The Recall Desk

Archive

October 2014 recalls

501 recalls were announced in October 2014.

What the numbers show

Critical
33
Severe
108
High
200
Moderate
147
Low
13

Of the 501 recalls this month scored against our rubric, 7% are Critical, 22% are Severe.

Which agencies issued them

101–200 of 501

  • ModerateFDA (Devices)·Z-0100-2015·2014-10-29

    Gyrus Medical Recalls Sterile Surgical Forceps and Scissors Due to Seal Defects

    Gyrus Medical is recalling specific sterile surgical forceps and scissors because a packaging anomaly may compromise the sterile barrier.

    Product
    GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm REF 3844- Everest BiCOAG LP Scissors 5mm/45cm REF 910010PK- PKS MOLly Forceps 5m
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-0101-2015·2014-10-29

    Estill Medical Recalls Ultra Battery 1 for Insufficient Charging Capacity

    Estill Medical Technologies is recalling 6,886 Ultra Battery 1 units because they may not reach full charge capacity within the standard 60-minute charging period.

    Product
    Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (TA-UB1) is a rechargeable power source for the Thermal Angel Blood and IV Fluid Infusion Warmer. The TA-UB1 battery was designed to provide sufficient power for the Thermal Angel to warm and deliver one
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0041-2015·2014-10-29

    ZEE Aspirin Recalled for Incorrect Inactive Ingredient Labeling

    ZEE Medical is recalling ZEE Aspirin 325mg tablets because the product label incorrectly lists inactive ingredients.

    Product
    ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC, Manufactured for ZEE Medical Inc., Irvine,CA 92606 by ULTRA Tab Laboratories, Inc. Highland, NY 12528
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D0032-2015·2014-10-29

    New GPC Inc. Recalls Ferrol Expectorant for Labeling Deficiencies

    New GPC Inc. is recalling Ferrol Expectorant because the product lacks required OTC drug listings and labeling, and is labeled as not approved for sale in the U.S.

    Product
    Ferrol EXPECTORANT, Net Contents: 100 mL. Product packaged within a plastic bottle individually placed in small blue carton. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0052-2015·2014-10-29

    Logan's Roadhouse Meatloaf Mix Recalled for Egg Spoilage Risk

    Processed Foods, Inc. is recalling 380 units of Logan's Roadhouse Meatloaf Mix because the eggs used in the product are susceptible to premature spoilage.

    Product
    Logan's Roadhouse Meatloaf Mix #25018, Keep Frozen, Net Weight: 40 Lbs. (20 - 2 Lb. Bags), FOR INSTITUTIONAL USE ONLY, Custom Foods of America, Knoxville, TN 37921
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-0028-2015·2014-10-29

    Bio-Pharm Recalls Acetaminophen Oral Suspension Due to Assay Failure

    Bio-Pharm, Inc. is recalling one lot of Acetaminophen Oral Suspension Liquid 160mg/5mL because the product failed the assay at the 6-month timepoint.

    Product
    Rugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/5 mL, Cherry Flavor, 2 FL. oz bottle, OTC, Distributed by: Rugby Laboratories Livonia, MI 48150, NDC 0536-3606-96 Major Children's Mapap Suspension Liquid, Cherry Flavor, 4 FL OZ bottle, OTC, Distributed
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D0033-2015·2014-10-29

    New GPC Inc. Recalls Whitfield Lotion for Labeling Deficiencies

    New GPC Inc. is recalling 360 units of Whitfield Lotion in New York because the product lacks required OTC drug listing and labeling.

    Product
    WHITFIELD LOTION, Net Contents: 60 mL. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0111-2015·2014-10-29

    Signal Medical Recalls Total Knee Femoral Components Due to Packaging Compromise

    Signal Medical Corporation is recalling 41 Symmetric Total Knee Femoral Components because their packaging was compromised. The components were distributed in Missouri and Panama.

