The Recall Desk

Archive

August 2014 recalls

458 recalls were announced in August 2014.

What the numbers show

Critical
18
Severe
90
High
160
Moderate
169
Low
21

Of the 458 recalls this month scored against our rubric, 4% are Critical, 20% are Severe.

Which agencies issued them

101–200 of 458

  • ModerateFDA (Devices)·Z-2275-2014·2014-08-27

    AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling

    AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 13.0, 13.5, 14.0 Product Usage: AMO TECNIS CL monofocal fol
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2284-2014·2014-08-27

    AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling

    AMO Puerto Rico Manufacturing is recalling specific Tecnis CL intraocular lenses because they may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 23, 23.5 & 24. Product Usage: AMO TECNIS CL monofocal folda
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2266-2014·2014-08-27

    Vascutek Recalls Gelweave Vascular Prostheses Due to Cautery Shelf Life Labeling

    Vascutek is recalling Gelweave Vascular Prostheses because the included cautery has a shorter shelf life than the graft, creating a labeling discrepancy.

    Product
    Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2242-2014·2014-08-27

    Biomet Recalls Vanguard 360 Femoral Boss Reamers Due to Sizing Defect

    Biomet is recalling 461 Vanguard 360 Femoral Boss Reamers because they were manufactured oversized and may not fit into mating components.

    Product
    Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581 USA
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-2267-2014·2014-08-27

    Intelerad IntelePACS Software Recall Due to Potential File Truncation Errors

    Intelerad Medical Systems is recalling IntelePACS software versions 3-8-1 to 4-9-1 because partially truncated files may be incorrectly reported as complete.

    Product
    IntelePACS software versions 3-8-1 to 4-9-1, Product Usage: IntelePACS is a device that receives digital images and data from various sources (such as, CT scanners, MRI scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2280-2014·2014-08-27

    AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling

    AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 18.5-19.0 Product Usage: AMO TECNIS CL monofocal foldable I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2279-2014·2014-08-27

    AMO TECNIS CL Intraocular Lenses Recalled for Incorrect Diopter Labeling

    AMO Puerto Rico Manufacturing is recalling 77,055 TECNIS CL intraocular lenses because they may be labeled with the incorrect diopter power.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model Z9002. Indicated for primary implantation for the visual correction of aphakia in adult patients. Tecnis CL Mono 13 mm with the following diopter sizes: 17.5, 18.0 Product Usage: AMO TECNIS CL monofocal foldable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2192-2014·2014-08-27

    FDA Recalls Gel-E Donut and Squishon Baby Pillows Due to Mold

    Childrens Medical Ventures is recalling Gel-E Donut and Squishon 2 gel pillows because of visible mold. The mold was identified as Cladosporium and Penicillium fungi.

    Product
    Gel-E Donut, Squishon 2 gel pillows Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral suppor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1544-2014·2014-08-27

    Triveen PRx RNF Capsules Recalled for Incorrect Vitamin B12 Labeling

    Trigen Laboratories is recalling Triveen PRx RNF Capsules because the label lists Vitamin B12, which is not in the formulation.

    Product
    Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872, NDC 13811-558-30, UPC 3 13811 55830 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1539-2014·2014-08-27

    Mylan Recalls Tolterodine Tartrate Tablets Due to Impurity Failures

    Mylan Pharmaceuticals is recalling 9,225 bottles of Tolterodine Tartrate Tablets, 1 mg, because the product failed impurity specifications for lactol and total impurities.

    Product
    Tolterodine Tartrate Tablets, 1 mg, 60 Tablet Bottles, Rx only. Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-5445-91.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2264-2014·2014-08-27

    Hyperion Medical Recalls HyperBlue 1530 Laser Brochures for Misleading Claims

    Hyperion Medical is recalling brochures and website information for the HyperBlue 1530 laser because they promoted features not cleared by the FDA.

    Product
    All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013.
    Category
    Medical Device
    Distribution
    10 states
  • SevereNHTSA·14V516000·2014-08-26

    Audi Recalls 2013 Q7 Vehicles Due to Brake Booster Oil Leak Risk

    Volkswagen is recalling 2013 Audi Q7 vehicles with 3.0L TDI engines because engine oil may leak into the brake booster, potentially causing a loss of power braking assist.

