The Recall Desk

Archive

September 2012 recalls

607 recalls were announced in September 2012.

What the numbers show

Critical
135
Severe
154
High
210
Moderate
83
Low
25

Of the 607 recalls this month scored against our rubric, 22% are Critical, 25% are Severe.

Which agencies issued them

101–200 of 607

  • HighFDA (Devices)·Z-2389-2012·2012-09-26

    Instrumentation Laboratory ACL TOP Analyzer Recalled for Fibrinogen Reporting Errors

    Instrumentation Laboratory is recalling ACL TOP analyzers because they may incorrectly report abnormal fibrinogen levels as normal or low.

    Product
    Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of throm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2428-2012·2012-09-26

    Integra CRW Precision Arc and HRAIM Head Ring Assembly Recalled

    Integra LifeSciences is recalling CRW Precision Arc and HRAIM Head Ring Assemblies because a T-handle screw may prevent proper seating of the arc system.

    Product
    Integra CRW Precision Arc (CRWPRECISE), CRW Arc System (CRWASL), HRAIM Head Ring Assembly with Intubation Mounts The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CTIMR compatible. T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2318-2012·2012-09-26

    Peppermint Leaf Recall Due to Pervasive Mouse Infestation in Facility

    San Francisco Herb & Natural Food Company is recalling peppermint leaf due to a pervasive mouse infestation found in its facility by California inspectors.

    Product
    Peppermint lf, org C/S; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2423-2012·2012-09-26

    Asahi Kasei Recalls REXEED 15 LX Hemodialyzers Due to Adverse Event Trend

    Asahi Kasei is recalling 24 units of REXEED 15 LX hemodialyzers due to a negative trend in adverse events potentially linked to manufacturing changes.

    Product
    Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-2311-2012·2012-09-26

    Rosemary Leaf Whole Recalled Due to Pervasive Mouse Infestation

    San Francisco Herb & Natural Food Company is recalling Rosemary Leaf Whole because inspectors found a pervasive mouse infestation in the facility.

    Product
    Rosemary Leaf Whole; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2403-2012·2012-09-26

    Roche Amplilink Software Recall Due to Potential Wrong Test Results

    Roche Molecular Systems is recalling Amplilink Software 3.2.3 because it may assign wrong results to orders when used with certain Laboratory Information Systems.

    Product
    Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2383-2012·2012-09-26

    Varian Linear Accelerators Recalled Due to X-Jaw Carrier Alloy Defect

    Varian Medical Systems is recalling 221 linear accelerators worldwide because incorrect metal alloy in X-jaw carriers may cause cracking and undetected under-dosing.

    Product
    Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indic
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2420-2012·2012-09-26

    Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trends

    Asahi Kasei is recalling 30,408 REXEED hemodialyzers due to a negative trend in adverse events potentially linked to manufacturing changes.

    Product
    Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-1676-2012·2012-09-26

    Dukal BZK Swabs Recalled for Burkholderia cepacia Contamination

    Dukal Corporation is recalling BZK Swabs, First Aid Antiseptic, due to microbial contamination with Burkholderia cepacia. The recall covers specific lots shipped since July 2009.

    Product
    Dukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0.133% w/v, Item 854-1000 contains 1000 individually packaged swabs per box. Item 854 contains 200 individually packaged swabs per box. Packaging labeled with Dukal Corporation, Hauppauge, NY 11788 --- NDC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2323-2012·2012-09-26

    Spearmint Recalled Due to Pervasive Mouse Infestation in Facility

    San Francisco Herb & Natural Food Company is recalling spearmint because inspectors found a pervasive mouse infestation in the facility.

    Product
    Spearmint LF/CS; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2399-2012·2012-09-26

    Biomet Recalls JuggerKnot In-Guide Punch Due to Knob Unfastening Risk

    Biomet is recalling 62 units of the JuggerKnot 2.9mm In-Guide Punch because the knob may unfasten and slide down the shaft during use.

    Product
    JUGGERKNOT IN¿GUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the JuggerKnot 2.9mm Suture Anchor is to be placed. The JuggerKnot 2.9mm Suture Anchor is intended to be used to attach soft tissue to bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2419-2012·2012-09-26

    Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend

    Asahi Kasei is recalling 152,016 REXEED hemodialyzers after identifying a negative trend in adverse events potentially linked to a manufacturing change.

