July 2012 recalls

445 recalls were announced in July 2012.

What the numbers show

Critical: 14
Severe: 125
High: 192
Moderate: 88
Low: 26

Of the 445 recalls this month scored against our rubric, 3% are Critical, 28% are Severe.

Which agencies issued them

201–300 of 445

ModerateFDA (Devices)·Z-1961-2012·2012-07-18
Stryker Arthroscope and Hardware Set Tray Recall for Sterilization Labeling
Stryker Endoscopy is recalling 6,388 Arthroscope and Hardware Set Trays because the Instructions for Use incorrectly listed sterilization methods that were not validated at worst-case conditions.
Product
Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distributed by Stryker Endoscopy, San Jose, CA The Arthroscope and Hardware Set Tray is used to hold and protect surgical devices during the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1955-2012·2012-07-18
CIVCO General Purpose Sensor Recalled for Calibration Errors
Civco Medical Instruments Inc is recalling 9 CIVCO General Purpose Sensor kits due to incorrect calibration that may affect needle path projection accuracy.
Product
CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor, for use with 3D Guidance medSAFE trackers, Ref. 610-1067. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose…
Category
Medical Device
Distribution
6 states
ModerateFDA (Food)·F-1731-2012·2012-07-18
Fertalin tablets recalled for unapproved synthetic botanical ingredients
H & L Jerch Sales, Inc. is recalling Fertalin tablets because they contain synthetic equivalents of botanical constituents that have not been approved for use in dietary supplements.
Product
Fertalin bottles of 90 tablets taken orally Nokomis Research Inc Bell Lifestyle Products #8
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1987-2012·2012-07-18
Philips Medical Systems Recalls IntelliSpace Portal and Extended Brillance Workspace Software
Philips Medical Systems is recalling 38 units of IntelliSpace Portal and Extended Brillance Workspace software due to inconsistent diagnostic results when using specific time-based methods.
Product
IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. The Philips Extended Brillance Workspace is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1969-2012·2012-07-18
Terumo Perfusion System 1 Recalled for Roller Pump Occlusion Malfunctions
Terumo CVS is recalling 648 Advanced Perfusion System 1 units due to roller pump occlusion malfunctions that could prevent pump use during surgery.
Product
System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1963-2012·2012-07-18
Terumo Advanced Perfusion System 1 Gas System Recall
Terumo is recalling 648 Advanced Perfusion System 1 units because users reported difficulty adjusting the gas system flow control knob.
Product
Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1979-2012·2012-07-18
Smiths Medical Recalls HOTLINE 3 Blood and Fluid Warmer Units
Smiths Medical is recalling 2,247 HOTLINE 3 Blood and Fluid Warmers because a microswitch may become damaged and unusable if not correctly installed.
Product
Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE¿ 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINE¿ 3 L-370 Fluid Warming Set are intended for the delivery of warmed…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1984-2012·2012-07-18
Integra Pudenz Flushing Valve Recalled for Incorrect Labeling
Integra LifeSciences is recalling 39 Pudenz Flushing Valves because the pouch labels list the wrong model and closing pressure.
Product
Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device is used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid from the ventricles of the brain.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1964-2012·2012-07-18
Terumo Advanced Perfusion System 1 Gas Control Recall
Terumo is recalling 992 Advanced Perfusion System 1 units due to reported difficulty adjusting the gas flow control knob.
Product
Terumo Advanced Perfusion System 1 System 1 Base, 220/240 V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1410-2012·2012-07-18
AstraZeneca Recalls Nexium Capsules Due to Foreign Product Contamination
AstraZeneca is recalling 2,556 bottles of Nexium 40 mg capsules because some may contain Nexium 20 mg capsules intended for the Japanese market.
Product
NEXIUM — NEXIUM (ESOMEPRAZOLE MAGNESIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1974-2012·2012-07-18
Abbott i-Stat Portable Clinical Analyzer Recall for Overheating Battery
Abbott Point of Care is recalling i-Stat Portable Clinical Analyzers because the battery area can become uncomfortably hot to touch. This is a recall extension.
Product
i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1733-2012·2012-07-18
Coca-Cola Zero Recalled for Off Odor and Taste
Coca-Cola Refreshments is recalling 20 fl. oz. Coca-Cola Zero bottles in Missouri, Iowa, and Illinois due to off odor and taste caused by low levels of ammonium salts.
Product
Coca Cola Zero, 20 fl. oz., The Coca Cola Company.
Category
Food
Distribution
3 states
LowFDA (Food)·F-1729-2012·2012-07-18
FDA Recalls Eroxil Tablets Containing Unapproved Synthetic Botanical Ingredients
H & L Jerch Sales, Inc. is recalling Eroxil tablets nationwide because they contain synthetic equivalents of spermine and/or spermidine, which are not approved for use in dietary supplements.
