The Recall Desk

Archive

September 2016 recalls

734 recalls were announced in September 2016.

What the numbers show

Critical
91
Severe
189
High
306
Moderate
125
Low
23

Of the 734 recalls this month scored against our rubric, 12% are Critical, 26% are Severe.

Which agencies issued them

101–200 of 734

  • HighFDA (Food)·F-2332-2016·2016-09-28

    Immune Tree Recalls Colostrum Capsules Due to Undeclared Milk Allergen

    Immune Tree is recalling specific colostrum capsule products because they contain an undeclared milk allergen. Consumers should stop using the affected items.

    Product
    Colostrum6 Capsules 500mg, Item No 9901, 180 ct. Sold under the brands: Immune Tree, Immune Pro-6 (Not purchased since 8/25/2014), Surthrival, Good For You Canada. Packaged using HDPE White bottle, except Surthrival which uses a Brown HDPE Bottle
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2334-2016·2016-09-28

    Immune Tree Recalls Colostrum Products Due to Undeclared Milk Allergen

    Immune Tree is recalling specific colostrum products because they contain undeclared milk, a major food allergen.

    Product
    LeptiTrim6 Vanilla Shake Item No. 9907; 860 g. Brand Immune Tree; Packaged using HDPE White bottle
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2848-2016·2016-09-28

    Smith & Nephew Recalls Renasys Sterile Transparent Film Due to Seal Failures

    Smith & Nephew is recalling Renasys Sterile Transparent Film and related dressing kits because sterility seal integrity failures may compromise the sterile barrier.

    Product
    RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2376-2016·2016-09-28

    Ajinomoto Recalls Frozen Battered Green Beans Due to Listeria Risk

    Ajinomoto Windsor is recalling Molly's Kitchen Battered Green Bags due to potential Listeria monocytogenes contamination.

    Product
    Molly's Kitchen Battered Green Beans, 6/2 lb. bags., Product # 671850
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2390-2016·2016-09-28

    Cambridge Farms Recalls Sweet & Savory Island Quinoa Due to Listeria

    Cambridge Farms is recalling Giant Eagle Sweet & Savory Island Quinoa after a related product tested positive for Listeria monocytogenes.

    Product
    Giant Eagle Sweet & Savory Island Quinoa, Giant Eagle, Pittsburgh, PA; 12 oz. pkgs; BB 06/10/18
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-2371-2016·2016-09-28

    Ajinomoto Windsor Recalls Frozen Sweet Cut Corn for Listeria Risk

    Ajinomoto Windsor is recalling VIP-STEAMWORKS Sweet Cut Corn due to potential Listeria monocytogenes contamination.

    Product
    VIP-STEAMWORKS SWEET CUT CORN, 12 pk./12 oz., Product # 7007706548
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2849-2016·2016-09-28

    TriMed Recalls Semi-Tubular Plates Due to Screw Failure During Implantation

    Trimed Inc is recalling 30 units of SMTP-10 Semi-Tubular Plates because a non-locking screw passed through a plate hole during implantation.

    Product
    TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm thick and 9.6 mm wide. The part is made of surgical steel conformance with ASTM F138 or F139. The plate is used to fixation of long bone…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2395-2016·2016-09-28

    Coca-Cola Recalls Huberts Lemonade Watermelon Bottles Due to Glass Contamination

    Coca-Cola is recalling Huberts Lemonade Watermelon bottles because they may contain glass fragments. Consumers should stop using the affected products.

    Product
    Huberts Lemonade Watermelon, 16 Fl. Oz. (473 ml), Manufactured for: Hamsen Beverage, Tustin, CA 92780.
    Category
    Food
    Distribution
    22 states
  • HighFDA (Devices)·Z-2871-2016·2016-09-28

    Merge Healthcare Recalls CADstream MRI Software Due to Grid Selection Error

    Merge Healthcare is recalling CADstream software versions 4.1.3 and prior because an incorrect grid selection could lead to an incorrect biopsy or missed target during MRI analysis.

