December 2012 recalls

411 recalls were announced in December 2012.

What the numbers show

Critical: 23
Severe: 79
High: 198
Moderate: 100
Low: 11

Of the 411 recalls this month scored against our rubric, 6% are Critical, 19% are Severe.

Which agencies issued them

101–200 of 411

ModerateFDA (Devices)·Z-0538-2013·2012-12-26
Zimmer Recalls Coonrad/Morrey Elbow Replacement Kits Due to Pin Error
Zimmer is recalling specific lots of Coonrad/Morrey elbow replacement kits because they may contain an incorrect small inner pin instead of the required regular pin.
Product
Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and securing It with the soli
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0529-2013·2012-12-26
DePuy Mitek Sterile Reamers Recalled for Incorrect Size Labeling
DePuy Mitek is recalling 20 sterile reamers because 7 units were labeled as 11MM but contained 10MM reamers.
Product
DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut through cortical and cancellous bone during Cruciate Ligament Repair/Reconstruction of the knee.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0563-2013·2012-12-26
Dako CoverStainer Slide Rack Recalled for Performance Defects
Dako Denmark A/S is recalling CoverStainer Slide Racks because their expected lifetime does not meet performance requirements due to manufacturing variations.
Product
CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instrument. The purpose is to hold microscopic slides, during transfer through the staining process. The rack can hold up to 10 slides at a time, and is necessary for optimal CoverStainer i
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0535-2013·2012-12-26
Titan Spine Recalls Endoskeleton TA VBR Implants for Labeling Errors
Titan Spine is recalling 92 Endoskeleton TA VBR implants because their labels contain incorrect indications for use.
Product
Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant VBR 2107-0218 18mm Large Endoskeleton Implant VBR 2107-0220 20mm Large Endoskeleton Implant VBR Endoskeleton TA VBR is intended
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0846-2013·2012-12-26
Arnold's Candies Wintergreen Puffs Recalled for Missing Color Additives on Label
Arnold's Candies Wintergreen Puffs are being recalled because the label failed to list Yellow #5 and Blue #1. The product was distributed in New York, Ohio, and Pennsylvania.
Product
Arnold's Candies Handmade Since 1953 www.arnoldscandies.com Wintergreen Puffs***INGREDIENTS: Sugar, Cream of Tarter, Artificial Flavoring and Coloring WARNING: Manufactured in a facility that also handles peanuts NET WT 6 oz (170g) 0 73629 00308 0 931 High Grove Blvd Akron, OH 4
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-0568-2013·2012-12-26
Medline Angio Drape Pack Recall Due to Sterility Misidentification
Medline is recalling 105 Angio Drape Packs because a non-sterile waste bag was assumed to be sterile by customers.
Product
Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste bag, for use by the Interventional Radiology Department; Packaged for Medline Industries, Inc.; Reorder #DYNJ35993D This custom pack includes components necess
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0558-2013·2012-12-26
Integra LifeSciences Recalls Mayfield Composite Series Base Units
Integra LifeSciences is recalling Mayfield Composite Series Base Units and Skull Clamps due to performance issues that could impact functionality.
Product
MAYFIELD Composite Series Base Unit, Model A3101, a Swivel Adaptor (A3018) is an integral component of the Base Unit, Model A3101. The MAYFIELD Base Unit (A3101) is an operating room table accessory intended to be used to support a patient during diagnostic examination and/or
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0527-2013·2012-12-26
Biomet Recalls EBI XFIX DFS Rail System Due to Missing Markings
Biomet is recalling 49 units of the EBI XFIX DFS Rail System because graduation markings were missing on 14 swivel clamps.
Product
EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fixator rail, modular bone screw clamps, and compression and distraction units. The device is used in the treatment of bone fractures.
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-0572-2013·2012-12-26
Beckman Coulter Recalls Access hLH Calibrators Due to Stability Test Failures
Beckman Coulter is recalling Access hLH Calibrators because stability testing failed to verify expiration dating. The affected lots did not meet procedural requirements for shelf-life.
Product
The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. The Access hLH Calibrators are intended to calibrate the Access h
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0565-2013·2012-12-26
Del Mar Reynolds Medical Recalls BleaseFocus Anesthesia Workstations Due to Manual Error
Del Mar Reynolds Medical is recalling BleaseFocus Anesthesia Workstations and 700/900 Series Ventilators because the user manuals describe a secondary oxygen supply failure alarm that is not actually installed in the devices.
Product
BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would co
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0598-2013·2012-12-26
Medrad Continuum MR Infusion System Tubing Sets Recalled for Flow Accuracy Issues
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Primary Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functio
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0532-2013·2012-12-26
Medline Total Knee CDS Recalled for Sterile Component Misplacement
Medline Industries is recalling 18 Total Knee CDS packs because a back table cover was placed in the non-sterile portion of the pack instead of the sterile portion.
