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Abbott Laboratories: AxSYM Folate Reagent Pack; Abbott Laboratories, Abbott P...
Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument.
FDAJan 19, 2009PR• Abbott Laboratories
Abbott Laboratories: AxSYM CORE 2.0 Reagent Pack; Abbott Laboratories, Abbott ...
Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument.
FDAJan 19, 2009PR• Abbott Laboratories
Children's Sunglasses (Axiom) – Lead Paint Violation (2009)

Children's Sunglasses (Axiom) – Lead Paint Violation (2009)

Ethicon Endo-Surgery Inc: ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutter...
Fire/Burn Risk
The mechanism that connects the articulation joint to the device shaft may cause the jaws of the cutters to remain closed and clamped down on tissue after the device is fired. If the jaws of the device remain clamped down on the tissue, there is a risk the surgery will need to be modified to remove the device. This may lead to an increase in procedure time, tissue manipulation, and a change in t
FDAJan 13, 2009AL, AK, AZ +48 more• Ethicon Endo-Surgery Inc

High Speed Pull-Back Toy Cars (TDI) – Lead Paint Violation (2009)
The recalled pull-back toy car is yellow with "PROWL" printed on the side, "VICTOR" printed on the hood, and a blue and red police warning light on the top.
CPSCJan 13, 2009Nationwide

Boston Scientific Corporation: Gold Probe 10FR Working Length: 300 cm, Probe Tip O.D. 3....
Packaging tray for the Gold Probe Single-Use BiPolar Electrohemostasis Catheters may have a crack. Cracks in the tray or damage to the tray of the Gold Probe device may lead to a compromised sterile barrier.
FDADec 24, 2008Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Gold Probe 7FR Working Length: 300 cm, Probe Tip O.D. 2.3...
Packaging tray for the Gold Probe Single-Use BiPolar Electrohemostasis Catheters may have a crack. Cracks in the tray or damage to the tray of the Gold Probe device may lead to a compromised sterile barrier.
FDADec 24, 2008Nationwide• Boston Scientific Corporation

Calypso Steel Drums (Woodstock) – Lead Paint Violation (2008)
The recalled steel drum is made of steel and comes with two wooden drum sticks and a wooden stand. The sides of the drums are painted red. The drum pan is painted black with silver markings to show the location of notes. Each rim is stamped with a #5 or #6. Not all drums stamped with a #5 are affected by this recall.
CPSCDec 23, 2008Nationwide• Woodstock Percussion Inc., of Shokan, N.Y.

Newport Cribs (Munire) – Lead Paint Violation (2008)
The recalled cribs and furniture are made of wood and have a rubbed black finish. Only the "Newport Rubbed Black" cribs and matching furniture manufactured in Indonesia between April 2006 and November 2008 are included in this recall. The model number, date, and country of manufacture are printed on the label attached to the side panel of the crib and the date of manufacture is on the back panel of the furniture. Models listed below are included in the recall: Model Name 7900 Newport Lifetime Crib 7918 Hutch for Combo & Double Dresser 7915 Mirror 7908 Combo 7902 Nightstand 7907 Conversion Kit for Lifetime Crib 7905 5-Drawer Dresser 7929 Armoire 7975 Guardrail for Lifetime Crib 7906 Double Dresser 7914 Bookcase 7901 Newport OldeWorld Crib
CPSCDec 23, 2008Nationwide• Munire Furniture Inc, of Piscataway, N.J.

Children's Jewelry – Lead Exposure Risk (2008)
This recall involves eight styles of silver-colored metal jewelry: flower ear ring, three flower pendant, necklace with red flower and metal leaf pendant, and miniature sandals in aqua, purple, green, orange and turquoise.
CPSCDec 18, 2008Nationwide

Dinosaur Epoch Toy Dinosaurs – Lead Paint Violation (2008)
The recalled "Dinosaur Epoch" Toy Dinosaurs are battery-operated dinosaurs that move and make sounds. The recall includes the orange-colored "Dinosaur Brachiosaurus" (model #1033) and the green, yellow and orange-colored "Dinosaur Carnotaurus" (model #1030). The model number can be located on the toy's battery cover.
CPSCDec 17, 2008Nationwide

Ethicon Endo-Surgery Inc: Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus I...
Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy or sensitivity. Ethicon Endo-Surgery determined the presence of free nickel in the affected product could elicit a reaction in those patients with nickel sens
FDADec 9, 2008PR• Ethicon Endo-Surgery Inc

Bio-Rad Laboratories Inc: Bio-Rad Variant II Hemoglobin Testing System with CDM v 4...
The wrong barcode number and tube position number may be assigned to samples leading to discrepant sample results.
FDADec 9, 2008Nationwide• Bio-Rad Laboratories Inc

Heart Sync, Inc: Medstorm Adult Radiolucent Leads-Out Electrode - Physio-C...
The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration.
FDADec 5, 2008Nationwide• Heart Sync, Inc

Heart Sync, Inc: Heart Sync Adult Radiolucent Electrode -Physio Control, P...
The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration.
FDADec 5, 2008Nationwide• Heart Sync, Inc

Army Figures – Lead Paint Violation (2008)
The recall involves 7½-inch tall plastic toy Army figures. The figures are dressed in Army fatigues and have guns.
CPSCDec 3, 2008Nationwide

Groovy Fashions Sassy Jammies Doll Clothes (Manhattan) – Lead Paint (2008)
The recalled doll clothing set features a two-piece pajama set, eye mask and slippers. The pajama top is pink satin and the pants are dark brown with multiple-colored flowers printed on them.
CPSCDec 3, 2008Nationwide• Manhattan Group, of Minneapolis, Minn.

Computerized Medical Systems Inc: Interplant Radiation Treatment Planning System, Interplan...
Interplant Software: If the trajectory needle with a non-zero retraction is adjusted in any of the planning views (Transverse, 3D) and the program is closed and reopened, the Needle Definitions page in the Dose Plan Summary (Plan View) displays the needle with a 0.00 retraction even when the needle is displayed correctly in the planning view. If the Eliminate Leading Spacers function is applied t
FDADec 1, 2008Nationwide• Computerized Medical Systems Inc

Millipore Corporation: LIGHT DIAGNOSTICS SimulFluor Flu A/Flu B DFA Kit Immun...
Certain lots of Simulfluor Flu A / Flu B Reagent may cross-react with Respiratory Synctial Virus. The continued use of Simulfluor Flu A / Flu B Reagent Catalog #5250 may lead to a potential misdiagnosis of influenza B.
FDANov 24, 2008AL, CA, CO +22 more• Millipore Corporation

Accuray Inc: Cyberknife Robotic Radiosurgery System. A radiation ther...
System may use random incorrect data to calculate dose. Resulting dose calculation error can exceed 100% of correct dose which may lead to serious patient injury.
FDANov 14, 2008Nationwide• Accuray Inc