    Product
    AUDI — AUDI Q7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V517000·2014-08-26

    NABI Transit Bus Recall for CNG Fuel Tank Abrasion Risk

    NABI is recalling 2012-2014 31LFW and 40LFW transit buses because CNG fuel tanks may be abraded by pressure relief devices, increasing fire risk.

    Product
    NABI — NABI 40LFW, 31LFW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E056000·2014-08-26

    Agility Fuel Systems Recalls CNG Fuel Hoses Due to Corrosion Risk

    Agility Fuel Systems is recalling specific CNG fuel systems because a hose component may corrode and leak gas, increasing fire risk.

    Product
    FUEL SYSTEM, OTHER:DELIVERY:HOSES, LINES/PIPING, AND FITTINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14746·2014-08-26

    Cree Recalls LED High-Bay Luminaires Due to Laceration Hazard

    Cree is recalling approximately 10,000 LED high-bay luminaires because the tempered glass lens can break, posing a laceration hazard. No injuries have been reported.

    Product
    LED High-Bay Luminaires
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V515000·2014-08-26

    Jayco Recalls 2015 Seismic Fifth Wheels for Incorrect Cargo Labels

    Jayco is recalling 2015 Seismic fifth wheel trailers because incorrect cargo capacity labels may lead to overloading, tire failure, and crashes.

    Product
    JAYCO FIFTH WHEEL — JAYCO FIFTH WHEEL SEISMIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V514000·2014-08-22

    Ford Recalls 2014 Focus and C-Max for Steering Gear Assembly Defect

    Ford is recalling 2014 Focus and C-Max vehicles manufactured in August 2014 due to incorrectly assembled steering gears that may cause loss of steering control.

    Product
    FORD — FORD C-MAX, FOCUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·054-2014·2014-08-21

    APPA Fine Foods Recalls Chicken Caesar Salad Kits for Listeria

    APPA Fine Foods is recalling approximately 92,657 pounds of chicken Caesar salad kits due to possible Listeria monocytogenes contamination.

    Product
    California Firm Recalls Chicken Caesar Salad Kits For Possible Listeria Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighCPSC·14745·2014-08-21

    StoveTop FireStop Microhood Recalled Due to Fire Suppression Failure Risk

    WilliamsRDM is recalling StoveTop FireStop Microhood units because the front canister may fall off and fail to suppress fires. No injuries have been reported.

    Product
    The StoveTop FireStop® Microhood™ Fire Suppressors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14260·2014-08-21

    SolarWorld Recalls Solar Systems with Copper Grounding Lugs

    SolarWorld is recalling solar systems installed with bare-copper grounding lugs due to corrosion risks that could cause electric shock, electrocution, or fire.

    Product
    SolarWorld Solar Systems
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1535-2014·2014-08-20

    Super ARTHGOLD Recalled for Undeclared Prescription Drugs

    Super ARTHGOLD dietary supplement is being recalled because it contains undeclared prescription drugs and was marketed without FDA approval.

    Product
    Super ARTHGOLD 500mg, 120 Capsule Bottle, Dietary Supplement. Manufactured for & Distributed by Nanowellbeing Health, Inc., 14747 Artesia Blvd, #5V, La Mirada, CA 90638. UPC: 7 99475 35350 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1534-2014·2014-08-20

    Lite Fit USA Recalled for Undeclared Sibutramine

    Bacai, Inc. is voluntarily recalling Lite Fit USA supplements containing undeclared sibutramine, making them unapproved new drugs.

    Product
    Lite Fit USA, For Men & Women, Extreme Fat Burner, Suppresses Appetite, Boosts Metabolism, Limits Fat Absorption, Increases Energy, Prevents lipid formation by limiting fat absorption 30 pills /Bottle, Distributed by: Bacai, INC. www.litefitusa.com
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2203-2014·2014-08-20

    Gambro Recalls Prismaflex M150 Dialysis Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex M150 dialysis sets because connector breakages can cause liquid or blood to leak.

    Product
    Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-2313-2014·2014-08-20

    Farmers Market Recalls Shelled Walnuts for Listeria Contamination Risk

    Farmers Market is recalling 8 oz. packages of shelled walnuts due to potential Listeria monocytogenes contamination.

    Product
    Shelled walnuts, 8 oz., packed in a clear plastic container and sold under the Farmer's Market brand.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2225-2014·2014-08-20

    Zimmer Recalls Nonsterile Orthopedic Rasp Handles Due to Assembly Failure

    Zimmer, Inc. is recalling 412 nonsterile VER2 D8L Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.

