The Recall Desk

Archive

October 2012 recalls

969 recalls were announced in October 2012.

What the numbers show

Critical
242
Severe
210
High
389
Moderate
113
Low
15

Of the 969 recalls this month scored against our rubric, 25% are Critical, 22% are Severe.

Which agencies issued them

801–900 of 969

  • ModerateFDA (Devices)·Z-0002-2013·2012-10-10

    Beckman Coulter PrepPlus Recalled for Reagent Level Sense Failures

    Beckman Coulter is recalling the PrepPlus pipetting system because it may fail to warn users when reagent levels are low or out.

    Product
    COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0001-2013·2012-10-10

    Synthes MIRS Spinal Fixation Devices Recalled for Labeling Correction

    Synthes is correcting labeling for MIRS spinal fixation devices to emphasize avoiding rod mis-alignment following reported complaints.

    Product
    MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-001-2013·2012-10-10

    McKesson Recalls bupropion Hydrochloride Extended-Release Tablets Due to Dissolution Failure

    McKesson Packaging Services is recalling 187 cartons of bupropion Hydrochloride Extended-Release Tablets, 150 mg, because they failed USP dissolution test requirements.

    Product
    buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 449 10 7, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-449-10, car
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0007-2013·2012-10-10

    Invuity Recalls Obsolete BriteField Illuminated Suction Devices

    Invuity is recalling 197 obsolete BriteField Illuminated Suction Devices nationwide. The devices were not distributed after March 2011.

    Product
    BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2072-2012·2012-10-10

    Eos Imaging Recalls EOS X-ray Systems Due to Generator Failures

    Eos Imaging Inc is recalling 12 EOS X-ray systems in the US because the anode controller board can fail, causing generator issues.

    Product
    EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0005-2013·2012-10-10

    Animas Insulin Pumps Recalled for Keypad Wear and Peeling

    Animas Corporation is recalling insulin pumps due to keypad wear that may cause tearing or peeling. The recall covers 236,470 units distributed worldwide.

    Product
    IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-003-2013·2012-10-10

    Caraco Recalls Nimodipine Capsules Due to Crystallization

    Caraco Pharmaceutical Laboratories is recalling Nimodipine Capsules 30 mg because crystals of the drug were found within the capsule solution.

    Product
    Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories,
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-002-2013·2012-10-10

    McKesson Recalls bupropion Hydrochloride Extended-Release Tablets for Dissolution Failures

    McKesson Packaging Services is recalling bupropion hydrochloride extended-release tablets because they failed USP dissolution test requirements.

    Product
    buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 450 10 3, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-450-10, car
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0008-2013·2012-10-10

    Gynex Electrosurgical Electrode Holder Recalled Due to Assembly Error

    Gynex Corporation is recalling 19 boxes of electrosurgical electrode holders because an incorrect connector pin was attached during assembly, rendering the devices unusable.

    Product
    Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activated*** Manufactured for GYNEX***" Gynex catalog number: 950 (Gynex REF 950,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1703-2012·2012-10-10

    Mylan Recalls Famotidine Tablets Due to Out-of-Specification Impurities

    Mylan Pharmaceuticals is recalling 31,867 bottles of Famotidine Tablets USP, 20 mg, due to out-of-specification results for related compounds found during routine stability testing.

    Product
    Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·12V492000·2012-10-09

    Mercedes-Benz Recalls 2012 E350 and E550 Coupes for Air Bag Defect

    Mercedes-Benz is recalling 2012 E350 and E550 Coupes because improper stitching on the right side window curtain air bag may cause it to deflate quickly, increasing injury risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ E550, E350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V490000·2012-10-09

    PACCAR Recalls 2012-2013 Kenworth and Peterbilt Trucks for Lighting Defect

    PACCAR is recalling 2012-2013 Kenworth and Peterbilt trucks because fog lamps and daytime running lights may remain on with high beams, increasing crash risk.

