The Recall Desk

Archive

March 2014 recalls

554 recalls were announced in March 2014.

What the numbers show

Critical
40
Severe
147
High
238
Moderate
117
Low
12

Of the 554 recalls this month scored against our rubric, 7% are Critical, 27% are Severe.

Which agencies issued them

201–300 of 554

  • HighFDA (Devices)·Z-1189-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip. The sterile, single-use devices are distributed worldwide.

    Product
    G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and 1 mL Line Draw Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile, single-use
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1161-2014·2014-03-19

    Smith & Nephew RENASYS-G Gauze Dressing Kit Recall for Sealing Issues

    Smith & Nephew is recalling RENASYS-G Sterile Gauze Dressing Kits due to inadequate Soft Port sealing that may prevent fluid evacuation and fail to trigger alarms.

    Product
    Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66800961 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1160-2014·2014-03-19

    Smith & Nephew Recalls RENASYS Gauze with Soft Port Kits

    Smith & Nephew is recalling RENASYS Gauze with Soft Port Kits because inadequate sealing can cause fluid to remain under the dressing and prevent the pump alarm from activating.

    Product
    Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933, 66800934, 66800935, and 66800936 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1167-2014·2014-03-19

    Biomet 3i Recalls Navigator Surgical Kits Due to Sterility Assurance Failure

    Biomet 3i, LLC is recalling 21 units of the Navigator Surgical Kit because the trays failed to meet required sterility assurance levels during validation testing.

    Product
    Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1188-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to a reported issue with the plunger tip. The devices are sterile, single-use, in-vitro diagnostic tools used for drawing arterial blood.

    Product
    G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Japan only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1208-2014·2014-03-19

    DePuy S-ROM Noiles Rotating Hinge Femur Recall for Sterile Barrier Defects

    DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices due to potential holes in the sterile barrier pouches.

    Product
    REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is n
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1197-2014·2014-03-19

    Elekta XiO RPT System Recalled for Incorrect Dose Calculations

    Elekta is recalling the XiO RPT System because dose and monitor unit values are not computed correctly when specific wedges are used with dynamic arcs.

    Product
    XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on screen and in hard-copy, either two or three dimensional rad
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1174-2014·2014-03-19

    Synthes Small Notch Titanium Reconstructive Plate Recalled for Contraindicated Spine Use

    Synthes, Inc. is recalling Small Notch Titanium Reconstructive Plate sets distributed for spine applications where they are contraindicated.

    Product
    Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. The wide selection of implants a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1668-2014·2014-03-19

    Pecan Shed Recalls Candied Pecans Due to Undeclared Soy Allergen

    Pecan Shed is recalling Candied Pecans: Dark Chocolate because the product contains undeclared soy. The recall affects customers in nine states and Washington DC.

    Product
    Candied pecans: dark chocolate
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-1159-2014·2014-03-19

    Smith & Nephew RENASYS-F XL Dressing Kits Recalled for Sealing Defects

    Smith & Nephew is recalling RENASYS-F XL with Soft Port dressing kits due to inadequate sealing that may prevent fluid evacuation and fail to trigger alarms.

    Product
    Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1169-2014·2014-03-19

    Biomet 3i Recalls Dental Torque Driver Kits Due to Sterility Failure

    Biomet 3i is recalling 541 Contra-Angle Torque Driver Kits because the trays failed to meet required sterility assurance levels during validation testing.

    Product
    Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14132·2014-03-19

    Vera Bradley Recalls Bear Rattles and Bunny Toys for Choking Hazard

    Vera Bradley is recalling about 98,000 Bear Ring Rattles and Bunny stuffed toys because the pom-pom tail can detach, posing a choking hazard to young children.

    Product
    Vera Bradley Bear Ring Rattles and Bunny Stuffed Toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1190-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Line Draw Syringes

    Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to a defect in the plunger tip.

    Product
    G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, syringe tip cap, and 5 mL Luer lock syringe Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-1153-2014·2014-03-19

    Carl Zeiss VisuMax Laser Keratome Treatment Packs Recalled for Size Mismatch

    Carl Zeiss Meditec AG is recalling VisuMax Laser Keratome treatment packs, Lot M130010, because Size M packs may contain Size S components.