    Product
    CADstream software. Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2325-2016·2016-09-28

    Pollio Italian Cheese Company Recalls Mozzarella Cheese Sticks Due to Choking Hazard

    Pollio Italian Cheese Company is recalling mozzarella cheese sticks because packaging film may remain on the cheese, posing a choking risk.

    Product
    12 oz flexible plastic bag containing 12 individually wrapped mozzarella cheese sticks, 24 oz flexible plastic bag containing 24 individually wrapped mozzarella cheese sticks. The product is packaged in a Blue and clear bag with white and black lettering. UPC number: 00 710400…
    Category
    Food
    Distribution
    0 states
  • HighNHTSA·16V699000·2016-09-28

    Newmar Recalls Canyon Star RVs Due to Wheelchair Door Defect

    Newmar is recalling 2015-2017 Canyon Star recreational vehicles because the wheelchair access door may open while driving, increasing crash risk.

    Product
    NEWMAR — NEWMAR CANYON STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2394-2016·2016-09-28

    Coca-Cola Recalls Huberts Lemonade Strawberry Bottles Due to Glass Contamination

    The Coca-Cola Company is recalling Huberts Lemonade Strawberry bottles because they may contain glass fragments. Consumers should stop using the product.

    Product
    Huberts Lemonade Strawberry, 16 Fl. Oz. (473 ml), Manufactured for: Hamsen Beverage, Tustin, CA 92780.
    Category
    Food
    Distribution
    22 states
  • HighFDA (Food)·F-2366-2016·2016-09-28

    Ajinomoto Windsor Recalls Frozen Corn Cut for Listeria Risk

    Ajinomoto Windsor is recalling VIP-CORN CUT frozen food items due to potential Listeria monocytogenes contamination.

    Product
    VIP-CORN CUT, Net Wt. 32 oz (2lbs) 907g, 12/32 oz., 12/16 oz., Product # 7007701048, 7007701248
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2333-2016·2016-09-28

    Immune Tree Recalls Colostrum Powder Due to Undeclared Milk Allergen

    Immune Tree is recalling specific colostrum powder products because they contain undeclared milk, a major food allergen.

    Product
    Colostrum6 Powder (6.5 oz) Item No. 9902; Sold under the following brands: Immune Tree, Surthrival, HealthWorks (Not purchased since 3/18/15). Packaged in HDPE White bottle, except Surthrival which uses a Brown HDPE Bottle
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2343-2016·2016-09-28

    El Alteno Raisinettes Recalled for Undeclared Milk and Soy Lecithin

    El Alteno is recalling 12 oz. Raisinettes Dovales packages due to undeclared milk and soy lecithin. The product was distributed in California, Arizona, and Nevada.

    Product
    El Alteno Raisinettes Dovales 12 oz. UPC: 8 20202 00411 4
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-2393-2016·2016-09-28

    Vegetable Soup Mix Recalled for Listeria Contamination

    Cambridge Farms of Hanover LLC is recalling vegetable soup mixes after a related product tested positive for Listeria monocytogenes.

    Product
    Key Foods Soup Mix Vegetables, Key Foods Stores/ Staten Island, NY 10314; 16 oz. pkgs; BB 05/02/18; Laura Lynn Vegetable Soup Mix, Ingle's Markets Inc./Asheville, NC 28816; 16 oz. pkgs.; BB 04/12/18
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-2344-2016·2016-09-28

    El Alteno Shredded Coconut Recalled for Undeclared Sulfites

    El Alteno is recalling 8 oz. packages of shredded coconut due to undeclared sulfites. The product was distributed in California, Arizona, and Nevada.

    Product
    El Alteno Coconut Shredded Coconut 8 oz. UPC: 8 20202 00362 9
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-2335-2016·2016-09-28

    Immune Tree Recalls Colostrum Powder Due to Undeclared Milk Allergen

    Immune Tree is recalling specific colostrum powder products because they contain undeclared milk, a major food allergen.

