The Recall Desk

Archive

August 2013 recalls

504 recalls were announced in August 2013.

What the numbers show

Critical
20
Severe
100
High
208
Moderate
144
Low
32

Of the 504 recalls this month scored against our rubric, 4% are Critical, 20% are Severe.

101–200 of 504

  • ModerateFDA (Food)·F-1843-2013·2013-08-28

    Galveston Shrimp Company Recalls Shrimp Due to Foreign Material

    Galveston Shrimp Company is recalling specific lots of wild-caught shrimp due to the presence of foreign material. The product was distributed in Texas.

    Product
    Texas Wild UPC, 10/15 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1846-2013·2013-08-28

    Harmony Chai Acidified Tea Recalled for Improper Processing

    Harmony Chai is recalling Black Spiced Chai tea in 22 oz and 64 oz glass bottles because the product was not properly processed.

    Product
    Acidified Tea in a glass bottle with a multi-colored, stick-on label that reads in part: " HARMONY Chai concentrated Fresh brewed on Orcas Island, WA Black Spiced Chai 22oz. (650 ml)***Ingredients: water, Organic Raw Sugar, Black Tea, cloves, cinnamon, Ginger, secret spices, c
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-894-2013·2013-08-28

    Duet DHA Balanced Recalled for Subpotent Beta Carotene Content

    Stayma Consulting Service is recalling Duet DHA Balanced tablets and softgels because the beta carotene (Vitamin A) content is subpotent.

    Product
    Duet DHA Balanced, 1) 30 count tablet blister cards and 5 count softgels blister cards combination pack (NDC 44118-775-30 and NDC 44118-800-30) 2) physician samples (carton contain 7 envelopes each with one 5 count tablet blister card and 5 softgels (NDC 44118-800-05) Rx only, Ma
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1819-2013·2013-08-28

    Plum Organics Mighty 4 Nutrition Blend Recalled for Packaging Seal Defects

    Plum Inc. is recalling Mighty 4 Essential nutrition blend pouches due to intermittent ineffective hermetic seals that may allow spoilage.

    Product
    Plum Organics Mighty 4 Essential nutrition blend; Kale, Strawberry, Amaranth, Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case USPC: 846675003409; Case USPC: 00846675003522 Distributed by Plum Inc., Emery ville, CA.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1821-2013·2013-08-28

    Plum Organics Mighty 4 Nutrition Blend Recalled for Seal Defects

    Plum Inc. is recalling 81,347 cases of Mighty 4 Essential nutrition blend pouches due to intermittent ineffective hermetic seals that may lead to spoilage.

    Product
    Plum Organics Mighty 4 Essential nutrition blend; Sweet Potato Blueberry Millet , Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case USPC: 846675003416; Case USPC:00846675003539 Distributed by Plum Inc., Emeryville, CA.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1844-2013·2013-08-28

    Galveston Shrimp Company Recalls Frozen Shrimp Due to Foreign Material

    Galveston Shrimp Company is recalling specific lots of frozen shrimp due to the presence of foreign material. The product was distributed in Texas.

    Product
    Texas Wild UPC, 10/15 WSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1985-2013·2013-08-28

    Sorin Group Recalls Edwards Lifesciences Suction Wands Due to Plastic Particles

    Sorin Group is recalling Edwards Lifesciences Suction Wand Model S099B because plastic particles were found inside the packaging pouch.

    Product
    Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1837-2013·2013-08-28

    Galveston Shrimp Company Recalls Shrimp Due to Foreign Material

    Galveston Shrimp Company is recalling specific lots of wild-caught shrimp due to the presence of foreign material. The product was distributed in Texas.

    Product
    Texas Wild UPC 41/50 BSO, Shrimp Headless Shell-on, IQF Wild Caught, Product of the USA 20# Net Weight, Galveston Shrimp Co., Galveston, Texas 77550
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1836-2013·2013-08-28

    Galveston Shrimp Company Recalls Frozen Shrimp Due to Foreign Material

    Galveston Shrimp Company is recalling specific lots of frozen shrimp due to the presence of foreign material. The product was distributed in Texas.

    Product
    Texas Wild UPC 51/60 BSO Shrimp Headless Shell-on IQF, Wild Caught, Product of the USA 20 # Net Weight, Galveston Shrimp Co., Galveston, TX 77550
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1814-2013·2013-08-28

    Evviva Peach Spumante Recalled for Unpermitted Coloring Ingredients

    Johnson Brothers Liquor Company is recalling Evviva Fresh Peach Spumante because it contains coloring ingredients not permitted for use in the United States.