    Product
    VER2 D8L OFFSET RASP HANDLE, RT Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2206-2014·2014-08-20

    Gambro Recalls PrisMARS Kits Due to Connector Breakage and Leakage

    Gambro Renal Products is recalling PrisMARS Kits because connector breakages can cause liquid or blood to leak.

    Product
    PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit per carton box, Product Number 800480, Batch
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1538-2014·2014-08-20

    Teva Recalls Carbidopa and Levodopa Tablets Due to Potential Superpotency

    Teva Pharmaceuticals USA is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg, due to the potential for superpotent tablets.

    Product
    Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, Manufactured in Israel by Teva Pharmaceutical IND, LTD., Jeruselem, Israel, for Teva Pharmaceuticals USA, Sellersville, PA, NDC 0093-0293-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2204-2014·2014-08-20

    Gambro Recalls Prismaflex HF 1000 Dialysis Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex HF 1000 dialysis sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·14E055000·2014-08-20

    Thermo King Inverters Recalled for Fire Risk in Tractor Cabins

    Thermo King is recalling specific 1100W, 1500W, and 2000W inverters sold between May and July 2014 because they may spark or overheat, posing a fire hazard.

    Product
    EQUIPMENT:ELECTRICAL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2209-2014·2014-08-20

    Medical Positioning Rapid Response HUT Table Recalled for Malfunction Risk

    Medical Positioning Inc is recalling two Model # 1019 HUT tables due to a component defect that may cause the table to drop into the Trendelenburg position more rapidly than normal.

    Product
    Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1019. Product Usage: Used to conduct syncope examinations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2177-2014·2014-08-20

    Carestream Recalls Kodak DirectView DR 7500 X-Ray Systems Due to Loose Parts

    Carestream Health is recalling 589 Kodak DirectView DR 7500 diagnostic x-ray systems because the x-ray tube assembly may detach from the overhead crane due to insufficiently tightened hardware.

    Product
    Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permanently installed diagnostic x-ray system composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2230-2014·2014-08-20

    Zimmer Recalls 23.5 Degree Rasp Handle Assemblies Due to Assembly Failure

    Zimmer, Inc. is recalling 412 units of 23.5 Degree Rasp Handle Assemblies because the handle may fail to remain assembled to the rasp during use.

    Product
    23.5 Deg Rasp Handle Assy- LEFT Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2199-2014·2014-08-20

    Gambro Recalls Prisma M100 PRE Pump Infusion Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma M100 PRE pump infusion sets because connector breakages can cause liquid or blood to leak.

    Product
    Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2202-2014·2014-08-20

    Gambro Recalls Prismaflex M100 Dialysis Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex M100 dialysis sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2207-2014·2014-08-20

    Gambro Recalls X-MARS Sets Due to Connector Breakage and Leakage

    Gambro Renal Products is recalling X-MARS Sets because connector breakages can cause leakage of liquid or blood.

    Product
    X-MARS Set (component of MARS Treatment Kit Type 1116/1 X-MARS US), Product Number 800541
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2194-2014·2014-08-20

    Gambro Recalls Prisma TPE 2000 Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma TPE 2000 sets because connector breakages can cause liquid or blood leakage.

    Product
    Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2208-2014·2014-08-20

    Medical Positioning Rapid Response HUT Table Recall for Malfunction Risk

    Medical Positioning Inc is recalling 20 Rapid Response HUT tables because a defective component may cause the table to drop into the Trendelenburg position too rapidly.

    Product
    Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1017. Product Usage: Used to conduct syncope examinations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2223-2014·2014-08-20

    Zimmer Recalls Nonsterile Orthopedic Rasps Due to Handle Failure

    Zimmer, Inc. is recalling 412 units of nonsterile orthopedic rasps because the handle may fail to remain assembled during use.

    Product
    Vl DBL OFFST WI LRG STPL, RT Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2196-2014·2014-08-20

    Gambro Recalls Prisma M60 Postdilution Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma M60 POSTDILUTION sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2226-2014·2014-08-20

    Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure

    Zimmer, Inc. is recalling 412 Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.

    Product
    Double Offset Rasp Handle, Left Hand A/S Rasp Handle (Left)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2229-2014·2014-08-20

    Zimmer Recalls Nonsterile VER2 Handle Due to Assembly Failure

    Zimmer, Inc. is recalling 412 units of the VER2 Handle, Pin Rework, RT Nonsterile because the handle may fail to remain assembled to the rasp during use.