    Product
    Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2382-2012·2012-09-26

    Spacelabs Ultraview SL Integrated Module Housing Recalled for Potential Failure

    Spacelabs Healthcare is recalling Ultraview SL Integrated Module Housings because they may fail, causing patient module parameters to drop off the monitor display or preventing modules from signing on.

    Product
    Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm prior
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2385-2012·2012-09-26

    Tedan Surgical Innovations Recalls Sterile Distraction and XL Screws

    Tedan Surgical Innovations is voluntarily recalling sterile distraction and XL screws because mechanical packaging failures may compromise sterility.

    Product
    Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction Sc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2378-2012·2012-09-26

    RaySearch TomoTherapy SharePlan Software Field Notice for Unexpected Behaviors

    RaySearch Laboratories issued a field notice for TomoTherapy SharePlan software due to two unexpected behaviors not clearly described in the user manual. No patient mistreatment or incidents have occurred.

    Product
    The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10. Intended use: t-
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2426-2012·2012-09-26

    Steris Recalls 5085 Surgical Tables Due to Hydraulic Column Damage

    Steris is recalling 379 surgical tables because external impact damage to the hydraulic column can misalign shrouds and impede table movement.

    Product
    STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. It accommodates all general surgical procedures including but not limited to,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2315-2012·2012-09-26

    Olive Leaf Organic Recalled Due to Mouse Infestation in Facility

    San Francisco Herb & Natural Food Company is recalling Olive Leaf Organic due to a mouse infestation found in its facility by California health inspectors.

    Product
    Olive Leaf Organic; Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2326-2012·2012-09-26

    Spearmint Leaf Recalled Due to Pervasive Mouse Infestation in Facility

    San Francisco Herb & Natural Food Company is recalling Spearmint Leaf C/S because inspectors found a pervasive mouse infestation in the facility.

    Product
    Spearmint Leaf C/S Distributed by San Francisco Herb and Natural Food Co. Fremont, Ca.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2384-2012·2012-09-26

    Philips DigitalDiagnost Systems Recalled for Electrical Safety Standard Non-Compliance

    Philips Healthcare Inc. is recalling four DigitalDiagnost Systems because the GEO Transformer does not meet international electrical safety standards.

    Product
    Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2424-2012·2012-09-26

    Asahi Kasei Recalls REXEED Hemodialyzers Due to Adverse Event Trend

    Asahi Kasei is recalling REXEED hemodialyzers because of a negative trend in adverse events potentially linked to a manufacturing change.

    Product
    Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER dialysis filter
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-2355-2012·2012-09-26

    Friendly's Nutty Caramel Crunch Sundae Recalled for Foreign Material

    Friendly Ice Cream Corp. is recalling 86,136 cups of Nutty Caramel Crunch Sundae due to the presence of foreign material.

    Product
    Friendly's Brand Nutty Caramel Crunch Sundae, 6 0z. UPC: 0-29839-00050 Weis Crunchy Caramel Nut Sundae, 6 0z cup UPC 0-41497-01573-3
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-2409-2012·2012-09-26

    Siemens ADVIA Centaur Prolactin Assay Recalled for Analytical Sensitivity Failure

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Prolactin Assay and Calibrator B kits because they fail to meet the analytical sensitivity stated in the instructions for use.

    Product
    ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 110758: US:Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP Prolactin assay: For in v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2411-2012·2012-09-26

    Haag-Streit Recalls Octopus 101 Perimeters Due to Luminance Deviation

    Haag-Streit USA Inc recalled 64 Octopus 101 Perimeters because of a possible deviation in stimulus luminance. The devices are used to determine the extent of a patient's peripheral visual field.

    Product
    Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2398-2012·2012-09-26

    Bio-Rad MONOLISA Anti-HBs EIA Recalled Due to Light Exposure Issues

    Bio-Rad Laboratories is recalling MONOLISA Anti-HBs EIA kits because light exposure to the Conjugate Diluent may cause false positive or grey zone results.

    Product
    The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Ra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2348-2012·2012-09-26

    R&S Tomato Basil Tortillas Recalled for Undeclared Yellow Dye

    R&S Mexican Food Products is recalling Tomato/Basil Pressed Tortillas because they contain undeclared FD&C Yellow #6. The product was distributed to four accounts in Arizona.

