The Recall Desk

Archive

September 2014 recalls

675 recalls were announced in September 2014.

What the numbers show

Critical
61
Severe
345
High
167
Moderate
91
Low
11

Of the 675 recalls this month scored against our rubric, 9% are Critical, 51% are Severe.

Which agencies issued them

501–600 of 675

  • SevereFDA (Devices)·Z-2310-2014·2014-09-10

    Customed Recalls Universal Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Universal Packs containing surgical items due to potential packaging integrity issues that could compromise sterility.

    Product
    Universal Pack- - (1) TABLE COVER REINFORCED 50" X 90" LIF (3) TOWEL ABSORBENT 15" X 20" LIF (1) MAYO STAND COVER REINFORCED LIF (1) TUBE SUCTION CONNECT. X" X 12' LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (1) BAG SUTURE FLORAL (1) DRAPE TOP WITH ADHESIVE 100" X…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2476-2014·2014-09-10

    Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 93 units of Laparotomy Packs (900-2516) because packaging integrity may be compromised, risking product contamination or loss of sterility.

    Product
    Laparotomy Pack, 900-2516, pack contains: ( I) TABLE COVER44" X 90" ( I) CAUTERY PENCIL PUSH BOTTOM (4) TOWELS ABSORBENT 15" X 20" L/F ( I) BULB SYRINGE 60cc LIF (4) DRAPE UTILITY WIT APE LIF (I) SKIN MARKER W/RULER ( I) SUTURE BAG FLORAL LIF ( I) Y ANKAUER SUCTION…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2443-2014·2014-09-10

    Customed Recalls Neuro Packs Due to Potential Packaging Integrity Compromise

    Customed, Inc. is recalling Neuro Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    NEURO PACK CONTENTS: (4) TOWEL ABSOSRBENT 15" X 20" LIF ( I ) BAG BI OH AZARD 30" X 37" (2) MAYO STAND COYER REINFORCED UF (20) GAUZE SPONGE 4" X 4" 1 6PLY XRD UF ( I ) CAUTERY POLISHER TIP LIF ( I ) BLADE SU RGICAL# II CARBON STEEL (I) TRAY MAYO LARGE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2417-2014·2014-09-10

    Customed Recalls EO Sterilized Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling EO sterilized surgical convenient packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    BASIC PACK - (1) TABLE COVER REINF. LIF (1) MAYO STAND COVER REINF. LIF (2) TOWELS ABSORBENT LIF (10) GAUZE SPONGES XRD 4" X 4" 12PLY (2) DRAPE SHEET 41" X 58" SMS (4) DRAPE UTILITY WIT APE L/F EO sterilized surgical convenient packs packaged into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2497-2014·2014-09-10

    Customed Recalls Debridement Trays Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling specific lots of Debridement Trays (code 900-2702) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Bandeja para Debridacion, code 900-2702, contains: (1) FORCEP ADSON TISS (20) GAUZE SPONGES 4 X 4 12PL Y (1) SCISSORS IRIS STRAIGHT 4.5 W/PROTECTOR TIP (1) TOWEL 3 PLY POLY 13 X 18 (1) DRAPE 18 X 26 WHITE/WHITE POLYPROPYLENE (1) CHLORASCRUB SWABSTICK 1.6 ML (1) TRAY…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2586-2014·2014-09-10

    Spacelabs Ariatele Telemetry Transmitter Recalled for SpO2 Display Errors

    Spacelabs is recalling Ariatele Telemetry Transmitters because they may display SpO2 values when sensors are disconnected or failed.

    Product
    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment.
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·14V551000·2014-09-10

    Mack Recalls 2015 Titan Trucks Due to Engine Stall Risk

    Mack Trucks is recalling 2015 Titan trucks because a software error may cause the engine to stall, increasing crash risk.

    Product
    MACK — MACK TITAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2576-2014·2014-09-10

    Zimmer Persona Knee Trial Articular Surface Provisional Recall for Breakage

    Zimmer, Inc. is recalling 77,737 Persona Knee Trial Articular Surface Provisional units due to reports of breakage and updated surgical techniques.