    Product
    VER2 HANDLE, PIN REWORK, RT Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2210-2014·2014-08-20

    Medical Positioning Rapid Response HUT Table Recall for Malfunction Risk

    Medical Positioning Inc. is recalling 17 Rapid Response HUT tables because a defective component may cause the table to drop into the Trendelenburg position more rapidly than normal under excessive weight.

    Product
    Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section, Powered Medical Examination table, Model # 1217. Product Usage: Used to conduct syncope examinations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2227-2014·2014-08-20

    Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure

    Zimmer, Inc. is recalling 412 Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.

    Product
    Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2167-2014·2014-08-20

    Esaote PA230E Ultrasound Transducer Recalled for Excessive Surface Temperature

    Biosound Esaote, Inc. is recalling 1,301 PA230E ultrasound transducers because they may exceed maximum allowable surface temperature limits under specific settings.

    Product
    Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2232-2014·2014-08-20

    BioMerieux Recalls VIDAS D-Dimer Exclusion II Test Kits

    BioMerieux SA is recalling 2,160 units of VIDAS D-Dimer Exclusion II tests due to complaints of non-repeatable results that may cause false negatives.

    Product
    VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products in human plasma using the Enzyme Linked Fluorescent Assay technique. Also indicated for use in conjunction w
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-2216-2014·2014-08-20

    Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure

    Zimmer, Inc. is recalling 412 nonsterile Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.

    Product
    Double Offset Rasp Handle, Left Hand Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2200-2014·2014-08-20

    Gambro Recalls Prisma HF1000 Presets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma HF1000 presets because connector breakages can cause leakage of liquid or blood.

    Product
    Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2220-2014·2014-08-20

    Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure

    Zimmer, Inc. is recalling 412 units of Double Offset Rasp Handles because the handles may fail to remain assembled to the rasp during use.

    Product
    Double Offset Rasp Handle, Right Hand Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2213-2014·2014-08-20

    Brainlab Navigation Spine & Trauma 3D Software Recalled for Registration Error

    Brainlab AG is recalling 17 Navigation Spine & Trauma 3D software systems worldwide due to a defect in automatic CT image registration.

    Product
    Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoper
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2217-2014·2014-08-20

    Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure

    Zimmer, Inc. is recalling 412 nonsterile Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.

    Product
    Double Offset Rasp Handle, Left Hand Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2197-2014·2014-08-20

    Gambro Recalls Prisma M 100 PRE Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma M 100 PRE sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2182-2014·2014-08-20

    Integra Recalls NewPort MIS System Due to Potential Component Mixing

    Integra LifeSciences is recalling four units of the NewPort MIS System because demonstration components may have been mixed with surgical components.

    Product
    Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP (NewPort Instrument Tray w/ Components) The NewPort System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2198-2014·2014-08-20

    Gambro Recalls Prisma M100 Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma M100 sets because connector breakages can cause liquid or blood to leak.

    Product
    Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-2325-2014·2014-08-20

    Miceli Dairy Products Recalls Ricotta Cheese Due to Beta Lactam Residues

    Miceli Dairy Products is recalling Farimont Foods Ricotta Cheese because the whey protein concentrate used in manufacturing tested positive for beta lactam residues.

    Product
    Farimont Foods Ricotta Cheese packaged in 30 pound bags.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2201-2014·2014-08-20

    Gambro Recalls Prismaflex M60 Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex M60 sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2228-2014·2014-08-20

    Zimmer VER2 Handle Recalled Due to Assembly Failure During Use

    Zimmer, Inc. is recalling 412 units of VER2 Handle, Pin Rework, LT Nonsterile because the handle may fail to remain assembled to the rasp during use.

    Product
    VER2 HANDLE, PIN REWORK, LT Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2306-2014·2014-08-20

    Ronzoni Roasted Garlic Fettuccine Recalled for Undeclared Soy Allergen

    EBRO North America is recalling Ronzoni Roasted Garlic Fettuccine because it may contain undeclared soy, a major food allergen.

    Product
    Ronzoni Roasted Garlic Fettuccine Net Wt. 12 OZ. Enriched Macaroni Product shelf-stable packed in blue paperboard box all codes
    Category
    Food
    Distribution
    12 states
  • HighNHTSA·14V513000·2014-08-20

    Spartan Emergency Vehicles Recalled for Engine Surge Risk

    Spartan is recalling certain 2011-2015 Gladiator and MetroStar emergency vehicles because a software issue may cause engine surges, increasing the risk of personal injury.

