October 2013 recalls

353 recalls were announced in October 2013.

What the numbers show

Critical: 3
Severe: 124
High: 116
Moderate: 95
Low: 15

Of the 353 recalls this month scored against our rubric, 1% are Critical, 35% are Severe.

Which agencies issued them

301–353 of 353

HighFDA (Food)·F-1913-2013·2013-10-02
Breaded Frozen Shrimp Recalled for Undeclared Shellfish and Wheat Allergens
Gourmet Express Marketing is recalling breaded frozen shrimp because the packaging failed to declare shellfish and wheat allergens.
Product
Breaded, frozen shrimp packaged in plastic bags labeled in part: BREADED SHRIMP; NET WEIGHT; 2.0 LBS or 3 LBS
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-1951-2013·2013-10-02
Snoqualmie Falls Candy Factory Recalls Almond Brittle for Milk Allergen Mislabeling
Snoqualmie Falls Candy Factory is recalling Almond Brittle because the label lists butter and cream but omits milk, a major allergen. The product was distributed in Washington.
Product
Almond Brittle's label is read in parts:"***ALMOND BRITTLE***INGREDIENTS: Sugar, corn syrup, almonds, brown sugar, butter (cream, salt), baking soda, salt. NO PRESERVATIVES ADDED***Net Wt. 8 oz.***www.snofallscandy.com***Toll Free 1-888-636-CANDY***".
Category
Food
Distribution
1 state
HighFDA (Food)·F-1958-2013·2013-10-02
Taylor Farms Salad Kit Recalled for Undeclared Milk Allergen
Taylor Farms is recalling Sensations Asian Supreme Salad Kits because they contain feta cheese with undeclared milk, a FALCPA violation.
Product
Sensations Asian Supreme Salad Kit; 220 g/7.8 oz. Product os USA/Produit des E. U. A. Taylor Farms, Salinas, CA 93901
Category
Food
Distribution
0 states
HighFDA (Food)·F-1947-2013·2013-10-02
Semifreddi's Almond Biscotti Recalled for Undeclared Milk and Soy Allergens
Semifreddi's Inc. is recalling Almond Biscotti products due to undeclared milk and soy allergens. Consumers should check their 'Enjoy By' dates and stop consuming the product.
Product
Almond Biscotti, 1 oz. and 0.5 oz. wrapped in plastic, with "Enjoy By dates prior to 091614, manufactured by Semifreddi's Inc, Alameda, CA. Product size and UPC codes 0.5 oz., case of 100 units 758843915936, 1.0 oz., box of 4 units 758843915738 , 1.0 oz., box of 12 unit
Category
Food
Distribution
8 states
HighFDA (Food)·F-1952-2013·2013-10-02
Snoqualmie Falls Candy Factory Recalls Coconut Peanut Brittle for Milk Allergen
Snoqualmie Falls Candy Factory is recalling Coconut Peanut Brittle because the label lists butter and cream but omits milk, a major allergen.
Product
Coconut Peanut Brittle's label is read in parts:"***COCONUT PEANUT BRITTLE***INGREDIENTS: Coconut (preserved with sodium metabisulfate), peanuts, white sugar, glucose, water, butter (cream, salt), vanilla, salt***Net Wt. 8 oz.***www.snofallscandy.com***Toll Free 1-888-636-CANDY**
Category
Food
Distribution
1 state
HighFDA (Food)·F-1909-2013·2013-10-02
Bubbles Baking Co. Recalls Blueberry Muffins and Loaf Cakes for Allergens
Bubbles Baking Co. is recalling blueberry muffins and loaf cakes because they may contain undeclared milk and soy.
Product
First Street Blueberry Muffins (S 45395), 14 oz., 9 trays/case, UPC 0 4151210833 4
Category
Food
Distribution
1 state
HighFDA (Food)·F-1945-2013·2013-10-02
James Farm Cut Green Beans Recalled for Listeria Contamination
Restaurant Depot is recalling James Farm brand cut green beans due to Listeria monocytogenes contamination found in private laboratory testing.