    Product
    PETERBILT — PETERBILT, KENWORTH 210, K370, K270, MODEL 220
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12E041000·2012-10-09

    Thermo King Recalls TK486 Diesel Engines for Fuel Valve Crack Risk

    Thermo King is recalling TK486 series diesel engines used in cargo trailer climate control units and generator sets because a fuel delivery valve may crack and leak diesel fuel.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V489000·2012-10-09

    Maserati Recalls 2012 Models for Tire Pressure Monitoring System Software Error

    Maserati is recalling 485 model year 2012 Quattroporte and Granturismo vehicles because a software error may prevent the tire pressure monitoring system from warning drivers of low tire pressure.

    Product
    MASERATI — MASERATI QUATTROPORTE, GRANTURISMO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13006·2012-10-09

    Graco Recalls Classic Wood Highchairs Due to Fall Hazard

    Graco is recalling Classic Wood Highchairs because the seat can detach from the base, posing a fall hazard to children.

    Product
    Graco Classic Wood Highchairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V487000·2012-10-05

    BMW Recalls 2,483 Motorcycles for Front Brake Fluid Foaming

    BMW is recalling 2,483 motorcycles because front brake fluid can foam, reducing braking capability and increasing crash risk.

    Product
    BMW — BMW K1300 S, K1200 R, K1200 R SPORT, K1200 S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V485000·2012-10-04

    Land Rover Recalls 2012 Range Rovers for Windshield Installation Defect

    Land Rover is recalling 2012 Range Rovers because windshields may have been installed incorrectly. This defect could cause the windshield to come loose in a crash, increasing injury risk.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13004·2012-10-04

    Buy Buy Baby Recalls Pink Angel Girls' Denim Shorts for Choking Hazard

    Buy Buy Baby is recalling Pink Angel embroidered girls' denim shorts because decorative studs can detach and pose a choking hazard to young children.

    Product
    Pink Angel Embroidered Girls' Denim Shorts
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2369-2012·2012-10-03

    True Nutrition Recalls Whey Protein Products for Undeclared Milk

    True Nutrition is recalling specific whey protein products because they contain undeclared milk, posing a risk to individuals with milk allergies.

    Product
    Whey Protein Isolate MicroFiltration, Net Weight: 1lb (454g)
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2398-2012·2012-10-03

    McClure's Apple Cinnamon Streusel Cake Recalled for Undeclared Walnuts

    McClure's Pies & Salads is recalling Apple Cinnamon Streusel Cakes because the ingredient list mentions nuts but fails to specifically identify walnuts.

    Product
    McClure's Pies & Salads, Inc. Apple Cinnamon Streusel Cake
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Drugs)·D-1698-2012·2012-10-03

    FDA Recalls Hard Ten Days Capsules for Unapproved Sildenafil

    The FDA is recalling Hard Ten Days Capsules because they contain sildenafil, an unapproved active ingredient. Consumers should stop using the product.

    Product
    Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: American Federal International Living Creature Group and Tibet Gold Source Living Creature Engineering Limited Company, Unit 18, 55 Beijing Road Central, Lhasa, Tibet
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2390-2012·2012-10-03

    Gordon Food Service Recalls Pistachios Due to Potential Peanut Contamination

    Gordon Food Service is recalling shelled raw pistachios because they may be mis-packed with chopped peanuts, posing a risk to people with peanut allergies.

    Product
    Pistachios, Shelled Raw, 4 /2.5 Packed by Tropical Food Nut & Fruit- Orlando, FL 32811
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-2371-2012·2012-10-03

    True Nutrition Recalls Whey Protein Products for Undeclared Milk

    True Nutrition is recalling specific whey protein products because they contain undeclared milk, posing a risk to individuals with milk allergies.

    Product
    Hydrolyzed Whey Protein High Grade, Net Weight: 1lb (454g)
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1700-2012·2012-10-03

    Japan Weight Loss Blue Capsules Recalled for Unapproved Sibutramine

    Vitaminbestbuy.com is recalling Japan Weight Loss Blue Capsules because they contain sibutramine, an unapproved drug ingredient.

    Product
    Japan Weight Loss Blue Capsules, 9 g (300 mg), 30 count box, Green algae lipotropic (fat dissolving) agent, OTC, Distributed by Vitaminbestbuy.com, Brewerton, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2433-2012·2012-10-03

    FDA Recalls Covidien Duet TRS Surgical Staplers Due to Injury Risk

    The FDA is recalling 94,301 units of the Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit because the device may injure adjacent anatomical structures.

