July 2013 recalls

741 recalls were announced in July 2013.

What the numbers show

Critical: 104
Severe: 251
High: 252
Moderate: 109
Low: 25

Of the 741 recalls this month scored against our rubric, 14% are Critical, 34% are Severe.

Which agencies issued them

1–100 of 741

CriticalFDA (Devices)·Z-1761-2013·2013-07-31
LeMaitre Vascular Recalls AlboGraft Vascular Grafts Due to Surface Leaking
LeMaitre Vascular is recalling 3 units of AlboGraft Knitted with Collagen vascular grafts because they may leak blood from the surface after implantation.
Product
AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
CriticalFDA (Drugs)·D-810-2013·2013-07-31
Med Prep Consulting Recalls Magnesium Sulfate Injection Bags Due to Mold
Med Prep Consulting is recalling 403,883 bags of Magnesium Sulfate 2 grams in Dextrose 5% for Injection due to non-sterility and mold contamination.
Product
Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infusion Bags, Med Prep Consulting Inc., Tinton Falls, NJ 07712
Category
Drug
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1757-2013·2013-07-31
LeMaitre Recalls AlboGraft Vascular Grafts Due to Blood Leakage
LeMaitre Vascular is recalling 3 units of AlboGraft Knitted with Collagen, Bifurcate 18x09 due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
CriticalFDA (Food)·F-1739-2013·2013-07-31
Bergin Pistachio Products Recalled Due to Salmonella Risk
Bergin Fruit and Nut Company is recalling specific pistachio products because Salmonella was found in the environment at the supplier, ARO Pistachio Inc.
Product
601911 PISTACHIO KERNELS HOT & SPICY 30#, UPC 2052601911 601913 PISTACHIOS HOT AND SPICY 12/5 OZ BERGIN RED BAG, UPC 2052601913
Category
Food
Distribution
15 states
CriticalFDA (Devices)·Z-1788-2013·2013-07-31
GE Healthcare Recalls Nuclear Medicine Imaging Systems Due to Patient Death
GE Healthcare is recalling Varicam/VG and VG Hawkeye devices after a patient died from injuries sustained during a scan at a US VA Medical Center.
Product
GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by vario
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1740-2013·2013-07-31
Bergin Fruit and Nut Pistachio Recall Due to Salmonella Risk
Bergin Fruit and Nut is recalling raw pistachio products because Salmonella was found in the environment at the supplier, ARO Pistachio Inc.
Product
600943 PISTACHIOS KERNELS RAW 8/11 OZ SQ TUB, UPC 2052600943 601902 PISTACHIOS KERNELS RAW 10/14 OZ TAPE BAG, UPC 2052601902 601902.09 PISTACHIOS KERNELS RAW 10/14 OZ TAPE BAG BYERLYS, UPC 2052601902 600899 PISTACHIOS KERNELS RAW 30#, IUPAC 600901 PISTACHIOS KERNELS
Category
Food
Distribution
15 states
CriticalFDA (Devices)·Z-1791-2013·2013-07-31
GE Healthcare Recalls Discovery NM 630 Nuclear Imaging Systems
GE Healthcare is recalling 108 Discovery NM 630 nuclear imaging systems worldwide due to a failure mode that can cause serious injury or death.
Product
Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1792-2013·2013-07-31
GE Healthcare Recalls Nuclear Medicine Imaging Systems Due to Patient Death
GE Healthcare is recalling 213 Discovery NM/CT 670 systems worldwide after a patient died from injuries sustained during a scan on a related system.
Product
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1741-2013·2013-07-31
Bergin Fruit and Nut Pistachio Products Recalled Due to Salmonella Risk
Bergin Fruit and Nut Co is recalling pistachio products because Salmonella was found in the environment at the supplier, ARO Pistachio Inc.
Product
600908.03 PISTACHIOS KERNELS R/S 12/16 OZ TRAY KOWALSKI, UPC 2052600908 600909 PISTACHIOS KERNELS R/S 16/7 OZ CLAMSHELL, UPC 2052600909 600909.03 PISTACHIOS KERNELS R/S 16/7 OZ CLAMSHELL KOWALSKI, IUPAC 600904 PISTACHIOS KERNELS R/S 30#, UPC 2052600904 600905 PISTAC
Category
Food
Distribution
15 states
CriticalFDA (Devices)·Z-1765-2013·2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Surface Leakage
LeMaitre Vascular is recalling 2 units of AlboGraft Woven with Collagen, Straight 15x26 (Lot 56890A) because blood blushing or leaking was observed from the graft surface after implantation.
Product
AlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
CriticalFDA (Devices)·Z-1793-2013·2013-07-31
GE Healthcare Recalls Optima NM/CT 640 Systems Due to Patient Death
GE Healthcare is recalling 25 Optima NM/CT 640 systems worldwide after a patient died from injuries sustained during a scan on a related system.
