The Recall Desk

Archive

July 2014 recalls

688 recalls were announced in July 2014.

What the numbers show

Critical
18
Severe
140
High
292
Moderate
204
Low
34

Of the 688 recalls this month scored against our rubric, 3% are Critical, 20% are Severe.

501–600 of 688

  • ModerateFDA (Drugs)·D-1417-2014·2014-07-09

    MD Custom Rx Recalls Diphenhydramine Solution Due to Incorrect Solvent

    MD Custom Rx is recalling Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution because specific products were compounded with an incorrect solvent.

    Product
    Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1415-2014·2014-07-09

    Caraco Recalls Venlafaxine Hydrochloride Extended-Release Tablets for Dissolution Failures

    Caraco Pharmaceutical Laboratories is recalling specific lots of Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, because stability results showed the product did not meet drug dissolution specifications.

    Product
    Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highwa
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1414-2014·2014-07-09

    West-Ward Recalls Isoniazid Tablets Due to Dissolution Failure

    West-Ward Pharmaceutical Corp. is recalling Isoniazid Tablets, USP, 300 mg because stability lots failed to meet dissolution specifications.

    Product
    Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; c) 30-count bottles, NDC 61748-013-30, d) 100-count bottles, NDC 61748-013-
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1421-2014·2014-07-09

    MD Custom Rx Recalls HCG and Methylcobalamin Drops Due to Incorrect Solvent

    MD Custom Rx is recalling HCG and Methylcobalamin drops because they were compounded with an incorrect solvent. The product was distributed in Wisconsin.

    Product
    HCG (Human Chorionic Gonadotropin) + Methylcobalamin (Methyl B12), 1500 units + 1000 mcg/mL drop, 8 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1412-2014·2014-07-09

    Forest Pharmaceuticals Recalls Bystolic Tablets for Dissolution Failure

    Forest Pharmaceuticals is recalling Bystolic (nebivolol) 20 mg tablets because they failed stage III dissolution testing. The recall affects 92,544 bottles distributed nationwide.

    Product
    Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only. Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, Missouri 63045. NDC 0456-1420-07.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1420-2014·2014-07-09

    MD Custom Rx Recalls HCG Drops Due to Incorrect Solvent

    MD Custom Rx is recalling HCG drops compounded with an incorrect solvent. The recall covers specific lots distributed in Wisconsin.

    Product
    HCG (Human Chorionic Gonadotropin) 200 units/ 0.1 mL drops, packaged in 5 mL and 10 mL bottles, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI 53045
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1936-2014·2014-07-09

    Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues

    Zimmer, Inc. is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.

    Product
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 5. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1967-2014·2014-07-09

    Intuitive Surgical Recalls da Vinci Surgical System Instrument Release Kits

    Intuitive Surgical is recalling Instrument Release Kits for the da Vinci Surgical System to remove the Emergency Grip Release Wrench.

    Product
    Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1934-2014·2014-07-09

    Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues

    Zimmer, Inc. is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.

    Product
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1946-2014·2014-07-09

    Origio Pasteur Pipets Recalled Due to Packaging Sterility Breach

    Origio, Inc. is recalling Pasteur Pipets used in IVF laboratories because a breach in the nylon pouch sterile barrier was identified.

    Product
    Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5.75-90 PP-9-90 PP-5.75-90PL PP-9-90PL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1982-2014·2014-07-09

    Philips BrightView XCT Gamma Camera Recall for Flat Panel Display Defect

    Philips Medical Systems is recalling 407 BrightView XCT and BrightView X- gamma cameras because the Flat Panel Display may fail to remain securely locked in the deployed position.

    Product
    BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454. Gamma camera for Single Photon Emission Computed Tomography (SPECT) Medical Device for imaging.
    Category
    Medical Device
    Distribution
    32 states
  • ModerateFDA (Devices)·Z-1969-2014·2014-07-09

    Intuitive Surgical Recalls Vessel Sealer Addendum for da Vinci Systems

    Intuitive Surgical is recalling Vessel Sealer Addendum software for da Vinci surgical systems to update user manuals and remove the Emergency Grip Release Wrench.