    Product
    Colostrum6 Powder Kilo (35.3 oz); Item No. 9903; Brand Name Immune Tree, Surthrival, Packaged using HDPE White bottle, except Surthrival which uses a Brown HDPE Bottle
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2369-2016·2016-09-28

    Ajinomoto Recalls Organic Peas Due to Listeria Risk

    Ajinomoto Windsor is recalling VIP-STEAMWORKS Organic Peas due to potential Listeria monocytogenes contamination.

    Product
    VIP-STEAMWORKS ORGANIC PEAS, 6 pk./24 oz., Product # 7007706464
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2372-2016·2016-09-28

    Ajinomoto Recalls Frozen Vegetable Mixes for Listeria Risk

    Ajinomoto Windsor is recalling VIP-STEAMWORKS MIX VEGETABLES due to potential Listeria monocytogenes contamination.

    Product
    VIP-STEAMWORKS MIX VEGETABLES, 12 pk./12 oz., Product # 7007706576
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2361-2016·2016-09-28

    Ajinomoto Windsor Recalls Frozen Corn Nuggets Due to Listeria Risk

    Ajinomoto Windsor is recalling frozen spicy corn nuggets because they may be contaminated with Listeria monocytogenes.

    Product
    SPICY BREADED CORN NUGGET w/JALAPENO, 6/2 lb. bags, Product # 241720, 864964
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2866-2016·2016-09-28

    Sorin S5 Heart-Lung Machine Recalled for Power Supply Failure Risk

    Sorin Group USA is recalling 5,264 Stöckert S5 Heart-Lung Machines worldwide due to a potential failure of the Uninterruptible Power Supply.

    Product
    St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The St¿ckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. These devices come in direct contact with the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2363-2016·2016-09-28

    Ajinomoto Recalls TAI PEI Garden Vegetable Rice Due to Listeria Risk

    Ajinomoto Windsor is recalling TAI PEI Garden Vegetable Rice because it may be contaminated with Listeria monocytogenes. The recall covers 1,915,263 cases distributed in the U.S.

    Product
    TAI PEI GARDEN VEGETABLE RICE, Net Wt. 18oz (510g), 8/18 oz. pails, Product # 82070
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2324-2016·2016-09-28

    Pollio Italian Cheese Company Recalls Mozzarella Cheese Sticks Due to Choking Hazard

    Pollio Italian Cheese Company is recalling 10 oz bags of mozzarella cheese sticks because packaging film may remain on the cheese, posing a choking risk.

    Product
    10 oz flexible plastic bag containing 12 individually wrapped mozzarella cheese sticks. The product is packaged in a Blue and clear bag with white and black lettering. UPC number: 0 71040 00060 2
    Category
    Food
    Distribution
    0 states
  • HighNHTSA·16V698000·2016-09-28

    Ford Recalls 2013-2017 Focus Hatchbacks for Latch Defect

    Ford is recalling 2013-2017 Focus hatchbacks with manual transmissions because the rear hatch may unlatch with a single button press, increasing injury risk.

    Product
    FORD — FORD FOCUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2870-2016·2016-09-28

    Global Healthcare Recalls VacuFlow Safe Blood Collection Sets

    Global Healthcare Inc is recalling 282 cartons of VacuFlow Safe blood collection sets because the needle sheath may not fully retract.

    Product
    MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientific, Sarasota, FGL 34243  Made in China.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2842-2016·2016-09-28

    Philips HeartStart MRx Monitor/Defibrillator Recall for Handle Separation

    Philips is recalling 394 HeartStart MRx Monitor/Defibrillators because the handle can separate from the housing due to broken mounts.

    Product
    HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2084-2016·2016-09-28

    Campbell's SpaghettiOs Recalled for Potential Choking Hazard from Plastic Pieces

    Campbell Soup Supply Co. is recalling 14,789 cases of SpaghettiOs due to a potential choking hazard from red plastic pieces found in the cans.

    Product
    Campbell's SpaghettiOs Original Pasta in Tomato and Cheese Sauce Net Wt. 14.2 ounces in metal cans, NDC: 0-51000-22432-3
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-2330-2016·2016-09-28

    Southern Grove Cashews Recalled for Possible Peanut Presence

    Kanan Enterprises is recalling Southern Grove Cashews with Sea Salt due to the possible presence of peanuts. The product was distributed in Ohio, Kansas, and Minnesota.