    Product
    SPARTAN — SPARTAN GLADIATOR, METROSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2221-2014·2014-08-20

    Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure

    Zimmer, Inc. is recalling 412 nonsterile Double Offset Rasp Handles that may fail to remain assembled during use.

    Product
    Double Offset Rasp Handle, Left Hand Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V512000·2014-08-20

    Autocar Recalls 2015 Xspotter Trucks Due to Fuel Filter Defect

    Autocar is recalling 19 model year 2015 Xspotter heavy-duty trucks because a fuel filter defect may cause the engine to stall without warning, increasing the risk of a crash.

    Product
    AUTOCAR — AUTOCAR XSPOTTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2312-2014·2014-08-20

    Uncle Ben's Ready Rice Recalled for Undeclared Barley Gluten

    Mars Food US is recalling Uncle Ben's Ready Rice Garden Vegetable pouches because some contain undeclared barley, a gluten source.

    Product
    Uncle Ben's(R) Ready Rice GARDEN VEGETABLE, with PEAS, CARROTS, AND CORN, NET WT. 8.8 OZ (250g), UPC 5480023334
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2175-2014·2014-08-20

    Agfa Healthcare Recalls DX-D 600 Imaging Packages Due to Crane Movement

    Agfa Healthcare is recalling 17 DX-D 600 imaging packages because the overhead tube crane may move uncontrolled. Customers should stop using the equipment.

    Product
    DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extr
    Category
    Medical Device
    Distribution
    9 states
  • HighCPSC·14259·2014-08-20

    Attwood Recalls Kayak and Watersports Storage Hangers Due to Injury Hazard

    Attwood is recalling kayak and watersports storage hangers because the length adjustment buckles may release unexpectedly, causing stored items to fall and injure people nearby.

    Product
    Kayak and Watersports Storage Hanger
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2172-2014·2014-08-20

    Medtronic Recalls Ascenda Intrathecal Catheters Due to Retainer Ring Defect

    Medtronic is recalling specific lots of Ascenda Intrathecal Catheters and Revision Kits because a retainer ring component may not meet specifications, risking catheter disconnection.

    Product
    Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit, model 8784. The Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2174-2014·2014-08-20

    Siemens Linear Accelerators Recalled for Potential Patient Collision Risk

    Siemens Medical Solutions is recalling 160 linear accelerators because automatic treatment movements could cause the machine to collide with patients.

    Product
    Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2222-2014·2014-08-20

    Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure

    Zimmer, Inc. is recalling 412 units of Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.

    Product
    Double Offset Rasp Handle, Right Hand Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2314-2014·2014-08-20

    Interbake Recalls Mrs. Fields Cookies Due to Undeclared Walnuts

    Interbake Foods LLC is recalling specific lots of Mrs. Fields Milk Chocolate Chip Cookies because some cartons contain undeclared walnuts.

    Product
    Mrs. Fields Milk Chocolate Chip Cookies, Net Wt. 8 oz (227 g) cardboard carton with 8 individually wrapped 1 oz cookies. 12 cartons in a case. UPC 8-86002-50651-7.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2183-2014·2014-08-20

    Ortho-Clinical Diagnostics Recalls VITROS CA 19-9 Reagent Packs and Calibrators

    Ortho-Clinical Diagnostics is recalling VITROS CA 19-9 Reagent Packs and Calibrators, Lot 1320, because they may produce positively biased results on specific VITROS systems.

    Product
    VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS¿ CA 19-9 Reagent Packs are used on VITROS¿ ECi/ECiQ Immunodiagnostic Systems, VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600 Integrated Systems for the quantitative measurement of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2224-2014·2014-08-20

    Zimmer Recalls Nonsterile Orthopedic Rasp Handles Due to Assembly Failure

    Zimmer, Inc. is recalling 412 units of VER2 DBL OFFSET RASP HANDLE, LT Nonsterile because the handle may fail to remain assembled to the rasp during use.