Product
JAMES FARM brand CUT GREEN BEANS (EJOTES CORTADOS), FRESH FROZEN, NET WT. 32 OZ. (2 LBS.) 907 g, UPC 7 60695 01004 2, PRODUCT OF POLAND -- Distributed by RD/JET, LLC 15-24 132nd Street, College Point, NY 11356 --- Product is harvested, sorted, graded, washed, cut/processed and bl
Category
Food
Distribution
8 states
HighFDA (Devices)·Z-2262-2013·2013-10-02
Maquet Cardiovascular Recalls QUADROX Oxygenators Due to Bond Strength Defects
Maquet Cardiovascular is recalling specific lots of QUADROX oxygenators used in cardiac surgery because they may not meet specifications for bond strength on connectors.
Product
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2264-2013·2013-10-02
Endoplus 5mm Laparoscopic Grasper Recalled for Broken Jaw
Endoplus is recalling 81 units of 5mm Atraumatic Graspers because the moveable jaw broke during surgery. The devices were distributed in Florida, Texas, and Virginia.
Product
ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2284-2013·2013-10-02
Medtronic Xomed Recalls Universal Titanium Ear Prosthesis Due to Assembly Error
Medtronic Xomed is recalling 60 units of Universal Titanium Prosthesis because one lot was assembled with the wrong component.
Product
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2261-2013·2013-10-02
Terumo Pall AL6X Arterial Blood Line Filter Recall for Defective Device
Terumo is recalling 15,817 arterial blood line filters used in cardiovascular procedures because the devices are defective.
Product
Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit Single/Sterile Terumo Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1943-2013·2013-10-02
Healthmaxx Global Recalls Max Probiotic Tablets Due to Mislabeling
Healthmaxx Global Inc. is voluntarily recalling Max Probiotic-90 tablets because the product label does not match the actual ingredients or product contained.
Product
Max Probiotic-90 tablets UPC 6 65176 30625 9***Dietary Supplement Product labeling reads in part:"*DIETARY SUPPLEMENT***Manufactured for:HealthMax Products Inc. Altadena, CA 91001
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-1924-2013·2013-10-02
Healthmaxx Recalls Brazilian Bee Propolis Softgels Due to Mislabeling
Healthmaxx Global Inc. is voluntarily recalling MAX Brand Brazilian Bee Propolis softgels because the label does not match the actual product or ingredients.
Product
MAX Brand BRAZILIAN BEE PROPOLIS, 180 Count Softgels Product labeling reads in part:"MAX***BRAZILIAN BEE PROPOLIS DIETARY SUPPLEMENT 180 Softgels***6 65176 31465 0***Manufactured For:HealthMax Products Co. Altadena, CA 91001***".
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-1912-2013·2013-10-02
Maplehurst Bakeries Recalls Meijer Carrot Cake Layers Due to Plastic
Maplehurst Bakeries is recalling Meijer 8-inch carrot cake layers found to contain flexible plastic. The product was distributed in Michigan and Ohio.
Product
Meijer 8 Inch Carrot Uniced Split Cake Layers (product is packed in bulk cartons of 24 units/paper bags lined with flexible blue plastic liner).
Category
Food
Distribution
2 states
ModerateFDA (Food)·F-1916-2013·2013-10-02
Healthmaxx Global Recalls MAX Brand Proste-Support Tablets Due to Mislabeling
Healthmaxx Global Inc. is voluntarily recalling 7,074 bottles of MAX Brand Proste-Support tablets because the label does not match the actual product or ingredients.
Product
Dietary Supplements under the same formulation, Labeled and Packaged in the Following: MAX Brand Proste-Support, 150 Count Tablets. Product labeling reads in part:"Manufactured for: HealthMax Products Inc. Altadena, CA 91001***".
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-1937-2013·2013-10-02
Healthmaxx Recalls Organic OPC69 Dietary Supplements Due to Mislabeling
Healthmaxx Global Inc. is voluntarily recalling 3,816 bottles of MAX Brand Organic OPC69 dietary supplements because the label does not match the actual product or ingredients.