Product
Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scannin
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1738-2013·2013-07-31
Bergin Fruit and Nut Recalls Pistachio Products Due to Salmonella Risk
Bergin Fruit and Nut Company is recalling specific Mega Omega Mix pistachio products because Salmonella was found in the environment at the supplier, ARO Pistachio Inc.
Product
604293 MEGA OMEGA MIX 12/8 OZ SQ TUB, UPC 2052604293 604293.04 MEGA OMEGA MIX 12/8 OZ SQ TUB BOULDER, UPC 2052604293 604293.05 MEGA OMEGA MIX 12/8 OZ SQ TUB FESTIVAL, UPC 2052604293 604290 MEGA OMEGA MIX 15#, UPC 2052604290 604292 MEGA OMEGA MIX 16/7 OZ - CLAMSHELL,
Category
Food
Distribution
15 states
CriticalFDA (Food)·F-1737-2013·2013-07-31
Bergin Low Glycemic Snack Mix Recalled Due to Salmonella Risk
Bergin Fruit and Nut Company is recalling Low Glycemic Snack Mix products because pistachios used in manufacturing were supplied by a facility where Salmonella was detected.
Product
601180 LOW GLYCEMIC SNACK MIX 12/4 OZ BERGIN RED BAG, UPC 2052601180 601082 LOW GLYCEMIC SNACK MIX 12/8 CLAMSHELL, UPC 2052601082 601082.03 LOW GLYCEMIC SNACK MIX 12/8 CLAMSHELL KOWALSKI, UPC 2052601082 601080 LOW GLYCEMIC SNACK MIX 30#, UPC 2052601080 601084 LOW GLYC
Category
Food
Distribution
15 states
CriticalFDA (Devices)·Z-1756-2013·2013-07-31
LeMaitre Recalls Albo Graft Vascular Implants Due to Surface Leaking
LeMaitre Vascular is recalling 7 units of Albo Graft Knitted with Collagen, Bifurcate 16x08 due to blood blushing or leaking from the graft surface after implantation.
Product
Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
CriticalFDA (Devices)·Z-1790-2013·2013-07-31
GE Healthcare Recalls Nuclear Medicine Imaging Systems Due to Patient Death
GE Healthcare is recalling 13 Brivo NM615 nuclear medicine imaging systems worldwide after a patient died from injuries sustained during a scan on a related system.
Product
Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Product Usage: The Brivo NM 615 is an emission computed tomography system intended to detect the location and distribution of gamma ray photon emitting radionuclides in the body and to produc
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1789-2013·2013-07-31
GE Healthcare Recalls Elscint APEX Helix Gamma Cameras Due to Patient Death
GE Healthcare is recalling 50 Elscint APEX Helix gamma cameras worldwide after a patient died from injuries sustained during a scan at a US VA Medical Center.
Product
Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of sc
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1736-2013·2013-07-31
Bergin Fruit and Nut Recalls Pistachio Products Due to Salmonella Risk
Bergin Fruit and Nut Co Inc is recalling pistachio products because Salmonella was found in the environment at the supplier, ARO Pistachio Inc.
Product
604320 LOW GLYCEMIC INSTANT OATMEAL 25#, UPC 2052604320
Category
Food
Distribution
15 states
CriticalFDA (Food)·F-1742-2013·2013-07-31
Bergin Fruit and Nut Pistachios Recalled Due to Salmonella Risk
Bergin Fruit and Nut Co is recalling pistachio products because Salmonella was found in the environment at the supplier, ARO Pistachio Inc.
Product
603684 PISTACHIOS S/I/S 12/10 OZ GOLD BAG, UPC 2052603684 600913 PISTACHIOS S/I/S 12/12 OZ BAGLINE, UPC 2052600913 600913.11 PISTACHIOS S/I/S 12/12 OZ BAGLINE AMAZON, UPC 2052600913 600913.07 PISTACHIOS S/I/S 12/12 OZ BAGLINE DISPLAY BOX, UPC 2052600913 600923.05 PIST
Category
Food
Distribution
15 states
CriticalFDA (Food)·F-1744-2013·2013-07-31
High Quality Organics Recalls Dried Oregano Due to Salmonella Risk
High Quality Organics is recalling dried oregano sold in 25 lb boxes because a customer's test found Salmonella in the product.
Product
Dried Oregano, cut and sifted; Organic; Product of Turkey, sold in 25 lb boxes High Quality Organics, Reno, NV
Category
Food
Distribution
3 states
CriticalFDA (Devices)·Z-1787-2013·2013-07-31
GE Healthcare Recalls Infinia Hawkeye 4 Gamma Cameras Due to Patient Death
GE Healthcare is recalling Infinia Hawkeye 4 Nuclear Medicine Systems after a patient died from injuries sustained during a scan at a US VA Medical Center.
Product
GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Qua
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1743-2013·2013-07-31
Bergin Fruit and Nut Recalls Raw Pistachios Due to Salmonella Risk
Bergin Fruit and Nut Co Inc is recalling raw pistachios because Salmonella was found in the environment at the supplier, ARO Pistachio Inc.