    Product
    VER2 DBL OFFSET RASP HANDLE, LT Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2195-2014·2014-08-20

    Gambro Recalls Prisma M 60 PRE Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prisma M 60 PRE sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2155-2014·2014-08-20

    Cardiovascular Systems Recalls Diamondback 360 Peripheral Orbital Atherectomy System

    Cardiovascular Systems, Inc. is recalling 48 Diamondback 360 Peripheral Orbital Atherectomy Systems because the saline sheath may crack or fracture, releasing particulate during use.

    Product
    CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2193-2014·2014-08-20

    Gambro Recalls Prismaflex TPE 2000 Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex TPE 2000 sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2234-2014·2014-08-20

    Vital Sync Virtual Patient Monitoring Platform software recall for alarm mismatch

    Nellcor Puritan Bennett Inc. is recalling Vital Sync software due to a mismatch between alarm priorities on medical devices and the monitoring system.

    Product
    Vital Sync" VPMP & IM, software, V2.4. (DVD), packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professionals fo
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2211-2014·2014-08-20

    Medical Positioning Rapid Response HUT Table Recalled for Malfunction Risk

    Medical Positioning Inc. is recalling Model # 1219 HUT tables because a defective component may cause the table to drop rapidly into the Trendelenburg position under excessive weight.

    Product
    Medical Positioning Rapid Response HUT table, Powered Medical Examination table, Model # 1219. Product Usage: Used to conduct syncope examinations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2218-2014·2014-08-20

    Zimmer Recalls Double Offset Rasp Handles Due to Assembly Failure

    Zimmer, Inc. is recalling 412 Double Offset Rasp Handles because the handle may fail to remain assembled to the rasp during use.

    Product
    Double Offset Rasp Handle, Left Hand Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2212-2014·2014-08-20

    Biomet Recalls Distal Radius Fracture Drill Guides Due to Jig Sticking

    Biomet, Inc. is recalling 37 units of Distal Radius Fracture Repair System drill guides because they become stuck in the jig during use.

    Product
    Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2205-2014·2014-08-20

    Gambro Recalls Prismaflex HF 1400 Dialysis Sets Due to Connector Breakage

    Gambro Renal Products is recalling Prismaflex HF 1400 dialysis sets because connector breakages can cause leakage of liquid or blood.

    Product
    Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2173-2014·2014-08-20

    Medtronic MiniMed Implantable Insulin Pump Recalled for Malfunction

    Medtronic MiniMed is recalling 764 Implantable Insulin Pumps due to reports of pump malfunction causing insulin delivery to stop before the device's 7-year useful life ends.

    Product
    Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2190-2014·2014-08-20

    Codman Certas Valve Recalled for Pressure Specification Clarification

    Codman & Shurtleff is recalling 9,498 Codman Certas In Line Valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.

    Product
    Codman Certas - In Line Valve with SIPHONGUARD¿, Unitized Catheter and Accessories; Product Code: 82-8806 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2236-2014·2014-08-20

    Nanosphere Recalls Verigene BC-GN Test Kits Due to Missing Particles

    Nanosphere is recalling Verigene BC-GN Test Kits because some extraction trays are missing magnetic microparticles required for DNA extraction.

    Product
    Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, oligonucleotide probe solution and signal amplification solutions required to ge
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2326-2014·2014-08-20

    Cool Tropics Rips Slush Recalled Due to Spoilage Bacteria and Yeasts

    Manufacturing Solutions International is recalling specific lots of Cool Tropics Rips Slush, Sour Apple Flavored, because laboratory results revealed spoilage-type bacteria and yeasts.

    Product
    Cool Tropics Rips Slush, Sour Apple Flavored 100% Juice No artificial colors or flavors, Juice from Concentrate 4 fl oz, (118 mL), Contains: Water, Apple Juice Concentrate***Manufactured in USA for Tropical Paradise, Inc., www.cool-tropics.com DO NOT MICROWAVE" UPC Code 9 76017 0
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Food)·F-2316-2014·2014-08-20

    Nutrition Express Recalls Vitamins Due to Excess Folic Acid Content

    Nutrition Express is recalling specific vitamin products because the folic acid content was found to be higher than the label claim.

    Product
    Fitness Labs Fitness Multi 1, 90 capsules (UPC 654186946555) and 180 capsules (UPC 654186946609).
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2235-2014·2014-08-20

    Vital Sync Virtual Patient Monitoring Platform Recalled for Alarm Priority Mismatch

    Nellcor Puritan Bennett Inc. is correcting Vital Sync Virtual Patient Monitoring Platform units due to a mismatch between device alarm priorities and the system.