Product
Medline Total Knee CDS; a single patient prescription procedure pack and disposables, including a back table cover; Product Usage: This Complete Delivery Systems (CDS) custom pack includes components necessary for a total knee replacement surgical procedure.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0607-2013·2012-12-26
Varian Segmented Cervix Applicator Set Recalled for Difficult Disconnection
Varian Medical Systems is recalling 15 units of the Segmented Cervix Applicator Set because the guide tube is difficult to disconnect from the cervical sleeve.
Product
Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tube for segments and cervical sleeves in the Segmented Cervix Applicator Set was developed to treat cancer of the cervix, vagina, endometrium, v
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0571-2013·2012-12-26
BioMotion SpineSix Medical Device Field Correction for Regulatory Deficiencies
BioMotion Medical Systems is issuing a field correction for SpineSix treatment tables to address regulatory deficiencies and prepare for premarket clearance.
Product
SpineSix consists of a motorized treatment table that is controlled by an integral computer. The system is operated by means of 12-inch Color LCD touch screen that displays treatment time, positioning and magnitude and direction of motion. There are eight fully customizable Pati
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-0596-2013·2012-12-26
Medrad Continuum MR Infusion System Tubing Sets Recalled for Flow Rate Issues
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Standard Administration Kit Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR p
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0604-2013·2012-12-26
Medrad Continuum MR Infusion System tubing sets recalled for flow accuracy issues
Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.
Product
Medrad(R) Continuum MR Infusion System Secondary VSA Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure f
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0528-2013·2012-12-26
Mindray Recalls V Series Patient Monitors Due to Touchscreen Malfunction
Mindray is recalling V Series patient monitors because the touchscreens may stop responding to touch.
Product
Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China One product, V Series monitor, available in two sizes: The V12 has a 12 inch screen,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0593-2013·2012-12-26
Bausch + Lomb Stellaris PC Vision Enhancement System Recall
Bausch & Lomb is recalling 124 Stellaris PC Vision Enhancement System modules because they may need recalibration.
Product
Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of cataracts, anterior, and posterior segment vitrectomy.
Category
Medical Device
Distribution
0 states
LowFDA (Drugs)·D-097-2013·2012-12-26
Genentech Recalls CellCept Capsules Due to Short Fill Issues
Genentech is recalling 1,128 bottles of CellCept (mycophenolate mofetil) 250 mg capsules because some bottles contained fewer than 120 capsules as labeled.
Product
CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per carton, NDC 0004-0259-05; b) 120-count capsules per bottle, NDC 0004-0259-51; Made in Ireland; Distributed by: Genentech USA, Inc., South San Francisco, CA 94080.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Food)·F-0829-2013·2012-12-26
Garden Fresh Gourmet Recalls Salted Tortilla Chips for Quality Standards
Garden Fresh Salsa, Inc. is recalling specific lots of Garden Fresh Gourmet Salted Tortilla Chips because the ingredients did not meet quality standards.
Product
Garden Fresh Gourmet Kettle Style Original Salted Tortilla Chips 14oz (397 g) bags
Category
Food
Distribution
3 states
LowFDA (Drugs)·D-094-2013·2012-12-26
Watson Recalls Caziant Tablets Due to Out-of-Specification Impurities
Watson Laboratories is recalling Caziant tablets because out-of-specification results were obtained for a known impurity.
Product
Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Wa
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-095-2013·2012-12-26
Bracco Recalls Choletec Kits Due to Particulate Matter
Bracco Diagnostic Inc is recalling Choletec kits because they may contain particulate matter, including potential charcoal particulates.
Product
CHOLETEC — CHOLETEC (MEBROFENIN)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-098-2013·2012-12-26
Johnson & Johnson Recalls Clean & Clear Foaming Wash for High Salicylic Acid
Johnson & Johnson is recalling Clean & Clear Advantage 3-in-1 Foaming Wash because it contains superpotent levels of salicylic acid.
Product
Clean & Clear advantage, 3-in-1 foaming wash 8 FL. OZ. (240 mL) bottle, OTC, Distributed in the US by: Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies Inc. Skillman, NJ 08558-9418 NDC 58232-0326-8
Category
Drug
Distribution
Distributed nationwide
LowFDA (Food)·F-0827-2013·2012-12-26
Garden Fresh Recalls Nacho Cheese Tortilla Chips for Quality Standards
Garden Fresh Salsa, Inc. is recalling specific lots of Nacho Cheese Tortilla Chips because ingredient quality standards were not met.
Product
Garden Fresh Gourmet Nacho Cheese Tortilla Chips 14oz bags
Category
Food
Distribution
3 states
SevereNHTSA·12V599000·2012-12-21
Keystone Recalls 2012-2013 Springdale Travel Trailers Due to Propane Leak Risk
Keystone is recalling 2012-2013 Springdale travel trailers because the suspension may contact the propane line, creating a fire or explosion risk.
Product
KEYSTONE — KEYSTONE SPRINGDALE
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·12V601000·2012-12-21
Freightliner Trucks Recalled for APU Door Detachment Hazard
Daimler Trucks North America is recalling 2012 Freightliner Cascadia and Coronado trucks because an auxiliary power unit door may fall off, creating a road hazard.
