The Recall Desk

Archive

March 2013 recalls

461 recalls were announced in March 2013.

What the numbers show

Critical
39
Severe
115
High
192
Moderate
84
Low
31

Of the 461 recalls this month scored against our rubric, 8% are Critical, 25% are Severe.

401–461 of 461

  • HighFDA (Devices)·Z-0875-2013·2013-03-06

    KY TINGLING JELLY Personal Lubricant Recalled for Lack of FDA Clearance

    McNeil-PPC Inc. is recalling KY TINGLING JELLY Personal Lubricant because the product is not cleared for marketing in the US.

    Product
    KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it. Distributed By: McNeil-PPC Inc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0893-2013·2013-03-06

    Stryker XIA 3 Iliac Screwdriver Recalled Due to Unthreading Risk

    Stryker Spine is recalling 46 units of the XIA 3 Iliac Screwdriver because the outer shafts may unthread during surgical use.

    Product
    Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial screws into the Ilium. Orthopedic manual surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0889-2013·2013-03-06

    Cellestis Recalls QuantiFERON TB Blood Collection Tubes Due to Contamination

    Cellestis is recalling QuantiFERON-TB Gold blood collection tubes due to potential contamination. The recall affects 29,690 units distributed worldwide.

    Product
    Vacuette Cellestis 1 ml QuantiFERON¿ TB ANTIGEN (HA) High Altitude: Shake 10x; REF 454413. HE0396. greiner bio-one; 13x75 50pcs.,1200 pcs in total. Product Usage: QuantiFERON¿-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0895-2013·2013-03-06

    Orthofix ISKD Limb Lengthener Recalled for Potential Post-Operative Failure

    Orthofix, Inc. is recalling ISKD limb lengtheners because the device may stop distracting after surgery, potentially causing premature bone consolidation and the need for revision surgery.

    Product
    Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. The ISKD is intended for limb lengthening of the tibia and femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0880-2013·2013-03-06

    Philips Brilliance CT Scanners Recalled for Software Data Flipping Error

    Philips is recalling Brilliance CT scanners because a software anomaly causes Intensity Projection datasets to be flipped and incorrectly labeled left-to-right.

    Product
    Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244.
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Food)·F-1019-2013·2013-03-06

    Giant Greens Recalls Organic Pea Shoots Due to Listeria Risk

    Giant Greens, Inc. is recalling Organic Pea Shoots sold under Life Force and Trader Joe's brands due to potential Listeria monocytogenes contamination.

    Product
    Organic Pea Shoots are packaged in a 3 oz. or 4 oz packages. Product is sold under the Life Force or Trader Joe's brand. The Life Force, 3 oz, has UPC 8 51042 00414 9. The Trader Joe's, 4 oz, has UPC 0092 7567. The Life Force, 3 oz, is labeled in parts: "***Organic Pe
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0899-2013·2013-03-06

    Philips MX 16-Slice CT Scanner Recall Due to Loose Table Screws

    Philips Medical Systems is recalling 412 MX 16-Slice CT Scanner Systems because loose screws may cause the patient table top to detach.

    Product
    Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Food)·F-1018-2013·2013-03-06

    Giant Greens Recalls Sprouters Northwest Wheatgrass Due to Listeria Risk

    Giant Greens, Inc. is recalling Sprouters Northwest brand wheatgrass due to potential contamination with Listeria monocytogenes. The product was distributed in the Pacific Northwest and British Columbia.

    Product
    Wheatgrass is packaged in a pint or cup, 16 oz. bag, or 5 lb. Flat cardboard box and sold under the Sprouters Northwest brand. The Wheatgrass in a pint or cup has UPC 0 79566 12380 5; The wheatgrass in 16 oz. bag or 5 lb. Flat cardboard box does not have any UPC. The wh
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1017-2013·2013-03-06

    Giant Greens Recalls Mung Bean Sprouts Due to Listeria Risk

    Giant Greens, Inc. is recalling specific Mung Bean sprouts due to potential contamination with Listeria monocytogenes. Consumers in the Pacific Northwest and British Columbia should check their products.

    Product
    Mung Bean sprouts is packaged in a 8 oz clamshell container or 5 lb. bag and sold under the Sprouters Northwest or Life Force brand. The Life Force foods, 8 oz, has UPC 8 15098 00107 1; The Sprouters Northwest, 5 lb., has UPC 0 33383 70258 2. The Life Force foods, 8 o
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-1015-2013·2013-03-06

    Giant Greens Recalls Deli Sprouts Due to Listeria Contamination Risk

    Giant Greens, Inc. is recalling Sprouters Northwest brand Deli Sprouts due to potential Listeria monocytogenes contamination. The product was distributed in the Pacific Northwest and British Columbia.