Product
MAX Brand Organic OPC69, 300 Count Capsules Product labeling reads in part:"MAX ORGANIC OPC69 MAXIMUM STRENGTH***DIETARY SUPPLEMENT 300 Capsules***0 65176 51257 3***Manufactured in FDA Approved Facility for:HealthMax Products Inc. Altadena, CA 91001***".
Category
Food
Distribution
3 states
ModerateFDA (Food)·F1920-2013·2013-10-02
Healthmaxx Recalls MAX Kidney Strong Tablets Due to Mislabeling
Healthmaxx Global Inc. is voluntarily recalling MAX Brand Kidney Strong tablets because the label does not match the actual product or ingredients.
Product
MAX Brand Kidney Strong, 120 Count Tablets Product labeling reads in part:"MAX KIDNEY STRONG***Dietary Supplement 120 Tablets***6 65176 13427 2***Manufactured for: HealthMax Products, Inc. Altadena, CA 91001***".
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-1941-2013·2013-10-02
Healthmaxx Global Recalls Max Blood Sugar Defense Due to Mislabeling
Healthmaxx Global Inc. is voluntarily recalling Max Blood Sugar Defense dietary supplements because the product and ingredient labels do not match the actual contents.
Product
Max Blood Sugar Defense 150 tablets Dietary Supplement Product labeling reads in part:"*DIETARY SUPPLEMENT 150 tablets***Manufactured for:HealthMax Products Inc. Altadena, CA 91001***".UPC 6 65176 52047 1
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-1927-2013·2013-10-02
Healthmaxx Recalls Hyper II Lecithin Softgels Due to Mislabeling
Healthmaxx Global Inc. is voluntarily recalling 817 bottles of Hyper II Lecithin softgels because the label does not match the actual product or ingredients.
Product
Hyper II LECITHIN, 100 Count Softgels. Product labeling reads in part:"Hyper II LECITHIN***Dietary Supplement 100 Softgels***6 65176 01115 3***Manufactured for:HealthMax Products Co. Altadena, CA 91001***".
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-2267-2013·2013-10-02
Microgenics Recalls DRI Cocaine Metabolite Assay Due to Reagent Degradation
Microgenics Corp is recalling specific lots of DRI Cocaine Metabolite Assay because surveillance showed unexpected reagent degradation. The recall affects 1,473 units distributed across multiple US states.
Product
DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by: Microgenics Corporation, 46360 Fremont Blvd. Fremont, CA 94538 The DRI Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme intended for the qualitativ
Category
Medical Device
Distribution
21 states
ModerateFDA (Food)·F-1918-2013·2013-10-02
Healthmaxx Recalls MAX Brand Glucosamine Tablets Due to Mislabeling
Healthmaxx Global Inc. is voluntarily recalling MAX Brand Glucosamine 1500 mg + MSM 400 mg tablets because the label does not match the actual product or ingredients.
Product
MAX Brand Glucosamine 1500 mg + MSM 400 mg, 300 Count Tablets. Product labeling reads in part:"MAX Triple Strength MOVE FREE Glucosamine 1500 mg + MSM 400 mg 300 Tablets***6 65176 36159 3***Manufactured in FDA Approved Facility for: HealthMax Products Co. Altadena, CA 91001***
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-1929-2013·2013-10-02
Healthmaxx Recalls Stem Cell Enhance Supplements Due to Mislabeling
Healthmaxx Global Inc. is voluntarily recalling MAX Brand Stem Cell Enhance dietary supplements because the product label does not match the actual contents or ingredients.
Product
MAX Brand Stem Cell Enhance, 1.0 fl. oz. Product labeling reads in part:"MAX Stem Cell Enhance***1.0fl. oz(30ml)***".
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-1938-2013·2013-10-02
Healthmaxx Global Recalls MAX Brand Resveratrol Capsules for Mislabeling
Healthmaxx Global Inc. is voluntarily recalling MAX Brand Resveratrol capsules because the label does not match the actual product or ingredients contained.
Product
MAX Brand RESVERATROL, 120 Count Capsules. Product labeling reads in part:"MAX RESVERATROL***Dietary Supplement 120 CAPSULES***Manufactured in FDA Approved Facility for:HealthMax Products Inc. Altadena, CA 91001***0 65176 30325 6".