Product
Product Name: Eroxil bottles of 30 tablets taken orally Nokomis Research Inc #6
Category
Food
Distribution
Distributed nationwide
LowFDA (Food)·F-1730-2012·2012-07-18
Erosyn tablets recalled for unapproved synthetic botanical ingredients
H & L Jerch Sales is recalling Erosyn tablets because they contain synthetic equivalents of botanical constituents that have not been approved for use in dietary supplements.
Product
Erosyn bottles of 30 tablets taken orally Nokomis Research Inc Bell Lifestyle Products #7
Category
Food
Distribution
Distributed nationwide
LowFDA (Drugs)·D-1411-2012·2012-07-18
Qualitest Recalls Hydrocortisone and Acetic Acid Otic Solution Due to Impurities
Vintage Pharmaceuticals is recalling 54,431 bottles of Hydrocortisone and Acetic Acid Otic Solution because impurity levels exceeded specifications.
Product
HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC 0603-7039-39; UPC 3 0603-7039-39 7.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1998-2012·2012-07-18
PSC Industries Recalls Surgical Forceps Due to Labeling Errors
PSC Industries is recalling 40 units of Model #20-1360K surgical forceps because of typos in the inner packaging labels. The errors did not affect the part or lot numbers.
Product
Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360K 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Food)·F-1732-2012·2012-07-18
FDA Recalls Middle-Age Energy Booster Tablets Due to Unapproved Ingredients
H & L Jerch Sales, Inc. is recalling 1,981 bottles of Middle-Age Energy Booster tablets nationwide because they contain unapproved synthetic botanical ingredients.
Product
Middle-Age Energy Booster bottles of 60 tablets taken orally Nokomis Research Inc Bell Lifestyle Products #65
Category
Food
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1994-2012·2012-07-18
PSC Industries Recalls Bipolar Bayonet Forceps Due to Packaging Labeling Error
PSC Industries is recalling 7 units of Bipolar Bayonet Forceps because the manufacturer symbol was incorrectly replaced by the expiry symbol on the packaging.
Product
Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1990-2012·2012-07-18
PSC Industries Recalls Button Switch Pen Electrodes Due to Labeling Errors
PSC Industries is recalling 50 units of Button Switch Pen Electrodes due to a labeling error where the manufacturer symbol replaced the expiration date symbol.
Product
Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Number: 75820. The device is packaged in a sterile Tyvek peel pouch within a cardboard box which contains 24 pouches per box. Pens/Pencils…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1996-2012·2012-07-18
PSC Industries Recalls Bayonet Forceps Due to Incorrect Expiration Date
PSC Industries is recalling 80 units of Bayonet Forceps because the outer carton lists an incorrect sterile expiration date, though the individual pouch labels are correct.
Product
Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use Surgical/Bipolar Forceps, Model #20-1360I, 510 (k) #K884656. The surgical device is package one (s) per plastic Tyvek peel pouch, 10 plastic Tyvek peel pouches per box. Bipolar Forceps and Cords…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1991-2012·2012-07-18
PSC Industries Recalls Button Switchpens Due to Labeling Errors
PSC Industries is recalling Button Switchpens because the packaging labels incorrectly state the devices include a holster. The recall covers 725 units distributed nationwide.
Product
Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use device, Electrosurgical./Extendable Pencils, 510(k)#K936304, Model Number: 75800. The device is packaged in a sterile Tyvek peel pouch within a cardboard box. The cartons contain 25 pouches per box.…
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·12V334000·2012-07-16
Nova Bus Recalls 2012 LFS Transit Buses for Brake Valve Defect
Nova Bus is recalling 2012 LFS transit buses because a brake valve plunger may fracture, potentially reducing braking ability and increasing crash risk.
Product
NOVA BUS — NOVA BUS NOVA LFS
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·12V341000·2012-07-16
Forest River Recalls 2005-2011 Motorhomes Due to Electrical Fire Risk
Forest River is recalling 1,069 Berkshire and Charleston motorhomes because a transfer switch may fail under heat, increasing the risk of fire and electrical damage.
Product
CHARLESTON — CHARLESTON, BERKSHIRE 410DST, 390TS, 410QS, 410FK
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·12V332000·2012-07-16
Kenworth T680 Recalled for Weak Upper Bunk Restraint Belts
PACCAR is recalling 2013 Kenworth T680 trucks because the upper bunk restraint belts may be weaker than specified, increasing injury risk in crashes.
Product
KENWORTH — KENWORTH T680
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·12V331000·2012-07-16
Volkswagen Recalls 2012 Beetles for Non-Compliant Summer Tires
Volkswagen is recalling 2012 Beetles because some were equipped with summer tires that do not meet federal safety standards, potentially increasing crash risk.