    Product
    Deli sprouts is a mixture of Clover, Fenugreek, Lentils, an Radish sprouts. Product is packaged in a 4 oz. or 5 oz clamshell container. Product is sold under the Sprouters Northwest brand. The Deli sprouts, 4 oz., has UPC 8 79566 12305 4. The Deli sprouts, 5 oz., as UPC
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0894-2013·2013-03-06

    Brio DBS implantable pulse generators recalled for unintended fluid ingress

    Advanced Neuromodulation Systems Inc. is recalling Brio DBS System Model 6788 implantable pulse generators because unintended fluid ingress into the device header has been shown.

    Product
    Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1013-2013·2013-03-06

    Giant Greens Recalls Alfalfa Sprouts Due to Listeria Contamination Risk

    Giant Greens, Inc. is recalling specific packages of alfalfa sprouts due to potential contamination with Listeria monocytogenes.

    Product
    Alfalfa sprouts, packaged in a 4 oz. clamshell container or 85 gram package. Product is sold under Sprouters Northwest or LifeForce brand. The Sprouters Northwest, 4oz., has UPC 8 15098 00108 8; The LifeForce, 85 gram, has UPC 8 51042 00402 6. The Sprouters Northwest, 4o
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0877-2013·2013-03-06

    Intel-GE Care Innovations Recalls QuietCare Facility Servers for Software Defect

    Intel-GE Care Innovations is recalling 19 QuietCare Facility Servers due to a software defect that may prevent Wander Alerts from being generated.

    Product
    QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0888-2013·2013-03-06

    Cellestis Recalls QuantiFERON TB Blood Collection Tubes Due to Contamination

    Cellestis is recalling QuantiFERON-TB Gold blood collection tubes due to potential contamination. The recall affects 309,400 units distributed worldwide.

    Product
    VACUETTE Cellestis 1 ml QuantiFERON¿ - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.,1200 pcs. in total; Product Usage: QuantiFERON¿-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0897-2013·2013-03-06

    Philips Ingenuity TF PET/CT System Recalled for Gating Trigger Risk

    Philips Medical Systems is recalling one Ingenuity TF PET/CT unit in Ohio because the system may not default to the correct gating trigger, posing a risk to patients.

    Product
    Ingenuity TF PET/CT. Diagnostic imaging system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1023-2013·2013-03-06

    Productos 2001 Dough Rounds Recalled for Undeclared Allergens

    Productos 2001 Inc. is recalling 28-ounce packages of dough rounds for tacos and turnovers due to undeclared FD&C color additives.

    Product
    "***Productos 2001**Plantillas para Pastelillos-Empanadillas-Tacos-Cheese Dog y Otros (dough rounds for tacos and turnovers)***18 units***Keep refrigerated***NET WT. 28 oz***"
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0878-2013·2013-03-06

    Medacta Recalls Versafitcup Impacting Rings for Fit Issues

    Medacta USA is recalling Versafitcup Impacting Rings because they may not fit properly in the implant shell, potentially causing surgical delays and complications.

    Product
    Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136 (52mm), 01.26.10.0137 (54mm), 01.26.10.0138 (56mm), 01.26.10.0139 (58mm), 01.26.10.0140 (60mm), 01.26.10.0141 (62mm), 01.26.10.0142 (64mm). Designed for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0885-2013·2013-03-06

    Elekta Apex add-on Micro MLC collimator recall for installation defect

    Elekta, Inc. is recalling Apex add-on Micro MLC collimators for radiation therapy because incorrect installation may cause the touchguard inhibit to activate and restrict the view restrictions dialog box.

    Product
    Elekta, Apex add-on Micro MLC, collimator for radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0883-2013·2013-03-06

    Philips GEMINI TF Big Bore PET/CT Systems Recalled for Software Error

    Philips is recalling 37 GEMINI TF Big Bore PET/CT systems because a software error may cause generated Intensity Projection data to be flipped and incorrectly labeled.

    Product
    Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning system, a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed To
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-0786-2013·2013-03-06

    Philips CT Systems Recalled for Deteriorating Image Quality Phantom Pins

    Philips Medical Systems is recalling 1,474 CT scanners because low-contrast pins in the Image Quality phantom deteriorate, preventing required daily checks.

    Product
    Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0703-2013·2013-03-06

    GE Healthcare Definium 5000 X-Ray System UI Display Recall

    GE Healthcare is recalling Definium 5000 X-Ray Systems because the user interface may display incorrect exposure settings during rapid protocol switching.