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-1915-2013·2013-10-02
Shenandoah Growers Recalls Fresh Basil Due to Pesticide Adulteration
Shenandoah Growers is recalling fresh Giant brand basil in 2.5 oz packages because it may be adulterated with pesticides. The product was distributed in PA, VA, and MD.
Product
Basil, fresh, Giant brand, packaged in 2.5 oz. package and labeled in part ***Distributed by FoodHold USA Landover, MD 20785***
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-1925-2013·2013-10-02
Healthmaxx Recalls MAX Bio-Cell Collagen II Softgels for Mislabeling
Healthmaxx Global Inc. is voluntarily recalling MAX Brand Bio-Cell Collagen II softgels because the product label does not match the actual ingredients contained.
Product
MAX Brand Bio-Cell Collagen II, 100 Count Softgels Product labeling reads in part:"MAX Bio-Cell CollagenII Dietary Supplement 100 Softgels*** 0 65176 08108 6***Manufactured for:HealthMax Products Co. Altadena, CA 91001***".
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-1928-2013·2013-10-02
Healthmaxx Global Recalls Liver Aid Supplements Due to Mislabeling
Healthmaxx Global Inc. is voluntarily recalling specific Liver Aid dietary supplements because the labels do not match the actual products or ingredients contained.
Product
Dietary Supplements Under the Same Formulation, Labeled and Packaged as the Following: LIVERAID, 200 Count Softgels; LIVER AID, 200 Count Softgels; MAX Brand LIVER STRONG, 200 Count Softgels. Product labeling reads in part:"LIVERAID***Dietary Supplement 200 Softgels***6 651
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-1931-2013·2013-10-02
Healthmaxx Recalls MAX GOUT AID Tablets Due to Mislabeling
Healthmaxx Global Inc. is voluntarily recalling 2,245 bottles of MAX GOUT AID tablets because the label does not match the actual product or ingredients.
Product
MAX Brand GOUT AID, 130 Count Tablets Product labeling reads in part:"MAX GOUT AID***Dietary Supplement 130 Tablets***6 0 65176 26512 7***HealthMax Products Co. Altadena, CA 91001***".
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-1954-2013·2013-10-02
Dannon Recalls ACTIVIA Light Yogurt Due to Potential Mold
Dannon is recalling specific lots of ACTIVIA Light Nonfat Yogurt due to the potential for mold. Consumers should check expiration codes and stop using affected products.
Product
Dannon ACTIVIA¿ LIGHT Nonfat Yogurt Strawberry-Banana & Peach Flavor, 12 PACK of 4oz cups, Form fill seal 4oz cup
Category
Food
Distribution
7 states
ModerateFDA (Food)·F-1922-2013·2013-10-02
Healthmaxx Global Recalls MAX Brand LIVERAID Dietary Supplement for Mislabeling
Healthmaxx Global Inc. is voluntarily recalling MAX Brand LIVERAID dietary supplements because the product and ingredient labels do not match the actual contents.
Product
MAX Brand LIVERAID, 200 Count Bottle. Product labeling reads in part:"MAX LIVERAID Dietary Supplement 200 Counts***6 65176 35168 6***Manufactured in FDA Approved Facility For:HealthMax Products Co. Altadena, CA 91001***".
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-1917-2013·2013-10-02
Healthmaxx Recalls MAX Glucosamine Tablets Due to Mislabeling
Healthmaxx Global Inc. is voluntarily recalling MAX Brand Glucosamine tablets because the label does not match the actual product or ingredients.
Product
MAX Brand Glucosamine 1500 mg + MSM 400 mg, 120 Count Tablets. Product labeling reads in part:"MAX Triple Strength MOVE FREE Glucosamine 1500 mg + MSM 400 mg 120 Tablets***6 65176 08218 4***Manufactured in FDA Approved Facility for: HealthMax Products Co. Altadena, CA 91001***
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-1930-2013·2013-10-02
Healthmaxx Global Recalls MAX Brand CoQ10 Capsules Due to Mislabeling
Healthmaxx Global Inc. is voluntarily recalling MAX Brand CoQ10 capsules because the label does not match the actual product or ingredients.