    Product
    PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the following: L 3-5 CD; L 6-9 CD; L 3-5 EF; L 6-9 EF; L 10-11 EF; L 6-9 GH; L 10-12 GH; L 10-12 J; R 3-5 CD; R 6-9 CD; R 3-5 EF; R 6-9 EF; R 10-11 EF; R 6-9 GH; R…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2562-2014·2014-09-10

    Hill-Rom Affinity Four Birthing Bed Recall for Latch Mechanism Defect

    Hill-Rom is recalling 13,000 Affinity Four Birthing Beds because the attachment latch mechanism can bend, potentially causing the foot section to fail and resulting in user injury from a fall.

    Product
    Affinity¿ Four Birthing Bed, Product Usage: Product is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2584-2014·2014-09-10

    Zimmer Recalls Natural-Knee System Patella Bushings Due to Corrosion

    Zimmer, Inc. is recalling Natural-Knee System Patella Bushings because of a trend of complaints indicating product corrosion.

    Product
    Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number: 6290-00-703. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-2406-2014·2014-09-10

    GoMacro Recalls MACROBAR Bars for Potential Salmonella Contamination

    GoMacro is recalling specific lots of MACROBAR sunflower butter + chocolate and almond butter + carob bars due to potential Salmonella contamination.

    Product
    gomacro MACROBAR brand sunflower butter + chocolate Net Wt. 2.3 oz (65 g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2581-2014·2014-09-10

    Elekta Monaco System Recalled for Incorrect Radiation Treatment Plan Delivery

    Elekta is recalling Monaco software versions 3.20.00 and higher because exported VMAT plans may not match approved treatment plans.

    Product
    Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2578-2014·2014-09-10

    Zimmer Persona Knee Trial Articular Surface Provisional Breakage Recall

    Zimmer, Inc. is recalling 77,737 units of Persona Knee Trial Articular Surface Provisionals due to reports of breakage and updated surgical techniques.

    Product
    PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the following: Size CD +0 mm Thickness Bottom(TB); Size CD +6 mm Thickness Bottom; Size EF +0 mm Thickness Bottom; Size EF +6 mm TB; Size GH +0 mm TB; Size GH +6 mm TB; Size J +0 mm TB; Size J…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2588-2014·2014-09-10

    Galt Medical Recalls Valved Tearaway Introducer Sets Due to Embolic Risk

    Galt Medical Corporation is recalling 11,155 Valved Tearaway Introducer Sets because the adhesive may dislodge, posing an embolic risk to patients.

    Product
    GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V552000·2014-09-10

    Mazda Recalls 2008 Tribute Hybrids for Coolant Pump Failure Risk

    Mazda is recalling 2008 Tribute Hybrid vehicles because a coolant pump failure may cause the hybrid system to overheat and shut down, increasing crash risk.

    Product
    MAZDA — MAZDA TRIBUTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2590-2014·2014-09-10

    Ellex iScience Recalls iTRACK250A Canaloplasty Microcatheter Kits

    Ellex iScience is recalling 148 iTRACK250A Canaloplasty Microcatheter Kits because one lot may not have been properly sealed, resulting in non-sterile devices.

    Product
    iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V550000·2014-09-10

    Yamaha Recalls 2014 FZ09 Motorcycles Due to Headlight Harness Defect

    Yamaha is recalling 5,300 model year 2014 FZ09 motorcycles because a short headlight harness may break when handlebars are turned, causing the headlight to go out.

    Product
    YAMAHA — YAMAHA FZ-09
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2589-2014·2014-09-10

    Galt Medical Recalls Valved Tearaway Kits Due to Embolic Risk

    Galt Medical Corporation is recalling 11,155 Valved Tearaway Kits because the adhesive could dislodge, posing an embolic risk to patients.

    Product
    GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2565-2014·2014-09-10

    Bio-Detek Recalls Medsolutions4U Multi-Function Electrodes Due to Connector Defect

    Bio-Detek, Inc. is recalling Medsolutions4U Multi-Function Electrodes because an incorrect wire connector prevents them from interfacing with PhysioControl Lifepak Defibrillators.