Product
600910 PISTACHIOS SPLITS RAW 30#, UPC 2052600910
Category
Food
Distribution
15 states
CriticalFDA (Devices)·Z-1770-2013·2013-07-31
LeMaitre Recalls AlboGraft Vascular Grafts Due to Surface Bleeding
LeMaitre Vascular is recalling 3 units of AlboGraft Woven with Collagen, Straight 30x26 (Lot 56890A) because blood blushing or leaking was observed from the graft surface after implantation.
Product
AlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
SevereFDA (Food)·F-1735-2013·2013-07-31
Bergin Fruit and Nut Recalls Pistachio Products Due to Salmonella Risk
Bergin Fruit and Nut Company is recalling specific pistachio products because Salmonella was detected in the environment at the supplier, ARO Pistachio Inc.
Product
601041 HEALTHY HEART MIX 12/14 OZ TRAY, UPC 2052601041 601078 HEALTHY HEART MIX 12/8 OZ CLAMSHELL, UPC 2052601078 601078.03 HEALTHY HEART MIX 12/8 OZ CLAMSHELL KOWALSKI, UPC 2052601078 601089 HEALTHY HEART MIX 16/6 OZ CLAMSHELL, UPC 2052601089 601089.1 HEALTHY HEART M
Category
Food
Distribution
15 states
SevereNHTSA·13V332000·2013-07-31
Blue Bird Recalls School Buses Due to Window Panel Adhesive Defect
Blue Bird is recalling 2007-2014 All American and Vision school buses because missing window adhesive may cause panels to separate in a crash.
Product
BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-811-2013·2013-07-31
Med Prep Consulting Recalls Compounded Products Due to Sterility Concerns
Med Prep Consulting, Inc. is recalling all compounded products due to a lack of assurance of sterility and potential mold contamination.
Product
All Compounded Products, packaged in plastic infusion bags, devices, syringes and glass vials, Med Prep Consulting Inc., Tinton Falls, NJ 07712
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-825-2013·2013-07-31
West-Ward Recalls Belladonna Alkaloids Tablets Due to Cross-Contamination
West-Ward Pharmaceutical Corp. is recalling Belladonna Alkaloids with Phenobarbital Tablets because they contain a trace amount of Methocarbamol.
Product
West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1727-2013·2013-07-31
Amport Foods Recalls Vanilla Almond Granola Due to Metal Fragments
American Importing Co. is voluntarily recalling specific packages of 16 oz Vanilla Almond Granola because they may contain pliable metal wire mesh fragments from a defective flour sifter.
Product
Vanilla almond granola, Net WT 16 oz(454g), UPC 0 71725 71239 4, Distributed by American Importing Co., Inc, Minneapolis, MN 55414. Vanilla Almond Granola, Net Wt 16 oz (454g), UPC 7 25439 20038 7, Distributed by DZA Brands LLC, Salisbury,NC 28147. Hy-Vee Granola Vanilla A
Category
Food
Distribution
12 states
SevereFDA (Devices)·Z-1766-2013·2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Blood Leakage
LeMaitre Vascular is recalling AlboGraft Woven with Collagen vascular grafts due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1768-2013·2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Bleeding
LeMaitre Vascular is recalling AlboGraft Woven with Collagen grafts due to blood leaking from the graft surface after implantation.
Product
AlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1755-2013·2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Surface Bleeding
LeMaitre Vascular is recalling specific AlboGraft Vascular Grafts due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Knitted with Collagen, Straight 15x06 Catalog Number: AMC1506 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1754-2013·2013-07-31
LeMaitre Recalls AlboGraft Vascular Grafts Due to Blood Leakage
LeMaitre Vascular is recalling specific AlboGraft vascular grafts because blood may blush or leak from the surface after implantation.
Product
AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1759-2013·2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Bleeding
LeMaitre Vascular is recalling 3 units of AlboGraft Knitted with Collagen, Bifurcate 20x10 (Lot 56890A) due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1760-2013·2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Bleeding
LeMaitre Vascular is recalling AlboGraft Knitted with Collagen vascular grafts due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1764-2013·2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Bleeding
LeMaitre Vascular is recalling AlboGraft Knitted with Collagen grafts due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
SevereFDA (Food)·F-1734-2013·2013-07-31
Bergin Fruit and Nut Recalls Pistachio Products Due to Salmonella Risk
Bergin Fruit and Nut Company is recalling specific pistachio products because Salmonella was found in the environment at the supplier, ARO Pistachio Company.
Product
601009 ANTIOXIDANT SUPERSTAR MIX 100/2 OZ FLAT PACK, UPC 2052601009 601076 ANTIOXIDANT SUPERSTAR MIX 12/6 OZ BERGIN RED BAG, UPC 2052601076 601051 ANTIOXIDANT SUPERSTAR MIX 12/8 OZ CLAMSHELL, UPC 2052601051 601051.03 ANTIOXIDANT SUPERSTAR MIX 12/8 OZ CLAMSHELL KOWALSKI,
Category
Food
Distribution
15 states
SevereFDA (Drugs)·D-820-2013·2013-07-31
Astellas Recalls AmBisome Injection Lots Due to Sterility Concerns
Astellas Pharma US is voluntarily recalling specific lots of AmBisome (amphotericin B) liposome for injection because a routine simulation detected bacterial contamination.