Product
FREIGHTLINER — FREIGHTLINER CORONADO, CASCADIA
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·12V597000·2012-12-20
Suzuki Recalls 2007 XL-7 Vehicles for Fuel Pump Module Cracking Risk
American Suzuki is recalling 2,830 model year 2007 XL-7 vehicles in four states because a cracked fuel pump module could cause a fuel leak and potential fire.
Product
SUZUKI — SUZUKI XL7
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·12V596000·2012-12-20
Airstream Recalls 2008-2013 Interstates Due to Electrical Fire Risk
Airstream is recalling 2008-2013 Interstate motorhomes with rear sofa floor plans because electrical equipment may contact metal components, posing a fire risk.
Product
AIRSTREAM — AIRSTREAM INTERSTATE
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·12V598000·2012-12-20
Jerr-Dan Recalls 50 Ton Wreckers Due to Frame Mounting Hardware Defect
Jerr-Dan is recalling 2009-2012 50 Ton Heavy-Duty Wreckers because mounting hardware may become loose or fracture, increasing crash risk.
Product
JERR-DAN — JERR-DAN 50 TON WRECKER
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·13078·2012-12-20
Muddy Outdoors Recalls Tree Climbing Sticks Due to Breakage Risk
Muddy Outdoors is recalling tree climbing sticks because they can break, posing a risk of serious injury or death. Consumers should stop using them and seek a refund or replacement.
Product
Muddy Outdoors Tree Climbing Sticks
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·13081·2012-12-20
Papyrus Red Decorative Trees Recalled Due to Mold Exposure Risk
Papyrus is recalling red 17-inch decorative trees because Aspergillus mold spores were found on the products, posing a risk to individuals with chronic health problems or impaired immune systems.
Product
2012 PAPYRUS Signature Collection Tree
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·13082·2012-12-20
Papyrus Picture Frames Recalled Due to Mold Spore Exposure Risk
CPSC recalls 2012 Papyrus Signature Collection picture frames due to Aspergillus mold spores. Consumers should return the frames to Papyrus stores for a refund.
Product
2012 PAPYRUS Signature Collection Picture Frames
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·13080·2012-12-20
Papyrus Holiday Ornaments Recalled Due to Mold Exposure Risk
CPSC recalls 2012 Papyrus holiday ornaments due to Aspergillus mold spores. Consumers should return the items to Papyrus or Carlton Cards stores for a refund.
Product
2012 PAPYRUS Holiday Signature Ornaments
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·13079·2012-12-20
Sassy and Carter's Hug N' Tug Toys Recalled for Choking Hazard
Sassy and Carter's Hug N' Tug baby toys are recalled because beads inside the clear plastic sphere can be released, posing a choking hazard to young children.
Product
Sassy®- branded Hug N' Tug Puppy and Monkey and Carter's®-branded Hug N' Tug Monkey Toys
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·12E056000·2012-12-20
Vega Recalls XTS Motorcycle Helmets for Impact Safety Noncompliance
Vega Helmet Corporation is recalling specific XTS motorcycle helmets that may fail to meet federal impact attenuation standards, increasing injury risk in crashes.
Product
EQUIPMENT:MOTORCYCLE:HELMETS recall
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0812-2013·2012-12-19
Berres Brothers Coffee Recalled for Undeclared Walnut Allergen
Berres Brothers Coffee Roasters is recalling specific coffee products because they contain undeclared walnut, a major food allergen.
Product
Berres Brothers Coffee Roasters Mocha Monkey regular whole bean coffee packaged in 5 lb bulk bags with UPC 746774-00509.
Category
Food
Distribution
39 states
CriticalFDA (Food)·F-0820-2013·2012-12-19
Baugher's Unpasteurized Apple Cider Recalled Due to E. coli 0157:H7 Illnesses
Baugher Enterprises is recalling unpasteurized apple cider linked to confirmed E. coli 0157:H7 foodborne illnesses. The product was sold in Maryland and the Gettysburg, PA area.
Product
Baugher's Apple Cider, one gallon and half gallon plastic jugs, with plastic caps labeled in part ***Fresh*** Preservatives added-keep under refrigeration***. Jugs are labeled in part ***FDA Required Warning: This product has not been pasteurized and therefore may contain harmful
Category
Food
Distribution
1 state
CriticalFDA (Food)·F-0818-2013·2012-12-19
Lin-Mar Partners Recalls Longhorn Bars Due to Salmonella Risk
Lin-Mar Partners Inc. is recalling Longhorn Bars because they may be contaminated with Salmonella, which can cause serious illness.
Product
Longhorn Bar Roasted Peanut with Chocolate (1.23 oz), 144 units per case. The bars are in packaging labeled as Longhorn Bars and have a picture of roasted peanuts and chocolate.
Category
Food
Distribution
1 state
CriticalFDA (Food)·F-0816-2013·2012-12-19
Berres Brothers Coffee Recalled for Undeclared Walnut Allergen
Berres Brothers Coffee Roasters is recalling three coffee flavors because they contain undeclared walnut, a major food allergen.