    Product
    GE Healthcare Definium 5000 / 5220493 X-Ray System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-178-2013·2013-03-06

    Dr. Reddy's Recalls Citalopram Tablets Due to Chemical Odor Complaints

    Dr. Reddy's is recalling 27,805 bottles of Citalopram tablets 10mg due to reports of a strong garlic or chemical smell.

    Product
    Citalopram tablets USP, 10mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-342-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-173-2013·2013-03-06

    Amedra Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures

    Amedra Pharmaceuticals is recalling 10,968 bottles of Dextroamphetamine Sulfate Extended Release Capsules because they may not meet dissolution specifications over the product shelf life.

    Product
    Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-329-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-180-2013·2013-03-06

    Dr. Reddy's Recalls Citalopram Tablets Due to Chemical Odor Complaints

    Dr. Reddy's is recalling specific lots of Citalopram tablets because patients reported a strong garlic or chemical smell.

    Product
    Citalopram tablets USP, 40mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-344-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0884-2013·2013-03-06

    Philips DigitalDiagnost X-Ray System Recalled for Image Rotation Errors

    Philips Healthcare Inc. is recalling 551 DigitalDiagnost X-Ray Systems because images may rotate in the wrong direction, causing electronic side markers to be placed incorrectly.

    Product
    Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-172-2013·2013-03-06

    Amedra Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures

    Amedra Pharmaceuticals is recalling 12,948 bottles of Dextroamphetamine Sulfate Extended Release Capsules because they may not meet dissolution specifications over their shelf life.

    Product
    Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-328-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0873-2013·2013-03-06

    KY Sensitive Jelly Personal Lubricant Recalled for Lack of FDA Clearance

    McNeil-PPC Inc. is recalling KY Sensitive Jelly Personal Lubricant because the product is not cleared for marketing in the US.

    Product
    KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0761-2013·2013-03-06

    GE Healthcare Recalls Brivo XR385 X-Ray Systems Due to Software Issue

    GE Healthcare is recalling nine Brivo XR385 X-Ray systems in the US due to a software issue affecting visual indications required by regulations.

    Product
    GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0704-2013·2013-03-06

    GE Healthcare Definium 5000 X-Ray System UI Display Recall

    GE Healthcare is recalling Definium 5000 X-Ray systems because the user interface may display incorrect exposure settings during rapid protocol switching.

    Product
    GE Healthcare Definium 5000/5220493-2 X-Ray System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0882-2013·2013-03-06

    Philips GEMINI PET/CT Systems Recalled for Software Data Flipping Error

    Philips is recalling 30 GEMINI PET/CT systems because a software error causes Intensity Projection data to be flipped and mislabeled left-to-right.

    Product
    Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #882470 and Model #882473; GEMINI TF 64 - Model #882471, Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanning systems, diagnostic imaging systems for fixed or mobile installations
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-0890-2013·2013-03-06

    Oculus Innovative Sciences Recalls Atrapro Antipruritic Hydrogel Due to Preservative Failure

    Oculus Innovative Sciences is recalling Atrapro Antipruritic Hydrogel because stability testing showed insufficient free available chlorine, a preservative required to maintain product safety.

    Product
    Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, Professional Sample, Not for Sale. Pre-printed tube: MS31071, Shelf carton: PL51091-08 Atrapro Antipruritic HydroGel is indicated to manage and relieve the burning, itching and pain experienced with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-174-2013·2013-03-06

    West-ward Recalls Isoniazid Tablets for Failed Dissolution Specifications

    West-ward Pharmaceutical Corp. is recalling Isoniazid Tablets 300 mg due to failed dissolution specifications and a 36-month stability timepoint issue.

    Product
    Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100 tablets - NDC 61748-013-01, Mfd for: VersaPharm Incorporated Marietta, GA 30065-1505, Mfd by: West - Ward Pharmaceutical Corp.., Eatontown, NJ 07724
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0874-2013·2013-03-06

    KY SilkE Vaginal Moisturizer Recalled for Lack of FDA Clearance

    McNeil-PPC is recalling KY SilkE Vaginal Moisturizer because the product is not cleared for marketing in the US.

    Product
    KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0879-2013·2013-03-06

    Baylis Medical Recalls Unsealed Sterile RF Cannulas for Pain Relief

    Baylis Medical is recalling 1,780 sterile RF cannulas distributed to Australia because some pouches were not sealed, risking sterility loss.

