The Recall Desk

Archive

July 2017 recalls

930 recalls were announced in July 2017.

What the numbers show

Critical
40
Severe
116
High
613
Moderate
135
Low
26

Of the 930 recalls this month scored against our rubric, 4% are Critical, 12% are Severe.

801–900 of 930

  • HighFDA (Food)·F-2444-2017·2017-07-12

    Oxford Frozen Foods Recalls Beer Battered Onion Rings for Undeclared Milk

    Oxford Frozen Foods is recalling 10 lb cases of Beer Battered Onion Rings because they may contain undeclared milk.

    Product
    1/2" Thick Cut Beer Battered Onion Rings: ALE HOUSE BEER BATTERED STEAK CUT ONION RINGS NET WT. 10 lb (4.45 kg) - 33074
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-2429-2017·2017-07-12

    Sailors Choice Breaded Clam Strips Recalled for Undeclared Milk

    Sea Watch International is recalling Sailors Choice Breaded Clam Strips because the bread coating may contain undeclared milk, a major allergen not listed on the label.

    Product
    Sailors Choice Brand Breaded Clam Strips Pack Size: 24/4 oz. bags/case
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2432-2017·2017-07-12

    Concord Foods Recalls Tempo Seafood Bake for Undeclared Milk

    Concord Foods is recalling Tempo Seafood Bake - Lemon Dill because the product may contain undeclared milk. The recall affects 1,725 cases distributed in eight states.

    Product
    Tempo Seafood Bake - Lemon Dill- packaged in 3.5 oz. (99g), small corrugated boxes containing one pouch of breadcrumb seasoning Item Code: 30281 UPC Code: 0 41409 00040 6
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-2684-2017·2017-07-12

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems Due to Software Issue

    Ion Beam Applications S.A. is voluntarily recalling six Proteus 235 Proton Therapy Systems worldwide due to a software issue. Five of these units are located in the United States.

    Product
    Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Food)·F-2416-2017·2017-07-12

    Greek Pasta Salad Recalled for Undeclared Milk Allergen

    A.S.K. Foods is recalling Taste of Inspirations Greek Pasta Salad because some packages have incorrect labels that do not list milk as an ingredient.

    Product
    Taste of Inspirations; Greek Pasta Salad, Net Wt. 10 oz.; Distributed By: DZA Brands, LLC, Salisbury, NC 28147/Scarborough, ME 04074;
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2446-2017·2017-07-12

    Atlantic Gold Battered Mushrooms Recalled for Undeclared Milk Allergen

    Oxford Frozen Foods is recalling Atlantic Gold Battered Mushrooms because the product may contain undeclared milk, a major food allergen.

    Product
    Small White Button Mushroom Regular Batter: ATLANTIC GOLD Battered Mushrooms Net Weight 5 lb (2.27 kg) - 34086; Atlantic Gold Battered Mushrooms 6 x 2 lbs 12 lbs - 34112;
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-2428-2017·2017-07-12

    Sea Watch Beer Battered Clam Strips Recalled for Undeclared Milk Allergen

    Sea Watch International is recalling Beer Battered Clam Strips because the bread coating may contain undeclared milk, which is not listed on the label.

    Product
    Sea Watch Brand Beer Battered Clam Strips Pack Size: 24/4 oz. bags/case
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2433-2017·2017-07-12

    Don's Salads Recalls Egg Salad Due to Undeclared Milk

    Don's Salads is recalling egg salad products because an ingredient used in their manufacture contains undeclared milk.

    Product
    Don's Salads; Egg Salad; Net Wt. 5 lbs., MFGD by Aldon Food Corp, Schwenksville, PA 19473; Sell by dates: 6/7, 6/9, 6/13, 6/15; UPC: 740247005061; AND; Block & Barrel Classic Egg Salad; Net Wt. 5 lbs; Distributed by Sysco Corporation, Houston, TX 77077; Sell By Dates: 6/7,
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-2430-2017·2017-07-12

    Sailors Choice Breaded Clam Strips Recalled for Undeclared Milk

    Sea Watch International is recalling Sailors Choice Breaded Clam Strips because the bread coating may contain undeclared milk, a major allergen not listed on the label.

    Product
    Sailors Choice Breaded Clam Strips Pack Size: 24/6 oz. bags/case
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2414-2017·2017-07-12

    GoMacro Recalls Specific Thrive Bars Due to Listeria Risk

    GoMacro is recalling specific THRIVE Chocolate, Nuts & Sea Salt bars because they may be contaminated with Listeria monocytogenes.