Product
AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc, San Dimas, CA 91773, NDC: 0469-3051-30.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1733-2013·2013-07-31
Hearthside Recalls Salted Pistachios Due to Vendor FDA Class 2 Recall
Hearthside Food Solutions LLC is recalling salted pistachios in the shell because a vendor, ARO Pistachio Inc., issued an FDA Class 2 voluntary recall.
Product
Pistachios, Salted in the Shell packaged in the following configurations: 1. Gurley's Golden Recipe Natural Pistachios in 2 oz., 2.25 oz., 12 oz., 3 lb., and 25 lb; 2. Mountain Country Natural Pistachios, in 2. 25 oz., and 3.5 oz.; 3. Rachael's Natural Pistachios in 2 oz.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1797-2013·2013-07-31
Philips HeartStart MRx Monitor/Defibrillator Recalled for Incorrect Therapy Risk
Philips is recalling HeartStart MRx Monitor/Defibrillators because they may deliver non-synchronized cardioversion shocks, potentially inducing ventricular fibrillation.
Product
Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1769-2013·2013-07-31
LeMaitre Recalls AlboGraft Vascular Grafts Due to Blood Leaking
LeMaitre Vascular is recalling two units of AlboGraft Woven with Collagen vascular grafts because blood may leak from the graft surface after implantation.
Product
AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
SevereFDA (Drugs)·D-809-2013·2013-07-31
Mobius Recalls Mitosol Ophthalmic Kits Due to Yeast Contamination
Mobius Therapeutics is recalling 83 boxes of Mitosol ophthalmic kits because components were found to be contaminated with yeast.
Product
MITOSOL — MITOSOL (MITOMYCIN)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1763-2013·2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Surface Bleeding
LeMaitre Vascular is recalling two units of AlboGraft Knitted with Collagen vascular grafts due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-1777-2013·2013-07-31
Ethicon Recalls LIGACLIP Endoscopic Clip Appliers Due to Clip Formation Issues
Ethicon Endo-Surgery is voluntarily recalling LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Appliers due to potential clip formation and feeding issues that may cause vessel damage.
Product
LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk non-sterile Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a single patient use instrument designed to provide a means of ligation through ENDOPATH¿ surgical trocars. The ins
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1767-2013·2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Surface Bleeding
LeMaitre Vascular is recalling AlboGraft Woven with Collagen grafts due to blood blushing or leaking from the surface after implantation.
Product
AlboGraft Woven with Collagen, Straight 30x16 Catalog Number: ATC3016 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
SevereFDA (Drugs)·D-813-2013·2013-07-31
Hospira Recalls Sodium Chloride Injection Vials Due to Particulate Matter
Hospira is recalling 268,700 vials of Sodium Chloride Injection, USP, 0.9% due to a confirmed report of visible particulate matter embedded in the plastic vial.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-1748-2013·2013-07-31
Jacqueline's Brownie Burst Cookies Recalled for Undeclared Milk Allergen
Price Chopper is recalling Jacqueline's Brownie Burst Cookies due to an undeclared milk allergen. The product was distributed in six northeastern states.
Product
Jacqueline's GOURMET COOKIES Brownie Burst Cookies, Net Wt. 11 oz (8 units in total) packed in clear plastic with white labeling--Shelf life is 12 months frozen and 7 days after baked.
Category
Food
Distribution
6 states
HighNHTSA·13V331000·2013-07-31
Jayco Recalls 2014 Precept Motorhomes Due to Wiper Arm Defect
Jayco is recalling 2014 Precept motorhomes because the windshield wiper arm attachment may crack, potentially detaching the wiper and reducing visibility.
Product
JAYCO — JAYCO PRECEPT
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1772-2013·2013-07-31
Ethicon Recalls Endopath Electrosurgery Probes Due to Potential Sterility Compromise
Ethicon Endo-Surgery Inc is recalling 327,648 Endopath Electrosurgery Probe Plus II instruments because a tear in the Tyvek packaging may affect the sterility of the devices.
Product
Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and stone retrieval cannula, packaged and sterilized individually in a transparent flex
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1728-2013·2013-07-31
Amport Foods Recalls Vanilla Almond Granola Due to Metal Wire Fragments
American Importing Co. is voluntarily recalling 16 oz Vanilla Almond Granola packages that may contain pliable metal wire mesh fragments from a defective flour sifter.
Product
Orchard Reserve, Fiber Health Blend, Net WT 6.5 oz , UPC 0 71725 74211 7, Distributed by Amport Foods, Minneapolis, MN 55414.