    Product
    Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1184-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Line Draw Syringes

    Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.

    Product
    4043W-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, syringe tip cap and 6 mL Luer slip syringe Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawin
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-1192-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling G2001 Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip. The devices are sterile, single-use in-vitro diagnostic tools used for drawing arterial blood.

    Product
    G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, Needle-Pro¿ Device and 23G x 1 needle Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of art
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Food)·F-1627-2014·2014-03-19

    F & S Produce Recalls Mislabeled Roasting Cinnamon Butternut Squash

    F & S Produce Co., Inc. is recalling Roasting Cinnamon Butternut Squash because the product is mislabeled. The recall covers 429 units distributed in California.

    Product
    Roasting Cinnamon Butternut Squash Net Wt. 2 lbs (907 g) Foam Tray with 3 per case. Keep Refrigerated Distributed by Renaissance Food Group LLC UPC 825786790333
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1156-2014·2014-03-19

    Mindray Recalls Panorama Central Station for Time Clock Data Lag

    Mindray is recalling 732 Panorama Central Stations because Full Disclosure data and event indicators may lag behind the system time clock.

    Product
    Panaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data. The device can also set independent alarm limits for data send by the bedside monitor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1152-2014·2014-03-19

    Leica Biosystems Recalls Digital Slide Analysis Software for Breast Cancer Testing

    Leica Biosystems is recalling 78 units of the ScanScope System software to clarify usage with specific RUO products.

    Product
    HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast Tissue Manual Read of Digital Slides The ScanScope¿¿ System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Food)·F-1634-2014·2014-03-19

    Valued Naturals Natural Coconut Recalled for Sulfite Content

    International Foodsource, LLC is recalling Valued Naturals Natural Coconut because laboratory analysis found 28.1 ppm sulfites.

    Product
    Valued Naturals Natural Coconut Net wt. 8oz (216.80g) Imported by Philippines International Foodsource LLC 52 Richboynton Rd, Dover, NJ 07801 Packaged in 8 oz bag 12 per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateNHTSA·14V129000·2014-03-19

    Infiniti Recalls 2014 QX80 Vehicles for Incorrect Certification Label

    Nissan is recalling 2014 Infiniti QX80 vehicles because the certification label lists an incorrect Gross Axle Weight Rating, potentially allowing vehicle overload.

    Product
    INFINITI — INFINITI QX80
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1626-2014·2014-03-19

    Sysco Blueberry Pie Filling Withdrawn Due to Metal Contact Risk

    Lyons Magnus is withdrawing Sysco Blueberry Pie Filling after inspection found metal on metal contact in production equipment. No metal has been found in the product.

    Product
    Classic Sysco Custom Ready to Use Blueberry Pie Filling; Artificial Flavor #10 can - Net wt 7 lbs 1 oz (2kg) UPC 1 00 74865 38258 5 Manufactured for Sysco by Lyons Magnus, Fresno, CA
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-1648-2014·2014-03-19

    Nicomex Recalls Color Para Tamal and Camaron Entero for Labeling Issues

    Nicomex Inc. is recalling Color Para Tamal and Camaron Entero due to unapproved color and undeclared sulfites found by NYSDAM.

    Product
    Nicomex Color Para Tamal Net Wt 1/8 oz (3.54gms) Productos Mexicanos Distributed by Nicomex Inc. 88 First Street, Passaic, NJ 07055 Tel. (973) 815-2062.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1625-2014·2014-03-19

    Lyons Magnus Recalls Cherry Pie Filling Due to Metal Contact Risk

    Lyons Magnus is withdrawing 500 cases of Classic Sysco Custom Ready to Use Cherry Pie Filling after an inspection found metal-on-metal contact on a production auger.

    Product
    Classic Sysco Custom Ready to Use Cherry Pie Filling; with other Natural Flavors #10 can - Net wt 7 lbs (3.18kg) UPC 1 00 74865 38257 8 Manufactured for Sysco by Lyons Magnus, Fresno, CA
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1196-2014·2014-03-19

    Gyrus Medical Recalls Disposable Falope-Ring Band Applicator Kits

    Gyrus Medical is recalling 856 units of Disposable Falope-Ring Band Applicator Kits due to a packaging anomaly that may compromise sterility.