    Product
    Vessel Sealer Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1937-2014·2014-07-09

    Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues

    Zimmer is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.

    Product
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 6. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2058-2014·2014-07-09

    Roselani Tropics Kona Mud Pie Ice Cream Recalled for Incorrect Contents

    Maui Soda & Ice Works is recalling 2,045 cartons of Roselani Tropics Kona Mud Pie Ice Cream because a complaint reported the cartons contained chocolate Macadamia Nut Ice Cream instead.

    Product
    Roselani Tropics Kona Mud Mud Pie Ice Cream: 1.75QT, - 56 oz. carton. Maui Soda & Ice Works, Ltd. Wailuku, HI
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1977-2014·2014-07-09

    BD FACS Canto Flow Cytometer Recalled for Non-Operational Cooling Fans

    BD Biosciences is recalling 35 BD FACS Canto flow cytometers and associated fluidics carts because the laser cooling fans and internal fans are not operational.

    Product
    BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2055-2014·2014-07-09

    Physique Enhancing Science Pre-Workout Recalled for Unapproved Ingredient

    Physique Enhancing Science is recalling ENHANCED Ultra Advanced Pre-Workout supplements because they contain Aegeline, an unapproved new dietary ingredient.

    Product
    Physique Enhancing Science ENHANCED, Ultra Advanced Pre-Workout, DIETARY SUPPLEMENT Net Wt. 5.22 oz (148 g). In BlueRazz and Fruit Punch flavors
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1932-2014·2014-07-09

    Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues

    Zimmer is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.

    Product
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 2. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1968-2014·2014-07-09

    Intuitive Surgical Recalls da Vinci Stapler Addendum Documentation

    Intuitive Surgical is recalling documentation for the da Vinci Surgical System stapler addendum to remove references to the Emergency Grip Release Wrench.

    Product
    Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1980-2014·2014-07-09

    Nidek AFC-330 Fundus Camera Recalled for Image Defects

    Nidek Inc. is recalling 185 AFC-330 Non-Mydriatic Auto Fundus Cameras because images may contain white spots that could affect diagnosis.

    Product
    Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1970-2014·2014-07-09

    Intuitive Surgical Recalls Vessel Sealer QRG for da Vinci Systems

    Intuitive Surgical is recalling Vessel Sealer QRGs for da Vinci systems to remove the Emergency Grip Release Wrench from documentation.

    Product
    Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1971-2014·2014-07-09

    Intuitive Surgical Recalls da Vinci Manuals Due to Wrench Removal

    Intuitive Surgical is recalling da Vinci Surgical System manuals to remove the Emergency Grip Release Wrench from the documentation.

    Product
    Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1984-2014·2014-07-09

    Synthes B37 Replacement Screws Recalled for Potential Mislabeling

    Synthes, Inc. is recalling 44 B37 Replacement Screws because the package may not contain the screws identified on the label.

    Product
    Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instrument for use with Low Bend Medial Distal Tibia Plate. Orthopedic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1976-2014·2014-07-09

    Integra LED Battery Charger Recalled for Premature Failure

    Integra LifeSciences is recalling 1,250 LED battery chargers because they may fail prematurely and not charge the LED battery as intended.

    Product
    Integra¿ LED Battery Charger, Single Bay. Product Number: 90523 The LED Headlight System Battery Charger (90523) is an accessory to the LED Headlight System: 90520US - LED Headlight w/Battery & AC/DC Power Supply - US 90520EU - LED Headlight w/Battery & AC/DC Power Supply
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1943-2014·2014-07-09

    Blue Belt Technologies Recalls Mislabeled Stride Femoral Knee Components

    Blue Belt Technologies is recalling two lots of Stride Femoral Knee Components due to packaging mislabeling that could lead to the implantation of the wrong side or size.

    Product
    Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1836-2014·2014-07-09

    Claymount Harmony2 Grid Cabinet Recalled for Labeling and Insulation Defects

    Claymount Assemblies BV is recalling 12 Harmony2 grid cabinets because they lack required labeling information and have non-compliant insulation values.