    Product
    go macro THRIVE Chocolate, Nuts & Sea Salt bar, Net Wt 1.4 oz / 40 G, UPC 8 53555-00650 4
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2667-2017·2017-07-12

    Exactech Equinoxe Reamer Recalled for Updated Instructions on Glenoid Reaming

    Exactech is recalling the Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer to update instructions for use, clarifying proper reaming technique to prevent instrument breakage.

    Product
    EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Food)·F-2452-2017·2017-07-12

    Gourmet Bay Honey Mustard Breaded Tilapia Recalled for Undeclared Milk

    Slade Gorton & Company is recalling refrigerated Gourmet Bay Honey Mustard Breaded Tilapia due to undeclared milk, a major food allergen.

    Product
    Gourmet Bay - Honey Mustard Breaded Tilapia, 5-7 oz.. refrigerated (Bulk 5 lbs container) Product Code: 7324801
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2665-2017·2017-07-12

    Exactech Equinoxe Modular Reverse Pilot-Tip Starter Reamer Recall

    Exactech is recalling 928 Equinoxe Modular Reverse Pilot-Tip Starter Reamers to update instructions for use. The update clarifies proper reaming technique to prevent instrument breakage.

    Product
    EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01
    Category
    Medical Device
    Distribution
    33 states
  • ModerateFDA (Devices)·Z-2668-2017·2017-07-12

    Exactech Equinoxe Reamer Recall Due to Updated Instructions for Use

    Exactech is recalling Equinoxe Narrow Modular Reverse Pilot-Tip Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.

    Product
    EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-45-38, Catalog #: 321-45-42 and Catalog #: 321-45-46
    Category
    Medical Device
    Distribution
    33 states
  • ModerateFDA (Devices)·Z-2669-2017·2017-07-12

    Sterilmed Recalls Reprocessed EP Ablation Cables Due to Regulatory Status

    Sterilmed is recalling 963 reprocessed EP ablation cables because they are Class III devices that lack required premarket approval.

    Product
    Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables serve two different purposes. They either serve as an extension between an EP catheter and equi
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-2674-2017·2017-07-12

    Boston Scientific Retrieval Balloon Catheter Recalled for Incorrect Injection Labeling

    Boston Scientific is recalling 32 units of Extractor Pro RX-S Retrieval Balloon Catheters because the labels incorrectly identify the injection location relative to the balloon.

    Product
    Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2662-2017·2017-07-12

    Exactech Recalls Logic Fit Tibial Tamp Heads for Labeling Clarification

    Exactech, Inc. is recalling 573 Logic Fit Tibial Tamp Heads to update surgical labeling. The update clarifies proper removal techniques to prevent instrument breakage.

    Product
    Logic Fit Tibial Tamp Head
    Category
    Medical Device
    Distribution
    32 states
  • ModerateFDA (Drugs)·D-0937-2017·2017-07-12

    Methocarbamol USP Recalled for Quality Assurance Deviations

    American Pharmaceutical Ingredients LLC is recalling Methocarbamol USP due to lack of quality assurance at the API manufacturer.

    Product
    Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 58597-8023-7), c) 1,000 g container (NDC: 58597-8023-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2658-2017·2017-07-12

    Encore Medical Recalls 3DKnee Tibial Inserts Due to Mis-packaging Error

    Encore Medical is recalling 9 units of 3DKnee Tibial Inserts because a size 6 left box contained a size 8 right insert.

    Product
    3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2689-2017·2017-07-12

    Beckman Coulter PrepPlus Recalled for Imprecise Sample Preparation

    Beckman Coulter is recalling 43 PrepPlus systems because they may produce imprecise absolute counts in the first tube of a flow cytometry run.

    Product
    Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a microprocessor-controlled pipetting and diluting system designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2673-2017·2017-07-12

    Boston Scientific Retrieval Balloon Catheter Recalled for Labeling Error

    Boston Scientific is recalling 39 units of the Extractor Pro RX-S Retrieval Balloon Catheter because the label incorrectly identifies the injection location.

    Product
    Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN: M00547300
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0942-2017·2017-07-12

    Lantheus Recalls Fludeoxyglucose F 18 Injection Due to Residual Solvent

    Lantheus is recalling 26 doses of Fludeoxyglucose F 18 Injection in Puerto Rico because the product failed impurity specifications for acetonitrile residual solvent.

    Product
    Fludeoxyglucose F 18 Injection, 20mCi/mL to 200 mCi/mL at EOS, 30 mL Multiple-Dose Vial, Rx Only, Manufactured by: Lantheus MI Radiopharmaceuticals, Inc., San Juan, PR --- NDC 11994-015-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-2423-2017·2017-07-12

    Nutri-Dyn Calcium D-Glucarate Plus Recalled Due to Mislabeling

    Nutri-Dyn Midwest, Inc. is recalling 856 bottles of Calcium D-Glucarate Plus because they were mistakenly labeled as St. John's Wort during production.