    Product
    Evviva Fresh Peach Spumante, UPC 84279-99137
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Drugs)·D-916-2013·2013-08-28

    Medicis Recalls CLENZIderm Pore Therapy Due to CLENZIderm Cleanser Mislabeling

    Medicis Pharmaceutical Corp is recalling CLENZIderm M.D. Pore Therapy kits because some bottles were incorrectly filled with Daily Foam Cleanser. The recall covers specific lots distributed in the US and internationally.

    Product
    CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit, Distributed by OMP, Inc., Long Beach, CA 90806, Kit is comprised of: Daily Care Foaming Cleanser (Salicylic Acid 2%) NDC 62032-111; Pore Therapy (Salicylic Acid 2%) NDC 62032-110 and Therapeutic Lotion (Benzoyl Pero
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1835-2013·2013-08-28

    Grove Grow Notes Dried Mushrooms Recalled for Undeclared Sulfites

    S & M International Inc is recalling Grove Grow Notes Dried Mushrooms due to undeclared sulfites. The product was distributed in New York.

    Product
    Grove Grow Notes Dried Mushroom, Net Wt. 200g/7 oz. packaged in plastic tray in plastic bag. UPC 6949682800734 Product of China Product label is in Chinese
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1840-2013·2013-08-28

    Galveston Shrimp Company Recalls Shrimp for Foreign Material

    Galveston Shrimp Company is recalling specific lots of frozen shrimp due to the presence of foreign material. The product was distributed in Texas.

    Product
    Texas Wild UPC 16/25 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1820-2013·2013-08-28

    Plum Organics Mighty 4 Nutrition Blend Recalled for Seal Defects

    Plum Inc. is recalling Mighty 4 Essential nutrition blend pouches due to intermittent ineffective hermetic seals that may allow spoilage.

    Product
    Plum Organics Mighty 4 Essential nutrition blend; Spinach, Kiwi, Barley, Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case USPC: 846675003447; Case UPC: 00846675003560 Distributed by Plum Inc., Emeryville, CA.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1841-2013·2013-08-28

    Galveston Shrimp Company Recalls Shrimp Due to Foreign Material

    Galveston Shrimp Company is recalling specific lots of frozen shrimp in Texas due to the presence of foreign material.

    Product
    Texas Wild UPC, 16/20 BSO, Shrimp Headless Shell-on, IQF, Wild Caught, Product of USA, 20# Net Weight, Galveston Shrimp Co., Galveston, TX 77550
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1981-2013·2013-08-28

    Zimmer Recalls Moore Hip Prosthesis Stems for Sterile Barrier Testing

    Zimmer is recalling 1,710 Moore Hip Prosthesis Long Fenestrated Stems to test sterile barrier integrity after a review of historic packaging validations.

    Product
    Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bone cement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1987-2013·2013-08-28

    Atrium Medical Recalls PleuraGuide Chest Tube Kits Due to Missing Instructions

    Atrium Medical Corporation is recalling 6,516 PleuraGuide Disposable Chest Tube Kits because individual component instructions for use are missing.

    Product
    PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the insertion of thoracic catheters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1996-2013·2013-08-28

    Smith & Nephew Recalls Genesis II Knee Trial Inserts Due to Color Error

    Smith & Nephew is recalling nine Genesis II Cruciate Retaining Articular Insert trial units because they were produced with the wrong color material.

    Product
    GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1997-2013·2013-08-28

    Beckman Coulter Recalls Hemoccult ICT Fecal Occult Blood Test Kits

    Beckman Coulter is recalling 68,116 Hemoccult ICT units due to increased sensitivity at borderline positive levels, which may cause false positives.

    Product
    Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1991-2013·2013-08-28

    ConvaTec Flexi-Seal Signal Plus Recalled for Packaging Labeling Error

    Convatec Inc. is recalling 22,896 units of Flexi-Seal Signal Plus due to a manufacturing irregularity where lot numbers were duplicated on the packaging.

    Product
    ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-910-2013·2013-08-28

    Novartis Recalls Maalox Nighttime Antacid Tablets Due to Illegible Labeling

    Novartis is recalling Maalox Nighttime Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle packaging.

    Product
    Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Cherry flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-902-2013·2013-08-28

    Novartis Recalls Maalox Extra Strength Antacid Tablets Due to Illegible Labeling

    Novartis is recalling Maalox Extra Strength Antacid with Anti-Gas chewable tablets because the lot number and expiration date may be illegible on the packaging.

