January 2013 recalls

322 recalls were announced in January 2013.

What the numbers show

Critical: 24
Severe: 82
High: 140
Moderate: 51
Low: 25

Of the 322 recalls this month scored against our rubric, 7% are Critical, 25% are Severe.

Which agencies issued them

301–322 of 322

SevereFDA (Drugs)·D-105-2013·2013-01-02
Roche Recalls Cymevene Powder for Infusion Due to Sterility Concerns
F. Hoffmann-LaRoche Ltd. is recalling Cymevene 500 mg Powder for Infusion due to container closure issues that compromise sterility assurance. No product was distributed in the USA.
Product
Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche Products Limited, Welwyn Garden City, AL7 1TW, United Kingdom
Category
Drug
Distribution
0 states
SevereNHTSA·13V001000·2013-01-02
GM Recalls 2013 Trucks and SUVs for Transmission Shift Defect
General Motors is recalling 54,686 model year 2013 vehicles due to a transmission defect that may allow the vehicle to roll away.
Product
CHEVROLET — CHEVROLET, GMC, CADILLAC SILVERADO, AVALANCHE 1500, SIERRA, EXPRESS
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Food)·F-0854-2013·2013-01-02
Taylor Farms Hearts of Romaine Lettuce Recalled for Listeria Monocytogenes
Taylor Farms is recalling specific bags of Hearts of Romaine Lettuce after a positive sample of Listeria Monocytogenes was found.
Product
Taylor Farms Hearts of Romaine Lettuce, All Natural, Fresh Hand Selected, Triple Washed and Ready to Enjoy. 10 oz. bags. Taylor Farms, Salinas, CA. UPC 0 30223 04032 3
Category
Food
Distribution
2 states
SevereFDA (Drugs)·D-104-2013·2013-01-02
Alara Recalls Subpotent Levothyroxine Sodium Tablets Due to Stability Issues
Alara Pharmaceutical is recalling 7,432 bottles of Levothyroxine Sodium Tablets because the product is subpotent and has stability issues.
Product
Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San Juan, PR
Category
Drug
Distribution
Distributed nationwide
SevereCPSC·13085·2013-01-02
Brower Recalls Top Hatch Egg Incubators Due to Fire Hazard
Brower is recalling about 2,500 Top Hatch egg incubators because the base can ignite during use, posing a fire hazard. Three fires with property damage have been reported.
Product
Egg Incubator
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Food)·F-0853-2013·2013-01-02
Spence & Co Nova Lox and Smoked Salmon Trimmings Recalled for Listeria
Spence & Co. is recalling refrigerated Nova Lox and Smoked Salmon Trimmings due to Listeria monocytogenes contamination. Consumers should discard or return these products.
Product
Spence &amp; Co New York-Style Nova Lox 4oz , refrigerated Spence &amp; Co Smoked Salmon Trimmings, 2lb bulk (bag)
Category
Food
Distribution
22 states
HighCPSC·13086·2013-01-02
Academy Sports Recalls Game Winner Crossbow Cocking Ropes Due to Laceration Hazard
Academy Sports + Outdoors is recalling Game Winner crossbow cocking ropes because the hooks can break and recoil, posing a laceration hazard.
Product
Game Winner® crossbow cocking ropes
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0594-2013·2013-01-02
Zimmer Spine Ardis Inserter Recalled for Potential Spacer Fragmentation
Zimmer, Inc. is recalling the Spine Ardis Inserter because excessive force can break the PEEK spacer, causing sharp fragments that may damage adjacent structures.
Product
Zimmer Spine Ardis Inserter, Rx, non-sterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-102-2013·2013-01-02
Lloyd Inc. Recalls Subpotent Thyro-Tab 0.075 mg. Tablets
Lloyd Inc. of Iowa is recalling 1.9 million Thyro-Tab 0.075 mg. tablets due to subpotency and stability issues.
Product
Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0611-2013·2013-01-02
Greatbatch Medical Recalls MobiCath Bi-Directional Guiding Sheaths Due to Liner Anomalies
Greatbatch Medical is recalling MobiCath Bi-Directional Guiding Sheaths because visual inspections found loose or frayed liner material inside the device.
Product
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the cor
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-0610-2013·2013-01-02
Stryker T2 Humerus System Teflon Tube Recalled Due to Material Embrittlement
Stryker Howmedica Osteonics is recalling 100 units of the T2 Humerus System Teflon Tube because a manufacturing error caused the tube material to become embrittled.
Product
Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing System is designed to treat complex fractures in Humeral, Femoral, Tibial and Ankle applications. The Teflon Tube is an optional instrument used to exchange the Ball Tip