    Product
    BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined num
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0898-2013·2013-03-06

    MedComp Recalls 785 PICC Kits Packaged with Incorrect Needles

    Medical Components, Inc. is recalling 785 power injectable infusion PICC insertion kits because they were packaged with non-safety needles instead of the safety needles indicated on the label.

    Product
    REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0881-2013·2013-03-06

    Philips Medical Systems Recalls Extended Brilliance Workspace X-Ray Scanners

    Philips Medical Systems is recalling 39 Extended Brilliance Workspace X-Ray Scanners because a software anomaly may cause generated data sets to be flipped and incorrectly labeled.

    Product
    Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, Model #728260. A component of the Computed Tomography X-Ray System.
    Category
    Medical Device
    Distribution
    43 states
  • ModerateFDA (Devices)·Z-0891-2013·2013-03-06

    Myco Medical Recalls Technocut Plus Safety Scalpels Due to Sterility Concerns

    Myco Medical is recalling Technocut Plus safety scalpels due to labeling errors and defective packaging that may compromise sterility.

    Product
    Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Drugs)·D-179-2013·2013-03-06

    Dr. Reddy's Recalls Citalopram Tablets Due to Chemical Odor Complaints

    Dr. Reddy's is recalling 86,093 bottles of Citalopram tablets due to reports of a strong garlic or chemical smell.

    Product
    Citalopram tablets USP, 20mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-343-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1022-2013·2013-03-06

    Koda Farms Recalls Sweet Rice Flour Due to Foreign Object

    Koda Farms is recalling 50 lb. bags of Mochiko Blue Star Sweet Rice Flour after a customer reported finding a hard yellow material in dough made with the product.

    Product
    Mochiko Blue Star Sweet Rice Flour; Net Wt. 50 lbs. (22.68 k) Koda Farms Milling, Inc. South Dos Palos, CA 93665
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-1006-2013·2013-03-06

    Whole Foods Market Panettone Chocolate Recalled for Mispackaging

    Whole Foods Market is recalling Panettone Chocolate because some units were mispackaged with Cranberry Panettone, creating a potential soy allergen discrepancy.

    Product
    Whole Foods Market Panettone Chocolate - 26.4 oz, 12 per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-170-2013·2013-03-06

    West-ward Recalls Belladonna Alkaloids Tablets Due to Foreign Substance

    West-ward Pharmaceutical Corp. is recalling Belladonna Alkaloids with Phenobarbital tablets because uncharacteristic black spots were found in the product.

    Product
    Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065 mg) with Phenobarbital (USP 16.2 mg) Tablets, packaged in a) 1000-count tablets per bottle (NDC 0143-1140-10; b) 5000-count tablets per bottle (NDC 143-1140-51);
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1008-2013·2013-03-06

    Aptalis Recalls SourceCF Pediatric Multivitamin Drops Due to Shelf Life Concerns

    Aptalis Pharma is recalling SourceCF Pediatric Drops because the formulation may not support the labeled shelf life. The recall covers 14,439 units distributed in the US, Italy, Canada, and Brazil.

    Product
    SourceCF(R) Pediatric Drops, Multivitamins with A, B, D, E and K Plus Zinc, 2 FL OZ. (60ML), NDC 66212-300-60, UPC 668212300600
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0886-2013·2013-03-06

    Integra Jarit Monopolar Cable Recall for Updated Safety Warnings

    Integra LifeSciences is recalling 22,500 Jarit Monopolar Cables to distribute an addendum to the Instructions for Use. The update emphasizes existing warnings and adds new precautions for electrosurgical equipment.

    Product
    Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar electrosurgical current can be used
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-171-2013·2013-03-06

    Amedra Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures

    Amedra Pharmaceuticals is recalling 1,176 bottles of Dextroamphetamine Sulfate Extended Release Capsules because they may not meet dissolution specifications.

    Product
    Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-175-2013·2013-03-06

    Actavis Recalls BuPROPion Hydrochloride Tablets Due to Dissolution Failure

    Actavis Pharmaceuticals is recalling 14,856 bottles of buPROPion Hydrochloride Extended-Release Tablets 300 mg because they failed dissolution specifications during stability testing.

    Product
    buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0876-2013·2013-03-06

    Ultradent Recalls Mislabelled Avex CX Orthodontic Brackets

    Ultradent Products, Inc. is recalling 124 units of Avex CX orthodontic brackets due to incorrect labeling. The affected products were distributed nationwide in the US.

    Product
    Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-177-2013·2013-03-06

    Bayer Recalls Bronkaid Dual Action Formula Due to Labeling Errors

    Bayer Healthcare is recalling Bronkaid Dual Action Formula caplets because the carton label is missing a warning or Rx legend and other information.