    Product
    Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-900-2013·2013-08-28

    Stayma Recalls Subpotent Nata Komplete Multi-Vitamin Tablets

    Stayma Consulting Service is recalling specific lots of Nata Komplete multi-vitamin tablets because they contain subpotent levels of beta carotene (Vitamin A).

    Product
    Nata Komplete, containing one 30-count bottle of multi-vitamin tablets (imprinted 909), Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-909-30) and physician samples of nine bottles of 5-multi-vitamin tablets (NDC 76331-909-05 )
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-908-2013·2013-08-28

    Novartis Recalls Maalox Extra Strength Antacid Due to Illegible Labeling

    Novartis is recalling Maalox Extra Strength Antacid chewable tablets because the lot number or expiration date may be illegible on the packaging.

    Product
    Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 600 mg/60 mg, Wild Berry flavor, 35-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN 02243
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-907-2013·2013-08-28

    Novartis Recalls Maalox Antacid Tablets Due to Illegible Labeling

    Novartis Consumer Health is recalling Maalox Regular Strength Antacid chewable tablets because the lot number and expiration date may be illegible on the packaging.

    Product
    Maalox, Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wintergreen flavor, 50-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238290, UPC 0 58478 44824 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-896-2013·2013-08-28

    Stayma Recalls Duet DHA 400 ec Due to Subpotent Beta Carotene

    Stayma Consulting Service is recalling specific lots of Duet DHA 400 ec because the beta carotene (Vitamin A) content is subpotent.

    Product
    Duet DHA 400 ec, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Rx only, Manufactured for Eckson Labs, Wilmington, DE (NDC 44118-809-30) and Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-895-2013·2013-08-28

    FDA Recalls Duet DHA 400 for Subpotent Beta Carotene

    Stayma Consulting Service is recalling Duet DHA 400 multi-vitamin and Omega-3 products because they contain subpotent levels of beta carotene (Vitamin A).

    Product
    Duet DHA 400, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Rx only, Manufactured for Eckson Labs, Wilmington, DE (NDC 44118-807-30) --- Also Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 763
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-906-2013·2013-08-28

    Novartis Recalls Maalox Extra Strength Antacid Tablets Due to Illegible Labeling

    Novartis is recalling Maalox Extra Strength Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle packaging.

    Product
    Maalox Extra Strength Antacid (calcium carbonate) chewable tablets,1000 mg, Wild Berry flavor, packaged in a) 35-count (UPC 0 58478 44829 9) and b) 65-count (UPC 0 58478 44842 8) tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling c
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-903-2013·2013-08-28

    Novartis Recalls Maalox Antacid Tablets Due to Illegible Packaging Labels

    Novartis Consumer Health is recalling Maalox Regular Strength Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle packaging.

    Product
    Maalox Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wild Berry flavor, packaged in a) 50-count (UPC 0 58478 44825 1), b) 100-count (UPC 0 58478 44826 8) and c) 145-count (UPC 0 58478 44836 7) tablets per bottle, Novartis Consumer Health Canada Inc., Miss
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-914-2013·2013-08-28

    Bracco Recalls Tagitol V Barium Sulfate Suspension Due to Stability Failure

    Bracco Diagnostics Inc is recalling Tagitol V Barium Sulfate Suspension Lot #65846 because samples failed viscosity specifications.

    Product
    Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc. Lake Success, NY 11042 Tel: 1-516-333-8230 1-800-544-4624 NDC 32909-814-53
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1990-2013·2013-08-28

    ConvaTec Flexi-Seal Fecal Management System Recalled for Packaging Error

    Convatec is recalling Flexi-Seal Signal Fecal Management Systems because the lot number convention was duplicated on the packaging for certain lots.

    Product
    ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-899-2013·2013-08-28

    Duet DHA 430 ec Recalled for Subpotent Beta Carotene

    Stayma Consulting Service is recalling Duet DHA 430 ec because the beta carotene (Vitamin A) content is subpotent.

    Product
    Duet DHA 430 ec, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-810-30)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-905-2013·2013-08-28

    Novartis Recalls Maalox Antacid Tablets Due to Illegible Labeling

    Novartis is recalling Maalox Advanced Maximum Strength Antacid & Antigas chewable tablets because the lot number and/or expiration date may be illegible on the outer plastic bottle packaging.