Category
Food
Distribution
12 states
HighFDA (Devices)·Z-1776-2013·2013-07-31
Ethicon Recalls LIGACLIP Endoscopic Clip Appliers Due to Clip Formation Issues
Ethicon Endo-Surgery is voluntarily recalling LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Appliers due to potential clip formation and feeding issues that may cause vessel damage.
Product
LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Trays), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instrument designed to provide a means of ligation through ENDOPATH¿ surgical tro
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1729-2013·2013-07-31
Amport Foods Recalls Vanilla Almond Granola Due to Metal Fragments
American Importing Co. is voluntarily recalling 16 oz Vanilla Almond Granola packages that may contain pliable metal wire mesh fragments from a defective flour sifter.
Product
Smart Sense Fruit & Granola Trail Mix, Net WT 4.0 oz , UPC 8 83967 29091 8, Distributed by Kmart corporation, Hoffman Estates, Il 60179, Minneapolis, MN 55414.
Category
Food
Distribution
12 states
HighFDA (Devices)·Z-1775-2013·2013-07-31
Ethicon Recalls LIGACLIP Endoscopic Clip Appliers Due to Clip Formation Issues
Ethicon Endo-Surgery is voluntarily recalling LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Appliers because potential clip formation and feeding issues may cause vessel damage or insufficient occlusion.
Product
LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instrument designed to provide a means of ligation through ENDOPATH¿ surgical trocars. The instrument
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1783-2013·2013-07-31
Pemco Rultract Retractor Ratchet Cover Plate Recalled for Corrosion
Pemco Inc. is recalling 87 Rultract Retractor Ratchet Cover Plates because a returned unit showed signs of corrosion. The devices are used in surgery to lift incision sites.
Product
Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site
Category
Medical Device
Distribution
27 states
HighFDA (Devices)·Z-1807-2013·2013-07-31
Etac Swift Mobil Shower Chairs Recalled for Stability Risk
Etac is voluntarily recalling Swift Mobil shower chairs because a lost caster can cause instant instability and potential injury.
Product
Swift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt shower chair. Height adjustable four wheeled shower chairs for persons of various weights.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1786-2013·2013-07-31
Steris Recalls Fine Traction Devices Due to Bearing Defect
Steris Corporation is recalling 16 units of Fine Traction Devices because a bearing failed pre-release reliability testing. The devices were distributed in five US states and Canada.
Product
STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is used to provide traction and enable fine adjustments to traction and orientation of the leg during orthopedic procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1758-2013·2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Surface Leaking
LeMaitre Vascular, Inc. is recalling specific AlboGraft vascular grafts because they may leak blood from the surface after being implanted in patients.
Product
AlboGraft Knitted with Collagen, Bifurcate 18x10 Catalog Number: AMC1810 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1785-2013·2013-07-31
St. Jude Medical Recalls Eon and Eon Mini Charging Systems
St. Jude Medical is recalling Eon and Eon Mini charging systems due to reported warmth or heating at the implant site during charging.
Product
Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger); This is a continuation of the firm's July 2012 recall. Product Usage: The Eon Wall Charger (3701) provides the capability to recharge the IPG Batte
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1798-2013·2013-07-31
Becton Dickinson Recalls Vancomycin Screen Agar Due to Reduced Antimicrobial Levels
Becton Dickinson is recalling specific lots of Vancomycin Screen Agar because the media may contain reduced levels of vancomycin, potentially affecting test accuracy.
Product
BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to vancomycin and to pred
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-819-2013·2013-07-31
Alkermes Recalls VIVITROL Vials Due to Sterility Assurance Concerns
Alkermes, Inc. is recalling 3,325 vials of VIVITROL (naltrexone) because the product failed container closure integrity testing, raising concerns about sterility.
Product
VIVITROL — VIVITROL (NALTREXONE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-821-2013·2013-07-31
Gilead Recalls AmBisome Injection Due to Potential Sterility Assurance Issues
Gilead Sciences is recalling 478,352 vials of AmBisome (amphotericin B) liposome for Injection due to a lack of sterility assurance detected during routine manufacturing simulations.
Product
AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc., San Dimas, CA 91773, NDC 0469-3051-30.
Category
Drug
Distribution
0 states
HighFDA (Devices)·Z-1774-2013·2013-07-31
Topcon PASCAL Laser Recall Due to Power Mismatch Risk
Topcon Medical Laser Systems is recalling PASCAL and PASCAL Streamline lasers because a software function may cause power output mismatches, leading to over or under treatment.
Product
PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1762-2013·2013-07-31
LeMaitre AlboGraft Vascular Grafts Recalled for Surface Bleeding
LeMaitre Vascular is recalling 3 units of AlboGraft Knitted with Collagen vascular grafts due to blood blushing or leaking from the graft surface after implantation.
Product
AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1794-2013·2013-07-31
Hill-Rom TotalCare Bed Recall Due to Mattress Egress Injury Risk
Hill-Rom is recalling 4,121 TotalCare Beds because the mattress may not stay flat in the chair egress position, creating a risk of patients falling or sliding to the floor.