    Product
    Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4535A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric su
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-2424-2012·2012-10-03

    McClure's Cole Slaw Recalled for Undeclared Allergens in Mayonnaise

    McClure's Pies & Salads is recalling 30 lb containers of Cole Slaw because the mayonnaise ingredient lacks a full sub-ingredient list, posing an undeclared allergen risk.

    Product
    McClure's Pies & Salads, Inc. Cole Slaw
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-2381-2012·2012-10-03

    Ready Pac Fruit Platter Recalled for Potential Salmonella Contamination

    Ready Pac Foods is voluntarily recalling Fruit & Chocolate Platters containing mangoes due to potential Salmonella Braenderup contamination.

    Product
    Ready Pac¿ Fruit & Chocolate Platter, 40oz , UPC 7774523673, Use by dates 9/6/2012 & 9/7/2012
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2432-2012·2012-10-03

    FDA Recalls Covidien Duet TRS Staplers Due to Injury Risk

    The FDA is recalling 433,528 units of the Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit because the device may injure adjacent anatomical structures.

    Product
    Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code: DUET4535. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surger
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1702-2012·2012-10-03

    Mylan Recalls Levetiracetam Tablets Due to Foreign Tablet Presence

    Mylan Pharmaceuticals is recalling 960 bottles of Levetiracetam 500 mg tablets because foreign tablets may have been distributed in the bottles.

    Product
    LEVETIRACETAM — LEVETIRACETAM (LEVETIRACETAM)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1697-2012·2012-10-03

    Ben Venue Recalls Vecuronium Bromide Injection Due to Particulate Matter

    Ben Venue Laboratories is recalling Vecuronium Bromide for Injection due to the presence of particulate matter.

    Product
    Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg Vials, lyophilized powder per carton, Rx Only, Mfr. By: Ben Venue Laboratories, Bedford, OH 44146: Mfg for: Bedford Labs, Bedford, OH 44146, NDC 55390-039-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2438-2012·2012-10-03

    FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk

    The FDA is recalling 15,936 units of the Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit because the device may injure adjacent anatomical structures.

    Product
    Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET6048. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2436-2012·2012-10-03

    FDA Recalls Covidien Duet TRS Staplers Due to Injury Risk

    The FDA is recalling 22,218 units of the Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit because the device may injure adjacent anatomical structures.

    Product
    Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Product Code: DUET6035. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2459-2012·2012-10-03

    Boston Scientific Z Flex 270 Steerable Sheath Recalled for Embolic Risk

    Greatbatch Medical is recalling 787 units of Boston Scientific Z Flex 270 Steerable Sheaths because damaged internal liners could pose an embolic risk to patients.

    Product
    Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441. To facilitate transv
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1699-2012·2012-10-03

    Man King Capsules Recalled for Unapproved Sildenafil Presence

    The FDA is recalling Man King Capsules because they contain sildenafil, an unapproved active ingredient. Consumers should stop using the product.

    Product
    Man King Capsules, 2800 mg, boxes of 5 packets, OTC, Developed by: American Wanbao Pharmaceutical International Group and Hainan Wanbao Biological Engineering Co., Ltd., 27 Heping Road, Haikou, Henan Province, UPC 9 009900 0032328
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2462-2012·2012-10-03

    Varian Eclipse Treatment Planning System Recalled for Dose Calculation Error

    Varian is recalling Eclipse Treatment Planning Systems because a clock synchronization issue can cause incorrect dose calculations, potentially leading to under- or over-dosing of patients.

    Product
    Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2384-2012·2012-10-03

    Ready Pac Gourmet Fruit Bowl Recalled for Salmonella Risk

    Ready Pac Foods is voluntarily recalling 64oz Gourmet Fruit Bowls containing mangoes due to potential Salmonella Braenderup contamination.