    Product
    Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24 coated caplets per blister pack, UPC 300240537879, b) 60 coated caplets per blister pack, UPC 300240537855, Bayer HealthCare LLC, Consumer Care, P.O. Box 1910, Morristown,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V078000·2013-03-05

    Subaru Recalls 2012 Legacy and Outback for Wiper Motor Fire Risk

    Subaru is recalling 2012 Legacy and Outback vehicles because wiper motor components may overheat, melt, and catch fire. Owners should contact a dealer for a free repair.

    Product
    SUBARU — SUBARU LEGACY, OUTBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V079000·2013-03-05

    Great Dane Recalls 2011 Dry Freight Semi-Trailers for Frame Weld Defects

    Great Dane is recalling 2011 Dry Freight Semi-Trailers because improper welds on the bogie frame may crack, causing axle disengagement and loss of control.

    Product
    GREAT DANE — GREAT DANE DRY FREIGHT SEMI-TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13728·2013-03-05

    Briggs & Stratton Recalls Ariens Snow Blowers Due to Fire Hazard

    Briggs & Stratton is recalling Ariens Snow-Thro 24-inch snow blowers because the carburetor bowl nut can allow gas to escape, creating a fire hazard.

    Product
    Ariens Snow-Thro 24-inch snow blower
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13130·2013-03-05

    Tween Brands Recalls Disco Lights Due to Electrical Shock Hazard

    Tween Brands is recalling Style My Room by Justice Disco Lights because accessible wiring and overheating pose an electrical shock risk.

    Product
    Style my Room by Justice Disco Lights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • LowNHTSA·13V084000·2013-03-05

    Volvo Recalls 2013 S60 and XC60 for Incorrect Certification Labels

    Volvo is recalling 2013 S60 and XC60 vehicles manufactured on January 7, 2013, because their certification labels list the incorrect manufacture year.

    Product
    VOLVO — VOLVO S60, XC60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V075000·2013-03-04

    Terex Recalls 2012 Utility Trucks Due to Leveling Arm Defect

    Terex is recalling 2012 utility trucks with SCM Aerial Devices because the leveling arm may break, potentially causing occupants to fall.

    Product
    TEREX — TEREX AERIAL DEVICES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V073000·2013-03-04

    Freightliner Van Chassis Recalled for Fuel Tank Cracks and Fire Risk

    Daimler Trucks North America is recalling 2011-2014 Freightliner MT45G and MT55G van chassis because fuel tank cracks may cause gasoline leaks and vehicle fires.

    Product
    FREIGHTLINER — FREIGHTLINER MT45G, MT55G
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V074000·2013-03-04

    Daimler Trucks Recalls 2012-2013 Freightliner Chassis Due to Electrical Defect

    Daimler Trucks North America is recalling 2012-2013 Freightliner chassis because manufacturing residue in the switch hub module may cause intermittent shorts, increasing the risk of injury or a crash.

    Product
    FREIGHTLINER — FREIGHTLINER 114SD, BUSINESS CLASS M2, 108SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V068000·2013-03-01

    Nissan Recalls 2013 Sentra Vehicles for Fuel Tank Leak Risk

    Nissan is recalling certain 2013 Sentra vehicles because improperly sealed fuel tanks may leak gasoline, posing a fire risk.

    Product
    NISSAN — NISSAN SENTRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V069000·2013-03-01

    Nissan Recalls 2013 Models Due to Passenger Airbag Sensor Defect

    Nissan is recalling 2013 Altima, LEAF, Pathfinder, Sentra, and Infiniti JX35 vehicles because defective sensors may permanently suppress the passenger airbag.

    Product
    NISSAN — NISSAN, INFINITI LEAF, JX35, ALTIMA, SENTRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V071000·2013-03-01

    Starcraft Recalls 2013 Travel Trailers Due to Power Converter Fire Risk

    Starcraft is recalling 2013 Autumn Ridge and Travel Star travel trailers because a power converter may short circuit, potentially causing a vehicle fire.

    Product
    STARCRAFT — STARCRAFT AUTUMN RIDGE, TRAVEL STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V070000·2013-03-01

    Jayco Recalls 2013 Travel Trailers and Fifth-Wheels Due to Fire Risk

    Jayco is recalling specific 2013 travel trailers and fifth-wheels because a power converter component may short circuit, posing a fire risk.

    Product
    JAYCO — JAYCO EAGLE, JAY FLIGHT DESTINATION, JAY FLIGHT BUNGALOW, EAGLE PREMIER
    Category
    Vehicle
    Distribution
    Distributed nationwide

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