Product
TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress The TotalCare Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System m
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1773-2013·2013-07-31
Physio Control Recalls LIFEPAK 500 AEDs Due to Assembly Error
Physio Control is recalling 139 LIFEPAK 500 AEDs because an assembly error could cause internal shorting, rendering the device inoperable.
Product
The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIF
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·13255·2013-07-31
Leisure Ways Kids' Outdoor Furniture Recalled for Lead Paint Violation
Far East Brokers is recalling about 14,000 Leisure Ways kids' outdoor furniture items because the red paint contains excessive lead, violating federal standards.
Product
Leisure Ways® Brands Kids Outdoor Furniture
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·13254·2013-07-31
Be Amazing! Toys Recalls Water-Absorbing Polymer Balls Due to Ingestion Hazard
Be Amazing! Toys is recalling Monster Science and Super Star Science Colossal Water Balls because the marble-sized toys can expand inside a child's body if ingested, causing intestinal obstructions.
Product
Water-Absorbing Polymer Balls
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1795-2013·2013-07-31
Siemens Axiom Aristos MX Flat Panel Imager Recalled for Finger Injury Risk
Siemens is recalling 401 Axiom Aristos MX digital imagers because the table top float function can trap and crush fingers.
Product
Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1811-2013·2013-07-31
Church & Dwight Recalls Contaminated Sodium Bicarbonate for Medical Use
Church & Dwight is recalling specific lots of Sodium Bicarbonate, USP, used in medical devices and drugs due to metal and other contamination.
Product
Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialysis Grade 2 As an API or excipient in the manufacture of Medical Devices and Drugs
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1747-2013·2013-07-31
Jacqueline's Almond Burst Cookies Recalled for Undeclared Milk Allergen
Price Chopper is recalling Jacqueline's Almond Burst Cookies because they contain an undeclared milk allergen. Consumers should not eat the product.
Product
Jacqueline's GOURMET COOKIES Almond Bursts COOKIES, Net Wt. 11 oz (8 units total) packed in clear plastic with white labeling----Shelf life is 12 months frozen and 7 days after baked.
Category
Food
Distribution
6 states
HighFDA (Food)·F-1749-2013·2013-07-31
Jacqueline's Raspberry Burst Cookies Recalled for Undeclared Milk Allergen
Price Chopper is recalling Jacqueline's Raspberry Burst Cookies due to an undeclared milk allergen. The cookies were sold in several northeastern states.
Product
Jacqueline's GOURMET COOKIES Raspberry Burst Cookies, Net Wt. 11 oz (8 units in total) packed in clear plastic with white labeling---Shelf life is 12 months frozen and 7 days after baked.
Category
Food
Distribution
6 states
HighNHTSA·13V330000·2013-07-31
Entegra Motorhomes Recalled for Windshield Wiper Arm Defect
Entegra Coach is recalling 2013-2014 Anthem, Aspire, and Cornerstone motorhomes because the windshield wiper arm attachment could crack, reducing visibility.
Product
ENTEGRA — ENTEGRA ANTHEM, ASPIRE, CORNERSTONE
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·13256·2013-07-31
JP Boden Recalls Kensington Court High Heel Shoes Due to Fall Hazard
JP Boden is recalling Kensington Court women's high heel shoes because the heels can loosen and cause falls. No injuries have been reported.
Product
Kensington Court Women's Shoes
Category
Consumer Product
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1771-2013·2013-07-31
Spacelabs ARKON Anesthesia Workstation Recalled for Software Defect
Del Mar Reynolds Medical is recalling nine Spacelabs ARKON Anesthesia Workstations due to a software defect that may cause false communication error alerts.
Product
Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1782-2013·2013-07-31
Siemens ARTIS zee and zeego X-ray Systems Recalled for Software Issue
Siemens is recalling 29 ARTIS zee and zeego x-ray systems due to a software issue affecting rotational 3D-acquisition programs with real-time subtraction.
Product
ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1784-2013·2013-07-31
Instrumentation Laboratory Recalls HemosIL RecombiPlasTin 2G Coagulation Reagent
Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G reagent kits due to out-of-specification quality issues. The product is used for evaluating the extrinsic coagulation pathway.
Product
HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1803-2013·2013-07-31
Becton Dickinson Recalls Brucella Laked Blood Agar Due to Reduced Vancomycin
Becton Dickinson is recalling specific lots of Brucella Laked Blood Agar because the media may contain reduced levels of Vancomycin.
Product
BBL Brucella Laked Blood Agar with Kanamycin and Vancomycin (KV), Catalog # 297840, packaged in cartons of 20 plates, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Brucella Laked Blood with KV is used for
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-818-2013·2013-07-31
Oklahoma Respiratory Care Recalls Compressed Oxygen Cylinders for Purity Failures
Oklahoma Respiratory Care Inc. is recalling 94 cylinders of compressed oxygen in Oklahoma because purity readings were out of specification.