    Product
    Ready Pac¿ Gourmet Fruit Bowl, 64oz , UPC 7774522620, Use by dates 9/9/2012 or earlier and 9/7/2012 & 9/8/2012.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1689-2012·2012-10-03

    Baxter Recalls 0.9% Sodium Chloride Injection Due to Chemical Contamination

    Baxter Healthcare is recalling 0.9% Sodium Chloride Injection USP in AVIVA containers due to potential trace levels of cumene hydroperoxide.

    Product
    0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02; b) 500 mL AVIVA Container, product code 6E1323, NDC 0338-6304-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2434-2012·2012-10-03

    FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk

    The FDA is recalling 4,867 units of the Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit because the device may injure adjacent anatomical structures.

    Product
    Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET4548. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-2389-2012·2012-10-03

    Ready Pac Foods Recalls Walmart Seasonal Blend Fruit Products

    Ready Pac Foods is voluntarily recalling Walmart Seasonal Blend fruit products due to potential Salmonella contamination from mangoes.

    Product
    Walmart¿ Seasonal Blend ,16oz, UPC 7774523761, Use by dates 9/6/2012 & 9/7/2012. Walmart¿ Seasonal Blend, 32oz, UPC 7774523765, Use by dates 9/6/2012 & 9/7/2012.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2387-2012·2012-10-03

    Ready Pac Foods Recalls Starbucks Seasonal Harvest Fruit Blend

    Ready Pac Foods is voluntarily recalling Starbucks Seasonal Harvest Fruit Blend due to potential Salmonella contamination in mangoes.

    Product
    Starbucks¿ Seasonal Harvest Fruit Blend, 6oz, UPC 6211171390, Use by dates 8/22/2012 through 9/7/2012 and 9/4/2012 & 9/5/2012.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2386-2012·2012-10-03

    Ready Pac Foods Recalls Mango Fruit Products Due to Salmonella Risk

    Ready Pac Foods is voluntarily recalling packaged fruit products containing mangoes due to potential Salmonella Braenderup contamination from a supplier recall.

    Product
    Ready Pac¿ Seasons Choice", 32oz, UPC 7774524276, Use by dates 9/8/2012 or earlier and 9/7/2012 & 9/8/2012.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2378-2012·2012-10-03

    Ready Pac Recalls Fruit Mixes Due to Potential Salmonella Contamination

    Ready Pac Foods Inc is voluntarily recalling specific fruit mixes containing mangoes due to potential Salmonella Braenderup contamination.

    Product
    Fruit Mixes: 1) Dining In¿ Super Fruit Medley,10.5oz, UPC 1122508396, Use by date 9/6/2012; 2) Ready Pac¿ Super Fruit Blend, 6oz , UPC 7774523076, Use by Dates 9/8/2012 or earlier, 9/6/2012 & 9/7/2012; 3) Ready Pac¿ Super Fruit Medley, 10.5oz, UPC 7774523746, Use by dates 9/8/201
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1693-2012·2012-10-03

    Actavis Recalls Fentanyl Transdermal Systems Due to Subpotent Product

    Actavis is recalling Fentanyl Transdermal Systems, 100 mcg/h, because some patches may not contain fentanyl gel. The recall covers 98,088 cartons distributed nationwide.

    Product
    Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only, supplied in single pouches (NDC 0591-3214-54 (pouch)), 5 pouches per carton (NDC 0591-3214-72 (Carton)), Manufactured by Watson laboratories Inc., Corona, CA,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2388-2012·2012-10-03

    Ready Pac Foods Recalls Super Fruit Blend Due to Salmonella Risk

    Ready Pac Foods is voluntarily recalling Walmart Super Fruit Blend containing mangoes due to potential Salmonella Braenderup contamination.

    Product
    Walmart¿ Super Fruit Blend, 10oz, UPC 7774523327, Use by dates 9/6/2012 & 9/7/2012.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2439-2012·2012-10-03

    FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk

    The FDA is recalling 135,712 units of the Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit because the device may injure adjacent anatomical structures.

    Product
    Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6048A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric su
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-2383-2012·2012-10-03

    Ready Pac Mango Fandango Recalled for Potential Salmonella Contamination

    Ready Pac Foods is voluntarily recalling Mango Fandango products due to potential Salmonella Braenderup contamination from mangoes supplied by Splendid Products.