    Product
    R&S Mexican Food Products, Inc. Tomato/Basil Pressed Tortillas, 1 Dozen. Packaged in sealed flexible plastic bag.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2350-2012·2012-09-26

    Hysteroscopic Sterilization Pack Recalled for Missing Microbial Testing

    Custom Medical Specialties is recalling Hysteroscopic Sterilization Packs because the included Povidone Iodine Prep Solution lacked required microbial testing.

    Product
    CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2356-2012·2012-09-26

    Custom Vein Tray Recalled for Unverified Povidone Iodine Solution

    Custom Medical Specialties is recalling Custom Vein Trays containing Povidone Iodine Prep Solution because the product lacked required microbial testing and failed specifications.

    Product
    CMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2413-2012·2012-09-26

    FDA Recalls Mislabeled Bard Ventralight ST Mesh Surgical Products

    Davol, Inc. is recalling 49 units of Bard Ventralight ST Mesh due to packaging mislabeling where product sizes do not match package labels.

    Product
    Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2396-2012·2012-09-26

    US Endoscopy Recalls Infinity Cytology Brushes Due to Deployment Issues

    US Endoscopy is recalling 393 Infinity sampling devices because the cytology brush may be difficult to deploy through the catheter.

    Product
    Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device is a disposable cytology brush used to retrieve cytological cell samples in the gastrointestinal tract.
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-2416-2012·2012-09-26

    Kimberly-Clark MIC PEG Kit Recall Due to Placement Guidewire Size Issue

    Kimberly-Clark is recalling MIC PEG Kits - Pull Type because the placement guidewire is too large to pass through the introducer needle.

    Product
    Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention disk.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2401-2012·2012-09-26

    Zoll X Series Defibrillators Recalled for Incorrect Software

    ZOLL Medical Corporation is recalling 11 Zoll X Series Defibrillator/Pacemaker/Monitor units because they were shipped with incorrect software.

    Product
    Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In add
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2349-2012·2012-09-26

    Custom Medical Specialties Recalls HSG Trays with Povidone Iodine Prep Solution

    Custom Medical Specialties is recalling CMS-4501-R1 Custom HSG Trays because the included Povidone Iodine Prep Solution lacked microbial testing and failed finished goods specifications.

    Product
    CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2415-2012·2012-09-26

    Kimberly-Clark MIC Safety PEG Kit Recall Due to Guidewire Size Issue

    Kimberly-Clark is recalling 277 units of MIC Safety PEG Kits because the placement guidewire is too large to pass through the introducer needle.

    Product
    Kimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - Pull type are Percutaneous Endoscopic gastrostomy (PEG) tubes intended for a non-surgical "pull" endoscopic placement technique. The PEG tube is held in place during use with an external retention
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2381-2012·2012-09-26

    Integra Recalls 2.7mm Drilling Guides Due to Breakage During Use

    Integra Life Sciences is recalling 2,389 units of 2.7mm Drilling Guides because they may break during surgical use, potentially increasing procedure time.

    Product
    The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to prepare oriented holes in bone for insertion of a Standard Surfix¿ Locking Screw with plates for the Tiblaxis, Uni-CP, Advansys MLP and Advansys DLP compression plate systems. The Drilling Guid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2417-2012·2012-09-26

    Steris Recalls Verify Bowie-Dick Test Cards Due to Performance Issues

    Steris Corporation is recalling Verify Bowie-Dick Test Cards because they may produce false fail results, potentially indicating sterilizer issues when performance is actually acceptable.

    Product
    Verify¿ Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mentor, OH 44060 The Verify Bowie-Dick Test Card consists of a card printed on one side with bars of chemical indicator ink. On the opposite side of the card, space is provided for c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2353-2012·2012-09-26

    Friendly's Sundae Nut Football Ice Cream Recalled for Foreign Material

    Friendly Ice Cream Corp. is recalling 59,052 cartons of Sundae Nut Football Limited Edition ice cream due to the presence of foreign material.

    Product
    Friendly's Sundae Nut Football Limited Edition, 48 oz. carton UPC :0-29839-00530-7
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Food)·F-2354-2012·2012-09-26

    Friendly's Fudge Nut Brownie Sundae Extreme Recalled for Foreign Material

    Friendly Ice Cream Corp. is recalling 19,860 cartons of Fudge Nut Brownie Sundae Extreme due to the presence of foreign material.