    Product
    Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0079-2015·2014-10-29

    Wild'erb Herbal Tea Recalled for Potential Illegal Sassafras Ingredient

    Ohio Valley Herbal Products is recalling Wild'erb Herbal Tea because it may contain sassafras leaves, an ingredient deemed illegal by the Ohio Department of Agriculture.

    Product
    Wild'erb Herbal Tea 1.2 oz. and 4 oz. paper bags, tea contained less than 5% sassafras leaves.
    Category
    Food
    Distribution
    6 states
  • LowFDA (Drugs)·D-0043-2015·2014-10-29

    American Health Packaging Recalls Subpotent Methylprednisolone Tablets

    American Health Packaging is recalling 2,005 cartons of Methylprednisolone 4 mg tablets because they failed to meet potency standards at a 6-month stability time point.

    Product
    METHYLPREDNISOLONE — METHYLPREDNISOLONE (METHYLPREDNISOLONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·14E070000·2014-10-28

    Meritor Wabco Recalls Quick Release Valves Due to Air Pressure Loss

    Meritor Wabco is recalling specific Quick Release Valves where damaged rubber diaphragms may reduce air pressure, potentially compromising braking performance.

    Product
    SERVICE BRAKES, AIR recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V674000·2014-10-27

    BMW Recalls 2014 i8 Vehicles for Potential Fuel Tank Weld Defect

    BMW is recalling 223 model year 2014 i8 vehicles because a ground cable bolt may not be properly welded to the fuel tank, creating a risk of fuel leaks and fire.

    Product
    BMW — BMW I8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V672000·2014-10-27

    Honda Recalls 2014 Grom125 and NSS300 Motorcycles for Fuel Pump Defect

    Honda is recalling 2014 Grom125 and NSS300 motorcycles because a fuel pump bracket may swell and seize, causing the bike to stall and increasing crash risk.

    Product
    HONDA — HONDA GROM125, NSS300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·074-2014·2014-10-25

    Murry's Recalls Gluten-Free Chicken Products Due to Staphylococcal Enterotoxin

    Murry's Inc. is recalling approximately 31,689 pounds of gluten-free breaded chicken products due to potential Staphylococcal enterotoxin contamination.

    Product
    Pennsylvania Firm Recalls Chicken Products Due to Staphylococcal Enterotoxin Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V668000·2014-10-24

    Nissan Recalls Infiniti QX56 and QX80 for Air Bag Defect

    Nissan is recalling 2013 Infiniti QX56 and 2014 QX80 vehicles because the driver's air bag inflator may contain an incorrect part that could rupture during deployment.

    Product
    INFINITI — INFINITI QX80, QX56
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V667000·2014-10-24

    Audi Recalls 2013-2015 Models Due to Air Bag Deployment Software Defect

    Volkswagen Group of America is recalling 2013-2015 Audi A4, S4, and Allroad vehicles because a software error may prevent front air bags from deploying in a secondary impact.

    Product
    AUDI — AUDI S4, ALLROAD, A4 ALLROAD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·073-2014·2014-10-24

    Aspen Foods Recalls Chicken Kiev Due to Salmonella Enteritidis Contamination

    Aspen Foods is recalling 28,980 pounds of chicken products sold in Minnesota due to a link with a Salmonella Enteritidis illness cluster.

    Product
    Illinois Firm Recalls Chicken Products Due to Possible Salmonella Enteritidis Contamination
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·14V670000·2014-10-24

    Volkswagen Recalls 2015 Jetta and Passat for Seatback Recliner Defect

    Volkswagen is recalling 2015 Jetta and Passat vehicles because a seatback recliner bracket may not engage correctly, causing unexpected movement that could distract the driver.

    Product
    VOLKSWAGEN — VOLKSWAGEN PASSAT, JETTA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·072-2014·2014-10-24

    Taylor Farms Recalls Broccoli Kale Salad with Chicken Due to Undeclared Walnuts

    Taylor Farms is recalling approximately 377 pounds of Signature Café Broccoli Kale Salad with Chicken because the product contains undeclared walnuts, a tree nut allergen.