    Product
    Ready Pac¿ Mango Fandango", 32oz, UPC 7774524099, Use by dates 9/8/2012 or earlier and 9/6/2012 & 9/7/2012.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2437-2012·2012-10-03

    FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk

    The FDA is recalling 268,022 units of the Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit because the device may injure adjacent anatomical structures.

    Product
    Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6035A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric su
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2435-2012·2012-10-03

    FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk

    The FDA is recalling 104,355 units of the Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit because the device may injure adjacent anatomical structures.

    Product
    Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4548A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric su
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-2429-2012·2012-10-03

    McClure's Potato Salad Recalled for Undeclared Allergens in Salad Dressing

    McClure's Pies & Salads, Inc. is recalling 36 lb units of Potato Salad because the ingredient list omits sub-ingredients for salad dressing, posing an undeclared allergen risk.

    Product
    McClure's Pies & Salads, Inc. Potato Salad
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1686-2012·2012-10-03

    Baxter Recalls 5% Dextrose Injection Due to Chemical Contamination

    Baxter Healthcare is recalling 5% Dextrose Injection USP in AVIVA containers due to potential trace levels of cumene hydroperoxide.

    Product
    5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02; b) 500 mL AVIVA Container, product code 6E0063, NDC 0338-6346-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1688-2012·2012-10-03

    Baxter Recalls 5% Dextrose and 0.45% Sodium Chloride Injection Due to Chemical Contamination

    Baxter Healthcare is recalling 5,064 containers of 5% Dextrose and 0.45% Sodium Chloride Injection USP due to potential trace levels of cumene hydroperoxide.

    Product
    5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0173, NDC 0338-6308-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2426-2012·2012-10-03

    McClure's Broccoli and Cauliflower Salad Recalled for Undeclared Allergens

    McClure's Broccoli & Cauliflower Salad is recalled because the label lists mayonnaise and cheese without their specific sub-ingredients, posing a risk to consumers with allergies.

    Product
    McClure's Pies & Salads, Inc. Broccoli & Cauliflower Salad
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2464-2012·2012-10-03

    Siemens MRI Systems Recalled for Potential Coil Heating During Imaging

    Siemens is recalling 370 MRI systems because the Flex Large 4 Coil can heat up in the electronic housing when positioned off-center.

    Product
    Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2465-2012·2012-10-03

    Philips Digital Diagnost Mobile Detector Holder Recall for Insecure Fit

    Philips is recalling 93 Mobile Detector Holders because the Wireless Portable Detector may not be fixed securely and could fall down.

    Product
    Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System codes: 712020, 712022, 712025 This system is used for making X-ray exposures for diagnostics.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2421-2012·2012-10-03

    McClure's Shoo Fly Pie Recalled for Undeclared Wheat Allergen

    McClure's Pies & Salads, Inc. is recalling Shoo Fly Pies because the ingredient list says 'flour' but does not specify wheat, an undeclared allergen.

    Product
    McClure's Pies & Salads, Inc. Shoo Fly Pie
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2432-2012·2012-10-03

    Derby City Vending Recalls Grilled Ham And Swiss Deli Selections

    Derby City Vending is recalling 3,142 grilled ham and Swiss deli selections due to missing allergen declarations for soy, milk, eggs, and wheat.

    Product
    Derby City Vending "Heckuva" Grilled Ham And Swiss Deli Selections Ingredients: Classic Pit-Style Ham, KLOSTERMAN sub bun, Swiss Cheese, mayonaise packet, SYSCO Clasic Redskin Potato Salad Fresh Thru***Derby City Vending Louisville, KY 40206
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2409-2012·2012-10-03

    McClure's French Apple Pie Recalled for Undeclared Wheat Allergen

    McClure's French Apple Pie is being recalled because the ingredient list says 'flour' but does not specify wheat, posing a risk to people with wheat allergies.

    Product
    McClure's Pies & Salads, Inc. French Apple Pie
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2410-2012·2012-10-03

    McClure's Peach Pie Recalled for Undeclared Wheat Allergen

    McClure's Pies & Salads is recalling Peach Pies because the ingredient list says 'flour' but does not specify wheat, posing a risk to people with wheat allergies.