    Product
    Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for Defibrillation, Cardioversion, Pacing, and Monitoring Part Number: 2033
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2577-2014·2014-09-10

    Zimmer Recalls Persona Knee Trial Articular Surface Provisionals Due to Breakage

    Zimmer, Inc. is recalling 77,737 units of Persona Knee Trial Articular Surface Provisionals due to reports of breakage and updated surgical techniques.

    Product
    PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional with the following: Left Size 3-9 CD Top; Left Size 3-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Left Size 3-9 CD Top; Left Size 3-11 EF Top; Right Size 7-12 GH Top; and Right Size 9-12 J…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2580-2014·2014-09-10

    Zimmer Recalls Persona Knee Trial Articular Surface Provisionals Due to Breakage

    Zimmer, Inc. is recalling 77,737 units of Persona Knee Trial Articular Surface Provisionals due to reports of breakage and updated surgical techniques.

    Product
    PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top; Left Size 4-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Right Size 3-7 CD Top; Right Size 4-11 EF Top; Right Size 7-12 GH Top; and Right Size 9-12 J Top.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2563-2014·2014-09-10

    Roche cobas IT 1000 Recalled for Potential Patient ID Mismatch

    Roche Diagnostics is recalling 148 cobas IT 1000 devices because they may assign test results to the wrong patient ID if specific system messages are received.

    Product
    Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14752·2014-09-10

    Honda Recalls Gas-Powered Generators Due to Frame Support Failure Risk

    American Honda is recalling 2014 EU7000isN AT generators because the rear frame support can fail during lifting, posing an impact hazard. The owner's manual may also contain errors.

    Product
    Gas-powered generators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14272·2014-09-10

    Benetton Recalls Boys' Jackets Due to Waist Drawstring Entanglement Hazard

    Benetton is recalling approximately 93 boys' hooded jackets because the waist drawstring poses an entanglement hazard. Consumers should remove the drawstring or contact the company for a refund.

    Product
    Boy's hooded jacket with a waist drawstring
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2579-2014·2014-09-10

    Zimmer Persona Knee Trial Articular Surface Provisionals Recalled for Breakage

    Zimmer, Inc. is recalling 77,737 units of Persona Knee Trial Articular Surface Provisionals due to reports of breakage and updated surgical techniques.

    Product
    PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top; Size 6-9 CD Top; Size 3-5 EF Top; Size 6-9 EF Top; Size 10-11 EF Top; Size 6-9 GH Top; Size 10-12 GH Top; Size 10-12 J Top; and RIGHT Size 3-5 CD Top; Right Size 6-9 CD Top…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1576-2014·2014-09-10

    Apotex Recalls Paroxetine Hydrochloride Tablets Due to Chemical Contamination

    Apotex Inc. is recalling Paroxetine Hydrochloride Controlled-Release Tablets 25 mg because they were manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.

    Product
    PAROXETINE HYDROCHLORIDE — PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2583-2014·2014-09-10

    Zimmer Recalls Natural-Knee Patella Bushings Due to Corrosion Complaints

    Zimmer, Inc. is recalling Natural-Knee System Patella Bushings after receiving a trend of complaints indicating product corrosion. The affected orthopedic surgical instruments were distributed worldwide.

    Product
    Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number: 6290-00-702. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2560-2014·2014-09-10

    OrthoPediatrics ACL Sleeve Installation Tool Recalled for Weld Fractures

    OrthoPediatrics Corp is recalling 56 ACL Sleeve Installation Tools due to weld fractures. The tools are used in pediatric and small stature adult ACL reconstruction systems.

    Product
    ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2561-2014·2014-09-10

    Siemens EasyLink Informatics System Recall for Potential Result Transmission Errors

    Siemens Healthcare Diagnostics is recalling the EasyLink Informatics System V4.0/V5 because it may release results to the Laboratory Information System that should have been held for manual review.

    Product
    Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487219 A clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2573-2014·2014-09-10

    Pioneer Surgical Technology Recalls Streamline CT Set Screws

    Pioneer Surgical Technology is recalling 11 sets of Streamline CT Cervico-Thoracic System set screws because some thread profiles were not within specifications.