    Product
    Taylor Farms New Jersey, Inc. — New Jersey Firm Recalls Salad with Chicken Due To Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    6 states
  • HighNHTSA·14V669000·2014-10-24

    Daimler Recalls 2015 Thomas Built Buses Saf-T-Liner HDX School Buses

    Daimler Trucks North America is recalling 2015 Thomas Built Buses Saf-T-Liner HDX school buses because a fuel filter defect may cause the engine to stall without warning, increasing crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0046-2015·2014-10-22

    Kendall Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs

    FDA recalls 133,930 pairs of Kendall defibrillation electrodes because they are not compatible with specific Philips AED models.

    Product
    Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number: 40000006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0021-2015·2014-10-22

    Taylor Farms Recalls Signature Cafe Sicilian Vegetable Salad Kits

    Taylor Farms Pacific Inc. is recalling Signature Cafe SWY Sicilian Vegetable Salad kits due to potential Salmonella contamination in the included Roma tomatoes.

    Product
    Signature Cafe SWY Sicilian Vegetable Salad 2CT Kit Pack Size: 2-6.75 lb bags S3197 Perishable Keep Refrigerated Distributed by Lucerne Foods Inc. PO Box 99 Pleasanton, CA 94566-0009 1-877-232-4271 Product is distributed to be assembled and sold at deli counters whe
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0020-2015·2014-10-22

    Taylor Farms Roma Tomatoes Recalled for Salmonella Contamination

    Taylor Farms Pacific Inc. is recalling specific lots of Roma tomatoes due to potential Salmonella contamination. The affected product was distributed in California, Arizona, Nevada, and Washington.

    Product
    CST Roma Tomatoes Whole Roma 1/25# Origin: USA Keep Refrigerated UPC: 40000356942 Taylor Farms, Pacific, Tracy, CA 95376
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0029-2015·2014-10-22

    Great American Marketing Recalls Turkey and Swiss Sandwiches for Listeria Risk

    Great American Marketing Company is recalling 264 Turkey & Swiss Sandwiches due to potential Listeria monocytogenes contamination. The product was distributed to one company in Schertz, TX.

    Product
    Turkey & Swiss Sandwiches, 10.5 oz . The sandwiches are wrapped in plastic and then placed in a clear plastic clamshell.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0025-2015·2014-10-22

    Fresh Finds Ground Black Pepper Recalled for Salmonella Risk

    Gel Spice Co. is recalling Fresh Finds ground black pepper due to potential Salmonella contamination. Consumers should stop using the product.

    Product
    Fresh Finds ground black pepper Net Wt. 3.53 oz (100g) Distributed by: Big Lots Stores, Inc. P.O. Box 28523 Columbus, OH 43228-0523 Packed in the USA UPC 411010982901 packaged in plastic jars; 12 jars per case
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0043-2015·2014-10-22

    Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs

    FDA recalls 317,550 pairs of defibrillation electrodes because they are not compatible with Philips FR3 or FRx AEDs.

    Product
    Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0081-2015·2014-10-22

    Siemens Clinitek Status+ Power Supply Adapters Recalled for Electric Shock Risk

    Siemens Healthcare Diagnostics is recalling approximately 4,200 external power supply adapters for the Clinitek Status+ urine analyzer due to damage that can cause electric shock.

    Product
    External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a urine analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0038-2015·2014-10-22

    Bumble Bee Recalls Chipotle Albacore Tuna Pouches Due to Seal Defects

    Bumble Bee Foods is recalling specific codes of Chipotle Albacore Tuna pouches because seal defects could allow contamination by spoilage organisms or pathogens.

    Product
    Bumble Bee Chipotle Albacore Tuna with Chipotle & Olive Oil, Net Wt. 2.5oz, UPC 5763800429.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0031-2015·2014-10-22

    Bumble Bee Recalls Pouched Albacore Tuna Due to Seal Defects

    Bumble Bee Foods is recalling specific codes of pouched Albacore tuna because seal defects could allow contamination by spoilage organisms or pathogens.