Product
VOLKSWAGEN — VOLKSWAGEN BEETLE
Category
Vehicle
Distribution
Distributed nationwide
ModerateNHTSA·12V333000·2012-07-16
Kenworth T680 Recall Issued for Unreadable Upper Bunk Warning Labels
Paccar is recalling 2013 Kenworth T680 trucks because warning labels on the upper bunk may deform and become unreadable, increasing injury risk.
Product
KENWORTH — KENWORTH T680
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·12V329000·2012-07-12
Porsche Recalls 2011-2012 Cayenne and Panamera Turbo Models for Fire Risk
Porsche is recalling 2011-2012 Cayenne and Panamera Turbo models because a defective turbocharger part may fracture, causing oil to enter the exhaust system and increasing the risk of a fire.
Product
PORSCHE — PORSCHE CAYENNE, PANAMERA
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·12V328000·2012-07-12
Nissan Recalls 2012 Juke Vehicles Due to Rear Seat Striker Weld Defect
Nissan is recalling 11,076 model year 2012 Juke vehicles because an incomplete weld may cause the rear seat back striker to separate in a crash, increasing injury risk.
Product
NISSAN — NISSAN JUKE
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·12224·2012-07-12
Molenaar Recalls Folding Step Stools Due to Fall Hazard
Molenaar LLC is recalling about 3,700 folding step stools because they can break or collapse unexpectedly, posing a fall hazard to consumers.
Product
Folding Step Stool
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·12222·2012-07-12
Family Dollar Recalls 200 Mini Light Sets Due to Fire and Shock Risk
Family Dollar is recalling 200 Mini Light sets because they do not meet UL standards and pose a fire and electrical shock hazard.
Product
200 Mini Lights
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·12221·2012-07-12
Chicco Polly High Chairs Recalled Due to Laceration Hazard
CPSC recalls Chicco Polly high chairs because children can fall against rear leg pegs, causing lacerations and other injuries.
Product
Chicco Polly High Chair
Category
Consumer Product
Distribution
Distributed nationwide
ModerateCPSC·12223·2012-07-12
Old Navy Recalls Toddler Girl Aqua Socks Due to Slip and Fall Hazard
Old Navy is recalling Toddler Girl Aqua Socks because they have less traction on wet or smooth surfaces, creating a slip and fall hazard.
Product
Old Navy Toddler Girl Aqua Socks
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1687-2012·2012-07-11
Hannaford Mini Frosted Cookies Recalled for Undeclared Egg
Hannaford Bros. is recalling 990 units of Mini Frosted Cookies sold in New England and New York due to undeclared egg.
Product
Hannaford brand Mini Frosted Cookies, 10 oz UPC # 4126872374
Category
Food
Distribution
5 states
SevereFDA (Food)·F-1722-2012·2012-07-11
Crispy Almond Cookies Recalled for Undeclared Milk Allergen
Deep Foods Inc is recalling Crispy by TWI Foods Almond Cookies because they may contain undeclared milk. Consumers with milk allergies should not eat the product.
Product
Crispy by TWI Foods Almond Cookies, Biscuit, Net Wt 7 oz., Product of Canada Manufactured by TWI Foods Inc. 1869 Gage Court, Mississauga, Ont, Canada L5S 1S3
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1900-2012·2012-07-11
CareFusion AirLife Infant Breathing Circuits Recalled for Cracking Adapter
CareFusion is recalling AirLife infant breathing circuits because a Y adapter may crack, causing a leak that reduces air delivery to ventilated patients.
Product
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1937-2012·2012-07-11
DePuy Spine Side Fire Needles Recalled for Breakage Reports
DePuy Mitek is recalling 683 units of Confidence Spinal Cement System Side Fire Needles due to reports of breakage during use.
Product
Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1697-2012·2012-07-11
Mexican Sweet Bread Recalled for Undeclared Milk, Wheat, and Dye
Mexicantown Wholesale is recalling Tortugas Mexican Sweet Bread for undeclared milk, wheat, and FD&C Yellow #6.
Product
TORTUGAS (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4.0oz
Category
Food
Distribution
0 states
SevereFDA (Food)·F-1690-2012·2012-07-11
Mexican Sweet Bread Recalled for Undeclared Soy Allergens
Mexicantown Wholesale recalled 26 units of Mexican Sweet Bread due to undeclared soy ingredients.
Product
MUFFIN PLAIN (MEXICAN SWEET BREAD) IMPORTED BY ELCAMPEON LEAMINGTON 519-324-2616 4oz, UPC: 9564000029; and item #001
Category
Food
Distribution
0 states
SevereFDA (Food)·F-1719-2012·2012-07-11
Seoul Trading Recalls Salted Fermented Oysters Due to Insanitary Conditions
Seoul Trading Inc. is recalling two types of salted and fermented oysters distributed in Oregon and Washington because they were prepared under insanitary conditions.