    Product
    Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, packaged in a) 35-count (NDC 0067-6279-35) (UPC 3 0067-0343-35 4); b) 65-count (NDC 0067-6279-65) (UPC 3 0067-0343-65 1); and c) 90-count
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-897-2013·2013-08-28

    Stayma Recalls Subpotent NataChew Multi-Vitamin Tablets

    Stayma Consulting Service is recalling specific lots of NataChew multi-vitamin tablets because they contain subpotent levels of beta carotene (Vitamin A).

    Product
    NataChew, 1) one 90-count bottle of multi-vitamin tablets (imprinted 902), (NDC 44118-902-90) and 2) physician samples containing nine bottles with 5 multi-vitamin tablets (imprinted 902) (NDC 44118-902-05), Manufactured for Eckson Labs, Wilmington, DE
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1964-2013·2013-08-28

    Philips MobileDiagnost wDR Recalled for Non-Compliant Instructions for Use

    Philips Healthcare is recalling MobileDiagnost wDR systems because the Instructions for Use fail to comply with a Federal standard regarding generator value tolerance levels.

    Product
    Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-909-2013·2013-08-28

    Novartis Recalls Maalox Nighttime Antacid Due to Illegible Packaging Labels

    Novartis Consumer Health is recalling Maalox Nighttime Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle packaging.

    Product
    Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Mint flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 80
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-901-2013·2013-08-28

    AbbVie Recalls Mavik Trandolapril Tablets Due to Outdated Package Insert

    AbbVie is recalling 704 bottles of Mavik trandolapril tablets 4mg because they were packaged with an outdated version of the package insert.

    Product
    Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories, North Chicago, IL 60064, USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-904-2013·2013-08-28

    Novartis Recalls Maalox Antacid Tablets Due to Illegible Packaging Labels

    Novartis Consumer Health is recalling Maalox Advanced Maximum Strength Antacid & Antigas chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle.

    Product
    Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Wild Berry flavor, 65-count tablets per bottle, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-62791-65, UPC 3 0067-0376-6
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V382000·2013-08-27

    Honda Recalls 2013 Odyssey and Pilot Vehicles for Engine Piston Defect

    Honda is recalling 2013 Odyssey and Pilot vehicles because engine pistons may have insufficient hardness, leading to premature wear and potential engine stalling.

    Product
    HONDA — HONDA ODYSSEY, PILOT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13E049000·2013-08-27

    Trans/Air Recalls Compressor Mount Kits for Ford Engines

    Trans/Air is recalling specific Compressor Mount Kits installed on Ford 5.4 or 6.8-liter engines due to a risk of alternator harness damage, vehicle stalling, or fire.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V384000·2013-08-27

    Sunset Park & RV Recalls 2014 EZ Traveler Trailer for Awning Defect

    Sunset Park & RV is recalling one 2014 EZ Traveler travel trailer because a design change in the power awning motor assembly may cause screws to shear, potentially allowing the awning to unfurl unexpectedly.

    Product
    SUNSET PARK & RV — SUNSET PARK & RV EZ TRAVELER (21LE)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13E048000·2013-08-27

    Polaris Recalls Lock & Ride Passenger Backrests for Crash Risk

    Polaris is recalling specific Lock & Ride passenger backrests for Victory motorcycles because they can fail if a luggage rack is attached, increasing crash risk.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V380000·2013-08-23

    Manning Equipment Recalls 2012 Ford F-Series Trucks for Exhaust Fire Risk

    Manning Equipment is recalling 37 model year 2012 Ford F-350, F-450, and F-550 trucks because the tailpipe design allows heat to build up in the rear storage compartment, posing a fire risk.

    Product
    FORD — FORD F-350, F-450, F-550
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1807-2013·2013-08-21

    Gold Star Herring Fillets Recalled for Listeria Contamination

    Gold Star Smoked Fish Corp. is recalling RYBACKA WIES brand Herring Fillets in Oil due to Listeria monocytogenes contamination found by New York State sampling.

    Product
    RYBACKA WIES brand HERRING FILLETS IN OIL (MATJES SLEDZ W OLEJU), Net Wt. 17.6 oz. (500g), UPC 0 21143 24122 8, Distributed By Gold Star, Inc., Brooklyn, NY 11231 --- The product is vacuum packed in a sealed plastic package.
    Category
    Food
    Distribution
    11 states
  • CriticalFDA (Food)·F-1809-2013·2013-08-21

    Crave Brothers Farmstead Cheese Recalled Due to Listeria Investigation

    Crave Brothers Farmstead Cheese is recalling specialty cheese products while regulatory agencies investigate a potential Listeria monocytogenes contamination.