    Product
    Bumble Bee Premium Albacore Tuna in Water, Net Wt. 2.5oz, UPC 8660024011, 8660024031, 5763800424. Bumble Bee Premium Albacore Tuna In Water, Net Wt. 5oz, UPC 8660024016; UPC 8660024051, 5763800425.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0020-2015·2014-10-22

    Hospira Recalls Lidocaine Hydrochloride Vials Due to Particulate Matter

    Hospira is recalling 109,110 vials of Lidocaine Hydrochloride Injection because the product was discolored and contained visible particulates.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0024-2015·2014-10-22

    Tullia's Italian Meatless Pasta Sauce Recalled for Botulism Risk

    Tullia's is recalling Italian Meatless Pasta Sauce because production records showed a pH level that could allow the growth of Clostridium botulinum.

    Product
    Tullia's Italian Meatless Pasta Sauce, packaged in a 16 oz. (436g) and 32 oz. (872g) glass jars with one-piece metal closures. The 32 oz. (872g) glass jar has the UPC 7 48863 64322 3. The 16 oz (436g) glass jar has the UPC 7 48863 64321 6.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0030-2015·2014-10-22

    Anova Recalls Wild Caught Seared Ahi Tuna for Listeria Risk

    Anova Food, LLC is recalling 6,475 cases of Wild Caught Seared Ahi Tuna due to possible contamination with Listeria monocytogenes.

    Product
    Wild Caught Seared Ahi Tuna Seasoned with Cracked Black Pepper and Garlic, manufactured by Lagniappe Louisiana Foods, Inc.-Instructions say to keep frozen.
    Category
    Food
    Distribution
    6 states
  • SevereNHTSA·14V665000·2014-10-22

    Neely Coble Recalls 2012-2014 Isuzu NQR Dual Steer Vehicles

    Neely Coble is recalling 52 Isuzu NQR vehicles with dual steering modifications due to a potential steering column separation risk.

    Product
    NEELY COBLE — NEELY COBLE ISUZU NQR W/DUAL STEER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0074-2015·2014-10-22

    Intuitive Surgical Recalls EndoWrist Stapler 45 Instruments

    Intuitive Surgical is recalling 1,034 EndoWrist Stapler 45 instruments because they may not be removable from tissue.

    Product
    EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V666000·2014-10-22

    Elgin Broom Badger Sweeper Trucks Recalled for Fire Risk

    Elgin is recalling 2012-2014 Broom Badger sweeper trucks because a hydraulic oil cooler fan may fail, causing overheating and potential vehicle fire.

    Product
    ELGIN — ELGIN BROOM BADGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0026-2015·2014-10-22

    Su Cocina Plain Bread Crumbs Recalled for Undeclared Allergens

    Dominguez Foods of Washington is recalling Su Cocina Plain Bread Crumbs due to undeclared wheat, milk, and soy.

    Product
    Su Cocina brand Pan Molido (Plain Bread Crumbs). Product is packaged in 8 oz. bags. The UPC is 6 79790 05912 5. The Label is read in parts: "***SU COCINA***Plain Bread Crumbs***INGREDIENTS: Bread Crumbs*** DOMINGUEZ FOODS OF WASHINGTON*** P.O. Box 506, Zillah, Washington 98
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0083-2015·2014-10-22

    Siemens Clinitek Status Power Supply Adaptors Recalled for Electric Shock Risk

    Siemens Healthcare Diagnostics is recalling external power supply adaptors for the Clinitek Status urine analyzer because they are damaged and can cause electric shock.

    Product
    External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The Clinitek Status system is a urine analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0075-2015·2014-10-22

    Biomet Recalls Discovery Elbow Humeral Trial Due to Incorrect Etching

    Biomet is recalling six Discovery Elbow Humeral Trials that were incorrectly manufactured as left-sided but etched as right-sided.

    Product
    Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow joint replacement prostheses intended for primary and revision joint arthoplasty for use in cemented applications. Elbow joint replacement components include humeral and ulnar components, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0079-2015·2014-10-22

    ArjoHuntleigh Recalls Spreader Bars for Ceiling Lifts Due to Hook Flexibility

    Arjo, Inc. is recalling 363 spreader bars for the Maxi Sky 2 Ceiling Lift because the hooks are too flexible to securely hold sling loops.