Product
Oxygen, Compressed USP UN1072 Medical Gas supplied in a) 682 litres and b)165 litres cylinders, Rx only, Oklahoma Respiratory Care 800.262.9857, Norman, OK 73071
Category
Drug
Distribution
1 state
ModerateFDA (Devices)·Z-1804-2013·2013-07-31
Becton Dickinson Recalls BCYE Selective Agar Plates Due to Reduced Vancomycin
Becton Dickinson is recalling 163 cartons of BCYE Selective Agar with PAV because the media may exhibit reduced levels of Vancomycin.
Product
BD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of 10 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isol
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1806-2013·2013-07-31
Aesculap ProSpace PEEK Spinal Implant Recalled for Incorrect Etching
Aesculap is recalling nine ProSpace PEEK spinal implants because they are incorrectly etched with an 8-degree lordosis instead of the labeled 5-degree lordosis.
Product
ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine. The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1780-2013·2013-07-31
Philips IntelliVue Smart-hopping 1.4 GHz Access Point Recalled for Signal Loss
Philips Healthcare is recalling IntelliVue Smart-hopping 1.4 GHz Access Points due to unexpected signal loss that impacts wireless connectivity.
Product
Radiohead Access Point 1.4 GHz Radiohead Access Point Firmware versions: C.00.04 & C.00.05 Part Number: 989803171211 Product Usage: IntelliVue Smart-hopping 1.4 GHz Access Point provides wireless connectivity between IntelliVue devices (listed below) and the Philips Inte
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1808-2013·2013-07-31
Stryker Neuroform 3 Stent System Recalled for Labeling Mismatch
Stryker Neurovascular is recalling 23 units of the Neuroform 3 Microdelivery Stent System because the model numbers on the outer carton and inner pouch labels do not match.
Product
Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number: M003450200, Product is manufactured by Boston Scientific Corporation, Fremont, CA and distributed by Stryker Neurovascular, Fremont, CA The Neuroform Micro
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1809-2013·2013-07-31
FDA Recalls Unapproved Advanced Orthogonal Percussion Adjusting Instruments
The FDA is recalling 54 Advanced Orthogonal Percussion Adjusting Instruments because they are unapproved medical devices. The recall covers units distributed nationwide to chiropractors.
Product
Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1805-2013·2013-07-31
Becton Dickinson Recalls BBL Campylobacter CSM Agar Due to Reduced Vancomycin
Becton Dickinson is recalling BBL Campylobacter CSM Agar because the media may exhibit reduced levels of Vancomycin.
Product
BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium), Catalog # 299614, packaged in cartons of 20 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualit
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1796-2013·2013-07-31
Haemonetics Recalls TEG 5000 Analyzers Due to Manual Errors
Haemonetics is recalling 1,590 TEG 5000 Thromboelastograph Coagulation Analyzers because the user manual incorrectly included Research Use Only parameters.
Product
TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1802-2013·2013-07-31
Becton Dickinson Recalls BBE Anaerobe Agar Due to Reduced Vancomycin
Becton Dickinson is recalling BBE Anaerobe Laked Sheep Blood Agar plates because they may contain reduced levels of Vancomycin.
Product
BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog # 297260, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Bacteroides Bile Esculin Agar (BBE) is reco
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1799-2013·2013-07-31
Becton Dickinson Recalls Schaedler K-V Agar Plates Due to Reduced Vancomycin
Becton Dickinson is recalling specific lots of Schaedler K-V Agar plates because they may contain reduced levels of Vancomycin, potentially affecting test accuracy.
Product
BD BBL Schaedler K-V Agar with 5% Sheep Blood, carton of 20 plates, catalog # 221555, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to vancom
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-814-2013·2013-07-31
LA MER Sunscreen Recalled for Potentially Reduced Sun Protection
Max Huber Research Labs is recalling LA MER SPF 18 Fluid Tint because the active ingredient avobenzone may be subpotent, potentially reducing the product's effectiveness.
Product
LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade LIGHT 02, UPC 7 47930 00481 3, MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-824-2013·2013-07-31
West-ward Belladonna Alkaloids with Phenobarbital Tablets Recalled for Foreign Substance
West-Ward Pharmaceutical Corp. is recalling specific lots of Belladonna Alkaloids with Phenobarbital Tablets due to the presence of black specks comprised of degraded organic material.
Product
West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-51), Rx only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1750-2013·2013-07-31
C. Pacific Foods Recalls Canned Mushroom Sliced Due to Pesticide Levels
C. Pacific Foods is recalling Canned Mushroom Sliced because it contains pesticide levels not approved for this product. The recall affects 159 cartons distributed in Texas.
Product
Canned Mushroom Sliced 6 cans, 53oz
Category
Food
Distribution
1 state
ModerateFDA (Drugs)·D-815-2013·2013-07-31
LA MER Sunscreen Recalled for Potentially Reduced Sun Protection Effectiveness
Max Huber Research Labs is recalling LA MER SPF 18 Fluid Tint because the active ingredient avobenzone may be subpotent, potentially reducing the product's sun protection.