    Product
    Southern Grove Cashews with Sea Salt, a 10 ounce stand up pouch bag with a UPC 0 38445 12286 5 and the date codes of Best By May 24 2017 KN and August 05 2017 KN
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2359-2016·2016-09-28

    Ajinomoto Windsor Recalls Battered Corn Nuggets for Listeria Risk

    Ajinomoto Windsor is recalling specific frozen Battered Corn Nuggets due to potential Listeria monocytogenes contamination.

    Product
    Battered Corn Nugget, Net Wt. 32oz (2lbs) 907g, 6/2lb bags, 4/3lb bags, Product #241120, 241620. UPC: 10050650024115
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2397-2016·2016-09-28

    Coca-Cola Recalls Huberts Original Lemonade Due to Glass Contamination

    The Coca-Cola Company is recalling Huberts Original Lemonade because some bottles may contain foreign material (glass). Consumers should stop using the product.

    Product
    Huberts Original Lemonade, 16 Fl. Oz. (473 ml), Manufactured for: Hamsen Beverage, Tustin, CA 92780.
    Category
    Food
    Distribution
    22 states
  • HighFDA (Food)·F-1011-2016·2016-09-28

    True North Salmon Recalled for Metal Pit Tags

    True North Salmon is recalling gutted farmed Atlantic salmon due to the presence of cylindrical metal pit tags.

    Product
    True North Gutted Farmed Whole Atlantic Salmon, various weights from 8 to more than 16 lbs. packaged in plastic in styrofoam container, 50 lbs/case. Product of Canada. Product Code: DHON 8¿10 50# DHDN 10¿12 5O#, DHON 14¿16 50#, DHON 16+ 5O#
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-2367-2016·2016-09-28

    Ajinomoto Windsor Recalls Frozen Peas Due to Listeria Risk

    Ajinomoto Windsor is recalling VIP-QP Petite Peas due to potential Listeria monocytogenes contamination.

    Product
    VIP-QP PETITE PEAS, 12/16 oz., Product # 7007701065
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2365-2016·2016-09-28

    Ajinomoto Windsor Recalls TAI PEI SHRIMP FRIED RICE Due to Listeria Risk

    Ajinomoto Windsor is recalling TAI PEI SHRIMP FRIED RICE due to potential Listeria monocytogenes contamination. The recall covers 1,915,263 cases distributed in the U.S.

    Product
    TAI PEI SHRIMP FRIED RICE, 8/12 oz. pails, Product # 7007700806
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2336-2016·2016-09-28

    Immune Tree Recalls Colostrum Powder Due to Undeclared Milk Allergen

    Immune Tree is recalling specific colostrum powder products because they contain undeclared milk, a major food allergen.

    Product
    Colostrum6 Powder (2.5 oz), Item No. 9915, Sold under brand Immune Tree (discontinued), Packaged using HDPE White bottle
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2839-2016·2016-09-28

    Anspach Effort G1 Dissection Tool Recall for Missing Product Codes

    The Anspach Effort, Inc. is recalling 63 G1 Dissection Tools because several product codes were inadvertently left off of Hold 1503.

    Product
    G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2855-2016·2016-09-28

    Abbott Recalls SENSAR Intraocular Lenses Due to Mislabeled Units

    Abbott Medical Optics is recalling 84 SENSAR Foldable Intraocular Lenses because they were not checked prior to release, which may result in the release of mislabeled units.

    Product
    SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2847-2016·2016-09-28

    Broselow Pediatric Emergency System Pouches Recalled for Incorrect Airway Size

    Carefusion 2200 Inc is recalling Broselow Pediatric Emergency System pouches because the PINK/RED Oxygen Delivery Module contains an 8 cm airway instead of the labeled 5 cm size.

    Product
    Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches, Product Code 7730MOD
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2867-2016·2016-09-28

    Invivo Recalls Philips Expression IP5 MRI Patient Monitoring Units

    Invivo Corporation is recalling 639 Philips Expression Information Portal (IP5) units because display numerics may freeze and menu keys may disable after extended run time.