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0606-2013·2013-01-02
GE T-Piece Resuscitation Circuits Recalled for Pressure Deficiency
GE Healthcare is recalling T-Piece Neonatal Patient Circuit Kits because they cannot achieve maximum Peak Inspiratory Pressure during pre-use checks.
Product
GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Ci
Category
Medical Device
Distribution
47 states
HighFDA (Devices)·Z-0614-2013·2013-01-02
Roche COBAS AmpliPrep Instruments Recalled Due to Disabled Clot Detection Feature
Roche is recalling 7 COBAS AmpliPrep instruments because the sample clot detection feature was disabled during quality control, potentially allowing unflagged clotted samples to be processed.
Product
COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland
Category
Medical Device
Distribution
4 states
HighFDA (Food)·F-0852-2013·2013-01-02
Golub Cinnamon Coffee Cake Recalled for Missing Walnut Allergen Labeling
Golub Corp is recalling CMC Cinnamon Coffee Cakes incorrectly labeled as Pumpkin Coffee Cake, which failed to list walnuts as an ingredient.
Product
CMC Pumpkin Coffee Cake 16 oz UPC: 041735225726 Price Chopper/Box
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-0612-2013·2013-01-02
Beckman Coulter Recalls Access Immunoassay Systems Due to Pulley Defects
Beckman Coulter is recalling Access Immunoassay Systems because pulley drive components may break or disconnect, causing inadequate washing or mixing.
Product
Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part Numbers: Access 81600; Access 2 81600N, 386220, A69186, A25656, A12900; Access 2 (LXi) A15642; Access 2 Section, DxC 600i
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0616-2013·2013-01-02
Brookstone Recalls Heated Body Beans Due to Burn Risk
Brookstone is recalling 109,956 electrically heated body bean products nationwide due to a risk of skin burns.
Product
Brookstone Heated Body Bean, electrically heated SKU numbers: 734863 (Blue), 734864 (Plum), 734865 (Red). Brookstone 3 in 1 wrap ,SKU734397 (Brown). The Products are liquid filled bean shaped pouches that are electrically heated and then detached from the charger prior to u
Category
Consumer Product
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0615-2013·2013-01-02
Arjo Flowtron Trio DVT Pump Recalled for Lack of FDA Approval
Arjo, Inc. is recalling 2,859 Flowtron Trio DVT Pumps because they were marketed without proper FDA approval.
Product
Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB, Eslov, Sweden; Model 512003; a non-invasive prophylaxis system for reducing the incidence of deep vein thrombosis.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0609-2013·2013-01-02
Sanofi-Aventis Recalls Diamigo Diabetes App Due to Unintended Global Access
Sanofi-Aventis is recalling the Diamigo iPhone app because it was inadvertently made available globally instead of being restricted to Brazil.
Product
Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0613-2013·2013-01-02
Beckman Coulter Recalls Access Total T4 Calibrators Due to Expiration Date Error
Beckman Coulter is recalling Access Total T4 Calibrators because specific lots do not meet their claimed 12-month expiration date.
Product
Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay S
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-103-2013·2013-01-02
Lloyd Inc. of Iowa Recalls Subpotent Levothroid 75 mcg Tablets
Lloyd Inc. of Iowa is recalling 16,548 bottles of Levothroid 75 mcg tablets because the product is subpotent and has a 9-month stability interval.
Product
Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0479-2013·2013-01-02
Philips CT System Software Update Addresses Nonhazardous Reliability Issues
Philips is updating Extended Brilliance Workspace software to version 4.5.5 to fix nonhazardous reliability issues and improve system functionality.
Product
Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of t
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0608-2013·2013-01-02
Radiometer Qualicheck 1+ Quality Control Solution Recalled for Barcode Error
Radiometer America Inc is recalling Qualicheck 1+ quality control solution due to a barcode error that incorrectly enters a pH control range into blood gas analyzers.
Product
Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers.
Category
Medical Device
Distribution
3 states

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