    Product
    Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and large on the Maxi Sky 2 Ceiling Lift; Model 700-19425. Intended to be used for general transfers in hospitals.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Food)·F-0033-2015·2014-10-22

    Bumble Bee Albacore Tuna Recalled for Pouch Seal Defects

    Bumble Bee Foods is recalling specific codes of pouched Albacore tuna due to seal defects that could allow contamination by spoilage organisms or pathogens.

    Product
    Bumble Bee Prime Fillet Albacore Tuna with Sundried Tomatoes and Olive Oil, Net Wt. 2.5oz, UPC 8660024013
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0037-2015·2014-10-22

    Bumble Bee Jalapeno Albacore Tuna Recalled for Pouch Seal Defects

    Bumble Bee Foods is recalling Jalapeno Albacore Tuna pouches due to seal defects that could allow contamination by pathogens.

    Product
    Bumble Bee Jalapeno Albacore Tuna with Jalapeno & Olive Oil, Net Wt. 2.5oz, UPC 5763800428
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0066-2015·2014-10-22

    Arrow Select Kits Recalled Due to Potential Sterility Compromise

    Arrow International is recalling Select Kits and Maximal Barrier Precautions Kits containing BD Posiflush syringes because open seals may compromise sterility.

    Product
    Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0069-2015·2014-10-22

    Invivo Recalls Philips Expression MR200 MRI Patient Monitoring Systems

    Invivo Corporation is recalling 24 Philips Expression MR200 MRI Patient Monitoring Systems because they may fail to produce Non-Invasive Blood Pressure (NIBP) measurements.

    Product
    Philips Expression MR200 MRI Patient Monitoring System
    Category
    Medical Device
    Distribution
    6 states
  • HighNHTSA·14V664000·2014-10-22

    Spartan Gladiator Recall: Engine Cooling Fan May Break and Separate

    Spartan Motors is recalling 2010-2015 Gladiator vehicles because the engine cooling fan may break during severe vibration, posing an injury risk if the hood is open.

    Product
    SPARTAN — SPARTAN GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0036-2015·2014-10-22

    Bumble Bee Recalls Pouched Albacore Tuna Due to Seal Defects

    Bumble Bee Foods is recalling specific codes of pouched Albacore tuna because seal defects could allow contamination by spoilage organisms or pathogens.

    Product
    Bumble Bee Premium Lightmeat Tuna in Water, Net Wt. 2.5oz, UPC 5763800426. Bumble Bee Premium Lightmeat Tuna in Water, Net Wt. 5oz, UPC 5763800427.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0028-2015·2014-10-22

    Great American Marketing Recalls Ham and Cheddar Sandwiches for Listeria Risk

    Great American Marketing Company is recalling 288 units of Ham & Cheddar Sandwiches due to potential Listeria monocytogenes contamination.

    Product
    Ham & Cheddar Sandwiches, 10.5 oz . The sandwiches are wrapped in plastic and then placed in a clear plastic clamshell.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0032-2015·2014-10-22

    Bumble Bee Recalls Pouched Albacore Tuna Due to Seal Defects

    Bumble Bee Foods is recalling specific codes of pouched Albacore tuna because seal defects could allow contamination by spoilage organisms or pathogens.

    Product
    Bumble Bee Prime Fillet Albacore Tuna with Jalapenos and Olive Oil, Net Wt. 2.5 oz, UPC 8660024012
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0039-2015·2014-10-22

    Bumble Bee Recalls Sun Dried Tomato Pouches Due to Seal Defects

    Bumble Bee Foods is recalling Sun Dried Tomato pouches because seal defects could allow contamination by spoilage organisms or pathogens.