Product
Berres Brothers Coffee Roasters Lunch with Elvis regular ground coffee packaged in the following sizes: 1.5 oz. (42.5g) with UPC 746774-000425, and 12 oz. (340g) bags with no UPC.
Category
Food
Distribution
39 states
CriticalFDA (Food)·F-0819-2013·2012-12-19
Lin-Mar Recalls Longhorn Peanut Butter Trail Mix Bars for Salmonella Risk
Lin-Mar Partners Inc is recalling Longhorn Bar Peanut Butter Trail Mix Protein Bars due to potential Salmonella contamination.
Product
Longhorn Bar Peanut Butter Trail Mix (1.80 oz), 144 units per case. The bars are in packaging labeled as Longhorn Bars and have a picture of roasted peanuts and trail mix.
Category
Food
Distribution
1 state
SevereFDA (Devices)·Z-0496-2013·2012-12-19
Medtronic SynchroMed EL Pumps Recalled Due to Unapproved Drug Interactions
Medtronic is recalling SynchroMed EL implantable infusion pumps because using unapproved drugs can cause the pump to stop working, halting drug delivery.
Product
SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump is part of an implanted infusion system that consists of a SynchroMed EL pump and a catheter. The SynchroMed EL Infusion System is indicated fo
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0497-2013·2012-12-19
Medtronic SynchroMed II Pumps Recalled for Motor Stall Risk
Medtronic is recalling SynchroMed II pumps because unapproved drugs can cause motor stalls and stop drug delivery.
Product
Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the Sy
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-0811-2013·2012-12-19
Berres Brothers Coffee Recalled for Undeclared Walnut Allergen
Berres Brothers is recalling specific coffee products because they contain undeclared walnut, a major food allergen.
Product
Berres Brothers Coffee Roasters Chocolate & Peanut Butter Decaffeinated ground coffee packaged in 12 oz. (340g) bags with no UPC.
Category
Food
Distribution
39 states
HighFDA (Food)·F-0815-2013·2012-12-19
Berres Brothers Coffee Recalled for Undeclared Walnut Allergen
Berres Brothers Coffee Roasters is recalling specific coffee products because they contain undeclared walnut, a major food allergen.
Product
Berres Brothers Coffee Roasters Lunch with Elvis decaffeinated whole bean coffee packaged in 12 oz. (42.5g) bags with no UPC.
Category
Food
Distribution
39 states
HighNHTSA·12V594000·2012-12-19
GM Recalls 2010-2012 Chevrolet Colorado and GMC Canyon for Hood Latch Defect
General Motors is recalling 2010-2012 Chevrolet Colorado and GMC Canyon vehicles because the hood may be missing a secondary latch, which could open unexpectedly and obstruct the driver's view.
Product
CHEVROLET — CHEVROLET, GMC COLORADO, CANYON
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·13076·2012-12-19
Canon Recalls WFT-E7A Wireless File Transmitter for Allergic Reaction Risk
Canon is recalling WFT-E7A wireless file transmitters because a chemical in the rubber top cover may cause skin irritation. Consumers should stop using the unit and contact Canon for a free repair.
Product
WFT-E7A Wireless File Transmitter
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·13712·2012-12-19
Arctic Cat Recalls Bearcat Snowmobiles Due to Fuel Leak Fire Hazard
Arctic Cat is recalling about 3,900 model year 2013 Bearcat snowmobiles because the fuel tank can leak, posing a fire hazard.
Product
Arctic Cat Snowmobiles
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0499-2013·2012-12-19
Voluntary Recall of Specific Lots of Reusable TENS Electrodes
Covidien is voluntarily recalling specific lots of reusable TENS electrodes because manufacturing process exposure to an employee with a minor cut may have occurred.
Product
Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0523-2013·2012-12-19
Becton Dickinson Recalls BD BBL Taxo XV Factor Strips Due to Manufacturing Defects
Becton Dickinson is recalling 650 vials of BD BBL Taxo XV Factor Strips because they were not manufactured to specifications and may cause false negatives or misidentification of Hemophilus species.
Product
BD BBL Taxo XV Factor Strips, Catalog number 231104, in shelf pack vials, fifty strips/vial labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152 USA 800-638-8663, www.bd.com/ds***
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0809-2013·2012-12-19
Berres Brothers Coffee Recalled for Undeclared Walnut Allergen
Berres Brothers is recalling specific coffee products because they contain undeclared walnut, a major food allergen.
Product
Berres Brothers Coffee Roasters Chocolate & Peanut Butter Decaffeinated whole bean coffee packaged in 12 oz. (340g) bags with no UPC code.
Category
Food
Distribution
39 states
HighFDA (Food)·F-0808-2013·2012-12-19
Berres Brothers Coffee Recalled for Undeclared Walnut Allergen
Berres Brothers Coffee Roasters is recalling specific coffee products because they contain undeclared walnut, a major food allergen.