    Product
    Friendly's Fudge Nut Brownie Sundae Extreme, 48 oz. carton UPC: 0-29839-00657-1
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-2351-2012·2012-09-26

    Custom Vein Tray Recalled for Missing Microbial Testing

    Custom Medical Specialties is recalling CMS-4316 Custom Vein Trays because the included PVP Prep Solution lacked required microbial testing.

    Product
    CMS-4316 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2359-2012·2012-09-26

    Custom Medical Specialties Recalls Myelogram Trays with PVP Prep Solution

    Custom Medical Specialties is recalling CMS-5284 Custom Myelogram Trays containing PVP Prep Solution because the solution lacked microbial testing and failed to meet finished goods specifications.

    Product
    CMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2358-2012·2012-09-26

    Tunnel Farms Recalls Watermelons Due to Unapproved Pesticide Residue

    Tunnel Farms is recalling seedless watermelons labeled 'IT'S WATERMELON TIME!' because unapproved pesticide residue was detected.

    Product
    Watermelon, labeled IT'S WATERMELON TIME!, Produce of USA, Seedless, #4032.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2412-2012·2012-09-26

    FDA Recalls Mislabeled Bard Ventralight ST Mesh Surgical Products

    Davol, Inc. is recalling 49 units of Bard Ventralight ST Mesh due to size mislabeling on the packaging.

    Product
    Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) Product Code 5954810. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2414-2012·2012-09-26

    DePuy S-ROM Total Hip System Poly Liner Recalled for Labeling Error

    DePuy Orthopaedics is voluntarily recalling four lots of S-ROM Total Hip System Poly Liners because the carton labels contain an incorrect color code series designation.

    Product
    S-Rom¿ Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch and sealed; the foil pouch and Tyvek/PET pouch are placed into a nylon outer pouch and sealed. This is then placed into a f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2431-2012·2012-09-26

    Sekisui Spectrolyse PAI-1 Assay Recalled for Lower Absorbance Values

    Sekisui Diagnostics is recalling Spectrolyse PAI-1 kits because they produce lower than expected absorbance values, which may require more frequent sample dilutions.

    Product
    Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. Catalog Number: 101201 For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2379-2012·2012-09-26

    FDA Recalls HALO Flex Energy Generators Due to Standby Mode Failure

    The FDA is recalling HALO Flex Energy Generators because they may fail to enter standby mode upon startup, rendering them unusable for patient care.

    Product
    HALO Flex Energy Generators Manufactured by B¿RRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085. The HALO Flex Energy Generator is indicated for use for the coagulation of soft tissue. The HALO Flex System is indicated for use in the coagulation of bleedi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2357-2012·2012-09-26

    Custom Medical Specialties Recalls CT Biopsy Trays with PVP Prep Solution

    Custom Medical Specialties is recalling CT biopsy trays containing PVP Prep Solution because the solution lacked microbial testing and did not meet specifications.

    Product
    CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2404-2012·2012-09-26

    Philips Brilliance CT 16 System Recalled for Software Logout Failure

    Philips is recalling 93 Brilliance CT 16 systems because a software defect may cause the system to fail to log out, requiring a forced restart.

    Product
    The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1683-2012·2012-09-26

    Apace Recalls Enalapril Maleate Tablets Due to Illegible Labeling

    Apace KY LLC is recalling 81,516 bottles of Enalapril Maleate 5mg tablets because some labels have incomplete NDC numbers and missing strength information.

    Product
    Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2410-2012·2012-09-26

    Siemens ADVIA Centaur FSH Calibrator B Recalled for Analytical Sensitivity Failure

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur FSH Calibrator B kits because they fail to meet the analytical sensitivity stated in the instructions for use.

    Product
    ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625 (2 pack ) OUS:OUS: 2 pack REF: 00650577 and Ref: 00654130 (6 pack) Product Usage: ADVIA Centaur CP FSH assay: For in vitro diagnostic use in the quantitative determination
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1678-2012·2012-09-26

    Sandoz Recalls Pramipexole Dihydrochloride Tablets Due to Impurity

    Sandoz Incorporated is recalling specific lots of Pramipexole Dihydrochloride Tablets because stability testing revealed an out-of-specification impurity.

    Product
    Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5248-92
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1677-2012·2012-09-26

    Sandoz Recalls Pramipexole Dihydrochloride Tablets Due to Impurity

    Sandoz Incorporated is recalling Pramipexole Dihydrochloride Tablets, 0.25 mg, because an out-of-specification result for a known impurity occurred during stability testing.