    Product
    Vital Sync RMS 1.0 when loaded with v2.4 software, packaged on a CD or other electronically controlled device. CDs are packaged in clam shell jeweled cases within a carton box. The Vital Sync Virtual Patient Monitoring Platform is intended to be used by healthcare professiona
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Food)·F-2322-2014·2014-08-20

    Miceli Dairy Recalls Ricotta Cheese for Beta Lactam Residues

    Miceli Dairy Products Co is recalling Sargento and Dutch Farms Fat Free Ricotta Cheese due to beta lactam residues found in the whey protein concentrate used.

    Product
    Sargento Fat Free Ricotta Natural Cheese and Dutch Farms Fat Free Ricotta Cheese packaged in 15 ounce plastic tubs.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2189-2014·2014-08-20

    Codman Certas Valve Recall Clarifies Pressure Specification in Instructions for Use

    Codman & Shurtleff, Inc. is recalling 9,498 Codman Certas valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.

    Product
    Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories; Product Code: 82-8805 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management o
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2181-2014·2014-08-20

    Beevers Recalls Luma Wrap Phototherapy Swaddlers for Regulatory Misclassification

    Beevers Manufacturing is recalling Luma Wrap neonatal phototherapy swaddlers because they were marketed without a required FDA 510(k) clearance.

    Product
    Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2171-2014·2014-08-20

    Intuitive Surgical Recalls EndoWrist Stapler Manuals for pH Specification Change

    Intuitive Surgical is recalling EndoWrist Stapler 45 User Manual Addenda and Wall Charts to correct the pH range specification for enzymatic cleaners.

    Product
    EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection, transection and/or creation of anastomoses in General, Gyn
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2184-2014·2014-08-20

    Codman Certas Valve Recall Clarifies Pressure Specification in Instructions for Use

    Codman & Shurtleff is recalling 9,498 Codman Certas valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.

    Product
    Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-2179-2014·2014-08-20

    Medtronic MiniMed Guardian Monitor Recall for Water Resistance Issue

    Medtronic MiniMed is recalling 86 Guardian REAL-Time monitors due to a manufacturing issue that may compromise water resistance.

    Product
    Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combination with the Minilink transmitter and Sof-sensor glucose sensor for continuous monitoring of subcuta
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2317-2014·2014-08-20

    Nutrition Express Recalls Vitamins Due to Excess Folic Acid Content

    Nutrition Express is recalling specific vitamin products because the folic acid content was found to be higher than the amount stated on the label.

    Product
    Fitness Labs Fitness Multi 2, 90 capsules (UPC 654186946203) and 180 capsules (UPC 654186946227).
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2324-2014·2014-08-20

    Sargento Ricotta Cheese Recalled for Beta Lactam Residues

    Miceli Dairy Products Co is recalling Sargento Whole Milk Ricotta Natural Cheese due to beta lactam residues found in the whey protein concentrate used in manufacturing.

    Product
    Sargento Whole Milk Ricotta Natural Cheese packaged in 15 ounce plastic tubs.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·F-2328-2014·2014-08-20

    Cool Tropics Rips Slush Cherry Limeade Recalled for Spoilage Bacteria

    Manufacturing Solutions International is recalling specific batches of Cool Tropics Rips Slush Cherry Limeade because laboratory tests revealed spoilage bacteria and yeasts.

    Product
    Cool Tropics Rips Slush, Cherry LimeadeFlavored 100% Juice No artificial colors or flavors, Juice from Concentrate 4 fl oz, (118 mL),Manufactured in USA for Tropical Paradise, Inc., www.cool-tropics.com DO NOT MICROWAVE
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2185-2014·2014-08-20

    Codman Certas Valve Recalled to Clarify Pressure Specifications in Instructions

    Codman & Shurtleff is recalling 9,498 Codman Certas In Line Valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.

    Product
    Codman Certas - In Line Valve with Catheter and Accessories; Product Code: 82-8801 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Food)·F-2323-2014·2014-08-20

    Sargento Light Ricotta Cheese Recalled for Beta Lactam Residues

    Miceli Dairy Products Co is recalling Sargento Light Ricotta Natural Cheese because the whey protein concentrate used in manufacturing tested positive for beta lactam residues.

    Product
    Sargento Light Ricotta Natural Cheese packaged in 15 ounce plastic tubs.
    Category
    Food
    Distribution
    4 states

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