    Product
    Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enable
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1178-2014·2014-03-19

    Lin-Zhi International Recalls Cannabinoid DAU Calibrator Controls

    Lin-Zhi International is recalling specific lots of Cannabinoid DAU Calibrator Controls because they may provide inaccurate concentration readings near expiration.

    Product
    Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liqu
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1180-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling specific lots of Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.

    Product
    4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, 22g x 1¿ needle, and Point-Lok¿ needle safety device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices u
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-1191-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.

    Product
    G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ devices and (2) Needle-Pro¿ Devices with 22G x 1¿needles Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-1195-2014·2014-03-19

    Veridex Recalls CELLTRACKS Analyzer II Microscopes Due to Camera Failures

    Veridex, LLC is recalling 19 CELLTRACKS Analyzer II fluorescence microscopes because of reported camera failures. The devices are used for analyzing rare cells in biological fluids.

    Product
    CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1203-2014·2014-03-19

    DePuy S-ROM Rotating Hinge Recall Due to Sterile Barrier Defect

    DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femur devices because holes may develop in the sterile barrier pouches.

    Product
    REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is ne
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1179-2014·2014-03-19

    Lin-Zhi International Recalls Cannabinoid DAU Calibrator Controls Due to Concentration Drift

    Lin-Zhi International is recalling specific lots of Cannabinoid DAU Calibrator Controls because they may provide inaccurate concentration readings near expiration.

    Product
    Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liqu
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1206-2014·2014-03-19

    DePuy S-ROM Rotating Hinge Femoral Components Recalled for Sterile Barrier Defects

    DePuy Orthopaedics is recalling S-ROM Noiles Rotating Hinge Femoral components due to potential holes in the sterile barrier pouches.

    Product
    REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is nee
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1154-2014·2014-03-19

    Clarity Medical Systems Recalls RetCam Devices Due to Age Calculation Error

    Clarity Medical Systems is recalling RetCam 3, Portable, and Shuttle devices because a software error causes incorrect patient age calculations.

    Product
    RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1183-2014·2014-03-19

    Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

    Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.

    Product
    4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and ice bag Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arter
    Category
    Medical Device
    Distribution
    40 states
  • LowFDA (Drugs)·D-1152-2014·2014-03-19

    Fougera Recalls Triamcinolone Acetonide Cream Due to Labeling Error

    Fougera Pharmaceuticals is recalling 493,192 tubes of Triamcinolone Acetonide Cream 0.1% because the end flap incorrectly displays 01% instead of 0.1%.

    Product
    TRIAMCINOLONE ACETONIDE — TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1155-2014·2014-03-19

    Mylan Recalls Carisoprodol Tablets Due to Failed Impurity Specification

    Mylan Institutional, Inc. is recalling 3,252 cartons of Carisoprodol Tablets, USP, 350 mg, because the product failed an impurity or degradation specification.

    Product
    Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL NDC 51079-819-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1193-2014·2014-03-19

    Ortho-Clinical Diagnostics Recalls VITROS Vitamin D Calibrators for Biased Results

    Ortho-Clinical Diagnostics is recalling VITROS 25-OH Vitamin D Total Calibrators because they may generate negatively biased results. Users must immediately discontinue use of all current lots.

    Product
    VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK --- For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Syst
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1166-2014·2014-03-19

    Steris Recalls VERIFY SixCess 270FP Challenge Packs Due to Labeling Error

    Steris is recalling VERIFY SixCess 270FP Challenge Packs because the outer shipping package for one lot incorrectly identifies the lot number.

    Product
    VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY¿ SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270¿F using typical healthcare dynamic air removal steam sterilizatio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V127000·2014-03-18

    Thor Motor Coach Recalls 2013-2014 RVs Due to Microwave Fire Risk

    Thor Motor Coach is recalling specific 2013-2014 recreational vehicles because the built-in microwave may start on its own, posing a fire hazard if unattended.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH TUSCANY, CHALLENGER, TUSCANY XTE, PALAZZO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14134·2014-03-18

    Schneider Electric Recalls Square D Circuit Breakers Due to Fire Hazard

    Schneider Electric is recalling specific Square D F and K frame circuit breakers because they may fail to trip during overloads, posing fire, burn, and shock risks.