    Product
    Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781- 5249-92,
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2425-2012·2012-09-26

    Kimberly-Clark Recalls Non-Commercial Sterile Surgical Gowns

    Kimberly-Clark is recalling 32 cases of sterile surgical gowns that were not intended for commercial distribution to end users.

    Product
    ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown is a sterile, single use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body flui
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2394-2012·2012-09-26

    Amsino Medical Recalls Mislabeled 0.9% Sodium Chloride Flush Syringes

    Amsino Medical USA is recalling one lot of 0.9% Sodium Chloride Flush syringes that may be mislabeled as 10 mL instead of 3 mL.

    Product
    0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2397-2012·2012-09-26

    BD FACS 7-color Setup Beads Recalled for Incorrect CD Version

    BD Biosciences is recalling 96 kits of BD FACS 7-color Setup Beads because the included CD contained the incorrect version.

    Product
    BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2297-2012·2012-09-26

    GMP Laboratories Recalls Herbal Supplement Due to Missing Capsules

    GMP Laboratories of America Inc is recalling 1,027 boxes of 'Rescue Me' herbal supplements because some packets contain fewer capsules than labeled.

    Product
    Dietary supplement. Product is labeled as :" Rescue Me***911 Damage Control***brantley living herbal formulas***HERBAL SUPPLEMENT 15 INDIVIDUAL PACKETS 4 VEGAN CAPSULES PER PACKET (2-368mg/2-584mg Each)***DISTRIBUTED EXCLUSIVELY BY: Living Herbal Pharmacy, LLC PO Box 56-2410, Mia
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2393-2012·2012-09-26

    Amsino Medical Recalls Mislabeled 0.9% Sodium Chloride Flush Syringes

    Amsino Medical USA is recalling one lot of 0.9% Sodium Chloride Flush syringes that may be mislabeled as 10 mL instead of 3 mL.

    Product
    0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 3 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-33, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-2430-2012·2012-09-26

    Impact Instrumentation Recalls Two On-Board Suction Systems Due to Shipment Mix-Up

    Impact Instrumentation, Inc. is recalling two Model 324JL On-Board Suction Systems due to a shipment mix-up. The devices were distributed nationwide, including in Florida and Ohio.

    Product
    Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V469000·2012-09-25

    Eldorado Recalls 2006-2008 Motorhomes with John Deere CNG Engines

    Thor Industries is recalling specific Eldorado motorhomes due to a potential turbocharger failure that could cause engine damage, oil leaks, or fires.

    Product
    ELDORADO — ELDORADO AXESS, TRANSMARK XHF, E-Z RIDER II, E-Z RIDER II MAX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V466000·2012-09-24

    New Flyer Recalls 2005-2006 C40LF and C40LFR Transit Buses

    New Flyer is recalling 163 transit buses due to a turbocharger defect that may cause engine damage, oil leaks, smoke, or fire.

    Product
    NEW FLYER — NEW FLYER C40LF, C40LFR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V467000·2012-09-24

    Newmar Recalls Dutch Star and Dutch Aire Motorhomes for Brake Defect

    Newmar is recalling 278 Dutch Star and Dutch Aire motorhomes because front brake chambers may contact the suspension, causing brakes to drag and potentially leading to a crash.

    Product
    NEWMAR — NEWMAR DUTCH STAR, DUTCH AIRE DP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V463000·2012-09-20

    Vermeer Recalls HG6000TX Trailers Due to Kingpin Wear Risk

    Vermeer is recalling three HG6000TX horizontal grinder trailers because a defective kingpin may fail, causing the trailer to separate from the towing vehicle.

    Product
    VERMEER — VERMEER HG6000TX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V462000·2012-09-20

    Nissan Recalls 2012 Frontier, Pathfinder, and Xterra for Front Wheel Hub Defect

    Nissan is recalling 2012 Frontier, Pathfinder, and Xterra vehicles because front wheel hubs may not meet hardness specifications, potentially leading to cracking and vehicle crashes.

    Product
    NISSAN — NISSAN FRONTIER, XTERRA, PATHFINDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V465000·2012-09-20

    Navistar Recalls International Trucks Due to Parking Brake Air Leak

    Navistar is recalling specific International trucks because an air leak in the parking brake chamber may prevent the brake from fully releasing, increasing crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL DURASTAR, WORKSTAR, PROSTAR, 8600
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·12750·2012-09-20

    ThyssenKrupp Recalls Residential Elevators Due to Fall Hazard

    ThyssenKrupp Access Manufacturing is recalling LEV II, Volant, and Rise residential elevators because the door can open without the car present, posing a fall risk.