    Product
    The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1939-2014·2014-07-09

    Zimmer Recalls NexGen Knee Components Due to Thread Specification Issues

    Zimmer, Inc. is voluntarily recalling specific lots of NexGen Complete Knee Solution stemmed tibial components because the threads may be out of specification.

    Product
    NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 8. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1835-2014·2014-07-09

    Claymount Harmony Grid Cabinets Recalled for Missing Label Information

    Claymount Assembli is recalling Harmony grid cabinets because their labels lack the manufacturer address, date of manufacture, and required compliance statements.

    Product
    The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Devices)·Z-1949-2014·2014-07-09

    DeVilbiss DV5x Series CPAP Units Recalled for Missing Serial Numbers

    DeVilbiss Healthcare LLC is recalling 1,809 DV5x Series CPAP units because they were shipped without programmed serial numbers, displaying 'RUN-TEST' on the screen.

    Product
    DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V411000·2014-07-08

    J.C. Madigan Recalls Two Ford Dump Trucks for Fire Risk

    J.C. Madigan is recalling two specific Ford dump trucks because a leaking pressure switch may cause a fire near the exhaust system.

    Product
    FORD — FORD F-550, F-450 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V408000·2014-07-07

    Genuine Scooter Recalls 2014 Stella 125 Automatic for Engine Stalling Risk

    Genuine Scooters is recalling 2014 Stella 125 Automatic scooters because a faulty engine control unit may cause the engine to stall without warning, increasing crash risk.

    Product
    GENUINE SCOOTER — GENUINE SCOOTER STELLA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V412000·2014-07-07

    Volkswagen Recalls 2015 Golf and GTI for Steering Interference Risk

    Volkswagen is recalling 2015 Golf and GTI vehicles because loose stabilizer link fasteners may interfere with steering, increasing crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN GOLF, GTI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·045-2014·2014-07-04

    Kanani Foods Recalls Chicken Rice Bowls Due to HACCP Plan Deficiencies

    Kanani Foods II, Inc. is recalling approximately 59 pounds of chicken rice bowls because they were produced without a fully implemented Ready-to-Eat HACCP plan.

    Product
    Kanani Foods II, Inc. — Nevada Firm Recalls Chicken Products That Were Produced Without Fully Implementing a Ready-To-Eat HACCP Plan
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·043-2014·2014-07-03

    HEB Recalls Fresh Beef Products Due to Possible Metal Contamination

    HEB Meat Processing is recalling approximately 75,465 pounds of fresh beef products sold in Texas because they may contain metal shavings.

    Product
    HEB Meat Plant — Texas Firm Recalls Beef Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·14V400000·2014-07-03

    GM Recalls 5.8 Million Vehicles for Ignition Switch Airbag Risk

    General Motors is recalling 5,877,718 vehicles from 1997-2008 because the ignition switch may move out of the run position, preventing airbags from deploying in a crash.

    Product
    CHEVROLET — CHEVROLET, PONTIAC, OLDSMOBILE IMPALA, GRAND AM, GRAND PRIX, MALIBU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E036000·2014-07-03

    Brake Parts Inc. Recalls Rear Wheel Brake Shoes Due to Detachment Risk

    Brake Parts Inc. is recalling specific ACDelco, Carquest, Federated, and Raybestos rear wheel brake shoes because the lining may detach from the steel shoe, potentially reducing braking force or causing wheel lockup.

    Product
    SERVICE BRAKES, AIR:DRUM:SHOES/LININGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2048-2014·2014-07-02

    Suntree Recalls Shelled Walnuts Due to Listeria Contamination Risk

    Suntree LLC is recalling specific lots of California Grown Shelled Walnuts because they may be contaminated with Listeria monocytogenes.

    Product
    California Grown Shelled Walnuts, Net Weight 12 oz (340g), UPC 69887507806 46 cases, 24 count, 12 oz packages.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-2045-2014·2014-07-02

    Navitas Naturals Organic Sprouted Chia Powder Recalled Due to Salmonella

    Navitas Naturals is recalling Organic Sprouted Chia Powder because it is linked to a multistate outbreak of Salmonella Newport.