    Product
    McClure's Pies & Salads, Inc. Peach Pie
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2382-2012·2012-10-03

    Ready Pac Sliced Mango Recalled for Potential Salmonella Contamination

    Ready Pac Foods is voluntarily recalling specific lots of Sliced Mango due to potential Salmonella Braenderup contamination from supplier ingredients.

    Product
    Ready Pac¿ Sliced Mango, 10.5oz , UPC 7774523751, Use by dates 9/8/2012 or earlier, 9/6/2012 & 9/7/2012. Ready Pac¿ Sliced Mango, 32oz, UPC 0000088356, Use by dates 9/6/2012 & 9/7/2012. Ready Pac¿ Sliced Mango, 32 oz, UPC 7774522859, Use by dates 9/8/2012 or earlier and 9/6/2012
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2412-2012·2012-10-03

    McClure's Cherry Pie Recalled for Undeclared Wheat Allergen

    McClure's Inc. is recalling 27 cherry pies because the ingredient list says 'flour' but does not specify wheat, posing a risk to people with wheat allergies.

    Product
    McClure's Pies & Salads, Inc. Cherry Pie
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2367-2012·2012-10-03

    True Nutrition Recalls Whey Protein Products for Undeclared Milk

    True Nutrition is recalling whey protein products because they contain undeclared milk, posing a risk to individuals with milk allergies.

    Product
    Whey Protein Concentrate, Net Weight: 1lb (454g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2411-2012·2012-10-03

    McClure's Blueberry Pie Recalled for Undeclared Wheat Allergen

    McClure's Pies & Salads, Inc. is recalling Blueberry Pies because the ingredient list says 'flour' but does not specify wheat, an undeclared allergen.

    Product
    McClure's Pies & Salads, Inc. Blueberry Pie
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2385-2012·2012-10-03

    Ready Pac Sweet Sunshine Platter Recalled for Salmonella Risk

    Ready Pac Foods is voluntarily recalling Sweet Sunshine Platters containing mangoes due to potential Salmonella Braenderup contamination.

    Product
    Ready Pac¿ Sweet Sunshine Platter, 37oz, UPC 7774524204, Use by dates 9/8/2012 or earlier and 9/6/2012 & 9/7/2012.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2391-2012·2012-10-03

    Indalco Foods Recalls Dulce De Leche Ice Cream Base for Missing Milk Label

    Indalco Foods Corp. is recalling specific lots of Dulce De Leche ice cream base because the packaging fails to list milk as an ingredient.

    Product
    ***Dulce De Leche "Del Campo"***Ice Cream "Base" (Flavor)***FB 23546***Mfg. Date***Keep Refrigerated at 40*f***Lot#***Net Wt 55 LBS***Indalco Food Corp., Miami, FLA (305) 620 1444*** Caramel milk spread is packed in white plastic pails of 55 lbs. under the firm's brand name "D
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2427-2012·2012-10-03

    McClure's Chicken Salad Recalled for Undeclared Allergens in Mayonnaise

    McClure's Pies & Salads, Inc. is recalling 43 lbs of Chicken Salad because the ingredient list omits sub-ingredients for mayonnaise, posing an undeclared allergen risk.

    Product
    McClure's Pies & Salads, Inc. Chicken Salad
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2414-2012·2012-10-03

    McClure's Pumpkin Pie Recalled for Undeclared Wheat Allergen

    McClure's Pies & Salads is recalling 97 pumpkin pies because the ingredient list says 'flour' without specifying wheat, posing a risk to those with wheat allergies.

    Product
    McClure's Pies & Salads, Inc. Pumpkin Pie
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2370-2012·2012-10-03

    True Nutrition Recalls Whey Protein Products for Undeclared Milk

    True Nutrition is recalling specific whey protein products because they contain undeclared milk, posing a risk to individuals with milk allergies.

    Product
    Whey Protein Isolate Cross-Flow Microfiltration, Net Weight: 1lb (454g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2431-2012·2012-10-03

    Derby City Vending Recalls Chicken Salads Due to Missing Allergen Labels

    Derby City Vending is recalling 3,560 chicken sandwiches because their labels failed to declare soy, milk, eggs, and wheat.