    Product
    Crave Brothers Farmstead Classics Les Freres Semi-Soft French Style Cheese, LF225. 2.5 lb wheel packaged in cheese paper. Two 2.5 lbs wheels in a case.
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-1810-2013·2013-08-21

    Crave Brothers Petit Frere Cheese Recalled Due to Listeria Investigation

    Crave Brothers Farmstead Cheese is recalling Petit Frere Soft Ripened Cheese because of a multi-state Listeria monocytogenes investigation.

    Product
    Crave Brothers Farmstead Classics Petit Frere Soft Ripened Cheese, PF88. Net Wt. 8 oz. (227g). Packaged in cheese paper and sold inside a wooden box. Eight 8 oz wheels per case.
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-1805-2013·2013-08-21

    Brach's Chocolate Malted Milk Balls Recalled for Undeclared Peanuts and Brazil Nuts

    Ferrara Candy Company is recalling Brach's Chocolate Malted Milk Balls because they may contain undeclared peanuts and Brazil nuts.

    Product
    Chocolate malted milk balls packaged in 6 lbs. bags and each case contains 3 x 6 lbs. bags; BEST BY 04/17/14; BRCH CHOC
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1811-2013·2013-08-21

    Crave Brothers Petit Frere Cheese Recalled Over Listeria Investigation

    Crave Brothers is recalling Petit Frere with Truffles Cheese due to a multi-state Listeria monocytogenes investigation.

    Product
    Crave Brothers Farmstead Classics Petit Frere with Truffles Cheese, PF88T. Net Wt. 8 oz. (227g). Packaged in cheese paper and sold inside a wooden box. Eight 8 oz. wheels per case.
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Devices)·Z-1899-2013·2013-08-21

    Nova Max Glucose Test Strips Recalled for False High Readings

    Nova Biomedical is recalling 721,810 Nova Max Glucose Test Strips because they may produce false abnormally high glucose readings.

    Product
    Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1897-2013·2013-08-21

    Nova Max Glucose Test Strips Recalled for False High Readings

    Nova Biomedical Corporation is recalling Nova Max Glucose Test Strips due to reports of false abnormally high glucose readings.

    Product
    Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-868-2013·2013-08-21

    Gentamicin Sulfate Irrigation Recalled Due to Sterility Assurance Concerns

    Pallimed Solutions is recalling Gentamicin Sulfate Irrigation nationwide because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.

    Product
    Gentamicin Sulfate Irrigation, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-869-2013·2013-08-21

    Pallimed Solutions Recalls HCG Vials Due to Sterility Concerns

    Pallimed Solutions is recalling 261 vials of compounded HCG Chorionic Gonadotropin nationwide due to FDA inspectional findings regarding sterility assurance.

    Product
    HCG Chorionic Gonadotropin, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-862-2013·2013-08-21

    Pallimed Recalls Buprenorphine Veterinary Injection Due to Sterility Concerns

    Pallimed Solutions is recalling 71 vials of Buprenorphine HCl Veterinary Injection nationwide due to FDA inspectional findings regarding sterility assurance.

    Product
    Buprenorphine HCl Veterinary Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1900-2013·2013-08-21

    Nova Max Glucose Test Strips Recalled for False High Readings

    Nova Biomedical is recalling Nova Max Glucose Test Strips because they may produce false abnormally high glucose readings, potentially affecting diabetes management.

    Product
    Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are inte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-876-2013·2013-08-21

    Pallimed Solutions Recalls Testosterone Injections Due to Sterility Concerns

    Pallimed Solutions is recalling Testosterone Cypionate/Enanthate injections nationwide due to FDA inspectional findings regarding sterility assurance and quality control.

    Product
    Testosterone Cypionate/Testosterone Enanthate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-866-2013·2013-08-21

    Pallimed Solutions Recalls Dexamethasone PF Due to Sterility Concerns

    Pallimed Solutions is recalling Dexamethasone PF compounded in Woburn, MA, due to FDA inspectional findings regarding quality control and sterility assurance.

    Product
    Dexamethasone PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-880-2013·2013-08-21

    Pallimed Vancomycin Ophthalmic PF Recalled for Sterility Assurance Concerns

    Pallimed Solutions is recalling Vancomycin Ophthalmic PF due to FDA inspectional findings regarding quality control and sterility assurance.