    Product
    Navitas Naturals Organic Sprouted Chia Powder, 8 oz (227g) package; Omega Fatty Acids, Protein, dietary Fiber. UPC 858847000369; Navitas Naturals, Novato, CA 94949
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2046-2014·2014-07-02

    Navitas Naturals Omega Blend Sprouted Smoothie Mix Recalled for Salmonella

    Navitas Naturals is recalling Omega Blend Sprouted Smoothie Mix because chia products were linked to a multistate Salmonella Newport outbreak.

    Product
    Navitas Naturals Omega Blend Sprouted Smoothie Mix, 8 oz. (227g) package; Dietary Fiber, Raw, Sprouted. UPC 858847000314; Also packaged for Williams Sonoma Omega Smoothie Mixer; SKU 506436 Navitas Naturals, Novato, CA
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2049-2014·2014-07-02

    Smith's Country Cheese Recalls Gouda Wheels Contaminated with Listeria monocytogenes

    Smith's Country Cheese, Inc. is recalling Gouda cheese wheels contaminated with Listeria monocytogenes. The affected products were distributed in Massachusetts.

    Product
    Gouda Cheese wheels, Whole Wheels 10 lbs and Half Wheels 5 lbs., packaged under the the brand names: Mountain Gouda and Smiths Farmstand
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-2047-2014·2014-07-02

    Navitas Naturals Omega 3 Smoothie Mixer Recalled Due to Salmonella Outbreak

    Navitas Naturals is recalling Omega 3 Smoothie Mixers because chia products were linked to a multistate Salmonella Newport outbreak.

    Product
    William & Sonoma Navitas Naturals brand Omega 3 Smoothie Mixer, 8 oz. (227g) package; Dietary Fiber, Raw, Sprouted.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2026-2014·2014-07-02

    GSF Shelled Walnuts Recalled Due to Listeria monocytogenes Contamination

    GSF Nut Company LLC is recalling 440 cases of shelled walnuts after an FDA sample tested positive for Listeria monocytogenes.

    Product
    GSF LLC Shelled Walnuts, Kernel Combo Halves & Pieces, 15% New Wt. 25 lbs. GSF LLC, Visalia, CA 93290
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-2050-2014·2014-07-02

    Green Smoothie Girl Recalls TriOmega Superfood Due to Salmonella Risk

    Green Smoothie Girl is recalling TriOmega Superfood products because they contain Organic Sprouted Chia Powder that may be contaminated with Salmonella.

    Product
    GreenSmoothieGirl TriOmega Superfood, GreenSmoothieGirl Sprouted Ground TriIOmega Superfood, Packaged in metalized resealable standup pouches in 1-pound units
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2044-2014·2014-07-02

    Oceans Cuisine Crab Stuffing Recalled for Listeria Contamination Risk

    Oceans Cuisine is recalling 3 lb. tubs of Crab Stuffing with Real Crabmeat due to potential Listeria monocytogenes contamination from raw crab meat.

    Product
    Oceans Cuisine brand CRAB STUFFING WITH REAL CRABMEAT, NET WEIGHT 3 LBS. (48 oz.) UPC 7 30692 00031 5, PRODUCT OF USA --- PACKED BY: OCEANS CUISINE LTD. FARMINGDALE, NY 11735 --- The product is packaged in plastic tub containers, 2 x 3 lb. containers per case
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1817-2014·2014-07-02

    FDA Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage

    Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 260 CM Length Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hyd
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1925-2014·2014-07-02

    Biomet Recalls Discovery Elbow Prosthesis Due to Surface Finish Defect

    Biomet, Inc. is recalling one unit of a Discovery Elbow prosthesis because the surface finish differs from specifications, potentially causing pain requiring surgery.

    Product
    DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow joint replacement prostheses are intended for primary and revision joint arthroplasty for use in cemented applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V404000·2014-07-02

    GM Recalls 2005-2007 SUVs for Power Window Fire Risk

    General Motors is recalling 2005-2007 Buick, SAAB, Isuzu, Chevrolet, and GMC SUVs because fluid in the power window switch may cause a fire.