    Product
    STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2566-2014·2014-09-10

    Biomet Microfixation Recalls TMJ Fossa Component Due to Product Mix-Up

    Biomet Microfixation is recalling one unit of a TMJ fossa component because a product mix-up occurred before final packaging and labeling.

    Product
    Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2591-2014·2014-09-10

    Mentor Saline Breast Implant Sizer Recalled for Volume Labeling Error

    Mentor Texas, LP. is recalling 34 units of saline breast implant sizers because the device labeling states 330cc while the actual device volume is 380cc.

    Product
    EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2582-2014·2014-09-10

    Zimmer Recalls Natural-Knee Patella Bushings Due to Corrosion Complaints

    Zimmer, Inc. is recalling Natural-Knee System Patella Bushings due to a trend of complaints indicating product corrosion. The affected orthopedic surgical instruments were distributed worldwide.

    Product
    Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1572-2014·2014-09-10

    Qualitest Recalls Oxycodone and Acetaminophen Tablets Due to Broken Tablets

    Qualitest Pharmaceuticals is recalling 23,544 bottles of Oxycodone and Acetaminophen tablets because broken tablets were found in sealed bottles.

    Product
    OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2571-2014·2014-09-10

    Siemens Recalls V5Ms Transesophageal Ultrasound Transducers Due to Material Deterioration

    Siemens is recalling 321 V5Ms transesophageal ultrasound transducers because the material covering the articulating section has deteriorated.

    Product
    V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2592-2014·2014-09-10

    MedComp Recalls Split Cath III Trays Due to Incorrect Length Labeling

    Medical Components, Inc. is recalling 110 Split Cath III Trays because they were incorrectly labeled as 32CM instead of 28CM.

    Product
    Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is indicated for use in attaining long term vascular access for hemodialysis and apheresis in adult patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2585-2014·2014-09-10

    Zimmer Recalls Natural-Knee System Patella Bushings Due to Corrosion

    Zimmer, Inc. is recalling Natural-Knee System Patella Bushings because of a trend of complaints indicating product corrosion.

    Product
    Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number 6290-00-704. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2568-2014·2014-09-10

    Datascope Recalls Linear Intra-Aortic Balloon Catheter for Labeling Error

    Datascope Corporation is recalling Linear 7.5 FR 40cc Intra-Aortic Balloon Catheters due to a duplicate serial number label detected during label reconciliation.

    Product
    LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group
    Category
    Medical Device
    Distribution
    1 state
  • SevereNHTSA·14V541000·2014-09-09

    GM Recalls 2013-2015 Cadillac XTS and Chevrolet Impala for Brake Fire Risk

    General Motors is recalling 2013-2015 Cadillac XTS and 2014-2015 Chevrolet Impala vehicles because the electronic parking brake may not fully retract, potentially causing a fire.

    Product
    CHEVROLET — CHEVROLET, CADILLAC IMPALA, XTS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V543000·2014-09-09

    GM Recalls 2014 Chevrolet Sonic Vehicles for Air Bag Defect

    General Motors is recalling 2014 Chevrolet Sonic vehicles because a steering column electrical issue may limit air bag deployment in severe crashes.

    Product
    CHEVROLET — CHEVROLET SONIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V542000·2014-09-09

    GM Recalls 2004-2007 Cadillac CTS-V and STS-V for Fuel Pump Fire Risk

    General Motors is recalling specific 2004-2007 Cadillac CTS-V and STS-V vehicles because fuel pump terminals may overheat, melt, and leak fuel, increasing the risk of stalling or fire.

    Product
    CADILLAC — CADILLAC CTS, STS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V540000·2014-09-09

    GM Recalls 2008-2013 Vehicles for Ignition Key Knee Interference Risk

    General Motors is recalling 2008-2009 Pontiac G8 and 2011-2013 Chevrolet Caprice vehicles because the driver's knee may accidentally knock the ignition key out of the run position, potentially disabling safety systems.