Product
LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade MEDIUM 03, UPC 7 47930 00482 0 --- MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1801-2013·2013-07-31
Becton Dickinson Recalls Anaerobe Agar Plates Due to Reduced Vancomycin Levels
Becton Dickinson is recalling specific lots of BD BBL Anaerobe CNA Agar plates because they may contain reduced levels of Vancomycin, potentially affecting test accuracy.
Product
BD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV Agar, packaged in cartons of 20 plates, Catalog # 297041, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Anaerobe Laked Shee
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1725-2013·2013-07-31
Whole Foods Recalls 365 Organic Apple Juice for Elevated Patulin Levels
Whole Foods Market is recalling 365 Organic 100% Apple Juice due to elevated patulin levels. The recall covers 6.75 fl oz and 64 fl oz bottles distributed nationwide.
Product
365 Organic 100% Apple Juice from concentrate with Vitamin C and Calcium in 6.75 fl oz (UPC 0 99482 42095 6) and 64 fl oz. (UPC 0 99482 42096 3) Distributed by: Whole Foods Market, Austin, TX 78703; 8 units peer shipping case
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-817-2013·2013-07-31
Watson Recalls Diclofenac Sodium and Misoprostol Tablets Due to Broken Tablets
Watson Laboratories is recalling Diclofenac Sodium and Misoprostol tablets because some are broken. Patients should stop using the product and contact their healthcare provider.
Product
DICLOFENAC SODIUM AND MISOPROSTOL — DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1584-2013·2013-07-31
Green Mountain Coffee Recalls Donut House K-Cup Packs Due to Mislabeling
Green Mountain Coffee Roasters is recalling Donut House K-Cup packs because regular caffeinated coffee was packaged in boxes labeled as decaffeinated.
Product
Master Cases, Product Code #8534 (6-12 count retail boxes) Label of master case bears the name: Donut House K -Cup Packs. 12-Count Retail Boxes, Product Code #8934, Donut House Decaffeinated K-Cup Packs
Category
Food
Distribution
11 states
ModerateFDA (Drugs)·D-812-2013·2013-07-31
Vi-Jon Alcohol-Free Antiseptic Mouth Rinse Recalled for Microbial Contamination
Vi-Jon, Inc. is recalling 18,408 bottles of Alcohol Free Antiseptic Mouth Rinse because a stability sample was found to be contaminated with Burkholderia contaminans.
Product
ALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, 33.8 FL OZ (1 L) bottle, Distributed By The Kroger Co., Cincinnati, OH 45202, UPC 0 41260 33606 5.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1781-2013·2013-07-31
Myoscience iovera Smart Tip Recalled for Missing US Labeling Requirements
Myoscience Inc is recalling three iovera Smart Tip units because their labels lacked required US regulatory text and symbols.
Product
Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number: STA0311-10. Product Usage: The Myoscience Cryo-Touch IV (a.k.a. iovera) is used to destroy tissue during surgical procedures by applying freezing cold. It can also be
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1800-2013·2013-07-31
Becton Dickinson Recalls CDC Anaerobe Agar Plates Due to Reduced Vancomycin
Becton Dickinson is recalling specific lots of CDC Anaerobe Agar plates because they may contain reduced levels of Vancomycin.
Product
BD BBL CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin (KV), packaged in cartons of 100 plates, Catalog # 221736, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** CDC Anaerobe 5% Sheep Bloo
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1726-2013·2013-07-31
NOW Foods Ashwagandha Extract Recalled for Undeclared Licorice Ingredient
NOW Foods is recalling Ashwagandha Extract capsules because they contain undeclared licorice extract. Consumers should stop using the product.
Product
White plastic bottle with blue cap containing 90 capsules; Ashwagandha Extract; 450 mg; CODE 4603; Manufactured by NOW FOODS; 395 S. Glen Ellyn Rd., Bloomingdale, IL 60108, USA
Category
Food
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1778-2013·2013-07-31
National Biological Dermalight 80 UVB Phototherapy Units Recalled for Incorrect Manual
National Biological Corp is recalling Dermalight 80 UVB phototherapy units because they may have been packaged with the manual for a different UVA-083 device.
Product
Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1810-2013·2013-07-31
Medtronic Preimplantation Test Kit Recalled for Incorrect Expiration Dates
Medtronic Neurosurgery is recalling Preimplantation Test Kits because the outer carton expiration dates are later than the dates on the individual sterile components.
Product
Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with Medtronic CSF-Flow Control Valves and Delta Valves, when a simple preimplantation test is desired to verify that the valve conforms to labeled product specifications.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-816-2013·2013-07-31
LA MER Sunscreen Recalled for Potentially Subpotent Active Ingredient
Max Huber Research Labs is recalling LA MER SPF 18 Fluid Tint because the active ingredient Avobenzone may be subpotent, reducing sunscreen effectiveness.
Product
LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade DARK 04, UPC 7 47930 00483 7 --- MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM
Category
Drug
Distribution
Distributed nationwide

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