Product
Na-Rae NR, Salted & Fermented Oyster, item no. MA1159, net wt. 44 lb per case. Cho-Rip-Dong Salted & Fermented Oyster, item no. MB3025, net wt. 7.4 oz per bag.
Category
Food
Distribution
2 states
SevereFDA (Devices)·Z-1940-2012·2012-07-11
DePuy Spine Side Fire Needles Recalled for Breakage Reports
DePuy Mitek is recalling 6,979 Confidence Spinal Cement System Side Fire Needles due to reports of breakage. The needles are used to place bone cement in the spine.
Product
Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904413. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1707-2012·2012-07-11
FDA Recalls Carrot Juice Due to Potential Botulism Contamination
Healthy Choice/Island Blends is recalling 118 gallons of carrot juice sold in California due to potential Clostridium botulinum contamination.
Product
Carrot juice. Labeling reads in part:"***LIQUID GOLD 24K CARROT JUICE***JUICE CONNECTION LOS ANGELES CALIFORNIA 90058*** 7 62313 00130 0***INGREDIENTS: PASTEURIZED CARROT JUICE***".
Category
Food
Distribution
0 states
SevereFDA (Devices)·Z-1938-2012·2012-07-11
DePuy Spine Side Fire Needles Recalled for Breakage Reports
DePuy Mitek is recalling 704 units of Confidence Spinal Cement System Side Fire Needles due to reports of breakage.
Product
Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1686-2012·2012-07-11
Pendleton Flour Mills Recalls Wheat Germ Contaminated with Metal Fragments
Pendleton Flour Mills is recalling bulk wheat germ contaminated with metal fragments. The product was distributed to consignees in California, Oregon, and Utah.
Product
Wheat Germ, brand name PFM, package in bulk tote, approximately 1650 lbs. per tote. Product SKU is 1344.
Category
Food
Distribution
3 states
SevereFDA (Food)·F-1721-2012·2012-07-11
Deep Foods Recalls Crispy Coconut Cookies for Undeclared Milk
Deep Foods Inc is recalling Crispy by TWI Foods Coconut Cookies because they may contain undeclared milk.
Product
Crispy by TWI Foods Coconut Cookies, Net Wt 7 oz., Product of Canada Manufactured by TWI Foods Inc. 2600 Drew Road, Mississauga, Ont, Canada L4T 3M5.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1717-2012·2012-07-11
Seoul Trading Recalls Frozen Oysters Due to Insanitary Conditions
Seoul Trading Inc. is recalling Cho-Rip-Dong Frozen Oysters because they were prepared or packed under insanitary conditions, potentially rendering them injurious to health.
Product
Cho-Rip-Dong Frozen Oysters in plastic bags: 1) Item no. BG1501, net wt. 1 lb.; 2) Item no. BG1521, net wt. 8 oz.; 3) Item no. BG1551, net wt. 3 lb.; 4) Item no. BG1601, net wt. 10 lb.; 5) Item no. BG1631, net wt. 1 lb.
Category
Food
Distribution
2 states
SevereFDA (Food)·F-1683-2012·2012-07-11
Tree Top Recalls Pear Juice Concentrate Due to Arsenic Levels
Tree Top Inc is recalling 6,708 gallons of pear juice concentrate because it contains inorganic arsenic levels exceeding FDA chronic exposure concerns.
Product
Pear juice concentrate 70 Brix in 55 gallon steel drums with plastic liner that are filled to 52 gallons. Labeled in part: "CLAREX PEAR JUICE CONCENTRATE "cRc-KOSHER"***52 GALLONS" and "TREE TOP***PEAR CONCENTRATE TYPE III***RESOURCE #: 4200815003***Selah, Wa. 98942***MADE IN…
Category
Food
Distribution
2 states
SevereFDA (Food)·F-1723-2012·2012-07-11
Deep Foods Recalls Pistachio Cookies for Undeclared Milk and Almonds
Deep Foods Inc. is recalling Crispy by TWI Foods Pistachio Cookies because they may contain undeclared milk and almonds.
Product
Crispy by TWI Foods Pistachio Cookies, Biscuit, Net Wt 7 oz. Product of Canada Manufactured by TWI Foods Inc. 1869 Gage Court, Mississauga, Ont, Canada L5S 1S3.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1915-2012·2012-07-11
DePuy Recalls Luster and Ultima Hip Stems Implanted with Metal-on-Metal
DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima hip stems implanted with metal-on-metal articulations.
Product
LUSTER HIP SZ 1 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1899-2012·2012-07-11
CareFusion AirLife Infant Respiratory Circuits Recalled for Cracking Adapter
CareFusion is recalling AirLife Isothermal Breathing Circuits because the Y adapter may crack, causing a leak that reduces the air volume delivered to ventilated patients.