    Product
    Bumble Bee Sun Dried Tomato with Sun Dried Tomatoes & Olive Oil, Net Wt. 2.5oz, UPC 5763800430.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·14V663000·2014-10-22

    Toyota Recalls 2015 Tacoma Vehicles for Incorrect Load Capacity Label

    Gulf States Toyota is recalling 142 model year 2015 Toyota Tacoma vehicles because they may have incorrect load carrying capacity labels, which could lead to vehicle overload.

    Product
    TOYOTA — TOYOTA TACOMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0035-2015·2014-10-22

    Bumble Bee Recalls Pouched Albacore Tuna Due to Seal Defects

    Bumble Bee Foods is recalling specific codes of pouched Albacore tuna because seal defects could allow contamination by spoilage organisms or pathogens.

    Product
    Bumble Bee Prime Fillet Omega-3 Albacore Tuna with Omega 3 Tuna Oil, Net Wt. 2.5oz, UPC 8660024191
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0048-2015·2014-10-22

    Philips HEARTSTART Electrode Pads Recalled for Incompatibility with AEDs

    Covidien is recalling Philips HEARTSTART Multifunction Electrode Pads because they are not compatible with Philips FR3 or FRx AEDs.

    Product
    Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0067-2015·2014-10-22

    Primus Medical Recalls AC Powered Adjustable Bed Frames

    Primus Medical LLC is recalling 1,726 AC powered adjustable bed frames used in nursing facilities because the head deck actuator bracket may separate from the frame.

    Product
    AC Powered adjustable bed frame. AC powered adjustable bed frame used in nursing facilities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0082-2015·2014-10-22

    Siemens Clinitek Status Power Supply Adaptors Recalled for Shock Risk

    Siemens Healthcare Diagnostics is recalling external power supply adaptors for the Clinitek Status urine analyzer due to damage that can cause electric shock.

    Product
    External power supply adaptors that accompany Clinitek Status Connect System The Clinitek Status system is a urine analyzer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0034-2015·2014-10-22

    Bumble Bee Recalls Pouched Albacore Tuna Due to Seal Defects

    Bumble Bee Foods is recalling specific codes of pouched Albacore tuna because seal defects could allow contamination by spoilage organisms or pathogens.

    Product
    Bumble Bee Prime Fillet Albacore Tuna with Chipotle and Olive Oil, Net Wt. 2.5oz, UPC 8660024014
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0068-2015·2014-10-22

    Merge Healthcare Recalls eFilm Workstation Software Due to Image Selection Error

    Merge Healthcare is recalling eFilm Workstation versions 4.0 and 4.0.1 because a software defect may cause users to select the wrong patient study when using the thumbnail panel.

    Product
    eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation receives digital image
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0078-2015·2014-10-22

    Ortho VITROS 5600 Integrated System Recalled for Calibration Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a software anomaly that may cause unexpected assay calibration when using specific calibrator kits.

    Product
    VITROS 5600 Integrated System, System Product Code 6802413. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0065-2015·2014-10-22

    Stryker T2 Tibia Nail Insertion Sleeve Recall Due to Diameter Mismatch

    Stryker is recalling T2 Tibia Nail Insertion Sleeves because some units have a different inner diameter than labeled.

    Product
    Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0023-2015·2014-10-22

    Gyma Recalls Clonidine Base Micronized Due to Manufacturing Deviations

    Gyma Laboratories of America, Inc. is recalling Clonidine Base Micronized due to lack of good manufacturing practices identified by the Italian Medicines Agency.

    Product
    Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 12660-0503-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0070-2015·2014-10-22

    KCI Recalls V.A.C. GranuFoam Silver Dressing Due to Expiry Date Error

    KCI USA, Inc. is recalling V.A.C. GranuFoam Silver Dressing because some sterile pouches display an incorrect expiry date.

    Product
    V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M8275099/10 STERILE Single Use only Latex Free Rx Only.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0026-2015·2014-10-22

    Valeant Recalls Subpotent Locoid Hydrocortisone Butyrate Cream Tubes

    Valeant Pharmaceuticals is recalling 1,663 tubes of Locoid cream because the active ingredient and preservatives were subpotent at the 18-month stability test point.