    Product
    Nutri-Dyn Calcium D-Glucarate Plus, Dietary Supplement, 60 Capsules, UPC 7 13757-09611 9
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-2690-2017·2017-07-12

    Beckman Coulter PrepPlus 2 Recalled for Sample Preparation Imprecision

    Beckman Coulter is recalling 473 PrepPlus 2 units because they may produce imprecise absolute counts in the first tube of a flow cytometry run.

    Product
    Coulter PrepPlus 2, Part Number 378600, Product Usage: The COULTER PrepPlus 2, when used in combination with the COULTER TQPrep Workstation, is intended to prepare human whole blood for In Vitro Diagnostic (IVD) Use with cleared Beckman Coulter IVD applications on cleared Be
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-2448-2017·2017-07-12

    Sabor Mexicano Corn Chips Recalled for Sodium Labeling Error

    Sabor Mexicano is recalling Homemade Corn Chips because the label listed 15 mg of sodium instead of the correct 250 mg.

    Product
    Sabor Mexicano Homemade Corn Chips: Packaged in 12 oz. (9 units per case), UPC 8-53094-00417-7, and Fun size 5 oz. ( 12 units per case), UPC 8-53094-00418-4.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2645-2017·2017-07-12

    Boston Scientific Imager II Angiographic Catheter Recall for Missing Seal

    Boston Scientific is recalling Imager II Angiographic Catheters because some units are missing the bottom pouch seal. The defect is obvious to the user.

    Product
    Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2672-2017·2017-07-12

    Ion Beam Applications Recalls Proteus Proton Therapy Systems for Software Issues

    Ion Beam Applications is recalling Proteus 235 and Proteus ONE proton therapy systems because on-site software installations were not performed consistently with standard operating procedures.

    Product
    Proteus 235 and Proteus ONE proton therapy systems
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2664-2017·2017-07-12

    Exactech Equinoxe Glenoid Reamer Recalled for Updated Instructions

    Exactech is recalling Equinoxe Glenoid Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.

    Product
    EXACTECH Equinoxe Glenoid Reamer - Catalog #: 321-05-38, Catalog #: 321-05-42, and Catalog #: 321-05-46
    Category
    Medical Device
    Distribution
    33 states
  • ModerateFDA (Devices)·Z-2663-2017·2017-07-12

    Exactech Equinoxe Reverse Starter Reamer Recalled for Updated Instructions

    Exactech is recalling 382 Equinoxe Reverse Starter Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.

    Product
    EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01
    Category
    Medical Device
    Distribution
    33 states
  • ModerateFDA (Drugs)·D-0943-2017·2017-07-12

    Sandoz Recalls Amitriptyline Hydrochloride Tablets Due to Cross-Contamination

    Sandoz Incorporated is recalling specific lots of Amitriptyline Hydrochloride 25 mg tablets because they were cross-contaminated with Imipramine.

    Product
    AMITRIPTYLINE HYDROCHLORIDE — AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0945-2017·2017-07-12

    G & W Clobetasol Propionate Ointment Recalled for Impurity

    G & W Laboratories is recalling Clobetasol Propionate Ointment 0.05% due to out-of-specification results for a known impurity.

    Product
    CLOBETASOL PROPIONATE — CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2661-2017·2017-07-12

    Medacta GMK Hinge Tibial Insert Recalled for Missing Attachment Screw

    Medacta USA Inc. is recalling one lot of GMK Hinge Tibial Inserts because they are missing a screw required for attachment to the tibial base plate.

    Product
    Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2687-2017·2017-07-12

    Mallinckrodt Recalls ArterX Surgical Sealant Due to Improper Labeling

    Mallinckrodt is recalling ArterX Surgical Sealant because improper labeling led to improper storage. The affected units were distributed to the UK.

    Product
    Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC Adjunct to sutures in vascular surgery.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-2422-2017·2017-07-12

    Bacalafoods Recalls Finola Style Octopus in Oil Due to Mislabeling

    Bacalafoods Corp is recalling Finola Style Octopus in Oil because the product contains squid but is labeled as octopus.

    Product
    Finola, Style Octopus in Oil, Product of Spain, Wild Caught, Net Weight 4.1/10oz (115g), Empacado para:/Packaged for: Bacalafoods Corp., San Juan, PR 00936-8060
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2421-2017·2017-07-12

    Bacalafoods Recalls Finola Style Octopus in Garlic Due to Mislabeling

    Bacalafoods Corp is recalling Finola Style Octopus in Garlic because the product contains squid instead of octopus. The recall covers 340 boxes distributed in Puerto Rico.