    Product
    Derby City Vending "Finish Line" Hand Made Chicken Salad Ingredients: 100% whole wheat bread, Fresh hand cut chicken breast, miracle whip, salt, pepper, celery, pickle relish Fresh Thru***Derby City Vending Louisville, KY 40206
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2394-2012·2012-10-03

    Dawn Foods Recalls Sam's Club Cinnamon Streusel for Allergen Mislabeling

    Dawn Foods is recalling 251 pails of Sam's Club Chunky Cinnamon Streusel because the labels omit milk and soy, which are major allergens present in the product.

    Product
    Sam's Club Chunky Cinnamon Streusel, Net Wt 25 lb, in white plastic pails, Manufactured for Sam's Club, Bentonville, AR 72716, Best if stored in a cool, dry location between 65 - 75 degrees Farenheit.
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-2377-2012·2012-10-03

    Triton Seafood Recalls Neptune Conch Fritters for Missing Wheat Allergen

    Triton Seafood Co. is recalling Neptune brand frozen conch fritters and batter because the label failed to identify wheat as an ingredient.

    Product
    Approximately 5 lb plastic bucket of Conch Fritter Batter labeled in part: "***NEPTUNE'S CONCH FRITTERS ALL NATURAL***Ingredients: Conch, Flour, Onions, Milk, Bell Peppers, Eggs, Garlic, Salt, Black Pepper, Lime Juice, Hot Pepper Sauce.***Packed by Triton Seafood Co. Miami, FL
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2423-2012·2012-10-03

    McClure's Pecan Pie Recalled for Undeclared Wheat Allergen

    McClure's Pies & Salads, Inc. is recalling Pecan Pies because the ingredient list says 'flour' but does not specify wheat, a major allergen.

    Product
    McClure's Pies & Salads, Inc. Pecan Pie
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2417-2012·2012-10-03

    McClure's Coconut Custard Pie Recalled for Undeclared Wheat Allergen

    McClure's Pies & Salads, Inc. is recalling Coconut Custard Pies because the ingredient list says 'flour' but does not specify wheat, an undeclared allergen.

    Product
    McClure's Pies & Salads, Inc. Coconut Custard Pie
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2425-2012·2012-10-03

    McClure's Macaroni Salad Recalled for Undeclared Allergens

    McClure's Pies & Salads, Inc. is recalling 42 lb Macaroni Salad because the ingredient list omits sub-ingredients for macaroni, posing an undeclared allergen risk.

    Product
    McClure's Pies & Salads, Inc. Macaroni Salad
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2418·2012-10-03

    McClure's Egg Custard Pie Recalled for Undeclared Wheat Allergen

    McClure's, Inc. is recalling Egg Custard Pies because the ingredient list says 'flour' without specifying wheat, posing a risk to consumers with wheat allergies.

    Product
    McClure's Pies & Salads, Inc. Egg Custard Pie
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2420-2012·2012-10-03

    McClure's Coconut Cream Pie Recalled for Undeclared Wheat Allergen

    McClure's Pies & Salads is recalling Coconut Cream Pies because the ingredient list says 'flour' without specifying wheat, posing a risk to people with wheat allergies.

    Product
    McClure's Pies & Salads, Inc. Coconut Cream Pie
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2374-2012·2012-10-03

    Haldeman Mills Recalls Yellow Corn Meal Due to Fumonisin Contamination

    Haldeman Mills is recalling specific 25 lb and 50 lb bags of Bulk Foods Yellow Corn Meal because FDA samples tested positive for Fumonisin.

    Product
    Bulk Foods, Inc. Yellow Corn Meal, Regular Roast, 25 lb; Bulk Foods, Inc. Yellow Corn Meal, Regular Roast, 50 lb
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2379-2012·2012-10-03

    Ready Pac Foods Recalls Mango Products Due to Salmonella Risk

    Ready Pac Foods Inc is voluntarily recalling packaged mango products distributed through August 30, 2012, due to potential contamination with Salmonella Braenderup.