    Product
    Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, Manufactured for: Onset Dermatologics, LLC, Cumberland, RI 02864 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 16781-382-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0022-2015·2014-10-22

    Kraft Recalls American Cheese Slices Due to Ingredient Storage Issue

    Kraft Heinz Foods is voluntarily recalling 7,691 cases of American cheese slices because a supplier failed to store an ingredient at the correct temperature.

    Product
    Individually 2/3 oz. slices of American cheese product individually wrapped in transparent plastic an packaged in 12 oz. and 16 oz.. packages, and 4 lb. cartons under the Kraft brand name. Cases of 12 oz. packages include 48 packages per case. Cases of 16 oz. packages inc
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0064-2015·2014-10-22

    Roche Omni Micro-electrode Recall for Inconsistent Reference Values

    Roche Diagnostics is recalling Omni Micro-electrodes for the cobas b221 analyzer because default reference values are inconsistent with other instruments and instructions.

    Product
    Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lact
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0073-2015·2014-10-22

    Ameditech Recalls ArcPoint Labs 10 Panel Dip Screen Due to Labeling Error

    Ameditech is recalling 320 kits of the ArcPoint Labs 10 Panel Dip Screen (OXY) because the positive interpretation illustration on the cap labels and package insert was incorrect.

    Product
    ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0077-2015·2014-10-22

    Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry Systems Due to Software Anomaly

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems because a software anomaly may cause unexpected assay calibration when using specific calibrator barcode labels.

    Product
    VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Sli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0063-2015·2014-10-22

    Intuitive Surgical Recalls EndoWrist One Vessel Sealer for Labeling and Software Issues

    Intuitive Surgical is voluntarily correcting labeling and software for the EndoWrist One Vessel Sealer used with the da Vinci Si Surgical System.

    Product
    EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0080-2015·2014-10-22

    Baxter 15 L Cycler Drainage Bag Recalled for Potential Drain Tube Leakage

    Baxter Healthcare is recalling 15 L Cycler Drainage Bags because the tube clamp may not fully close, potentially causing leakage.

    Product
    15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0021-2015·2014-10-22

    Gyma Recalls Dipyridamole API Due to Manufacturing Deviations

    Gyma Laboratories of America, Inc. is recalling Dipyridamole API due to lack of good manufacturing practices identified by the Italian Medicines Agency.

    Product
    Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0084
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0016-2014·2014-10-22

    Avella Recalls Hydroxyprogesterone Caproate Injectable Due to Crystallization

    Avella of Deer Valley, Inc. is recalling 197 vials of Hydroxyprogesterone Caproate 250 mg/mL injectable because crystals were observed in the product.

    Product
    HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoenix, AZ 85085.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0023-2015·2014-10-22

    Michael Foods Recalls Shell Eggs Contaminated with Pseudomonas fluorescens

    Michael Foods, Inc. is recalling 40,966 cases of shell eggs under six different brand labels due to contamination with Pseudomonas fluorescens.

    Product
    Shell Eggs packaged under the following labels: (1) Abbotsford Farms Cage Free Pasteurized Shell Eggs, Grade A Large Brown Eggs, packaged as 15 dozen per 1 case. Distributed by Abbotsford Farms, Gaylord, MN 55334. UPC Code 1 00 14616 64010 7. (2) AbbotsFord Farms Cage Fre
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0022-2015·2014-10-22

    Gyma Laboratories Recalls Propranolol HCl Due to Manufacturing Deviations

    Gyma Laboratories of America, Inc. is recalling Propranolol HCl due to lack of good manufacturing practices identified by the Italian Medicines Agency.

    Product
    Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0004
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0025-2015·2014-10-22

    Valeant Recalls Subpotent Hydrocortisone Butyrate Cream 0.1% Tubes

    Valeant Pharmaceuticals is recalling 34,218 tubes of Hydrocortisone Butyrate Cream 0.1% because the product failed stability testing for potency and preservative levels.