    Product
    Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Expression MRI Patient Monitoring System and the Expression MR200 MRI Patient Monitoring System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2872-2016·2016-09-28

    McKesson Radiology Software Recalled for Missing STAT Priority Icon

    McKesson Medical Imaging Group is recalling McKesson Radiology software versions 12.1.1 and 12.2 because the STAT priority icon was not displayed in the Study List when a study was opened.

    Product
    McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display, print and process digital…
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Drugs)·D-1503-2016·2016-09-28

    Lupin Recalls Lisinopril Tablets Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling 5,880 bottles of 40 mg Lisinopril tablets because they were manufactured using active pharmaceutical ingredients that failed specifications.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2859-2016·2016-09-28

    Abbott Recalls Intraocular Lenses Due to Mislabeled Product Release

    Abbott Medical Optics is recalling 131 TECNIS OptiBlue intraocular lenses because they were not checked prior to release, potentially resulting in mislabeled products.

    Product
    TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2857-2016·2016-09-28

    Abbott Recalls TECNIS Symfony Intraocular Lenses Due to Mislabeled Units

    Abbott Medical Optics is recalling 10 TECNIS Symfony intraocular lenses because they were not checked prior to release, potentially resulting in mislabeled products.

    Product
    TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is indicated primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1504-2016·2016-09-28

    Sun Pharmaceutical Recalls Carvediol Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling specific lots of Carvediol Tablets because they failed impurity and degradation specifications.

    Product
    Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-count bottle (NDC 57664-242-13), 1000-count bottle (NDC 57664-242-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2860-2016·2016-09-28

    Abbott Recalls SENSAR Intraocular Lenses Due to Mislabeled Units

    Abbott Medical Optics is recalling SENSAR 1-Piece Intraocular Lenses because they were not checked prior to release, which may result in the release of mislabeled units.

    Product
    SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2331-2016·2016-09-28

    Barbeque Seasoning Recalled for Missing MSG Labeling Statement

    Old World Spices & Seasonings Inc is recalling EAT Barbeque Zero to Hero Sweet Rub because some bottles lack a statement noting the product contains MSG.

    Product
    EAT Barbeque Zero to Hero, a Sweet Rub, packaged in 6.5oz bottles (mislabeled). The responsible firm named on the label is Pellet Envy, LLC in Kansas City, USA. UPC code is 859849005024. The correct label should read 6.7oz. Bottles are packed in cases of 6.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2868-2016·2016-09-28

    Integra Recalls Spinal Tray Kits Missing Needle Introducer

    Integra LifeSciences is recalling 320 packages of Spinal Tray 24G Gertie Marx kits because one lot was shipped without the required needle introducer.

    Product
    PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local anesthetics.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2852-2016·2016-09-28

    Siemens Syngo.x Software Recalled for Incorrect Volume Calculations

    Siemens Medical Solutions is recalling 338 Syngo.x PACS systems because a software error caused volume calculations for prostate and liver to be too high.

    Product
    Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2862-2016·2016-09-28

    Abbott Recalls Intraocular Lenses Due to Mislabeled Units

    Abbott Medical Optics is recalling 70 units of TECNIS OptiBlue Intraocular Lenses because they were not checked prior to release, potentially resulting in mislabeled products.

    Product
    TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00V The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1507-2016·2016-09-28

    Sun Pharmaceutical Recalls Carvediol Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling Carvediol Tablets, USP, 25 mg, because the product failed impurities and degradation specifications.

    Product
    Carvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count bottle (NDC 57664-247-13), 1000-count bottle (NDC 57664-247-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by: Sun Pharmaceutical…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2856-2016·2016-09-28

    Abbott Recalls TECNIS Multifocal Intraocular Lenses Due to Mislabeled Units

    Abbott Medical Optics is recalling 77 TECNIS Multifocal Intraocular Lenses because they were not checked prior to release, potentially resulting in mislabeled products.

    Product
    TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2869-2016·2016-09-28

    Hologic Sertera Biopsy Device Recalled for Incorrect Labeling

    Hologic is recalling 570 units of the Sertera Biopsy Device due to incorrect labeling on the sterile kit.