    Product
    BUICK — BUICK, SAAB, ISUZU RAINIER, 9-7X, ASCENDER, TRAILBLAZER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V394000·2014-07-02

    GM Recalls Cadillac CTS and SRX for Ignition Switch Defect

    General Motors is recalling 554,328 Cadillac CTS and SRX vehicles because the ignition switch may move out of the run position, potentially preventing airbags from deploying.

    Product
    CADILLAC — CADILLAC CTS, SRX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1854-2014·2014-07-02

    NxStage Dialysate Sacks Recalled for Excess Aluminum Levels

    NxStage Medical is recalling dialysate sacks used with the PureFlow SL system because they contain aluminum levels exceeding internal specifications.

    Product
    NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-301 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 100, Glucose (mg/dL) 100 Batch Size (liters) 60 The SAK is one of the disposables used with NxStage PureFlow SL Dialy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1822-2014·2014-07-02

    Nitinol Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage

    Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because reports indicate the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and inter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1815-2014·2014-07-02

    Nitinol Devices Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage

    Nitinol Devices and Components, Inc. is recalling HydroFinity Hydrophilic Guidewires because the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 150 CM Length Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hyd
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1408-2014·2014-07-02

    Teva Recalls Dextroamphetamine Sulfate Tablets Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling 9,882 bottles of Dextroamphetamine Sulfate 10 mg tablets because stability testing revealed out-of-specification impurities.

    Product
    DEXTROAMPHETAMINE SULFATE — DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1407-2014·2014-07-02

    Caraco Recalls Gemcitabine Injection Due to Sterility Assurance Concerns

    Caraco Pharmaceutical Laboratories is recalling 200 vials of Gemcitabine For Injection USP due to a lack of assurance of sterility.

    Product
    Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd, Gujarat, India, NDC 47335-154-40
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·14V407000·2014-07-02

    GM Recalls 2007-2011 Silverado and Sierra Trucks for Fire Risk

    General Motors is recalling 2007-2011 Chevrolet Silverado and GMC Sierra HD trucks equipped with auxiliary batteries due to a risk of electrical fire.

    Product
    GMC — GMC, CHEVROLET SIERRA 3500, SIERRA 2500, SILVERADO 2500, SILVERADO 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V392000·2014-07-02

    Chrysler Recalls 2014-2015 Vehicles for Rear Shock Absorber Weld Defect

    Chrysler is recalling 2014 Jeep Cherokee, Ram 1500, and 2015 Chrysler 200 vehicles because an insufficient weld may cause rear shocks to detach, potentially damaging tires or reducing braking.

    Product
    CHRYSLER — CHRYSLER, RAM, JEEP 200, 1500, CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1812-2014·2014-07-02

    FDA Recalls HydroFinity Hydrophilic Guidewires Due to Polymer Jacket Damage

    Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 150 CM Length Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V398000·2014-07-02

    Fontaine Recalls 2015 Magnitude 100 Trailers Due to Weld Defects

    Fontaine is recalling 2015 Magnitude 100 lowbed trailers because inadequate welds may cause structural components to separate, increasing crash risk.

    Product
    FONTAINE — FONTAINE MAGNITUDE 100
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V393000·2014-07-02

    Ford and Lincoln Recall Vehicles for Halfshaft Retention Defect

    Ford is recalling 2012-2014 Edge, MKX, Taurus, MKS, Flex, and MKT vehicles because a halfshaft may disengage, causing loss of power or vehicle roll-away.

    Product
    LINCOLN — LINCOLN, FORD MKS, FLEX, EDGE, TAURUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V403000·2014-07-02

    Ford Recalls 2014 Escape Vehicles for Panorama Roof Glass Bonding Defect

    Ford is recalling 2014 Escape vehicles because the panorama roof glass may not be properly bonded, which could cause the glass to separate and increase the risk of a crash or injury.