    Product
    PONTIAC — PONTIAC, CHEVROLET G8, CAPRICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E060000·2014-09-09

    Clean Fuel USA Recalls LPI Fuel Rails for Propane Leak Risk

    Clean Fuel USA is recalling specific LPI fuel rails for 6 and 8-liter engines because improperly secured injectors or leaking tubes may cause a propane leak, leading to stalling or fire.

    Product
    FUEL SYSTEM, OTHER:DELIVERY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14271·2014-09-09

    Cabrinha Recalls Kiteboarding Control Systems Due to Spring Jamming Risk

    Cabrinha is recalling 1X and Overdrive 1X kiteboarding control systems because the Recoil spring can jam, causing loss of control and injury risk.

    Product
    Cabrinha Kiteboarding 1X and Overdrive 1X Control Systems
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·056-2014·2014-09-06

    Perdue Recalls Raw Chicken Due to Temperature Processing Deviation

    Perdue Foods is recalling approximately 720 pounds of raw, fresh whole young chickens due to a temperature processing deviation. No adverse reactions have been reported.

    Product
    Perdue Foods, LLC — Maryland Firm Recalls Fresh, Raw Chicken Products Due To Possible Processing Flaw
    Category
    Food
    Distribution
    4 states
  • SevereNHTSA·14V536000·2014-09-05

    Harley-Davidson Recalls 2015 XG500 and XG750 Motorcycles for Fuel Leak Risk

    Harley-Davidson is recalling 2015 XG500 and XG750 motorcycles because the fuel tank filler neck may not seal properly, creating a risk of fuel leaks and vehicle fire.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON XG750, XG500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V537000·2014-09-05

    Harley-Davidson Recalls 2014 Motorcycles Due to Clutch Master Cylinder Defect

    Harley-Davidson is recalling 105,746 model year 2014 motorcycles because a clutch master cylinder component may fail, causing the bike to creep forward.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON FXSBSE, FLHTCUTG, FLHX, FLHRSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V538000·2014-09-04

    Jet Company Recalls 2014 Side Dump Trailers Due to Suspension Bolt Failure

    Jet Company is recalling 84 model year 2014 Side Dump Trailers because suspension pivot bolts may fail, potentially causing the axle to separate and increasing crash risk.

    Product
    JET COMPANY — JET COMPANY SIDE DUMP TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V529000·2014-09-04

    Chrysler Recalls 2013-2014 SRT Viper for Air Bag Deployment Defect

    Chrysler is recalling 2013-2014 SRT Vipers because inaccurate seat sensors may cause air bags to deploy at lower-than-designed velocities, increasing injury risk.

    Product
    SRT — SRT VIPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14269·2014-09-04

    Livie and Luca Recalls Children's Shoes Due to Laceration Hazard

    Livie and Luca is recalling Carta and Cotton children's shoes because a metal thread inside the liner can poke through and cut a child's foot.

    Product
    Carta and "Cotton" Children's Shoes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14270·2014-09-04

    JVC 42-Inch Flat Panel Televisions Recalled for Tip-Over Risk

    AmTRAN Video is recalling JVC 42-inch flat panel televisions because the stand neck can crack, causing the TV to tip over and pose an impact injury risk.

    Product
    JVC 42-inch flat panel televisions
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V534000·2014-09-04

    Monaco Holiday Rambler Fifth Wheel Trailers Recalled for Incorrect Tire Labels

    Allied Recreation Group is recalling 2015 Monaco Holiday Rambler fifth wheel trailers because incorrect Federal Certification labels may lead to improper tire inflation and increased crash risk.

    Product
    MONACO — MONACO HOLIDAY RAMBLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1560-2014·2014-09-03

    Central Admixture Recalls del Nido Cardioplegia Due to Microbial Contamination

    Central Admixture Pharmacy Services is recalling del Nido Cardioplegia with Lidocaine due to non-sterility and Aspergillus contamination.

    Product
    del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1565-2014·2014-09-03

    Pharmakon Recalls Midazolam HCl Vials Due to Undeclared Benzyl Alcohol

    Pharmakon Pharmaceuticals is recalling specific lots of Midazolam HCl 2 mg/ml vials because they contain undeclared benzyl alcohol.