Product
Berres Brothers Coffee Roasters Chocolate & Peanut Butter regular whole bean coffee packaged in the following sizes: 12 oz. (340g) UPC 746774-003594 and 5 LB bulk, UPC 746774-00499.
Category
Food
Distribution
39 states
HighFDA (Food)·F-0810-2013·2012-12-19
Berres Brothers Coffee Recalled for Undeclared Walnut Allergen
Berres Brothers Coffee Roasters is recalling specific coffee products because they contain undeclared walnut, a major food allergen.
Product
Berres Brothers Coffee Roasters Chocolate & Peanut Butter regular ground coffee packaged in the following sizes: 1.5 oz. (42.5g) with UPC 746774-00042, 2.5 oz. with no UPC, and 12 oz. (340g) bags with UPC 746774-00359.
Category
Food
Distribution
39 states
HighFDA (Food)·F-0807-2013·2012-12-19
Turkana Valley Dried Apricots Recalled for Undeclared Sulfites
Turkana Food Inc. is recalling Turkana Valley Dried Apricots because they contain undeclared sulfites, a potential allergen.
Product
Turkana Valley Dried Apricot 250 g, UPC 8692594007804 and 500 g UPC 8692594007811 Tunas Gida, San Ve Tic. Ltd. Sti 2 Org. San. Bol. Celal Dogan Bulvari No.:3 Baspinar Gaziantep/ Turkey packaged in plastic container
Category
Food
Distribution
0 states
HighNHTSA·12E055000·2012-12-19
Harsco Rail Recalls HY-RAIL Rear Guide Wheel Units Due to Weld Defect
Harsco Rail is recalling specific HY-RAIL rear guide wheel units installed on work trucks due to a potentially insufficient weld on the upper structure.
Product
EQUIPMENT recall
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-0813-2013·2012-12-19
Berres Brothers Coffee Roasters Recalls Coffee for Undeclared Walnut
Berres Brothers is recalling three coffee flavors because they contain undeclared walnut. Consumers should stop using the affected products.
Product
Berres Brothers Coffee Roasters Mocha Monkey regular ground coffee packaged in 1.5 oz. (42.5g) bags with UPC 746774-000425.
Category
Food
Distribution
39 states
HighFDA (Food)·F-0814-2013·2012-12-19
Berres Brothers Coffee Recalled for Undeclared Walnut Allergen
Berres Brothers Coffee Roasters is recalling specific coffee products because they contain undeclared walnut, a major food allergen.
Product
Berres Brothers Coffee Roasters Lunch with Elvis regular whole bean coffee packaged in the following sizes: 12 oz. (340g) bags with no UPC, and 5 lb bulk bags with UPC 746774-5093
Category
Food
Distribution
39 states
HighFDA (Devices)·Z-0495-2013·2012-12-19
Philips IntelliVue Information Center Recall for Audible Alarm Loss
Philips Healthcare is recalling IntelliVue Information Center software due to a potential loss of audible alarms caused by damaged internal audio cable contacts.
Product
Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0478-2013·2012-12-19
Verathon Recalls GlideScope Video Laryngoscopes Due to Blade Cracking
Verathon is recalling GlideScope GVL3, GVL4, and GVL5 video laryngoscopes because their reusable blades may crack.
Product
The GlideScope Video Laryngoscope (GVL) is a video laryngoscope that incorporates a high-resolution color camera, an LED light source, a rechargeable lithium battery, and video output to a remote monitor. It consists of a video laryngoscope and a portable video monitor. The af
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0823-2013·2012-12-19
Costco Recalls Cold-Smoked Atlantic Salmon Due to Salmonella Risk
Costco is recalling 41,601 packages of Foppen Norwegian Smoked Salmon because Salmonella was found on a production line in Greece.
Product
Cold-Smoked Atlantic Salmon in vacuum packed plastic, labeled in part: "FOPPEN NORWEGIAN SMOKED SALMON SLICES INCLUDES PACKET OF HONEY MUSTARD DILL SAUCE READY TO EAT PEPPERED TRADITIONAL DILL NET WT 12oz / 341g (291g Salmon + 50g Sauce 8 712224 129277***INGREDIENTS SALMON: Atlan
Category
Food
Distribution
0 states
HighFDA (Food)·F-0817-2013·2012-12-19
Berres Brothers Coffee Roasters Recalls Coffee for Undeclared Walnut
Berres Brothers Coffee Roasters is recalling three coffee flavors because they contain undeclared walnut.
Product
Berres Brothers Coffee Roasters Lunch with Elvis decaffeinated ground coffee packaged in 12 oz. (340g) bags with no UPC.
Category
Food
Distribution
39 states
ModerateFDA (Devices)·Z-0518-2013·2012-12-19
Quasar Bio-Tech Recalls Unapproved Infrared LED Lamps and Accessories
Quasar Bio-Tech is recalling the Quasar MD and other infrared LED devices because they are unapproved for marketing in the United States.