    Product
    LEV II®, Volant™ and Rise™ residential elevators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2186-2012·2012-09-19

    Garden-Fresh Foods Recalls Vegetable Spaghetti Due to Listeria Risk

    Garden-Fresh Foods is recalling Finest Traditions Garden Vegetable Spaghetti because it contains onions potentially contaminated with Listeria monocytogenes.

    Product
    Finest Traditions Garden Vegetable Spaghetti 8 lbs., 10 733147 10196 1
    Category
    Food
    Distribution
    14 states
  • CriticalFDA (Food)·F-2139-2012·2012-09-19

    Whole Foods Florida Recalls Prepared Foods Due to Listeria Risk

    Whole Foods Market in Florida is recalling prepared foods and one seafood item that may contain raw yellow onions processed by Gill Onions, LLC, due to possible Listeria monocytogenes contamination.

    Product
    Gills Onions were used in this product. The Thousand Island Potato Salad is sold at the chef's case, self serve counter, or packaged.It is also sold as "Family Sized Savings Thousand Island Potato Salad". Packaged product is labeled as listed below: "***WHOLE FOODS MARK
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-2220-2012·2012-09-19

    Garden-Fresh Creamy Cole Slaw Dressing Recalled for Listeria Risk

    Garden-Fresh Foods is recalling Creamy Cole Slaw Dressing because it contains onions potentially contaminated with Listeria monocytogenes.

    Product
    Garden-Fresh Creamy Cole Slaw Dressing , 2 lbs., 0 11596 43200 7
    Category
    Food
    Distribution
    14 states
  • CriticalFDA (Food)·F-2264-2012·2012-09-19

    Hannaford Apples and Caramel Snack Pack Recalled for Listeria Contamination

    Missa Bay, LLC is recalling Hannaford Apples & Caramel Snack Packs due to Listeria monocytogenes contamination. Consumers should stop eating the product and return it to the store.

    Product
    Hannaford Apples & Caramel Snack Pack Net Wt. 4 oz (113g) Distributed By: Hannaford Bros. Co., Scarborough, ME 04074 1-800-213-9040. www.hannaford.com On or before August 18 UPC 4126817191
    Category
    Food
    Distribution
    35 states
  • CriticalFDA (Food)·F-2289-2012·2012-09-19

    Missa Bay Recalls Wegmans Apples, Celery, Raisins, & Peanut Butter for Listeria

    Missa Bay, LLC is recalling Wegmans Apples, Celery, Raisins, & Peanut Butter due to Listeria monocytogenes contamination. The product was distributed in 35 states and DC.

    Product
    Wegmans Apples, Celery, Raisins, & Peanut Butter Net Wt 4 oz. (113g) Distributed by: Wegmans Food Markets, Inc. Rochester, NY 14603 On or before August 18; UPC 7789026744
    Category
    Food
    Distribution
    35 states
  • CriticalFDA (Food)·F-2172-2012·2012-09-19

    Garden-Fresh Creamy Cole Slaw Recalled for Listeria Risk

    Garden-Fresh Foods is recalling Creamy Cole Slaw products due to potential Listeria monocytogenes contamination from onions.

    Product
    Creamy Cole Slaw packaged under the following brand, salad name, container size, and UPC number: 1) Garden-Fresh Creamy Cole Slaw Kit , 6 lbs., 0 11596 63039 7; 2) Spartan Creamy Shredded Cole Slaw, 16 oz., 0 11213 90322 4, & 3 lbs., 0 11213 90327 9; 3) Garden-Fresh Creamy S
    Category
    Food
    Distribution
    14 states
  • CriticalFDA (Food)·F-2240-2012·2012-09-19

    Garden-Fresh Mustard Potato Salad Recalled for Listeria Risk

    Garden-Fresh Foods is recalling Dairy Fresh Special Recipe Mustard Potato Salad due to potential Listeria monocytogenes contamination in onions.