    Product
    Vancomycin Ophthalmic PF, compounded by Pallimed Solutions Pharmacy, Wobrun, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-857-2013·2013-08-21

    Pallimed Acetylcysteine Ophthalmic Solution Recalled for Sterility Concerns

    Pallimed Solutions is recalling Acetylcysteine Ophthalmic Solution due to FDA inspectional findings regarding quality control and sterility assurance.

    Product
    Acetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-873-2013·2013-08-21

    Pallimed Recalls Nandrolone Decanoate Injectable Due to Sterility Concerns

    Pallimed Solutions is recalling Nandrolone Decanoate Injectable vials because FDA inspectional findings raised concerns about sterility assurance and quality control.

    Product
    Nandrolone Decanoate Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-877-2013·2013-08-21

    Pallimed Solutions Recalls Testosterone Injection Due to Sterility Concerns

    Pallimed Solutions is recalling Testosterone Cypionate/Propionate Injection nationwide because FDA inspectional findings raised concerns about quality control procedures that impacted sterility assurance.

    Product
    Testosterone Cypionate/Propionate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1901-2013·2013-08-21

    Nova Max Glucose Test Strips Recalled for False High Readings

    Nova Biomedical is recalling Nova Max Glucose Test Strips because they may produce false abnormally high glucose readings.

    Product
    Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are kitted into Nova Max Glucose Test Strip System Kits 43435 and 45507 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-874-2013·2013-08-21

    Quadmix Injection Recalled Due to Sterility Assurance Concerns

    Pallimed Solutions is recalling Quadmix Injection vials because FDA inspectional findings raised concerns about quality control procedures impacting sterility assurance.

    Product
    Quadmix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1806-2013·2013-08-21

    FOSFOREL Herring Fillet in Oil Recalled for Listeria monocytogenes

    Zip International Group LLC is recalling FOSFOREL brand Herring Fillet in Oil due to the presence of Listeria monocytogenes detected by New York State sampling.

    Product
    FOSFOREL brand Herring Fillet in Oil 400 gram (14 oz.) in plastic packaging containers; refrigerated
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-861-2013·2013-08-21

    BiMix Injection Recalled Due to Sterility Assurance Concerns

    Pallimed Solutions is recalling 246 vials of BiMix Injection nationwide because FDA inspectional findings raised concerns about sterility assurance.

    Product
    BiMix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-863-2013·2013-08-21

    Pallimed Recalls Cidofovir Ophthalmic Solution Due to Sterility Concerns

    Pallimed Solutions is recalling 23 vials of compounded Cidofovir Ophthalmic Solution nationwide due to FDA inspectional findings regarding sterility assurance.

    Product
    Cidofovir Opthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1947-2013·2013-08-21

    CareFusion Recalls Adult and Pediatric Manual Resuscitators Due to Oxygen Flow Blockage

    CareFusion is recalling 14,112 manual resuscitators because a blocked oxygen connector may prevent supplemental oxygen from reaching the patient.

    Product
    1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask; 3) Adult Manual Resuscitator, 2K8017, Variable Volume Oxygen Reservoir Tubing, Adult Mask; 4) Adult Manual Resuscit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1957-2013·2013-08-21

    SpineFrontier Invue Solid Driver Recalled Due to Broken Nipple

    SpineFrontier, Inc. is recalling nine Invue Solid Drivers because the nipple broke off during use, potentially affecting spinal surgery.

    Product
    Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral.
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-878-2013·2013-08-21

    Pallimed Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    Pallimed Solutions is recalling 597 vials of compounded Testosterone Cypionate Injection nationwide due to FDA inspectional findings regarding sterility assurance.

    Product
    Testosterone Cypionate Injection,compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1966-2013·2013-08-21

    Medtronic Recalls Pediatric Arterial Filters Due to Potential Media Breach

    Medtronic is recalling 148 Affinity Pediatric Arterial Filters because a small breach in the filter media may allow unwanted particulate or gaseous emboli to pass through, posing a risk of serious injury or death to pediatric patients.

    Product
    Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. Recall Update 9/6/13: Medtronic, Red cross Infant Pack 1/B, South-Africa, REF M272403C, Sterile EO. The Affinity Pediatric Arterial Filters are single-use, sterile, nonpyro
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-867-2013·2013-08-21

    Pallimed Solutions Recalls DMSO Aqueous Irrigation 50% Due to Sterility Concerns

    Pallimed Solutions is recalling DMSO Aqueous Irrigation 50% because FDA inspectional findings raised concerns about quality control procedures that impacted sterility assurance.