Product
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1720-2012·2012-07-11
Deep Foods Recalls Crispy Almond Cake Rusk for Undeclared Milk
Deep Foods Inc is recalling Crispy by TWI Foods Almond Cake Rusk because the product may contain undeclared milk.
Product
Crispy by TWI Foods Almond Cake Rusk, Biscuit, Net Wt 26.4 oz. Product of Canada Manufactured by TWI Foods Inc. 1869 Gage Court , Mississauga, Ont, Canada . L5S 1S3
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1905-2012·2012-07-11
Invacare Recalls TDX Power Wheelchairs Due to Fire and Injury Risk
Invacare is recalling specific TDX power wheelchairs because a defect in the post fuse assembly could cause a short circuit, leading to fire and serious injury.
Product
TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1699-2012·2012-07-11
Mexican Sweet Bread Recalled for Undeclared Milk, Soy, and Wheat Allergens
Mexicantown Wholesale recalled 26 units of Mexican Sweet Bread for undeclared milk, soy, and wheat allergens. The product was distributed in Canada.
Product
MUFFINS PLAIN (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz 21-MAY-12
Category
Food
Distribution
0 states
SevereFDA (Food)·F-1689-2012·2012-07-11
Mexicantown Wholesale Recalls Muffins for Undeclared Soy and Milk Allergens
Mexicantown Wholesale is recalling 26 units of 4oz Muffin Chocochips imported by Elcampeon Leamington due to undeclared soy and milk ingredients.
Product
MUFFIN CHOCOCHIPS IMPORTED BY ELCAMPEON LEAMINGTON 519-324-2616 4oz
Category
Food
Distribution
0 states
SevereFDA (Devices)·Z-1923-2012·2012-07-11
DePuy Recalls Luster Hip Stems Implanted with Metal-on-Metal Articulations
DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima LX hip stems implanted with metal-on-metal articulations.
Product
LUSTER HIP SZ 9 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1939-2012·2012-07-11
DePuy Spine Side Fire Needles Recalled for Breakage Reports
DePuy Mitek is recalling 530 units of Confidence Spinal Cement System Side Fire Needles due to reports of breakage.
Product
Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904611. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1691-2012·2012-07-11
Mexicantown Wholesale Recalls Muffins with Pecans for Undeclared Soy Allergen
Mexicantown Wholesale is recalling specific muffin products containing pecans due to undeclared soy ingredients. The recall affects products distributed in Canada.
Product
Muffins with Pecans: 1) MUFFIN W/PECANS (MEXICAN BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4oz; UPC 9564000029, item #002; 2) MUFFIN W/PECANS MEXICAN SWEET BREAD IMPORTED BY MAX PRODUCTS LEAMINTON 519-325-1176 MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz, UPC…
Category
Food
Distribution
0 states
SevereNHTSA·12E026000·2012-07-11
John Deere 8.1L Natural Gas Engine Turbocharger Recall
Deere & Company is recalling certain 8.1-liter compressed natural gas engines due to potential turbocharger failures that may cause smoke, fire, and stalling.
Product
ENGINE AND ENGINE COOLING:ENGINE:OTHER FUEL TYPES:TURBO/SUPERCHARGER recall
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Food)·F-1706-2012·2012-07-11
Mexican Sweet Bread Recalled for Undeclared Wheat, Milk, and Soy Allergens
Mexicantown Wholesale is recalling 26 units of Mexican Sweet Bread for undeclared wheat, milk, and soy allergens. The products were distributed in Canada.
Product
MUFFINS PECAN (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY 21-MAY-12 4.0oz
Category
Food
Distribution
0 states
SevereFDA (Devices)·Z-1914-2012·2012-07-11
DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems
DePuy Orthopaedics is recalling ULTIMA LX and LUSTER cemented polished femoral hip stems implanted with metal-on-metal articulations due to a field safety notice.
Product
ULTIMA*LX STM,POL 10/12TAP/4M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1718-2012·2012-07-11
Seoul Trading Recalls Frozen Rice Cake and Mussel Product
Seoul Trading Inc. is recalling Nol-Boo Global Frozen Rice Cake & Mussel due to potential contamination from insanitary conditions.
Product
Nol-Boo Global Frozen Rice Cake & Mussel, Item no. EN5011, package in a plastic bag, net wt. 1.21 lb.
Category
Food
Distribution
2 states
SevereFDA (Food)·F-1698-2012·2012-07-11
Mexican Sweet Bread Muffins Recalled for Undeclared Allergens
Mexicantown Wholesale recalled 26 products of Mexican sweet bread muffins due to undeclared milk, soy, wheat, and FD&C yellow #6.
Product
MUFFINS CHOCOCHIPS (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz 24-MAY-12
Category
Food
Distribution
0 states
SevereFDA (Devices)·Z-1901-2012·2012-07-11
CareFusion Infant Y Connector Recall Due to Spontaneous Cracking
CareFusion is recalling AirLife Infant Patient Y Connectors because the adapter may crack, causing a leak that reduces the air volume delivered to ventilated patients.