    Product
    Dairy Fresh Special Recipe Mustard Potato Salad, 16 oz.., 0 70163 98105 8
    Category
    Food
    Distribution
    14 states
  • CriticalFDA (Food)·F-2166-2012·2012-09-19

    Whole Foods Florida Recalls Prepared Foods for Listeria Risk

    Whole Foods Market in Florida is recalling prepared foods and one seafood item that may contain raw yellow onions from Gill Onions, LLC, due to possible Listeria monocytogenes contamination.

    Product
    Gills Onions were used in this product. The Tuna With Sun-Dried Cranberries & Lemon is sold at the chef's case, self serve counter, or packaged. Packaged product is labeled as listed below: "***WHOLE FOODS MARKET***TUNA WITH SUN-DRIED CRANBERRIES AND LEMON*** TUNA ( TU
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-2203-2012·2012-09-19

    Garden-Fresh Taco Pasta Salad Recalled for Listeria Risk

    Garden-Fresh Foods is recalling specific lots of Taco Pasta Salad because they contain onions potentially contaminated with Listeria monocytogenes.

    Product
    Taco Pasta Salad: 1) Garden-Fresh Taco Pasta Salad, 5 lbs., 0 11596 52076 6; 2) Garden-Fresh Taco Pasta Salad, 5 lbs., 0 11596 52065 0
    Category
    Food
    Distribution
    14 states
  • CriticalFDA (Food)·F-2285-2012·2012-09-19

    Missa Bay Recalls Wawa Fruit and Cheese Sandwiches Due to Listeria

    Missa Bay, LLC is recalling Wawa fruit and cheese sandwiches distributed by Wawa, Inc. because they are contaminated with Listeria monocytogenes.

    Product
    ) Wawa fruit & cheese Net Wt 6 OZ Distributed by: Wawa, Inc. Wawa, PA 19063 wawa.com On or before August 11; UPC 261902567
    Category
    Food
    Distribution
    35 states
  • CriticalFDA (Food)·F-2275-2012·2012-09-19

    Missa Bay Recalls Ready Pac Super Fruit Blend for Listeria Contamination

    Missa Bay, LLC is recalling Ready Pac super fruit blend due to Listeria monocytogenes contamination. Consumers should check their pantries and discard or return the product.

    Product
    Ready Pac super fruit blend Net Wt 6 oz (170g) Distributed By Ready Pac Foods Inc., Irwindale, CA 91706 USA 1-800-800-7822 www.readypac.com On or before August 17; UPC 7774523076
    Category
    Food
    Distribution
    35 states
  • CriticalFDA (Food)·F-2251-2012·2012-09-19

    Garden-Fresh and Weis Red Potato Salads Recalled for Listeria Risk

    Garden-Fresh Foods is recalling specific Garden-Fresh and Weis red potato salads due to potential Listeria monocytogenes contamination from onions.

    Product
    Red Potato Salads: 1) Garden-Fresh Red Potato Salad, 2 lb., 0 11596 24205 7; 2) Weis Red Potato Salad, 16 oz., 0 41497 05848, 5 lb., 0 11596 51105 4
    Category
    Food
    Distribution
    14 states
  • CriticalFDA (Food)·F-2149-2012·2012-09-19

    Whole Foods Florida Recalls Prepared Foods for Listeria Risk

    Whole Foods Market in Florida is recalling prepared foods and seafood items that may contain raw yellow onions from Gill Onions, LLC, due to possible Listeria monocytogenes contamination.

    Product
    Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. SEASONAL SUCCOTASH
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-2291-2012·2012-09-19

    Wegmans Apples, Granola, and Low Fat Vanilla Yogurt Recalled for Listeria

    Missa Bay, LLC is recalling Wegmans Apples, Granola, & Low Fat Vanilla Yogurt due to Listeria monocytogenes contamination.

    Product
    Wegmans Apples, Granola, & Low Fat Vanilla Yogurt, 4.3 OZ (122g) Distributed by: Wegmans Foods Markets, Inc. Rochester, NY 14603 On or before August 18; UPC 7789026737
    Category
    Food
    Distribution
    35 states
  • CriticalFDA (Food)·F-2219-2012·2012-09-19

    Garden-Fresh Cranberry Walnut Red Cabbage Slaw Base Recalled for Listeria Risk

    Garden-Fresh Foods is recalling Cranberry Walnut Red Cabbage Slaw Base because it contains onions potentially contaminated with Listeria monocytogenes.