Product
MAX Brand CoQ10, 90 Count Capsules Product labeling reads in part:"MAX CoQ10***DIETARY SUPPLEMENT 90 Capsules***6 65176 30162 9***Manufactured in FDA Approved Facility for:HealthMax Products Co. Altadena, CA 91001***".
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-1933-2013·2013-10-02
Healthmaxx Global Recalls Mislabelled Dietary Supplements
Healthmaxx Global Inc. is voluntarily recalling MAX LUNG AID and MAX POMEGRANATE dietary supplements due to mislabeling of product names and ingredients.
Product
Dietary Supplements Under the Same Formulation, Labeled and Packaged as the following: MAX LUNG AID, 100 Count Capsules; MAX Brand POMEGRANATE, 100 Count Capsules. Product labeling reads in part:"MAX LUNG AID Extra Strength Dietary Supplement 100 CAPSULES***0 65176 26289 8**
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-1932-2013·2013-10-02
Healthmaxx Global Recalls MAX LIVER STRONG Capsules Due to Mislabeling
Healthmaxx Global Inc. is voluntarily recalling MAX LIVER STRONG dietary supplements because the label does not match the actual product or ingredients contained.
Product
MAX LIVER STRONG, 200 Count Capsules Product labeling reads in part:"MAX LIVER STRONG CoQ10***Dietary Supplement 200 Capsules***6 65176 32608 0***Manufactured in FDA Approved Facility for:HealthMax Products Co. Altadena, CA 91001***".
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-1914-2013·2013-10-02
Shenandoah Growers Recalls Fresh Basil Due to Pesticide Adulteration
Shenandoah Growers is recalling fresh basil that may be adulterated with pesticides. The product was distributed to Pennsylvania, Virginia, and Maryland.
Product
Fresh Herbs Everyday Basil, Shenandoah Growers brand, packaged in .75 oz; 2 oz.; and 2.5 oz. in 3 count and 6 count cardboard sleeves and labeled in part ***Shenandoah Growers Inc., Harrisonburg, Va 22802***
Category
Food
Distribution
3 states
ModerateFDA (Drugs)·D-1062-2013·2013-10-02
CorePharma Recalls Pyridostigmine Bromide Tablets Due to Stability Failure
CorePharma is recalling 960 bottles of Pyridostigmine Bromide Tablets 60 mg because stability testing showed out-of-specification results.
Product
Pyridostigmine Bromide Tablets 60 mg, USP Rx Only 100 Tablets, Manufactured and Distributed by: CorePharma, LLC Middlesex, NJ 08846 NDC 64720-128-10 NDC 64720-128-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2278-2013·2013-10-02
Synthes 3.5 MM LCP Distal Humerus System Recalled for Mislabeled Part Numbers
Synthes USA HQ, Inc. is recalling two units of the 3.5 MM LCP Distal Humerus System because the part was mislabeled with an incorrect part number.
Product
Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, distal humerus plate
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2268-2013·2013-10-02
Smiths Medical Recalls PORT-A-CATH Introducer Sets Due to Sizing Issues
Smiths Medical is voluntarily recalling PORT-A-CATH Introducer Sets because the sheath opening may be too small for the catheter width.
Product
Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, Rx Only PORT-A-CATH¿ and PORT-A-CATH¿ II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of
Category
Medical Device
Distribution
25 states
ModerateFDA (Food)·F-1935-2013·2013-10-02
Healthmaxx Recalls MAX Organic Blueberry Capsules for Mislabeling
Healthmaxx Global Inc. is voluntarily recalling MAX Brand Organic Blueberry capsules because the label does not match the actual product or ingredients.
Product
MAX Brand Organic Blueberry, 100 Count Capsules Product labeling reads in part:"MAX Organic Blueberry***Dietary Supplement 100 CAPSULES***6 65176 62165 9***Manufactured in FDA Approved Facility for:HealthMax Products Co. Altadena, CA 91001***".