    Product
    Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68.
    Category
    Drug
    Distribution
    4 states
  • CriticalFDA (Food)·F-2382-2014·2014-09-03

    Tiny Isle Mac Nut Fudge Recalled for Potential Salmonella Contamination

    Florimont, Inc. is recalling Tiny Isle Mac Nut Fudge because the carob powder used in the product is under recall for potential Salmonella contamination.

    Product
    Tiny Isle Mac Nut Fudge, 2 oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder, coconut oil, agave nectar, carob powder,mac nuts, vanilla, sea salt. Keep cold. Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-2397-2014·2014-09-03

    McCormick Ground Oregano Recalled Due to Salmonella Contamination

    McCormick & Company is recalling specific bottles of ground oregano because a retail sample tested positive for Salmonella. Consumers should check their pantries for the affected product codes.

    Product
    McCormick Ground Oregano in 0.75 oz plastic bottle. UPC NUMBER: 52100003566 (as seen on label: 0-523561-6) MCCORMICK ITEM NUMBER: 900356
    Category
    Food
    Distribution
    39 states
  • CriticalFDA (Drugs)·D-1559-2014·2014-09-03

    Pediatric Cardioplegia Recalled for Aspergillus Microbial Contamination

    Central Admixture Pharmacy Services is recalling Pediatric Cardioplegia due to non-sterility and Aspergillus contamination. The product was distributed in Michigan and Wisconsin.

    Product
    PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1563-2014·2014-09-03

    Abrams Royal Pharmacy Recalls Non-Sterile Mineral IV Injection

    Abrams Royal Pharmacy is recalling 74 units of Mineral IV Injection found to contain Sphingomonas paucimobilis, indicating non-sterility.

    Product
    MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2392-2014·2014-09-03

    Health Matters America Recalls Organic Traditions Sprouted Chia Seed Powder

    Health Matters America Inc. is voluntarily recalling Organic Traditions Sprouted Chia Seed Powder due to possible Salmonella contamination.

    Product
    ORGANIC TRADITIONS SPROUTED CHIA SEED POWDER NET WT. 8 oz. and 16 oz., UPC 854260006162, item number AHM616 and UPC 854260005462, item number AHM546
    Category
    Food
    Distribution
    25 states
  • CriticalFDA (Drugs)·D-1568-2014·2014-09-03

    Pharmakon Recalls Atropine Sulfate Syringes Due to Undeclared Benzyl Alcohol

    Pharmakon Pharmaceuticals is recalling specific lots of Atropine Sulfate Injection because they contain undeclared benzyl alcohol.

    Product
    Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78.
    Category
    Drug
    Distribution
    4 states
  • CriticalFDA (Food)·F-2386-2014·2014-09-03

    Tiny Isle Chocolate Truffles Recalled for Potential Salmonella Contamination

    Tiny Isle Chocolate Truffles Spicy Lava are being recalled due to potential Salmonella contamination in the carob powder used.

    Product
    Tiny Isle Chocolate Truffles Spicy Lava: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1562-2014·2014-09-03

    Central Admixture Pharmacy Recalls Contaminated Low Potassium Cardioplegia

    Central Admixture Pharmacy Services is recalling Low Potassium Cardioplegia doses due to non-sterility and Aspergillus contamination.

    Product
    LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
    Category
    Drug
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1561-2014·2014-09-03

    Adenosine Injection Recalled for Microbial Contamination

    Central Admixture Pharmacy Services is recalling adenosine 90 mg injections in Michigan and Wisconsin due to Aspergillus species contamination.

    Product
    adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Food)·F-2403-2014·2014-09-03

    Regeneca Recalls RegeneSlim Appetite Control Due to DMAA Presence

    Regeneca, Inc. is recalling RegeneSlim Appetite Control dietary supplements because FDA analysis found the product contains DMAA.