    Product
    Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 43478-270-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0072-2015·2014-10-22

    Ameditech Recalls ArcPoint Labs 10 Panel Dip Screen Due to Labeling Error

    Ameditech is recalling 80 kits of ArcPoint Labs 10 Panel Dip Screen because the positive interpretation illustration on the cap labels and package insert was incorrect.

    Product
    ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0071-2015·2014-10-22

    Ameditech Recalls ArcPoint Labs 5 Panel Dip Drug Screen Due to Labeling Error

    Ameditech is recalling 400 kits of the ArcPoint Labs 5 Panel Dip Drug Screen because the positive interpretation illustration on the labels and package insert was incorrect.

    Product
    ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0024-2015·2014-10-22

    Gyma Laboratories Recalls Clonidine HCL Due to Manufacturing Deviations

    Gyma Laboratories of America, Inc. is recalling Clonidine HCL chemical product for medicines preparation due to lack of good manufacturing practices.

    Product
    Clonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0002
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0044-2015·2014-10-22

    Coviden Defibrillation Electrodes Recalled for Incompatibility with Philips AEDs

    Coviden LLC is recalling 9,850 pairs of Medi-Trace Cadence defibrillation electrodes because they are not compatible with Philips FR3 or FRx AEDs.

    Product
    Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected Part Number: 22660PC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0019-2015·2014-10-22

    Valeant Recalls Vasotec Tablets Due to Incorrect Package Insert Labeling

    Valeant Pharmaceuticals is recalling 205,853 bottles of Vasotec (enalapril maleate) tablets because they were packaged with the incorrect version of the package insert.

    Product
    VASOTEC — VASOTEC (ENALAPRIL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0076-2015·2014-10-22

    Arrow International Recalls Central Venous Catheter Kits Due to Labeling Error

    Arrow International is recalling 65 Multi-Lumen Central Venous Catheterization Kits because the outer shipping box displays an incorrect expiration date. The kits inside are correctly labeled and pose no risk to patients.

    Product
    Multi-Lumen Central Venous Catheterization Kit
    Category
    Medical Device
    Distribution
    10 states
  • LowFDA (Drugs)·D-0018-2015·2014-10-22

    Vaseretic Tablets Recalled for Incorrect Package Insert Version

    Valeant Pharmaceuticals is recalling Vaseretic tablets because they were packaged with the incorrect version of the package insert.

    Product
    VASERETIC — VASERETIC (ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V660000·2014-10-21

    Pierce Emergency Vehicles Recalled for Front Control Arm Fracture Risk

    Pierce is recalling 2009-2013 emergency vehicles because front lower control arms may crack, potentially causing wheel separation and increasing crash risk.

    Product
    PIERCE — PIERCE IMPEL, QUANTUM, VELOCITY, ARROW XT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V661000·2014-10-21

    ARBOC Transit Buses Recalled for Fuel Pump Wiring Defect

    ARBOC is recalling 2009-2014 Spirit of Freedom and Spirit of Mobility buses due to an undersized fuel pump wire that may cause vehicle stalls.

    Product
    ARBOC — ARBOC SPIRIT OF FREEDOM, SPIRIT OF MOBILITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V659000·2014-10-21

    Freightliner M2 Trucks Recalled for Clutch Release Bearing Defect

    Daimler Trucks is recalling 2015 Freightliner Business Class M2 trucks because a defective clutch component may prevent disengagement, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER BUSINESS CLASS M2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V662000·2014-10-21

    Supreme Transit Buses Recalled for Wheelchair Lift Platform Cracking Risk

    Supreme is recalling 1,705 transit buses equipped with Ricon wheelchair lifts because the platform side plate may crack, posing an injury risk to operators.

    Product
    SUPREME — SUPREME, STARTRANS SENATOR, CANDIDATE, SENTINEL, SENATOR II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14T013000·2014-10-20

    ITG Voma Recalls Capitol Precision Trac II Tires for Tread Separation

    ITG Voma is recalling specific Capitol Precision Trac II tires due to a risk of tread separation, which could cause sudden air loss and increase the risk of a vehicle crash.

    Product
    TIRES:TREAD/BELT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide

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