    Product
    Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2399-2016·2016-09-28

    Keebler Sugar Wafers Recalled for Foreign Matter in Sugar Ingredient

    Shearer's Snacks is recalling Keebler Sugar Wafers, Vanilla, because the refined granulated sugar ingredient contains extraneous foreign matter.

    Product
    Keebler, Sugar Wafers, Vanilla, Net Wt 2.75 OZ (77 g), Made in Canada Distributed By Kellogg Sales Co, Battle Creek, MI 49016 USA
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2853-2016·2016-09-28

    Siemens Syngo.via Software Recalled for Incorrect Volume Calculations

    Siemens Medical Solutions is recalling 338 Syngo.via systems because a software error caused volume calculations for prostate and liver to be too high.

    Product
    Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2841-2016·2016-09-28

    Siemens IGF-I Reagent Recalled for Incubation Time Defect

    Siemens Healthcare Diagnostics is recalling IGF-I reagents because the required incubation time for pretreatment solution equilibration is 24 minutes, not as previously indicated.

    Product
    IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2861-2016·2016-09-28

    Abbott Recalls TECNIS Intraocular Lenses Due to Mislabeled Units

    Abbott Medical Optics is recalling 217 TECNIS 1-Piece Intraocular Lenses because they were not checked prior to release, potentially resulting in mislabeled products.

    Product
    TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2875-2016·2016-09-28

    Pentax Video Bronchoscopes Recalled for Incorrect Operation and Reprocessing Instructions

    Pentax of America Inc. is recalling 1,719 video bronchoscopes because they contain an incorrect Operation and Reprocessing IFUS.

    Product
    Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1505-2016·2016-09-28

    Sun Pharmaceutical Recalls Carvediol Tablets Due to Impurity Specifications

    Sun Pharmaceutical Industries is recalling specific lots of Carvediol Tablets, USP, 6.25 mg, because they failed impurities and degradation specifications.

    Product
    Carvediol Tablets, USP, 6.25 mg, 100-count bottle (NDC 57664-244-18), 500-count bottle (NDC 57664-244-13), 1000-count bottle (NDC 57664-244-18), Rx Only, Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2843-2016·2016-09-28

    OrthoPediatrics Recalls Mislabeled 3.5mm Bowed Locking Compression Femur Plates

    OrthoPediatrics Corp is voluntarily recalling 41 units of 3.5mm Bowed Locking Compression Femur Plates due to mislabeling.

    Product
    3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2858-2016·2016-09-28

    Abbott Recalls Mislabeled Intraocular Lenses Due to Quality Control Failure

    Abbott Medical Optics is recalling 65 units of TECNIS 1-Piece Intraocular Lenses because they were not checked prior to release, potentially resulting in mislabeled products.

    Product
    TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2838-2016·2016-09-28

    Anspach Effort Recalls G1 Dissection Tools Due to Labeling Error

    The Anspach Effort, Inc. is recalling 88 G1 Dissection Tools because product codes were inadvertently left off Hold 1503.

    Product
    G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2840-2016·2016-09-28

    Anspach Effort Recalls G1 Dissection Tools Due to Labeling Error

    The Anspach Effort, Inc. is recalling 69 G1 Dissection Tools because product codes were inadvertently left off Hold 1503.

    Product
    G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2846-2016·2016-09-28

    Carefusion Recalls Pediatric Oxygen Delivery Modules Due to Incorrect Airway Size

    Carefusion 2200 Inc is recalling Broselow/Hinkle Pediatric Emergency System Oxygen Delivery Modules because they contain an 8 cm airway instead of the labeled 5 cm size.

    Product
    Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1506-2016·2016-09-28

    Sun Pharmaceutical Recalls Carvediol Tablets Due to Impurity Failures

    Sun Pharmaceutical Industries is recalling specific lots of Carvediol Tablets, 12.5 mg, because they failed impurities and degradation specifications.