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-1921-2013·2013-10-02
Healthmaxx Global Recalls LiverAid Dietary Supplements Due to Mislabeling
Healthmaxx Global Inc. is voluntarily recalling 5,775 bottles of LiverAid and related liver supplements because the labels do not match the actual products or ingredients inside.
Product
Dietary Supplement labeled and packaged under the following: LIVERAID, 200 Count Softgels; LIVER AID, 200 Count Softgels; MAX Brand LIVER STRONG 200 Count Softgels. Product labeling reads in part:"LIVERAID***Dietary Supplement 200 Softgels***6 65176 82031 1***Manufactured in
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-1939-2013·2013-10-02
Healthmaxx Recalls MAX Brand Soy Isoflavones and Ultra Probiotics for Mislabeling
Healthmaxx Global Inc. is voluntarily recalling MAX Brand Soy Isoflavones and Ultra Probiotics because the labels do not match the actual products or ingredients inside.
Product
Dietary Supplements Under the Same Formulation, Labeled and Packaged as the Following: MAX Brand SOY ISOFLAVONES, 90 Count Capsules; MAX Brand ULTRA PROBIOTICS, 90 Count Capsules Product labeling reads in part:"MAX SOY ISOFLAVONES MENOPAUSE SUPPORT**DIETARY SUPPLEMENT 90 CAPS
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-2266-2013·2013-10-02
GE Healthcare Recalls MRI Scanners Due to Non-Unique Series Identifiers
GE Healthcare is recalling specific MRI scanners because they may generate non-unique series identifiers in image headers, which can cause data association errors when exported to PACS systems.
Product
GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4, 5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2. GE Discovery MR750w
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-2269-2013·2013-10-02
Smiths Medical Recalls Port-A-Cath Venous Access Systems Due to Sizing Issue
Smiths Medical is voluntarily recalling Port-A-Cath and Port-A-Cath II implantable venous access systems and introducer sets because the introducer sheath opening may be too small for the catheter.
Product
Smiths Medical, Deltec: REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access System. REF 21-8052-24 & REF 21-8053-24 , Port-A-Cath II Dual-Lumen, Polysulfone /Titanium Venous Access System. Sterile EO, Rx Only. PORT-A-CATH¿ and PORT-A-CATH¿ II implantable venou
Category
Medical Device
Distribution
25 states
ModerateFDA (Devices)·Z-2279-2013·2013-10-02
CareFusion Recalls SmartSite Infusion Sets Due to Incorrect Filter Assembly
CareFusion is recalling 600 units of SmartSite Low Sorbing Infusion Sets because an incorrect 0.2 micron filter may have been assembled instead of the required 1.2 micron filter.
Product
SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The SmartSite Low Sorbing set is comprised of components commonly foun
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2276-2013·2013-10-02
Elekta Monaco Radiation Treatment Planning System Software Recall
Elekta is recalling Monaco RTP System software versions 3.10.00 and later because an upgrade script may overwrite treatment couch files with incorrect default values.
Product
Monaco RTP System Radiation treatment planning
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2280-2013·2013-10-02
Horiba Medical Recalls ABX PENTRA Calcium CP Reagent for Incorrect Results
Horiba Medical is recalling ABX PENTRA Calcium CP Reagent because it may report incorrect calcium results on PENTRA 200 and 400 analyzers.
Product
ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone mineralization, in blood coagulation and in transmission of nerve impulses. Calcium
Category
Medical Device
Distribution
0 states
ModerateFDA (Food)·F-1919-2013·2013-10-02
Healthmaxx Recalls MAX Glucosamine Tablets Due to Mislabeling
Healthmaxx Global Inc. is voluntarily recalling MAX Brand Glucosamine tablets in California, Maryland, and New York because the label does not match the actual product or ingredients.