    Product
    RegeneSlim Appetite Control, 2 capsules/ packet, Dietary Supplement
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2243-2014·2014-09-03

    Cook CloverSnare 4-Loop Vascular Retrieval Snare Recalled for Tip Separation

    Cook Inc. is recalling CloverSnare 4-Loop Vascular Retrieval Snares because the snare may separate from the distal tip of the wire.

    Product
    CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in a box. The CloverSnare 4-Loop Vascular Retriever is intended for use in the cardiovascular system to manipulate and retrieve foreign…
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Food)·F-2395-2014·2014-09-03

    Health Matters America Recalls Organic Traditions Chia Seeds for Salmonella Risk

    Health Matters America Inc. is voluntarily recalling Organic Traditions chia seed products due to possible Salmonella contamination.

    Product
    ORGANIC TRADITIONS CHIA SEEDS; NET WT. 8 oz., 16 oz. and 50 lb., UPC 854260006131, UPC 854260006148, no UPC for 50 lb.
    Category
    Food
    Distribution
    25 states
  • SevereFDA (Food)·F-2389-2014·2014-09-03

    Tiny Isle Chocolate Truffles Recalled for Potential Salmonella Contamination

    Tiny Isle Chocolate Truffles are being recalled because they were made with carob powder potentially contaminated with Salmonella.

    Product
    Tiny Isle Chocolate Truffles Hawaiian Sea Salt: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1564-2014·2014-09-03

    Abrams Royal Pharmacy Recalls All Unexpired Sterile Drug Products

    Abrams Royal Pharmacy is recalling all unexpired sterile drug products due to a lack of assurance of sterility. The products were distributed nationwide and to Canada.

    Product
    All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc., Dallas, TX
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2380-2014·2014-09-03

    Tiny Isle Original Fudge Recalled for Potential Salmonella Contamination

    Tiny Isle Original Fudge is being recalled because it was made with carob powder under recall for potential Salmonella contamination.

    Product
    Tiny Isle Original Fudge, 2 oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder, coconut oil. agave nectar, carob powder, vanilla, sea salt. Keep cold. Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·14V523000·2014-09-03

    Collins and Mid Bus School Buses Recalled for Body Joint Adhesive Defect

    NHTSA is recalling 281 model year 2014 Collins and Mid Bus school buses because inadequate adhesive on interior side panel joints may fail to meet federal safety standards.

    Product
    COLLINS — COLLINS, MID BUS DE416WR, DH416, SL408, DE516WR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2402-2014·2014-09-03

    Honey Heaven Wholesale Recalls Organic Raw Carob Powder for Salmonella Risk

    Honey Heaven Wholesale is recalling Organic Raw Carob Powder due to potential Salmonella contamination. The product was distributed to processors and retail outlets in Oregon, Washington, and California.

    Product
    Organic Raw Carob Powder is shipped in original twenty pound case from supplier or re-packaged and sold in five pound plastic bags. Five pound bags are labeled in part "OG RAW CAROB POWDER*** C110-5# Lot: *** 5 lbs***Distributed by Hummingbird Wholesale Eugene, OR 97401…
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-2399-2014·2014-09-03

    Beta Labs Recalls Phentylene Dietary Supplement Containing DMAA

    Beta Labs is recalling Phentylene capsules because they contain DMAA, a substance not permitted in dietary supplements.

    Product
    PHENTALENE (TM), PHARMACEUTICAL GRADE, With 50 mg of Ephedra Extract, 90 CAPSULES, Distributed by Beta Labs, LTD, Newark, DE 19711, UPC 670541599822
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2391-2014·2014-09-03

    Tiny Isle Fudge Pack Recalled for Potential Salmonella Contamination

    Tiny Isle Fudge Pack is being recalled because it was made with carob powder under recall for potential Salmonella contamination.

    Product
    Tiny Isle Fudge Pack, Organic-Raw- Gluten Free: Mint Crunch, Mac Nut Fudge, Lava Fudge, 5-oz. Tiny Isle 4505 Kukui St. 20A Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2378-2014·2014-09-03

    Tiny Isle Chocolate Truffles Recalled for Potential Salmonella Contamination

    Tiny Isle Chocolate Truffles are being recalled because they were made with carob powder under recall for potential Salmonella contamination.