Product
Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD INCLUDES***QUASAR MD***USER MANUAL***12 VOLT POWER SUPPLY***1 OZ PURE SILK SERUM***Made in the USA.***Five year warranty***" The product emi
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0508-2013·2012-12-19
Siemens ADVIA Centaur CA 19-9 Assay Recalled for Temperature Sensitivity
Siemens Healthcare is recalling ADVIA Centaur CA 19-9 assays because room temperature changes can alter test results.
Product
Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use The ADVIA Centaur CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur and ADVIA Ce
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0486-2013·2012-12-19
Roche MagNA Pure 96 System Software Recall
Roche Molecular Systems is recalling 13 MagNA Pure 96 Systems due to a device-associated diagnostic software issue.
Product
The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instrument. There are no corresponding assays.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0506-2013·2012-12-19
Siemens Healthcare BNP Test Kit Recalled for Temperature Sensitivity
Siemens Healthcare is recalling BNP test kits because room temperature changes may affect assay results on ADVIA Centaur systems.
Product
Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test 02816138 10309045, 10309044 028 Intended Use For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur and A
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0507-2013·2012-12-19
Siemens Healthcare Recalls CA 27.29 Assay Kits Due to Temperature Sensitivity
Siemens Healthcare is recalling ADVIA Centaur BR Assay kits for CA 27.29 because room temperature changes can alter test results.
Product
Siemens Healthcare BR Assay for CA 27.29 250 Test Kits 03896216 50 Test Kit 02419937 Ref Kit (US only) 10340081 Intended Use The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0481-2013·2012-12-19
Hospira Recalls Plum A+ Infusion Pumps Due to Reversed Volume Knob
Hospira is recalling Plum A+ single channel infusion pumps because the volume control knob may function in reverse, causing alarm volume to increase when turned clockwise.
Product
Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area networking; Hospira, Inc., Lake Forest, IL 60045; pump list number 11971, module list numbers 12101, 12102 and 12393; pump list number 11973, module list number 12
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0509-2013·2012-12-19
Siemens ADVIA Centaur DHEAS Assay Recalled for Temperature Sensitivity
Siemens Healthcare is recalling ADVIA Centaur DHEAS assays because room temperature changes can alter test results.
Product
Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS) 50 Test 06489701 The ADVIA Centaur DHEAS assay is an in vitro diagnostic immunoassay for the quantitative determination of dehydroepiandrosterone sulfate (DHEAS) in human serum and plasma using the ADVIA Centaur and ADVIA Cent
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0490-2013·2012-12-19
Roche Recalls COBAS INTEGRA 400 Analyzer Software Due to Diagnostic Issue
Roche Molecular Systems is recalling 855 COBAS INTEGRA 400/400 plus systems due to a device-associated diagnostic software issue.
Product
The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0484-2013·2012-12-19
Roche Data Station AMPLILINK Software Recalled for Device-Associated Issue
Roche Molecular Systems is recalling Data Station AMPLILINK software due to a device-associated diagnostic software issue. The software is used with various COBAS instruments for molecular diagnostics.
Product
Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ TaqMan¿ analyzer, COBAS¿ TaqMan¿ 48 analyzer, COBAS¿ AMPLICOR¿ analyzer, and Cobas p 630 instrument for sample preparation, amplification and de
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0483-2013·2012-12-19
Hospira Recalls Plum A+ Infusion Pumps Due to Volume Knob Defect
Hospira is recalling Plum A+ infusion pumps because the volume control knob may reverse the alarm volume direction.
Product
Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local area networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming f
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0510-2013·2012-12-19
Siemens ADVIA Centaur Digitoxin Recalled for Temperature Sensitivity
Siemens Healthcare is recalling ADVIA Centaur Digitoxin tests because room temperature changes may affect assay results.
Product
Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Intended Use For in vitro diagnostic use in the quantitative determination of digitoxin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0488-2013·2012-12-19
Roche Recalls LightCycler 2.0 Instrument Due to Diagnostic Software Issue
Roche Molecular Systems is recalling 1,213 LightCycler 2.0 instruments due to a device-associated diagnostic software issue.
Product
LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0517-2013·2012-12-19
Quasar Bio-Tech Recalls Unapproved Baby Quasar Infrared LED Lamps
Quasar Bio-Tech is recalling Baby Quasar and Baby Quasar Pink infrared LED lamps because the devices are unapproved by the FDA.
Product
Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are labeled in part: "***BABY QUASAR***FOR YOUTHFUL RADIANT SKIN***Skin Rejuvenating System with Sequepulse***Manufactured by: Silver Bay, LLC; Made in the USA, with highest qual
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0513-2013·2012-12-19
Mindray Recalls DPM 6 and 7 Patient Monitors for Software Limitations
Mindray DS USA is recalling 124 DPM 6 and 7 patient monitors because specific calculation features may be unavailable.
Product
DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-le
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0511-2013·2012-12-19
Siemens ADVIA Centaur Folate Assay Recalled for Temperature Sensitivity
Siemens Healthcare is recalling ADVIA Centaur Folate assays because room temperature changes can alter test results.