    Product
    FORD — FORD ESCAPE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V401000·2014-07-02

    Ford Recalls F-59 Commercial Chassis Vehicles for Fire Risk

    Ford is recalling 2011-2014 F-59 commercial chassis vehicles because a short circuit in the electrical system may cause a fire.

    Product
    FORD — FORD F-59
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V405000·2014-07-02

    Ford Recalls 2014 F-53 and F-59 Chassis for Brake Caliper Defect

    Ford is recalling 2014 F-53 and F-59 chassis because incorrectly machined brake calipers may leak fluid, increasing stopping distances and crash risk.

    Product
    FORD — FORD F-59, F-53
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V397000·2014-07-02

    Autocar Recalls 2012-2015 Xpert Trucks Due to Bounce Hazard

    Autocar is recalling 287 model year 2012-2015 Xpert trucks because a gap between the cab and body may cause unexpected bouncing at speeds above 25 mph, increasing crash risk.

    Product
    AUTOCAR — AUTOCAR XPERT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V402000·2014-07-02

    Ford Recalls 2014 Fiesta Vehicles Due to Fuel Tank Leak Risk

    Ford is recalling certain 2014 Fiesta vehicles because a manufacturing error may cause the fuel tank to leak, increasing the risk of fire.

    Product
    FORD — FORD FIESTA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E034000·2014-07-02

    LiquidSpring Recalls Aftermarket Suspensions for Ford and Chevrolet Chassis

    LiquidSpring is recalling specific aftermarket suspension units for Ford and Chevrolet chassis because a mounting bracket may fail, allowing the fluid tank to separate and become a road hazard.

    Product
    SUSPENSION recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V409000·2014-07-02

    GM Recalls 2014 Vehicles for Steering Component Separation Risk

    General Motors is recalling 2014 Buick Regal, Cadillac XTS, Chevrolet Camaro, and Chevrolet Impala vehicles because improperly torqued fasteners may cause steering components to separate, increasing crash risk.

    Product
    CHEVROLET — CHEVROLET, BUICK, CADILLAC IMPALA, CAMARO, REGAL, XTS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1853-2014·2014-07-02

    Nidek RT-5100 and RT-3100 Refractors Recalled for Potential Injury

    Nidek Inc is recalling RT-5100 and RT-3100 refractors because the near point chart arm may lower spontaneously, posing a risk of patient injury.

    Product
    RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd., Aichi, Japan. Instrument provides means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subject's eyes for purpose of d
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1848-2014·2014-07-02

    SteriGear Recalls Urinary Drain Bags Due to Valve Malfunction

    SteriGear is recalling 110,560 urinary drain bags because the valve can close and create negative pressure, potentially blocking urine flow.

    Product
    SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-3259, SteriGear.com, Sterile, EO Urinary Drainage Collection Kit, for Indwelling Catheter. This device is intended to collect the U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1858-2014·2014-07-02

    NxStage Dialysate Sacks Recalled for Excess Aluminum Levels

    NxStage Medical is recalling dialysate sacks with concentrate due to aluminum levels exceeding internal product specifications.

    Product
    NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-305 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1 Chloride 100, Glucose (mg/dL) 100 Batch Size (liters) 40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1841-2014·2014-07-02

    SeaSpine Recalls UCR 3mm Hex Large Axial Driver Due to Tip Deformation

    SeaSpine Inc is recalling seven units of the UCR 3mm Hex, Large Axial Driver because the tip may twist or become rounded during use.

    Product
    Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying reduction heights provided with the Malibu", UCR, and NewPort" Systems. The Malibu", UCR, NewPort" Systems are intended to be used
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1828-2014·2014-07-02

    Beckman Coulter Recalls UniCel DxH 800 and DxH 600 Analysis Systems

    Beckman Coulter is recalling UniCel DxH 800 and DxH 600 systems because optical degradation may delay reporting of specific blood cell results.

    Product
    UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1829-2014·2014-07-02

    Beckman Coulter Recalls UniCel DxH 600 and DxH 800 Analysis Systems

    Beckman Coulter is recalling UniCel DxH 600 and DxH 800 systems because optical degradation may delay reporting of specific blood cell results.