    Product
    Tiny Isle Chocolate Truffles: Gluten Free, Raw, Vegan; Sold in 4 pack box - 4 oz: Flavors: Sea Salt, Coconut, Macadamia Nut, Mint Crunch Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2539-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue

    Smiths Medical ASD, Inc. is recalling 135,518 Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.

    Product
    H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • SevereNHTSA·14V527000·2014-09-03

    Western Star 4900 Trucks Recalled for Missing Anti-lock Brake Systems

    Daimler Trucks North America is recalling 2014-2015 Western Star 4900 trucks manufactured without Anti-lock Brake Systems, which increases the risk of wheel lockup and crashes.

    Product
    WESTERN STAR — WESTERN STAR 4900
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2384-2014·2014-09-03

    Tiny Isle Lava Fudge Recalled for Potential Salmonella Contamination

    Tiny Isle Lava Fudge is being recalled because it contains carob powder that may be contaminated with Salmonella.

    Product
    Tiny Isle Lava Fudge, 2 oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder,, agave nectar, carob powder, nioi chili's, vanilla, sea salt. Keep cold. Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2541-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kit Tube Holders

    Smiths Medical ASD, Inc. is recalling H4052 Endo Tube Holders because the fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.

    Product
    H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • SevereFDA (Food)·F-2394-2014·2014-09-03

    Health Matters America Recalls Sprouted Chia Seed Powder for Salmonella Risk

    Health Matters America Inc. is voluntarily recalling Organic Traditions Sprouted Chia Seed Powder and related products due to possible Salmonella contamination.

    Product
    ORGANIC SPROUTED DARK SPROUTED CHIA SEED POWDER BULK; NET WT. 50 lb; item number BLK548
    Category
    Food
    Distribution
    25 states
  • SevereFDA (Drugs)·D-1566-2014·2014-09-03

    Pharmakon Recalls Midazolam IV Bags Due to Undeclared Benzyl Alcohol

    Pharmakon Pharmaceuticals is recalling specific lots of Midazolam HCl IV bags because they contain undeclared benzyl alcohol.

    Product
    Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715.…
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Food)·F-2385-2014·2014-09-03

    Tiny Isle Chocolate Truffles Recalled for Potential Salmonella Contamination

    Tiny Isle Chocolate Truffles Kauai Coconut are being recalled because they were made with carob powder potentially contaminated with Salmonella.

    Product
    Tiny Isle Chocolate Truffles Kauai Coconut: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2390-2014·2014-09-03

    Tiny Isle Fudge Mix Recalled for Potential Salmonella Contamination

    Florimont, Inc. is recalling Tiny Isle Fudge Mix Organic due to potential Salmonella contamination in the carob powder used.

    Product
    Tiny Isle Fudge Mix Organic, Organic-Raw- Gluten Free; Cacao powder, carob powder, Hawaiian sea salt. Tiny Isle 4505 Kukui St. 20A Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2536-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue

    Smiths Medical ASD, Inc. is recalling Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty in locking the holder or passing a suction catheter.

    Product
    4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • SevereFDA (Food)·F-2388-2014·2014-09-03

    Tiny Isle Chocolate Truffles Recalled for Potential Salmonella Contamination

    Tiny Isle Chocolate Truffles Mint Crunch are being recalled due to potential Salmonella contamination in the carob powder used to make them.

    Product
    Tiny Isle Chocolate Truffles Mint Crunch: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2400-2014·2014-09-03

    Beta Labs Recalls PHEnFX Dietary Supplement Containing Unapproved DMAA

    Beta Labs is recalling 743 units of PHEnFX dietary supplements because they contain DMAA, a substance not permitted in dietary supplements.

    Product
    PHEnFX (TM), PHENO 550 mg, PHARMACEUTICAL GRADE, 90 CAPSULES, Manufactured for: Beta Labs, LTD, Newark, DE 19711, UPC 029882559802
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2540-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Compression

    Smiths Medical ASD, Inc. is recalling 135,518 Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.

    Product
    H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states

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