Product
MAX Brand Glucosamine 1500 mg, Plus MSM + Vit D 200 Count Tablets Product labeling reads in part:"MAX Glucosamine 1500mg***200 Tablets***6 65176 60566 6***Manufactured in FDA Approved facility for: HealthMax Products, Inc. Altadena, CA 91001***"
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-1936-2013·2013-10-02
Healthmaxx Recalls Organic Grapeseed Extract Due to Mislabeling
Healthmaxx Global Inc. is voluntarily recalling 4,022 bottles of MAX Brand Organic OPC31 Grapeseed Extract because the label does not match the actual product or ingredients.
Product
MAX Brand Organic OPC31 Grapeseed Extract, 200 Count Capsules. Product labeling reads in part:"MAX Organic OPC31 Grapeseed Extract***NEW WITH BLUEBERRY***Dietary Supplement 200 CAPSULES***Manufactured in FDA Approved Facility for:HealthMax Products Inc. Altadena, CA 91001***".
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-1926-2013·2013-10-02
Healthmaxx Recalls Hyper II DHA/EPA Softgels Due to Mislabeling
Healthmaxx Global Inc. is voluntarily recalling Hyper II DHA/EPA softgels because the label does not match the actual product or ingredients.
Product
Hyper II DHA/EPA, 100 Count Softgels. Product labeling reads in part:"Hyper II DHA/EPA Refined Deep Sea Fish Oil 50% DHA - 30% EPA***Dietary Supplement 100 Softgels***6 65176 05274 3***Manufactured for:HealthMax Products Co. Altadena, CA 91001***".
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-2283-2013·2013-10-02
Stryker FL23SE Hospital Bed Recall for Nurse Call Cable Damage Risk
Stryker is recalling 61 FL23SE adjustable hospital beds because inserting an accessory into the head box slot can damage the nurse call system circuit.
Product
The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes. It can be operated by the patient or the caregiver to adjust the height and surface contour of the bed. The bed includes movabl
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2281-2013·2013-10-02
CareFusion Recalls Gravity Sets Due to Incorrect Expiration Date Labeling
CareFusion is recalling 2,850 units of Gravity Set Model 44000-07 because they are labeled with a 5-year expiration date instead of the correct 3-year date.
Product
CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein. The CareFusion Gravity Set is comprised of components commonly found on intravascular admini
Category
Medical Device
Distribution
1 state
LowFDA (Food)·F-1940-2013·2013-10-02
Healthmaxx Recalls MAX Brand CoQ-10 Capsules Due to Mislabeling
Healthmaxx Global Inc. is voluntarily recalling MAX Brand CoQ-10 capsules because the label does not match the actual product or ingredients contained.
Product
MAX Brand CoQ-10, 780mg, 300 Count Capsules. Product labeling reads in part:"MAX CoQ-10 80 mg***DIETARY SUPPLEMENT 300 Capsules***6 65176 25166 5***Manufactured in FDA Approved Facility for:HealthMax Products Inc. Altadena, CA 91001***".
Category
Food
Distribution
3 states
LowFDA (Food)·F-1934-2013·2013-10-02
Healthmaxx Global Recalls MAX Nitric Oxide Enhance Due to Mislabeling
Healthmaxx Global Inc. is voluntarily recalling MAX Brand Nitric Oxide Enhance dietary supplements because the label does not match the actual product or ingredients.
Product
MAX Brand Nitric Oxide Enhance, 90 Count Capsules Product labeling reads in part:"MAX Nitric Oxide Enhance***DIETARY SUPPLEMENT 90 Capsules***0 65176 55958 5***Manufactured in FDA Approved Facility for:HealthMax Products Co. Altadena, CA 91001***".
Category
Food
Distribution
3 states
LowFDA (Food)·F-1942-2013·2013-10-02
Healthmaxx Global Recalls Max LUNG AID Dietary Supplement Due to Mislabeling
Healthmaxx Global Inc. is voluntarily recalling Max LUNG AID Extra Strength dietary supplements because the label does not match the actual product or ingredients.
Product
Max LUNG AID Extra Strength 100 capsules Dietary Supplement Product labeling reads in part:"*DIETARY SUPPLEMENT 100 capsules***Manufactured for:HealthMax Products Inc. Altadena, CA 91001***".UPC 0 65176 26289 8
Category
Food
Distribution
3 states

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