    Product
    DMSO Aqueous Irrigation 50%, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-884-2013·2013-08-21

    Dr. Reddy's Recalls Ranitidine Tablets Due to Microbial Contamination

    Dr. Reddy's is recalling specific lots of OTC Ranitidine Hydrochloride tablets because raw material tested positive for Pseudomonas sp.

    Product
    Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum Strength Acid Reducer, 65 count bottle Dist. By: Wal-Mart Stores, Inc., Bentonville, AR 72710, NDC 49035-404-61 b)Equaline brand maximum strength heartburn relief, , DISTRIBUTED BY SUPERVALU INC., EDEN
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-858-2013·2013-08-21

    Pallimed Recalls Alprostadil Injection Due to Sterility Assurance Concerns

    Pallimed Solutions is recalling 408 vials of Alprostadil IN NS Injection nationwide because FDA inspectional findings raised concerns about sterility assurance.

    Product
    Alprostadil IN NS Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-879-2013·2013-08-21

    Pallimed Solutions Recalls Trimix Injection Due to Sterility Assurance Concerns

    Pallimed Solutions is recalling 862 vials of Trimix Injection nationwide because FDA inspectional findings raised concerns about quality control procedures that impacted sterility assurance.

    Product
    Trimix Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-864-2013·2013-08-21

    Pallimed Recalls Compounded Cyclosporine Ophthalmic Due to Sterility Concerns

    Pallimed Solutions is recalling compounded Cyclosporine Ophthalmic because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Cyclosporine Ophthalmic, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-859-2013·2013-08-21

    Pallimed Solutions Recalls Atropine Injection Due to Sterility Concerns

    Pallimed Solutions is recalling Atropine Injection compounded in Woburn, MA, due to FDA inspectional findings regarding quality control and sterility assurance.

    Product
    Atropine Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-875-2013·2013-08-21

    Tacrolimus Ophthalmic Recalled Due to Sterility Assurance Concerns

    Pallimed Solutions is recalling Tacrolimus Ophthalmic nationwide due to FDA inspectional findings regarding quality control and sterility assurance.

    Product
    Tacrolimus Ophthalmic, Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-886-2013·2013-08-21

    Sanofi Recalls Subpotent Rifadin Capsules Due to Low Fill

    Sanofi-Synthelabo is recalling 998 bottles of Rifadin (rifampin) capsules because some capsules contained less medication than labeled.

    Product
    Rifadin (rifampin) capsules, USP, 150 mg, 100-count capsules per bottle, Manufactured by: Fabrique par Sanofi-Aventis Canada Inc., Laval, Quebec, Canada H7L4A8, DIN # 02091887
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-871-2013·2013-08-21

    Pallimed Methylcobalamin Recall Due to Sterility Assurance Concerns

    Pallimed Solutions is recalling Methylcobalamin PF vials nationwide due to FDA inspectional findings regarding quality control and sterility assurance.

    Product
    Methylcobalamin PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-865-2013·2013-08-21

    Pallimed Recalls Diazepam Injectable Due to Sterility Assurance Concerns

    Pallimed Solutions is recalling Diazepam Injectable vials because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.

    Product
    Diazepam Injectable, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-872-2013·2013-08-21

    Pallimed Solutions Recalls MIC with B6 and B12 Due to Sterility Concerns

    Pallimed Solutions is recalling MIC with B6 and B12 vials because FDA inspectional findings raised concerns about quality control procedures and sterility assurance.

    Product
    MIC with B6 and B12, compounded by Pallimed Solutions Pharmacy, Woburn, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-870-2013·2013-08-21

    Pallimed Solutions Recalls Hydroxyprogesterone Compounded Due to Sterility Concerns

    Pallimed Solutions is recalling compounded Hydroxyprogesterone CAPR. (G.S.) due to FDA inspectional findings regarding quality control and sterility assurance.

    Product
    Hydroxyprogesterone CAPR.(G.S.), compounded by Pallimed Solutions Pharmacy, Woburn MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1943-2013·2013-08-21

    GE Healthcare Recalls Signa MR Systems Due to Patient Data Mismatch Risk

    GE Healthcare is recalling multiple Signa MRI systems because a software issue can cause screen save images to be linked to the wrong patient exam, creating a risk of patient data mismatch.