    Product
    Mango: 1) Dining In¿ Mango ,10.5oz , UPC 1122508640, Use by Date 9/7/2012; 2) Wawa¿ Mango, 8oz, UPC 2619106437, Use by dates 9/6/2012 or earlier.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2461-2012·2012-10-03

    Invacare Recalls I-Fit Shower Chairs Due to Quality and Adverse Event Data

    Invacare is voluntarily recalling 21,168 I-Fit Shower Chairs (Models 9780, 9781, 9781-1) based on returned units and adverse event reports.

    Product
    Invacare¿ I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035. These shower chairs are designed for individuals who require seating support when bathing or showering and provide comfort and safety in the bathtub.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2403-2012·2012-10-03

    McClure's Black Walnut Cake Recalled for Undeclared Wheat Allergen

    McClure's Pies & Salads, Inc. is recalling Black Walnut Cakes because the ingredient list says 'flour' instead of 'wheat flour', posing a risk to people with wheat allergies.

    Product
    McClure's Pies & Salads, Inc. Black Walnut Cake
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2419-2012·2012-10-03

    McClure's Chocolate Cream Pie Recalled for Undeclared Wheat Allergen

    McClure's Inc. is recalling 20 chocolate cream pies because the ingredient list says 'flour' but does not specify wheat, posing a risk to people with wheat allergies.

    Product
    McClure's Pies & Salads, Inc. Chocolate Cream Pie
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2407-2012·2012-10-03

    McClure's Orange Cake Recalled for Undeclared Wheat Allergen

    McClure's Pies & Salads, Inc. is recalling Orange Cake because the ingredient list says 'flour' without specifying wheat, posing a risk to consumers with wheat allergies.

    Product
    McClure's Pies & Salads, Inc. Orange Cake
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2413-2012·2012-10-03

    McClure's Apple Pie Recalled for Undeclared Wheat Allergen

    McClure's Pies & Salads, Inc. is recalling 40 apple pies because the ingredient list says 'flour' without specifying wheat, posing a risk to people with wheat allergies.

    Product
    McClure's Pies & Salads, Inc. Apple Pie
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2466-2012·2012-10-03

    KCI Recalls BariAir Therapy System Hand Pendent Due to Positioning Risk

    KCI USA, Inc. is recalling 575 BariAir Therapy System Hand Pendants because patients may inadvertently place the bed into a pseudo-exit position, posing a safety risk.

    Product
    BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. The BariAir Therapy System provides low air-loss pressure management therapy, pulsation, percussion, Turn Assist. flexible patient
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2450-2012·2012-10-03

    Abbott Vascular Recalls Armada 35 PTA Catheters Due to Inflation Issues

    Abbott Vascular is recalling Armada 35 and Armada 35 LL PTA Catheters because some devices may have difficulty inflating or deflating.

    Product
    Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2368-2012·2012-10-03

    True Nutrition Recalls Whey Protein Products for Undeclared Milk

    True Nutrition is recalling whey protein products because they contain undeclared milk, posing a risk to individuals with milk allergies.

    Product
    Whey Protein Isolate Cold-Filtration, Net Weight: 1lb (454g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2430-2012·2012-10-03

    Derby City Vending Biscuit and Gravy Recalled for Missing Allergen Labels

    Derby City Vending is recalling 1,860 tubs of 'Infielder's Breakfast' Biscuit and Gravy because the labels failed to declare soy, milk, eggs, and wheat.

    Product
    "Derby City Vending "Infielder's Breakfast" Biscuit and Gravy, Daybreak Selections, Ingredients: PILLSBURY buttermilk biscuit, PIONEER biscuit gravy mix, PURNELLS sausage***Fresh Thru***Derby City Vending Louisville, KY 40206"
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2440-2012·2012-10-03

    OPTI Medical Systems Recalls BP7561 B-Lac Cassettes for Altitude Bias

    OPTI Medical Systems is recalling BP7561 B-Lac cassettes because PCO2 readings are biased at high altitudes.

    Product
    BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measurements of pH, PCOX2 PO2, lactate (lactic acid), total hemoglobin (tHb), and oxygen saturation (SO2), in heparinized whole blood samp
    Category
    Medical Device
    Distribution
    Distributed nationwide

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