    Product
    Square D branded, molded case F and K frame circuit breakers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V128000·2014-03-18

    Heartland Recreational Vehicle Recall for Microwave Fire Risk

    Heartland is recalling certain fifth wheel trailers because the installed microwave may start on its own, posing a fire risk if unattended.

    Product
    HEARTLAND — HEARTLAND CYCLONE, LANDMARK, BIGHORN SILVERADO, BIGHORN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V118000·2014-03-17

    GM Recalls 2008-2013 SUVs for Side Air Bag Wiring Defect

    General Motors is recalling specific 2008-2013 Buick, GMC, Chevrolet, and Saturn SUVs because side air bag wiring may prevent deployment in a crash.

    Product
    BUICK — BUICK, GMC, SATURN ENCLAVE, ACADIA, OUTLOOK, TRAVERSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V116000·2014-03-17

    GM Recalls 2013-2014 Cadillac XTS for Brake Booster Fire Risk

    General Motors is recalling 2013-2014 Cadillac XTS vehicles because a dislodged cavity plug may cause corrosion and a resistive short, increasing the risk of a fire.

    Product
    CADILLAC — CADILLAC XTS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V125000·2014-03-17

    Volkswagen Recalls 2012-2013 Passat Vehicles for Loose Headlight Bulbs

    Volkswagen is recalling 2012-2013 Passat vehicles because the low beam headlight bulb may become loose and lose electrical contact, potentially reducing visibility.

    Product
    VOLKSWAGEN — VOLKSWAGEN PASSAT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V112000·2014-03-14

    Honda Recalls 2005-2010 Odyssey Vehicles for Fuel Pump Leak Risk

    Honda is recalling 2005-2010 Odyssey vehicles because a deteriorating fuel pump strainer cover may leak fuel, increasing the risk of a fire.

    Product
    HONDA — HONDA ODYSSEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V124000·2014-03-14

    Crane Refuse Vehicles Recalled for Intake Manifold Freeze Risk

    Crane is recalling 2008-2014 refuse vehicles because condensation in the intake manifold may freeze, causing sensor failure and potential fire or burn injury.

    Product
    CRANE — CRANE LET2, LDT2, LE2, COE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V123000·2014-03-14

    Jaguar Recalls 2013 XJ and XF Vehicles for Missing Certification Labels

    Jaguar is recalling 2013 XJ and XF vehicles because they lack required certification labels specifying weight ratings. This non-compliance could lead to vehicle overloading and increased crash risk.

    Product
    JAGUAR — JAGUAR XJ, XF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14723·2014-03-14

    MobilePower Instant Boost 500 Power Packs Recalled for Fire Hazard

    MobilePower is recalling about 9,800 Instant Boost 500 power packs sold by QVC because they can overheat and cause fires. No injuries have been reported.

    Product
    MobilePower Instant Boost 500 power packs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V122000·2014-03-13

    Terex Recalls 2014 TZ-50 Aerial Work Platforms Due to Weld Defects

    Terex is recalling 2014 TZ-50 trailer-mounted aerial work platforms because a welding process change may cause cracks in the boom section, risking platform failure.

    Product
    TEREX — TEREX TZ-50
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1622-2014·2014-03-12

    Falafel King Recalls Green Chile Hummus Due to Listeria Risk

    Falafel King is recalling Green Chile Hummus because the green chile topping was recalled by Bueno Foods for Listeria monocytogenes.

    Product
    Falafel King Green Chile Hummus, 10 oz, Plastic Tub, packaged in 12count and 8 count cases. Labeled in part ** Falafel King green chile hummus GF 100% NATURAL**
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1620-2014·2014-03-12

    Yukon Concessions Recalls Hazelnut Biscotti Due to Undeclared Allergens

    Yukon Concessions Alaska LLC is recalling Tonia's Biscotti Hazelnut Biscotti because the product contains undeclared wheat, soy, and milk.

    Product
    Hazelnut Biscotti - individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1617-2014·2014-03-12

    Tonia's Biscotti Alaskan Birch Brittle Recalled for Undeclared Allergens

    Yukon Concessions Alaska LLC is recalling Tonia's Biscotti Alaskan Birch Brittle products due to undeclared wheat, soy, and milk.