Product
AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx device for single patient use; 30 connectors per box; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1910-2012·2012-07-11
DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems
DePuy Orthopaedics is issuing a Field Safety Notice for ULTIMA LX and LUSTER Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations.
Product
ULTIMA*LX STM,POL 10/12TAP/SZ5 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1909-2012·2012-07-11
DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems
DePuy Orthopaedics is issuing a Field Safety Notice for ULTIMA LX and LUSTER Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations.
Product
ULTIMA*LX STM,POL 10/12TAP/SZ4 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1693-2012·2012-07-11
Mexican Bread Recalled for Undeclared Yellow #6 Dye
Mexicantown Wholesale is recalling Conchas (Mexican Bread) for undeclared Yellow #6. The recall affects products distributed in Canada.
Product
CONCHAS: 1) CONCHAS (MEXICAN BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4/ 4oz, UPC: 0895640000; and item #002; 2) CONCHAS (MEXICAN BREAD) IMPORTED BY FIESTA WHOLESALE 226-440-3033 MY LITTLE MEXICO 4/4.0oz;, UPC 0895640000; 3) CONCHAS (MEXICAN BREAD) IMPORTED BY…
Category
Food
Distribution
0 states
HighFDA (Food)·F-1711-2012·2012-07-11
Cedar's Bakery White Pita Bread Recalled for Wheat Allergen Mislabeling
Cedar's Bakery is recalling White Pita Bread because the wheat flour ingredient is not labeled as an allergen.
Product
Cedar's Bakery Pita Bread, 10 loaves, White; ingredients flour water,yeast, sugar, salt. Nt. Wt. 22 oz.(1 lb. 6 oz. - 624 GMs)
Category
Food
Distribution
1 state
HighFDA (Food)·F-1710-2012·2012-07-11
Ultradent Recalls Xylishield Gum for Missing Soy Allergen Labeling
Ultradent is recalling specific lots of Xylishield gum because the packaging failed to list soy as an ingredient. A separate lot of spearmint gum was also recalled due to accidental cinnamon flavoring.
Product
Spearmint Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is aqua, blue and white with black, aqua and white print writing. The product is advertised for use in fighting against tooth decay. Part number 8418.
Category
Food
Distribution
1 state
HighFDA (Food)·F-1685-2012·2012-07-11
Newly Weds Foods Recalls Firewood Grill Seasoning Due to Salmonella
Newly Weds Foods is recalling Firewood Grill Seasoning X2 because it was manufactured with a yeast extract contaminated with Salmonella.
Product
Firewood Grill Seasoning X2, 25 lb. bags, Manufactured by Newly Weds Foods, Chicago, IL 60639, product G51189
Category
Food
Distribution
7 states
HighFDA (Devices)·Z-1921-2012·2012-07-11
DePuy Luster Hip Stems Recalled for Metal-on-Metal Articulation Concerns
DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima LX hip stems implanted with metal-on-metal articulations.
Product
LUSTER HIP SZ 7 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1913-2012·2012-07-11
DePuy Recalls Cemented Polished Femoral Hip Stems Implanted with Metal-on-Metal Articulations
DePuy Orthopaedics is issuing a Field Safety Notice for LUSTER and ULTIMA LX Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations.
Product
ULTIMA*LX STM,POL 10/12TAP/3M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1934-2012·2012-07-11
Aesculap S4 Cervical Revision Instruments Recalled for Tolerance Issues
Aesculap Implant Systems LLC is voluntarily removing S4 Cervical Revision Instruments because they may not thread into screws properly during surgery.
Product
S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·12220·2012-07-11
Troxel Recalls Flexible Flyer Swing Sets Due to Fall Hazard
The Troxel Company is recalling about 105,400 Flexible Flyer swing sets because see saw seats can break away, posing a fall hazard.
Product
Flexible Flyer Swing Sets
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Food)·F-1692-2012·2012-07-11
Mexican Sweet Bread Recalled for Undeclared Artificial Dyes
Mexicantown Wholesale recalled 26 units of Polvorones Fresa y Pina for containing undeclared artificial dyes. The products were distributed in Canada.
Product
POLVORONES FRESA Y PINA (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4/ 4oz
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-1906-2012·2012-07-11
DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems
DePuy Orthopaedics is recalling ULTIMA LX and LUSTER hip stems implanted with metal-on-metal articulations due to potential safety concerns.
Product
ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1935-2012·2012-07-11
Greiner Bio-One Recalls Vacuette Quickshield Complete Plus Blood Collection Devices
Greiner Bio-One is recalling specific lots of Vacuette Quickshield Complete Plus devices due to a defect that may cause the safety shield to become loose and unstable.