    Product
    UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-2051-2014·2014-07-02

    Eillien's Dark Old Fashioned Sponge Candy Recalled for Undeclared Milk

    Eillien's Candies is recalling Dark Old Fashioned Sponge Candy because it contains undeclared milk, posing a risk to consumers with milk allergies.

    Product
    Dark Old Fashioned Sponge Candy, sold under the following brand and sizes: 1. Eillien's in Net Wt. 6 oz (170g) UPC 34952-12994, 10 oz. (284g) UPC 34952-56927, 12 oz. (340g) UPC 34952-57307. 2. Blain's Farm & Fleet Net Wt. 14oz. (397g), UPC 34952-81171 3. Mae's Corner Mark
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1820-2014·2014-07-02

    Nitinol HydroFinity Hydrophilic Guidewire Recalled for Outer Polymer Jacket Damage

    Nitinol Devices and Components, Inc. is recalling HydroFinity Hydrophilic guidewires due to reports of the outer polymer jacket being damaged during use.

    Product
    HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 260 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1823-2014·2014-07-02

    FDA Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage

    Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Straight Tip, 260 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA; Manufactured in Costa Rica The HydroFinity Hydr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2030-2014·2014-07-02

    Key Lime Dip Recalled for Undeclared Allergens in Compound Ingredients

    Miami Interculinary Center, Inc. is recalling 1,164 bottles of Floribbean Key Lime Calypso Dip because the label failed to declare allergens in compound ingredients.

    Product
    Floribbean Key Lime Calypso Dip 12.5 oz Floribbean 68 SW 40 St. Suite 411 Miami, Florida 33155 1(800)282-8459
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-1821-2014·2014-07-02

    Nitinol HydroFinity Hydrophilic Guidewire Recalled for Outer Polymer Jacket Damage

    Nitinol Devices and Components, Inc. is recalling HydroFinity Hydrophilic guidewires because the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Straight Tip, 150 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hyd
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2014·2014-07-02

    Nitinol HydroFinity Hydrophilic Guidewire Recalled for Polymer Jacket Damage

    Nitinol Devices and Components, Inc. is recalling HydroFinity Hydrophilic guidewires because the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1813-2014·2014-07-02

    Nitinol HydroFinity Hydrophilic Guidewire Recalled for Outer Polymer Jacket Damage

    Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because the outer polymer jacket may be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V417000·2014-07-02

    GM Recalls 2012-2014 Vehicles for Damaged Block Heater Cords

    General Motors is recalling specific 2012-2014 Buick and Chevrolet vehicles because insulation on the engine block heater cord can damage in cold weather, exposing wires.

    Product
    CHEVROLET — CHEVROLET, BUICK SONIC, VERANO, CRUZE, ENCORE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V456000·2014-07-02

    Sutphen Minitower Fire Truck Seat Belt Buckle Recall

    Sutphen is recalling one 2013 Minitower fire truck because seat belt buckles may fail to release, potentially hindering emergency egress.

    Product
    SUTPHEN — SUTPHEN MINITOWER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1409-2014·2014-07-02

    Pfizer Recalls Pristiq 50 mg Tablets Due to Foreign 100 mg Tablet

    Pfizer is recalling Pristiq 50 mg extended-release tablets because a 100 mg tablet was found in a bottle labeled for 50 mg.

    Product
    PRISTIQ — PRISTIQ (DESVENLAFAXINE SUCCINATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2014·2014-07-02

    Zynex IF 8000 Interferential Electrical Stimulation Device Recalled for Overheating

    Zynex Medical is recalling 1,461 IF 8000 devices because a malfunction can cause them to stop working or overheat, posing a burn risk.

    Product
    IF 8000; 1/F Interferential Electrical Stimulation Device; NMES (neuromuscular electrical stimulation) mode. Designed for use in physical therapy, rehabilitation, and pain relief applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1873-2014·2014-07-02

    JAS Diagnostics Recalls Glucose Hexokinase Reagent Lots for Performance Issues

    JAS Diagnostics Inc. is recalling specific lots of Glucose Hexokinase Liquid Reagent because they do not perform according to specifications.