    Product
    SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE SIGNA 3.0T WITH EXCITE MR SYSTEM GE SIGNA EXCITE 1.5T MR SYSTEM GE SIGNA EXCITE 3.0T MR SYSTEM Signa HDx Signa HDxt Signa HDi Signa Vibrant GE 0.35T SIGNA OVAT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1950-2013·2013-08-21

    Veridex CellTracks Analyzer II Recalled for Patient Data Association Error

    Veridex is recalling CellTracks Analyzer II software versions 2.5.1 and below because patient demographics were incorrectly associated with another patient's ID.

    Product
    CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1951-2013·2013-08-21

    Beckman Coulter Recalls ISE Electrolyte Reference Reagent for Calibration Issues

    Beckman Coulter is recalling ISE Electrolyte Reference reagent because it may exceed instrument calibration limits, potentially affecting potassium measurements.

    Product
    ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX System(s), UniCe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1904-2013·2013-08-21

    Nova Max Glucose Test Strips Recalled for False High Readings

    Nova Biomedical is recalling Nova Max Glucose Test Strips because they may produce false abnormally high glucose readings, potentially affecting diabetes management.

    Product
    Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Product The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·13271·2013-08-21

    HALO SleepSack Wearable Blankets Recalled Due to Choking Hazard

    HALO SleepSack Wearable Blankets with Pink Satin Flowers are recalled because petals can detach and pose a choking hazard to infants.

    Product
    HALO® SleepSack® Wearable Blankets with Pink Satin Flowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1784-2013·2013-08-21

    Square Mile Original Hard Apple Cider Recalled Due to Bursting Risk

    Craft Brewers Alliance Inc. is recalling Square Mile Original Hard Apple Cider because bottles may burst. The product was distributed in California, Oregon, and Washington.

    Product
    Square Mile Original Hard Apple Cider is hard cider is in liquid form and is an alcoholic beverage. It is packaged in 22 fl oz glass bottles shipped in a corrugated master carton that contains 12 bottles. Individual bottle is sold at retail stores. UPC codes case: 7-02770-048
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1949-2013·2013-08-21

    Veridex CellTracks AutoPrep System Recalled for Patient Data Mismatch

    Veridex is recalling CellTracks AutoPrep System software due to a reported error where patient demographics were incorrectly associated with another patient's ID.

    Product
    CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in who
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1785-2013·2013-08-21

    Square Mile Spur & Vine Hopped Apple Cider Recalled for Bursting Risk

    Craft Brewers Alliance Inc. is recalling Square Mile Spur & Vine Hopped Apple Cider because bottles may burst. The product was distributed in California, Oregon, and Washington.

    Product
    Square Mile Spur & Vine Hopped Apple Cider is hopped hard cider is in liquid form and is an alcoholic beverage. It is packaged in 22 fl oz glass bottles shipped in a corrugated master carton that contains 12 bottles. Individual bottle is sold at retail stores. UPC codes case
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1808-2013·2013-08-21

    Gasco Golden Egg Yellow Shade Liquid Recalled for Undeclared Allergen

    Gasco Industrial is recalling 528 units of Golden Egg Yellow Shade Liquid in Puerto Rico due to undeclared Yellow #5 allergen.

    Product
    "***Gasco Golden Egg Yellow Shade Liquid***" 32 oz plastic bottles & 15 gallon drums
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1940-2013·2013-08-21

    GE LightSpeed CT750 HD Recalled for CT Number Variance and Software Issues

    GE Healthcare is recalling 244 GE LightSpeed CT750 HD systems due to CT number variance in head perfusion images and software defects.

    Product
    GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric),
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1963-2013·2013-08-21

    Edwards Lifesciences Recalls Anastaflo Intravascular Shunts Due to Adhesive Concerns

    Edwards Lifesciences is recalling specific lots of Anastaflo intravascular shunts because excessive adhesive on the shunt body may interfere with suturing during bypass graft construction.

    Product
    Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and IVS25 Anastaflo shunts are intended for use in preventing ischemia by shunting and/ or perfusing blood or cardioplegic solution distal to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V378000·2013-08-21

    Altec Recalls Aerial Devices Due to Electrical Shock Risk

    Altec is recalling 2005-2013 AH75, AH85, and AH100 aerial devices because a cable may breach insulation, increasing the risk of electrical shock to operators.

    Product
    ALTEC — ALTEC AH100, AH75, AH85
    Category
    Vehicle
    Distribution
    Distributed nationwide

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