2013-11-13

    EKOS EkoSonic Control Unit Recalled for Missing AC Filter

    EKOS Corporation is recalling EkoSonic Control Units because they have the incorrect power entry module installed and are missing an AC filter.

    Product
    The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature and to deliver solutions into the pulmonary arteries. The…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0178-2014·2013-11-13

    SEPPIM Recalls Calcium Arsenazo Reagent Due to Inaccurate Plasma Results

    SEPPIM SAS is recalling Calcium Arsenazo reagent kits because plasma specimens may report higher calcium results than serum.

    Product
    Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . CALCIUM ARSENAZO is intended use for the…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0144-2014·2013-11-13

    Insight Instruments Recalls MLS Torpedo Mini-Light Ophthalmic Illuminator

    Insight Instruments is recalling MLS Torpedo Mini-Light Ophthalmic illuminators because the product was registered as a Class I device but is actually a Class II device requiring FDA clearance.

    Product
    MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0128-2014·2013-11-13

    Helix Medical Recalls Blom-Singer Adjustable Tracheostoma Valve II Due to Missing Component

    Helix Medical LLC is recalling 47 units of the Blom-Singer Adjustable Tracheostoma Valve II because the essential body component is missing from the packaging, rendering the device unusable.

    Product
    Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0174-2014·2013-11-13

    St. Jude Medical Recalls Ablation Catheters Due to Incorrect Instructions

    St. Jude Medical is recalling 59 ablation catheters shipped with the wrong Instructions for Use (IFU). The recall covers specific batches distributed in six US states.

    Product
    US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO. The catheters are intended for use with a compatible external irrigation pump and the IBI-15500T9-CP RF Generator at a…
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Devices)·Z-0146-2014·2013-11-13

    Intuitive Surgical Recalls da Vinci Vision System Cart Components

    Intuitive Surgical is recalling da Vinci Vision System Cart components due to a coating incompatibility that triggers erroneous maintenance alerts.

    Product
    da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903 Illuminator (Illuminator + Lamp Module); Y1902 Replacement Lamp Modules. Intuitive Surgical, Sunnyvale, CA. As a component of the IS3000 da Vinci Si Surgical System, the 3DHD…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0173-2014·2013-11-13

    Siemens ADVIA Centaur Intact PTH Calibrator Recalled for Packaging Error

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Intact PTH Calibrators because some kits were packaged with only the high calibrator.

    Product
    ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13E061000·2013-11-12

    Seat Belt Assemblies Recalled for Non-Compliant Latch Plate Release Mechanism

    Indiana Mills and Manufacturing Inc. is recalling seat belt assemblies manufactured between August and October 2013 that may fail to release properly, potentially hindering vehicle egress during emergencies.

    Product
    SEAT BELTS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V560000·2013-11-07

    Terex Advance Concrete Trucks Recalled for Front Axle U-Bolt Fracture Risk

    Terex Advance is recalling 2013 concrete trucks because a front axle u-bolt can fracture, potentially causing the axle to separate and leading to a crash.

    Product
    TEREX ADVANCE — TEREX ADVANCE FD6000B, FD4000B, FD3000, 6 AXLE GLIDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V557000·2013-11-07

    Toyota Recalls 2013-2014 Tacoma Trucks for Engine Valve Spring Defect

    Toyota is recalling 2013-2014 Tacoma vehicles because engine valve springs may break, potentially causing the engine to stall while driving and increasing crash risk.

    Product
    TOYOTA — TOYOTA TACOMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V554000·2013-11-07

    Forest River Recalls 2012-2013 Travel Trailers Due to Tire Contact Risk

    Forest River is recalling 2012-2013 Rockwood, Windjammer, Vlite, and Flagstaff travel trailers because tires may contact the floor, risking blowouts and loss of control.

    Product
    FOREST RIVER — FOREST RIVER FLAGSTAFF, WINDJAMMER, ROCKWOOD, VLITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V559000·2013-11-07

    Starcraft Recalls 2013 RT and Comet Trailers for Roof Collapse Risk

    Starcraft RV is recalling 2013 RT and Comet pop-up camping trailers because a roof lifter failure could cause the roof to collapse, increasing injury risk.

    Product
    STARCRAFT — STARCRAFT COMET, STARCRAFT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13E067000·2013-11-07

    Lippert Travel Trailer Doors Recalled for Deadbolt Jamming Risk

    Lippert is recalling 2006-2013 travel trailer doors with Fastec deadbolts that may jam, potentially trapping occupants inside the vehicle.

    Product
    LATCHES/LOCKS/LINKAGES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0086-2014·2013-11-06

    Schwebel's Golden Rich Buns Recalled for Undeclared Eggs

    Schwebel Baking Company is recalling Golden Rich Buns with Honey because they contain undeclared eggs. The product was distributed to six states.

    Product
    Schwebel's Golden Rich Bun with Honey, 18 oz plastic bag, 12 count, UPC 0 71319 00083 8 Product labeled in part, "INGREDIENTS: ENRICHED WHEAT FLOUR***CONTAINS: WHEAT, SOY SCHWEBEL BAKING CO. YOUNGSTOWN, OH 44501"
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-0085-2014·2013-11-06

    Conagra Recalls Pork & Leek Dumplings Due to Undeclared Allergens

    Conagra is recalling specific lots of P.F. Chang's Pork & Leek Dumplings because they were inadvertently packaged with Shrimp & Pollack Fish dumplings, resulting in undeclared allergens.

    Product
    P.F. Chang's Home Menu, Pork & Leek Dumplings, frozen, packaged in 12.5 oz bags. UPC: 0 36200 21215 8
    Category
    Food
    Distribution
    33 states
  • CriticalFDA (Food)·F-0088-2014·2013-11-06

    Epicure Food Corp. Recalls St. Marcellin Cheese Due to Listeria Risk

    Epicure Food Corp. is recalling St. Marcellin cheese in several states because Listeria monocytogenes was detected in a related product in France.

    Product
    St. Marcellin Au lait pasteurise fabrique en Dauphine l'unite: poids net 80ge Fromagerie Qurtet 38470 VINAY
    Category
    Food
    Distribution
    7 states

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