    Product
    Alaskan Birch Brittle with Dark Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz. Alaskan Birch Brittle Drizzled in dark chocolate-individually wrapped in cellophane. Product is sold under Tonia's Biscotti bran
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1600-2014·2014-03-12

    Rise n Roll Bakery Recalls Raspberry Creme Donuts for Undeclared Egg

    Rise'n Roll Bakery, LLC is recalling Rise n Roll Bakery & Deli Raspberry Creme Donuts because they contain undeclared egg, which may cause allergic reactions in sensitive individuals.

    Product
    Rise n Roll Bakery & Deli, Raspberry Creme Donuts, sold individually and found in 6 count (436 g) UPC Code 6 26570 61744 0 or 12 count (861.83 g) UPC Code 6 26570 617457, variety donut box identifying all donut varieties Raspberry Creme Donuts Enriched wheat flour, soybea
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Drugs)·D-1149-2014·2014-03-12

    B-50 Capsules Recalled for Containing Unapproved Steroid Ingredients

    Mira Health Products Ltd. is recalling B-50 capsules because they contain unapproved steroid ingredients, making them unapproved new drugs.

    Product
    B-50 capsules, Healthy Life Chemistry By Purity First, packaged in 100 count bottles, Manufactured for: Purity First Health Products, Inc. dba Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1615-2014·2014-03-12

    Tonia's Biscotti Recalled for Undeclared Wheat, Soy, and Milk Allergens

    Yukon Concessions Alaska LLC is recalling Blueberry drizzled in White Chocolate Biscotti due to undeclared wheat, soy, and milk allergens.

    Product
    Blueberry drizzled in White Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1150-2014·2014-03-12

    Mira Health Recalls Super-DMZ Rx 2.0 Capsules for Unapproved Steroid Ingredient

    Mira Health Products Ltd. is recalling Super-DMZ Rx 2.0 Capsules because the product contains an unapproved steroid ingredient and was marketed without FDA approval.

    Product
    Super-DMZ Rx 2.0 Capsules, 60 count bottles, Dietary Supplement, Lean muscle mass, hardness and strength, Manufactured for Blackstone Labs Boca Raton, FL 33433.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1601-2014·2014-03-12

    Rise'n Roll Bakery Recalls Nutty Crunch Products for Undeclared Peanuts

    Rise'n Roll Bakery is recalling specific nut products due to undeclared peanuts, a major allergen. Consumers should check labels and discard affected items.

    Product
    A. Rise n Roll Specialties, Homemade, Nutty Crunch, ..., boiled to perfection, NT. WT 8 oz., ING cashews, pecans, almonds, butter (milk) sugar. Contains Nuts and Milk. UPC Code 8 27912 04158 3 B Simply Amish, Crunch N Nutter, Mixed Nut,... No Preservatives, ...NT. WT 4
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-1623-2014·2014-03-12

    Falafel King Recalls Green Chile Hummus Wraps Due to Listeria Risk

    Falafel King is recalling Green Chile Hummus Wraps because the green chile topping was recalled by Bueno Foods for Listeria monocytogenes.

    Product
    Falafel King Green Chili Hummus Wrap, 8.5 oz individual packages of the Green Chili Hummus Wraps
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1624-2014·2014-03-12

    Roth Farms Recalls Curly Parsley Due to Salmonella Contamination

    Roth Farms Inc is recalling 504 boxes of Curly Parsley because a sample tested positive for Salmonella. The product was shipped to distribution centers in Florida.

    Product
    18 lb box of Curly Parsley packaged in 3 wire wooden crates
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1137-2014·2014-03-12

    Testosterone Cypionate Recalled for Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all unexpired lots of Testosterone Cypionate 100mg/ml due to quality control issues affecting sterility.

    Product
    Testosterone Cypionate 100mg/ml
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1151-2014·2014-03-12

    Mira Health Recalls Unapproved Metha-Drol Extreme Dietary Supplement

    Mira Health Products Ltd. is recalling 5,555 bottles of Metha-Drol Extreme capsules because the product contains an unapproved steroid ingredient.