Product
Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit (US only) 09132781 Ref Kit (US only) 00203473 Intended Use For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cell
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0493-2013·2012-12-19
Roche DataCare POC Software Recalled for Diagnostic Issue
Roche Molecular Systems is recalling 126 units of DataCare POC software due to a device-associated diagnostic issue.
Product
DataCare POC is an information management system that provides data management functionality for managing point-of -care testing data.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0501-2013·2012-12-19
Voluntary Recall of Empi STIMC RE Self Adhesive Electrodes
Covidien is voluntarily recalling specific lots of Empi STIMC RE Self Adhesive electrodes because manufacturing exposure to an employee with a minor cut may have occurred.
Product
Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0492-2013·2012-12-19
Roche DataCara GM Software Recalled for Diagnostic Issue
Roche Molecular Systems is recalling DataCara GM software due to a device-associated diagnostic issue. 479 units were distributed nationwide.
Product
DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0491-2013·2012-12-19
Roche DataInnovations Instrument Manager Software Recalled for Diagnostic Issue
Roche Molecular Systems is recalling DataInnovations Instrument Manager software due to a device-associated diagnostic software issue.
Product
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0489-2013·2012-12-19
Roche COBAS 8000 Analyzer Software Recall for Diagnostic Issue
Roche Molecular Systems is recalling 77 COBAS 8000 modular analyzers nationwide due to a device-associated diagnostic software issue.
Product
The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in-vitro determinations using a wide variety of tests.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0520-2013·2012-12-19
Advanced Sterilization Products Recalls Sterrad Cyclesure 24 Biological Indicators
Advanced Sterilization Products is recalling Sterrad Cyclesure 24 Biological Indicators because the manufacturer lacks adequate data to support the full labeled shelf-life.
Product
STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0505-2013·2012-12-19
ConMed Recalls WANG Transbronchial Aspiration Needles Due to Fit Issues
ConMed is recalling WANG Transbronchial Aspiration Needles because they may not fit through a 2.0 mm bronchoscope, causing minor inconvenience.
Product
WANG Transbronchial Aspiration Needles Cat. No. MW-221, WANG Cytology Needles, Central or Peripheral Regions, 21 g x 15 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with
Category
Medical Device
Distribution
14 states
ModerateFDA (Drugs)·D-091-2013·2012-12-19
Physicians Total Care Recalls Subpotent Enjuvia Tablets
Physicians Total Care is recalling specific lots of Enjuvia tablets because they failed potency tests. The affected medication may contain less active ingredient than labeled.
Product
Enjuvia (synthetic conjugated estrogens, B) tablets, 0.625 mg, 30-count tablets per bottle, Rx only, Mfg. By: Teva Pharmaceuticals USA, Sellersville PA 18960; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6163-1.
Category
Drug
Distribution
1 state
ModerateFDA (Devices)·Z-0485-2013·2012-12-19
Roche MagNA Pure LC Software Recall for Diagnostic Issue
Roche Molecular Systems is recalling 816 MagNA Pure LC instruments due to a device-associated diagnostic software issue.
Product
The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0500-2013·2012-12-19
Voluntary Recall of Performa TENS Electrodes Due to Manufacturing Exposure
Covidien is voluntarily recalling specific lots of Performa TENS electrodes because wire surfaces may have been exposed to an employee with a minor cut during manufacturing.
Product
Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0521-2013·2012-12-19
Leica TdT Staining Reagent Recalled for Stability Issues
Leica Microsystems is recalling 322 vials of Novocastra TdT Staining Reagent because the product is not stable up to its expiry date, affecting staining intensity.
Product
Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro staining reagent for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections; Catalog No. RTU-Td
Category
Medical Device
Distribution
14 states
ModerateFDA (Food)·F0822-2013·2012-12-19
Ella's Kitchen Recalls Apple and Ginger Baby Cookies Due to Mold
Ella's Kitchen is recalling 10,700 units of apple and ginger baby cookies because they may contain mold. The product was distributed nationwide.
Product
Ella's Kitchen yum yummy apple + ginger baby cookies Net Wt. 3.8 oz (108 g) Ella's Daddy's Company Ella's Kitchen Inc. Montclair, NJ 07042 UPC 845901000533 packaged in a chipboard carton with 12 cookies per box
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0515-2013·2012-12-19
Siemens MAVIG PORTEGRA 2 Surgical Light Recall for Missing Component
Siemens is recalling 1,315 MAVIG PORTEGRA 2 surgical lights because a specific component may have been omitted during installation.
Product
MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical light
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0503-2013·2012-12-19
ConMed Recalls WANG Transbronchial Aspiration Needles for Fit Issues
ConMed is recalling WANG Transbronchial Aspiration Needles because they may not fit through a 2.0 mm bronchoscope channel, causing minor inconvenience.