    Product
    Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-1850-2014·2014-07-02

    Steris Surgical Lighting Monitor Spring Arms Recalled for Welding Defect

    Steris Corporation is recalling 68 vertical spring arms for surgical lighting systems because the welded seam may crack or break.

    Product
    Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. Model numbers YG19051 and YG19262.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1857-2014·2014-07-02

    NxStage Dialysate Sacks Recalled for Excess Aluminum Levels

    NxStage Medical is recalling dialysate sacks with concentrate due to aluminum levels exceeding internal product specifications.

    Product
    NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-304 Lactate 45, Potassium 2, Sodium 140, Calcium 3,Magnesium 1, Chloride 101, Glucose (mg/dL) 100 Batch Size (liters) 60 The SAK is one of the disposables used with NxStage PureFlow SL Dialys
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1818-2014·2014-07-02

    Nitinol Recalls HydroFinity Hydrophilic Guidewires Due to Jacket Damage

    Nitinol Devices and Components is recalling HydroFinity Hydrophilic Guidewires because reports indicate the outer polymer jacket can be damaged during use.

    Product
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 150 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA Manufactured in Costa Rica The HydroFinity Hydrophi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1859-2014·2014-07-02

    NxStage Dialysate Sacks Recalled for Excess Aluminum Levels

    NxStage Medical is recalling 2,711 cases of dialysate sacks because aluminum levels exceeded internal specifications.

    Product
    NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-306 Lactate 45, Potassium 2, Sodium 140, Calcium 3, Magnesium 1, Chloride 101, Glucose (mg/dL) 100 Batch Size (liters) 50 The SAK is one of the disposables used with NxStage PureFlow SL Dialy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2014·2014-07-02

    Intuitive Surgical Recalls Da Vinci Xi Endoscope Accessories Due to Visual Tint

    Intuitive Surgical is recalling 20 units of the IS4000 da Vinci Xi 30 Degree, 8mm Endoscope because an orange-yellow tint in the surgical view can make it difficult to differentiate between tissue.

    Product
    IS4000 da Vinci Xi - Endoscope accessory; 30 Degree, 8mm Endoscope. Intuitive Surgical Inc.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1849-2014·2014-07-02

    Western VIPR Pressure Regulators Recalled for Cylinder Separation Risk

    Western / Scott Fetzer Company is recalling Model RG3000 and RG4000 Series Valve Integrated Pressure Regulators (VIPR) because they may separate from aluminum cylinders.

    Product
    Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1872-2014·2014-07-02

    Stryker Shaver Handpiece Sterilization Tray Recalled for Validation Deficiencies

    Stryker Endoscopy is recalling 1,992 Shaver Handpiece Sterilization Trays because the provided STERRAD 100S sterilization parameters did not fully consider all worst-case scenarios during validation testing.

    Product
    Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1844-2014·2014-07-02

    Puritan Bennett 840 Ventilator Recall for Display Loss

    Nellcor Puritan Bennett is recalling 104 Puritan Bennett 840 Ventilators due to reports of loss of graphical user interface display information while the device continues to provide breath support.

    Product
    Puritan Bennett 840 Ventilator (4-840120DIUU-XX) The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1867-2014·2014-07-02

    Siemens StreamLAB Analytical Workcell Recalled for Trip and Fall Hazard

    Siemens is recalling 317 StreamLAB Analytical Workcells because protruding pins on the Input/Output Module have contributed to trip and fall incidents.

    Product
    Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and processing in the clinical laboratory.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1927-2014·2014-07-02

    Siemens Healthcare Recalls ADVIA Acid/Base Reagent Kits Due to Metal Contamination

    Siemens Healthcare is recalling ADVIA Acid/Base Reagent 1 and 2 Kits because trace metal contamination caused the acid bottles to swell.

    Product
    Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Number: 112219 SMN: 10310026 Intended Use: In vitro diagnostic use. Acid Regent is a component of the ADVIA Centaur and ADVIA Centaur XP instr
    Category
    Medical Device
    Distribution
    Distributed nationwide

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