Product
Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1933-2012·2012-07-11
Zimmer Recalls PathFinder NXT Pivoting Percutaneous Rod Holder
Zimmer, Inc. is recalling 77 units of the PathFinder NXT Pivoting Percutaneous Rod Holder because the set screw may break, preventing the surgeon from removing the rod during surgery.
Product
PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrument used during orthopedic surgery. The intended use of the pivoting percutaneous rod holder is to attach to the rod to facilitate rod insertion, positioning, and orientation through the extender…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1924-2012·2012-07-11
DePuy Luster and Ultima Hip Stems Recalled for Metal-on-Metal Use
DePuy Orthopaedics is recalling Luster and Ultima hip stems implanted with metal-on-metal articulations due to a field safety notice.
Product
LUSTER HIP SZ 10 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1918-2012·2012-07-11
DePuy Recalls Luster Hip Stems Implanted with Metal-on-Metal Articulations
DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima LX hip stems implanted with metal-on-metal articulations.
Product
LUSTER HIP SZ 4 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1695-2012·2012-07-11
Mexican Sweet Bread Recalled for Undeclared Sulfites
Mexicantown Wholesale is recalling Tacos de Manzana (Mexican Sweet Bread) due to undeclared sulfites. The product was distributed in Canada.
Product
TACOS DE MANZANA (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 3.4oz
Category
Food
Distribution
0 states
HighNHTSA·12V330000·2012-07-11
Turtle Top Recalls Buses with Stuck Roof Hatches
Turtle Top is recalling 361 commercial buses because roof hatches may be too hard to open in an emergency, potentially hindering passenger exit.
Product
TURTLE TOP — TURTLE TOP VANTERRA, TERRA TRANSPORT, ODYSSEY XL, ODYSSEY LT
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-1705-2012·2012-07-11
Mexican Sweet Bread Recalled for Undeclared Food Dyes
Mexicantown Wholesale recalled 26 units of Empanadas de Pina for containing undeclared Yellow #6 and Yellow #5.
Product
EMPANADAS DE PINA (MEXICAN SWEET BREAD) IMPORTED BY MAX PRODUCTS LEAMINTON 519-325-1176 MANUFACTURED BY MEXICANTOWN WHOLESALE DETROIT MI 48210 3.4oz
Category
Food
Distribution
0 states
HighCPSC·12219·2012-07-11
Nikon Recalls Digital SLR Camera Battery Packs Due to Burn Hazard
Nikon is recalling specific EN-EL 15 lithium-ion battery packs sold with D800 and D7000 cameras because they can overheat and melt, posing a burn risk.
Product
Nikon digital SLR camera battery packs
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Food)·F-1694-2012·2012-07-11
Mexican Sweet Bread Recalled for Undeclared Yellow #6
Mexicantown Wholesale recalled 26 units of Cuernos Mexican sweet bread for containing undeclared Yellow #6. The products were distributed in Canada.
Product
CUERNOS: 1) CUERNOS/CROISSANT (MEXICAN SWEET BREAD/Pain sucre) IMPORTED BY MAX PRODUCTS LEAMINGTON 519-325-1176, 4 oz., UPC 9564000035; 2) CUERNOS PLAIN (MEXICAN SWEET BREAD/PAIN SUCRE) IMPORTED BY FIESTA WHOLESALE MISSISSAUGA ON. 416-833-5959 416-509-8349 4.0OZ, UPC: 9564000035
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-1936-2012·2012-07-11
Microbiologics Recalls KWIK-QC Gram Stain Slides Due to Fixation Defect
Microbiologics is recalling KWIK-QC Gram Stain Slides because the control organism is not properly fixated, which may lead to slide contamination and potential patient misdiagnosis.
Product
Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed Derivative, MediMart Europe, 11 rue Emile, Zola B.P. 2332, 38933 Grenoble Cedex 2 France. They are microscope slide preparations contains specific organisms…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1708-2012·2012-07-11
Ultradent Recalls Cinnamon Xylishield Gum Due to Missing Soy Allergen Labeling
Ultradent is recalling 36 lots of Cinnamon Xylishield gum because the packaging fails to list soy as an ingredient. The gum was distributed globally.
Product
Cinnamon Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is red, white, and black with black, red and white print writing. The product is advertised for use in fighting against tooth decay. Part number 8419.
Category
Food
Distribution
1 state
HighFDA (Food)·F-1709-2012·2012-07-11
Ultradent Recalls Cinnamon Xylishield Gum Due to Missing Soy Allergen Labeling
Ultradent is recalling 36 lots of cinnamon Xylishield gum because the ingredients label failed to list soy, a major allergen.
Product
Xylishield Dental Care Kit containing 60 pieces of Cinnamon Xylishield gum. The product is packaged in blue and white packaging with black and white print writing. The product is advertised as a defense against cavities. Part number 8405.