    Product
    Carvediol Tablets, USP, 12.5 mg, 500-count bottle (NDC 57664-245-13), 1000-count bottle (NDC 57664-245-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2873-2016·2016-09-28

    Hospira LifeCare PCA Infusion System Recalled for Screw Rotation Error

    Hospira Inc. is recalling 8,794 LifeCare PCA Infusion Systems because a screw rotation error can cause the pump to alarm and stop infusion.

    Product
    LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administration or self-administration of analgesic medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2854-2016·2016-09-28

    EKOS Intelligent Drug Delivery Catheter Recalled for Potential Epoxy Defect

    EKOS Corporation is recalling 10 Intelligent Drug Delivery Catheters due to potential non-compliant manufacturing tests that may cause epoxy blisters.

    Product
    EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2864-2016·2016-09-28

    Abbott Recalls Mislabeled Intraocular Lenses Due to Quality Control Failure

    Abbott Medical Optics is recalling 41 intraocular lenses because they were not checked prior to release, potentially resulting in mislabeled products.

    Product
    AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z9002 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2837-2016·2016-09-28

    Anspach Effort Recalls G1 Dissection Tools Due to Release Error

    The Anspach Effort, Inc. is recalling 177 G1 Dissection Tools because they were inadvertently released from hold status and distributed.

    Product
    G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2836-2016·2016-09-28

    SybronEndo Recalls Sealapex Xpress Root Canal Resin Due to Labeling Error

    SybronEndo is recalling 179 units of Sealapex Xpress root canal filling resin because the product was labeled with an incorrect expiration date.

    Product
    Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of a tooth.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2865-2016·2016-09-28

    Merge Cardio software recall for missing patient information on report pages

    Merge Healthcare is recalling Merge Cardio software version 10.1 because patient information is missing from subsequent report pages.

    Product
    Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1517-2016·2016-09-28

    Mucinex Sinus-Max Day Night Recalled for Labeling Errors

    Reckitt Benckiser is recalling Mucinex Sinus-Max Day Night caplets because the outer carton lists incorrect drug strength and quantity.

    Product
    Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2844-2016·2016-09-28

    OrthoPediatrics Recalls Mislabeled 3.5mm Bowed Locking Compression Femur Plates

    OrthoPediatrics Corp is voluntarily recalling 41 units of 3.5mm Bowed Locking Compression Femur Plates due to mislabeling. The devices were distributed nationwide to specific states.

    Product
    3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2863-2016·2016-09-28

    Abbott Recalls 41 Intraocular Lenses Due to Mislabeled Product Risk

    Abbott Medical Optics is recalling 41 TECNIS Multifocal Intraocular Lenses because they were not checked prior to release, posing a risk of mislabeling.

    Product
    TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 The product is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2845-2016·2016-09-28

    Biomet 3i Recalls 92 Dental Implants Due to Packaging Error

    Biomet 3i is recalling 92 units of 3I Osseotite dental implants because they were incorrectly packaged. The affected units were distributed in the US and several international countries.

    Product
    3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-2851-2016·2016-09-28

    CooperSurgical Recalls Sage CSC Thawing Medium Due to Incorrect Package Insert

    CooperSurgical, Inc. is recalling 4 units of Sage CSC Thawing Medium because the products contain an international package insert instead of the correct USA package insert.

    Product
    Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intended for use in freezing embryos. This product is intended for thawing of embryos frozen with ART-8017, CSC Freezing Medium. This kit is designed to be used in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2398-2016·2016-09-28

    Shearer's Snacks Recalls Family Gourmet Sugar Wafers Due to Foreign Matter

    Shearer's Snacks is recalling Family Gourmet Sugar Wafers because an ingredient contained foreign matter. The product was distributed to specific states.

    Product
    Family Gourmet, Sugar Wafers, Strawberry, Net Wt 8 OZ (227 g), Distributed By: Family Dollar Services, Inc. Charlotte, NC 28201 USA Product of Canada
    Category
    Food
    Distribution
    10 states
  • LowFDA (Devices)·Z-2850-2016·2016-09-28

    Sage CSC Freezing Medium Recalled for Incorrect USA Package Insert

    CooperSurgical is recalling Sage CSC Freezing Medium because it shipped with an international package insert instead of the correct USA version.