    Product
    METHA-DROL Extreme capsules, packaged as 60 capsules per bottle Pro-Anabolic Mass Stack Dietary Supplement, Manufactured for Blackstone Labs, Boca Raton, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1604-2014·2014-03-12

    Big Red Tomato Packers Recalls Whole Tomatoes Due to Salmonella

    Big Red Tomato Packers, LLC is recalling 790 boxes of whole tomatoes due to a positive Salmonella finding. The product was distributed to Florida, Michigan, Minnesota, North Carolina, Pennsylvania, and Tennessee.

    Product
    Whole (round) Tomatoes packed in cardboard boxes of 20 and 25 lbs each.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-1613-2014·2014-03-12

    Tonia's Biscotti Recalled for Undeclared Wheat, Soy, and Milk Allergens

    Yukon Concessions Alaska LLC is recalling Tonia's Biscotti cranberry dipped in white chocolate due to undeclared wheat, soy, and milk.

    Product
    Cranberry dipped in White Chocolate Biscotti-individually wrapped in cellophane. Product is sold under Tonia's Biscotti brand, net wt. 2 oz.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1096-2014·2014-03-12

    Hospira Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

    Hospira is recalling 603,768 bags of 0.9% Sodium Chloride Injection because solution leaked through the port cover, compromising sterility.

    Product
    0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1109-2014·2014-03-12

    FDA Recalls Estradiol and Testosterone Compounds for Sterility Concerns

    Natures Pharmacy & Compounding Center is recalling all lots of Estradiol Cypionate and Testosterone Cypionate due to sterility assurance concerns identified during an FDA inspection.

    Product
    Estradiol Cypionate 2mg/cc testosterone cypionoate 50mg
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1125-2014·2014-03-12

    Novarel Injection Recalled for Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all non-expired lots of Novarel (IM) due to quality control issues affecting sterility assurance.

    Product
    Novarel (IM)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1136-2014·2014-03-12

    Terbutaline/Ipratropium Recall Due to Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all lots of Terbutaline/Ipratropium 0.5mg/2.5ml due to quality control issues affecting sterility assurance.

    Product
    Terbutaline/Ipratropium 0.5mg/2.5ml
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1102-2014·2014-03-12

    Bleomycin Sulfate Recalled Due to Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all non-expired lots of Bleomycin Sulfate 1unit/ml due to quality control issues affecting sterility assurance.

    Product
    Bleomycin Sulfate 1unit/ml
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1124-2014·2014-03-12

    Methylcobalamin Recalled Due to Sterility Assurance Concerns

    Natures Pharmacy & Compounding Center is recalling all non-expired lots of Methylcobalamin due to quality control issues affecting sterility assurance.

    Product
    Methylcobalamin
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1101-2014·2014-03-12

    Bladder Instillation Recalled for Lack of Sterility Assurance

    Natures Pharmacy & Compounding Center is recalling all lots of Bladder Instillation due to quality control concerns affecting sterility assurance.

    Product
    Bladder Instillation
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·14V120000·2014-03-12

    Keystone Recalls 2014 Fifth Wheels and Travel Trailers for Axle Bearing Defect

    Keystone is recalling specific 2014 fifth wheels and travel trailers because insufficient lubrication in the inner wheel bearings may cause the wheel to seize or separate, increasing crash risk.

    Product
    KEYSTONE — KEYSTONE BULLET, SPRINGDALE, PASSPORT, HIDEOUT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1609-2014·2014-03-12

    Diamond Foods Recalls Bakes Sea Salt Potato Chips Due to Undeclared Milk

    Diamond Foods Inc is recalling Bakes Sea Salt Potato Chips because they may contain undeclared milk, which poses a risk to individuals with milk allergies.

    Product
    Bakes Sea Salt Potato Chips, Kettle Brand, Item 07-10982-000. It is packaged in a 4 oz. retail bag, 15 bags per case. Bag UPC 84114 10984 2. Case UPC 84114 10982 5.
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Drugs)·D-1126-2014·2014-03-12

    Papaverine Injection Recalled for Lack of Sterility Assurance

    Natures Pharmacy & Compounding Center is recalling Papaverine 1nj 30mg/ml due to quality control concerns that present a potential risk to sterility assurance.

    Product
    Papaverine 1nj 30mg/ml
    Category
    Drug
    Distribution
    1 state

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