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1911-2012·2012-07-11
DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems
DePuy Orthopaedics is recalling ULTIMA LX and LUSTER Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations due to a Field Safety Notice.
Product
ULTIMA*LX STM,POL 10/12TAP/1M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1916-2012·2012-07-11
DePuy Recalls Luster and Ultima Hip Stems Implanted with Metal-on-Metal Articulations
DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima hip stems implanted with metal-on-metal articulations.
Product
LUSTER HIP SZ 2 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1922-2012·2012-07-11
DePuy Luster Hip Stems Recalled for Metal-on-Metal Articulation Concerns
DePuy Orthopaedics is recalling Luster and Ultima LX hip stems implanted with metal-on-metal articulations due to a field safety notice.
Product
LUSTER HIP SZ 8 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1917-2012·2012-07-11
DePuy Luster Hip Stems Recalled for Metal-on-Metal Articulation Concerns
DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima LX hip stems implanted with metal-on-metal articulations.
Product
LUSTER HIP SZ 3 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1684-2012·2012-07-11
Newly Weds Foods Recalls Turkey Marinade Due to Salmonella Risk
Newly Weds Foods is recalling 50 lb. bags of Turkey Dripping Type Marinade X1 because it was made with a yeast extract contaminated with Salmonella.
Product
Turkey Dripping Type Marinade X1, 50 lb. bags, Manufactured by Newly Weds Foods, Chicago, IL 60639, product G00988
Category
Food
Distribution
7 states
HighFDA (Devices)·Z-1920-2012·2012-07-11
DePuy Luster Hip Stems Recalled for Metal-on-Metal Articulation Use
DePuy Orthopaedics is issuing a Field Safety Notice for Luster and Ultima LX hip stems implanted with metal-on-metal articulations.
Product
LUSTER HIP SZ 6 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1696-2012·2012-07-11
Mexican Sweet Bread Recalled for Undeclared Yellow 6
Mexicantown Wholesale is recalling 26 units of Mexican Sweet Bread imported by El Campeon Leamington due to undeclared Yellow 6.
Product
MAGDALENAS (MEXICAN SWEET BREAD) IMPORTED BY EL CAMPEON LEAMINGTON 519-324-2616 4.0oz
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-1919-2012·2012-07-11
DePuy Recalls Luster and Ultima Hip Stems Implanted with Metal-on-Metal Components
DePuy Orthopaedics issued a Field Safety Notice for Luster and Ultima hip stems implanted with metal-on-metal articulations.
Product
LUSTER HIP SZ 5 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1907-2012·2012-07-11
DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems
DePuy Orthopaedics is issuing a Field Safety Notice for ULTIMA LX and LUSTER Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations.
Product
ULTIMA*LX STM,POL 10/12TAP/SZ2 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1700-2012·2012-07-11
Mexican Sweet Bread Recalled for Undeclared Yellow 6 Dye
Mexicantown Wholesale is recalling Tortugas Mexican Sweet Bread due to undeclared Yellow 6 dye. The recall affects 26 products distributed in Canada.
Product
TORTUGAS (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 4.0oz
Category
Food
Distribution
0 states
HighFDA (Food)·F-1704-2012·2012-07-11
Mexican Bread Recalled for Undeclared Food Dyes
Mexicantown Wholesale recalled Conchas (Mexican Bread) in Canada due to undeclared Yellow #5 and Yellow #6.
Product
CONCHAS (MEXICAN BREAD) IMPORTED BY MAX PRODUCTS LEAMINTON 519-325-1176 4/4.0oz
Category
Food
Distribution
0 states
HighFDA (Food)·F-1702-2012·2012-07-11
Mexican Sweet Bread Recalled for Undeclared Artificial Food Dyes
Mexicantown Wholesale recalled Polvorones Con Fresa (Mexican Sweet Bread) for containing undeclared Yellow #6 and Red #40.
Product
POLVORONES CON FRESA (MEXICAN SWEET BREAD) IMPORTED BY EL CHARRO MEXICANTOWN BAKERY DETROIT MI 48210 3.4oz 21-MAY-12
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-1912-2012·2012-07-11
DePuy Recalls Cemented Polished Femoral Hip Stems Due to Metal-on-Metal Use
DePuy Orthopaedics is issuing a Field Safety Notice for LUSTER and ULTIMA LX Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations.
Product
ULTIMA*LX STM,POL 10/12TAP/2M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1908-2012·2012-07-11
DePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems
DePuy Orthopaedics is issuing a Field Safety Notice for ULTIMA LX and LUSTER Cemented Polished Femoral Hip Stems implanted with metal-on-metal articulations.
Product
ULTIMA*LX STM,POL 10/12TAP/SZ3 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system…
Category
Medical Device
Distribution
Distributed nationwide

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