    Product
    Garden-Fresh Cranberry Walnut Red Cabbage Slaw Base, 8 lbs., 0 11596 83028 5;
    Category
    Food
    Distribution
    14 states
  • CriticalFDA (Food)·F-2272-2012·2012-09-19

    Missa Bay Recalls Apples and Cheese Snack Pacs Due to Listeria

    Missa Bay, LLC is recalling Ready Pac Ready Snax Apples & Cheese with Caramel Dip Snack Pacs because they are contaminated with Listeria monocytogenes.

    Product
    Ready Pac Ready Snax Apples & Cheese with Caramel Dip Snack Pac Net Wt. 4 OZ (113g) Distributed By Ready Pac Foods, Inc. Irwindale, CA 91706 USA 1-800-800-7822 readypac.com On or before August 18; UPC 7774523896
    Category
    Food
    Distribution
    35 states
  • CriticalFDA (Food)·F-2165-2012·2012-09-19

    Whole Foods Florida Recalls Prepared Foods Due to Listeria Risk

    Whole Foods Market in Florida is recalling fresh prepared foods and one seafood item that may contain raw yellow onions from Gill Onions, LLC, which are under recall for possible Listeria monocytogenes contamination.

    Product
    Gills Onions were used in this product. The product listed below is prepared at Whole Foods Market and distributed in their retail chef's case or on the self-service bar. It was not sold labeled. Tuna with Sun-Dried Cranberries
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-2278-2012·2012-09-19

    Safeway Farms Apple, Blue Cheese & Pecan Salad Recalled for Listeria

    Missa Bay, LLC is recalling Safeway Farms Complete Apple, Blue Cheese & Pecan salad due to Listeria monocytogenes contamination.

    Product
    Safeway farms Complete Apple, Blue Cheese & Pecan Total Net Wt. 8.75 OZ (248g) Salad & Toppings 6.75 OZ (191g) Dressing 2 OZ (!.83 FL OZ) 54 mL Distributed by Safeway Inc. PO Box 90 Pleasonton, CA 94506-0009 1-800-SAFEWAY/www.safeway.com On or before August 18; UPC 2113033680
    Category
    Food
    Distribution
    35 states
  • CriticalFDA (Food)·F-2263-2012·2012-09-19

    Missa Bay Recalls Fresh Apple Slices Contaminated with Listeria monocytogenes

    Missa Bay, LLC is recalling Crown Program BK Fresh Apple Slices contaminated with Listeria monocytogenes. The recall covers 264,662 cases and 296,224 units distributed across 36 states and DC.

    Product
    Crown Program BK Fresh Apple Slices, 2 oz On or before August 13; no upc code
    Category
    Food
    Distribution
    35 states
  • CriticalFDA (Food)·F-2277-2012·2012-09-19

    Missa Bay Recalls Ready Pac Sweet Sunshine Platter Due to Listeria

    Missa Bay, LLC is recalling Ready Pac Sweet Sunshine Platters because they are contaminated with Listeria monocytogenes. Consumers should stop using the product.

    Product
    Ready Pac Sweet Sunshine Platter Net Wt 37 OZ )2 LB 5 OZ) 1.05 Kg Dist. by Ready Pac Foods, Inc., Irwindale, CA 91706 USA 1-800-800-7822 www.readypac.com On or before August 16; UPC 7774524204
    Category
    Food
    Distribution
    35 states
  • CriticalFDA (Food)·F-2246-2012·2012-09-19

    Garden-Fresh and Weis Amish Potato Salads Recalled for Listeria Risk

    Garden-Fresh Foods is recalling specific Amish Potato Salads because they contain onions potentially contaminated with Listeria monocytogenes.

    Product
    Amish Potato Salads: 1) Garden-Fresh Amish Country Potato Salad, 5 lb., 0 11596 51005 7; 2) Weis Amish Potato Salad, 16 oz., 0 41497 05845 7, 3 lb., 0 41497 05901 0, 5 lb., 0 11596 51103 0
    Category
    Food
    Distribution
    14 states
  • CriticalFDA (Food)·F-2226-2012·2012-09-19

    Garden-Fresh Foods Recalls Finest Traditions Cole Slaw Due to Listeria Risk

    Garden-Fresh Foods is recalling Finest Traditions XTRA Creamy Cole Slaw because it contains onions potentially contaminated with Listeria monocytogenes.

    Product
    Finest Traditions XTRA Creamy Cole Slaw, 8 lbs., 10 733147 10017 9;
    Category
    Food
    Distribution
    14 states

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