    Product
    Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAGE In Vitro Fertilization, Inc. A CooperSurgical Company 95 Corporate Drive Trumbull, CT 06611 USA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1515-2016·2016-09-28

    West-Ward Recalls Amoxicillin Oral Suspension Due to Labeling Error

    West-Ward Pharmaceuticals is recalling specific lots of Amoxicillin For Oral Suspension because the bottles are missing the colored panel that displays the product strength.

    Product
    Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01,
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2345-2016·2016-09-28

    Shearer's Snacks Recalls Family Gourmet Sugar Wafers Due to Foreign Matter

    Shearer's Snacks is recalling Family Gourmet Sugar Wafers because an ingredient contained foreign matter. The product was distributed to Family Dollar locations in ten states.

    Product
    Family Gourmet, Sugar Wafers, Vanilla, Net Wt 8 OZ (227 g), Distributed By: Family Dollar Services, Inc. Charlotte, NC 28201 USA Product of Canada
    Category
    Food
    Distribution
    10 states
  • LowFDA (Food)·F-2400-2016·2016-09-28

    Keebler Sugar Wafers Recalled for Foreign Matter in Sugar Ingredient

    Shearer's Snacks is recalling Keebler Sugar Wafers, Strawberry, because the refined granulated sugar ingredient contained extraneous foreign matter.

    Product
    Keebler, Sugar Wafers, Strawberry, Net Wt 2.75 OZ (77 g), Made in Canada Distributed By Kellogg Sales Co, Battle Creek, MI 49016 USA
    Category
    Food
    Distribution
    10 states
  • LowFDA (Drugs)·D-1502-2016·2016-09-28

    Lupin Recalls Lisinopril Tablets Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling 20,556 bottles of Lisinopril 30 mg tablets because they were manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Food)·F-2342-2016·2016-09-28

    Panera Bread Balsamic Vinaigrette Recalled Due to Bulging Bottles

    Arcobasso Foods is recalling 240,000 bottles of Panera Bread Balsamic Vinaigrette Dressing due to consumer complaints of bulging bottles.

    Product
    Panera Bread Balsamic Vinaigrette Dressing, NET 20 FL OZ (1.25 PT) 591 mL, most responsible firm on the label is Panera Bread St. Louis, MO 63127 PaneraAtHome.com. Product packaged in plastic bottles and shrink wrapped as a twin pack (2 bottles together). UPC code is…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·089-2016·2016-09-27

    Tyson Recalls Chicken Nuggets Due To Possible Hard Plastic Contamination

    Tyson Foods is recalling approximately 132,520 pounds of fully cooked chicken nuggets that may contain hard plastic. The recall covers products produced on July 18, 2016, distributed nationally and in Pennsylvania.

    Product
    Tyson Foods, Inc. — Tyson Foods Inc. Recalls Chicken Nugget Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·16V696000·2016-09-27

    Thor Motor Coach Recalls 2016-2017 Motorhomes for Spare Tire Bracket Defect

    Thor Motor Coach is recalling 2016-2017 Four Winds and Chateau motorhomes because the spare tire bracket may loosen and detach, creating a road hazard.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH CHATEAU, FOUR WINDS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V694000·2016-09-27

    Subaru Recalls 2010-2014 Legacy and Outback for Wiper Motor Fire Risk

    Subaru is recalling 2010-2014 Legacy and Outback vehicles because windshield wiper motor components may interfere, causing overheating, wiper failure, or fire.

    Product
    SUBARU — SUBARU OUTBACK, LEGACY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·090-2016·2016-09-27

    Caviness Beef Packers Recalls Beef Products Due to E. Coli O103

    Caviness Beef Packers is recalling approximately 2,100 pounds of boneless beef trim products that may be contaminated with E. coli O103.

    Product
    Caviness Beef Packers, Ltd. — Caviness Beef Packers Recalls Beef Products Due to Possible E. Coli O103 Contamination
    Category
    Food
    Distribution
    1 state

Looking for a different month? Back to 2016.