Product
WANG Transbronchial Aspiration Needles Cat. No. MW-322, WANG Cytology Needles, Central, Mediastinal and Hilar Regions, 22 g x 13 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-0498-2013·2012-12-19
Voluntary Recall of Specific Lots of TENS Electrodes Due to Manufacturing Exposure
Covidien is voluntarily recalling specific lots of TENS electrodes because wire surfaces may have been exposed to an employee with a minor cut during manufacturing.
Product
Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulati
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0519-2013·2012-12-19
Quasar Bio-Tech Recalls Unapproved LED Skin Treatment Devices
Quasar Bio-Tech is recalling specific LED skin treatment devices because they are unapproved by the FDA.
Product
Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is an infrared LED lamp. The Baby Blue uses blue LED light to be used in combination with the Baby Quasar to treat acne. The Quasar Power Pack is labeled in part: "***BABY QUASAR & BABY BLUE***QUASAR POWER
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0502-2013·2012-12-19
ConMed Recalls WANG Transbronchial Aspiration Needles Due to Fit Issues
ConMed is recalling WANG Transbronchial Aspiration Needles because they may not fit through a 2.0 mm bronchoscope, causing minor inconvenience.
Product
WANG Transbronchial Aspiration Needles Cat. No. MW-222, WANG Cytology Needles, Central or Peripheral Regions, 22 g x 13 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed for use with
Category
Medical Device
Distribution
14 states
ModerateFDA (Devices)·Z-0487-2013·2012-12-19
Roche LightCycler 1.2 Diagnostic Software Recalled for Device-Associated Issue
Roche Molecular Systems is recalling LightCycler 1.2 software due to a device-associated diagnostic software issue. The recall covers 3,772 units distributed nationwide.
Product
LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis with corresponding assays.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0512-2013·2012-12-19
Siemens Healthcare Recalls ADVIA Centaur Theophylline 2 Assay Kits
Siemens Healthcare is recalling ADVIA Centaur Theophylline 2 assay kits because room temperature changes may affect test results.
Product
Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test 08838753 50 Test 03009619 Intended Use For in vitro diagnostic use in the quantitative determination of theophylline in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0522-2013·2012-12-19
Roche Recalls Cobas b 123 Fluid Pack Cuvettes Due to Thickness Defect
Roche Diagnostics is recalling specific lots of Cobas b 123 Fluid Pack COOX cuvettes because a production error caused a change in layer thickness, leading to a higher failure rate.
Product
Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+, iCa2+ (ISE), hematocrit (Hct), metabolites (Gluc, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHB, COH
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-090-2013·2012-12-19
Physicians Total Care Recalls Subpotent Enjuvia Tablets
Physicians Total Care is recalling 5 bottles of Enjuvia tablets due to low assay results. The medication was distributed in Virginia.
Product
Enjuvia (synthetic conjugated estrogens, B) tablets, 0.3mg, 30-count tablets per bottle, Rx only, Mfg. By: Duramed Pharmaceuticals, Pomona NY 10970; Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK 74146; NDC 54868-6164-1.
Category
Drug
Distribution
1 state
ModerateFDA (Food)·F-0806-2013·2012-12-19
Unified Grogers Recalls Pure Apricot Pecan Flats for Undeclared Sulfites
Unified Grocers is recalling Pure Apricot Pecan Flats because the product may contain undeclared sulfites. The recall covers 2,120 units distributed in California, Alaska, Washington, and Oregon.
Product
Pure Apricot Pecan Flats, 10 units/case, 6oz. UPC 8 73376 00303.
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0821-2013·2012-12-19
Ella's Kitchen Recalls Milk and Vanilla Baby Cookies Due to Mold
Ella's Kitchen is recalling 26,400 units of milk and vanilla baby cookies because they may contain mold. Consumers should stop eating the product and return it to the store.
Product
Ella's Kitchen yum yummy milk + vanilla baby cookies Net Wt. 3.8 oz (108 g) Ella's Daddy's Company Ella's Kitchen Inc. Montclair, NJ 07042 UPC 845901000526 packaged in a chipboard carton with 12 cookies per box
Category
Food
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0504-2013·2012-12-19
ConMed Recalls WANG Transbronchial Aspiration Needles Due to Fit Issues
ConMed is recalling WANG Transbronchial Aspiration Needles because they may not fit through a 2.0 mm bronchoscope, causing minor inconvenience.
Product
WANG Transbronchial Aspiration Needles Cat. No. SW-121, WANG Cytology Needles, Central, Carinal and Mediastinal Regions, 21 g x 15 mm long needle. --- Common Name: Bronchoscope (flexible or rigid) and accessories. The ConMed WANG Transbronchial Aspiration Needles are designed f
Category
Medical Device
Distribution
14 states
LowFDA (Devices)·Z-0482-2013·2012-12-19
Hospira Plum A+ Infusion Pumps Recalled for Reversed Volume Control Knob
Hospira is recalling Plum A+ Hyperbaric Infusion Pumps because the volume control knob may function in reverse, causing alarm volume to increase when turned clockwise.
Product
Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-program
Category
Medical Device
Distribution
Distributed nationwide

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