    Product
    Finola, Style Octopus in Garlic, Product of Spain, Wild Caught, Net Weight 4.1/10oz (115g), Empacado para:/Packaged for: Bacalafoods Corp., San Juan, PR 00936-8060
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0944-2017·2017-07-12

    GSK Recalls Parodontax Toothpaste Due to Possible Metal Presence

    GSK Consumer Healthcare is recalling 15,708 tubes of Parodontax Whitening toothpaste due to the possibility of metal in the product.

    Product
    PARODONTAX — PARODONTAX (STANNOUS FLUORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2666-2017·2017-07-12

    Exactech Equinoxe Modular Reverse Pilot-Tip Reamer Recall for Labeling Clarification

    Exactech is recalling Equinoxe Modular Reverse Pilot-Tip Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.

    Product
    EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Catalog #: 321-25-42 and Catalog #: 321-25-46
    Category
    Medical Device
    Distribution
    33 states
  • LowFDA (Devices)·Z-2659-2017·2017-07-12

    Encore Medical Recalls 3DKnee Tibial Inserts Due to Mis-Packaging

    Encore Medical is recalling 3DKnee Tibial Inserts because a size 6 left box contained a size 8 right insert.

    Product
    3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 01 The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0934-2017·2017-07-12

    PharMEDium Recalls Ropivacaine HCl Injection Due to Labeling Errors

    PharMEDium Services, LLC is recalling 21 pumps of Ropivacaine HCl 0.2% injection due to incorrect or missing lot and expiration dates.

    Product
    Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in 0.9% Sodium Chloride Injection, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-100-13
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0935-2017·2017-07-12

    PharMEDium Recalls Bupivacaine Pumps Due to Incorrect Labeling

    PharMEDium Services is recalling two Bupivacaine HCl ON-Q pumps due to incorrect or missing lot and expiration date labeling.

    Product
    Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 270 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-044-57
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0931-2017·2017-07-12

    PharMEDium Recalls Ropivacaine Pumps Due to Labeling Errors

    PharMEDium Services is recalling 22 Ropivacaine HCl pumps nationwide because of incorrect or missing lot and expiration dates.

    Product
    Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-258-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0930-2017·2017-07-12

    PharMEDium Recalls Ropivacaine Pumps Due to Incorrect Labeling

    PharMEDium Services is recalling 79 Ropivacaine HCl IV pumps because of incorrect or missing lot and expiration dates.

    Product
    Ropivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-256-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0933-2017·2017-07-12

    PharMEDium Recalls Ropivacaine Pumps Due to Incorrect Lot and Expiration Dates

    PharMEDium Services, LLC is recalling 10 Ropivacaine HCl 0.2% ON-Q pumps nationwide due to incorrect or missing lot and expiration dates.

    Product
    Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 600 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-279-33
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0932-2017·2017-07-12

    PharMEDium Recalls Ropivacaine Pumps Due to Labeling Errors

    PharMEDium Services is recalling 147 Ropivacaine HCl IV pumps nationwide because of incorrect or missing lot and expiration dates.

    Product
    Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-258-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0936-2017·2017-07-12

    PharMEDium Recalls Bupivacaine Pumps Due to Incorrect Labeling

    PharMEDium Services is recalling seven Bupivacaine HCl ON-Q pumps because of incorrect or missing lot and expiration dates.

    Product
    Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-023-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalNHTSA·17E034000·2017-07-10

    Takata Driver Frontal Air Bag Inflator Recall for Rupture Risk

    Takata is recalling specific driver-side air bag inflators that may rupture due to propellant degradation, posing a risk of serious injury or death.

    Product
    AIR BAGS:FRONTAL:DRIVER SIDE:INFLATOR MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V437000·2017-07-10

    GM Recalls 40,683 Vehicles for Air Bag and Seat Belt Software Defect

    General Motors is recalling 40,683 vehicles from 2014-2017 because a software error may prevent front air bags and seat belt pretensioners from deploying in a crash.

    Product
    CHEVROLET — CHEVROLET, GMC, BUICK CORVETTE, SILVERADO 1500, SIERRA 1500, LACROSSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V435000·2017-07-10

    Chrysler Recalls 2011-2014 Vehicles for Alternator Failure Risk

    Chrysler is recalling specific 2011-2014 Dodge, Chrysler, and Jeep vehicles because the alternator may fail, causing the vehicle to stall or catch fire.

    Product
    DODGE — DODGE, CHRYSLER, JEEP DURANGO, 300, CHARGER, CHALLENGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V438000·2017-07-10

    BMW Recalls 2014-2017 R1200GS Motorcycles for Fork Tube Separation Risk

    BMW is recalling 2014-2017 R1200GS and R1200GS Adventure motorcycles because the fixed fork tube may separate from the seal plug, increasing crash risk.

    Product
    BMW — BMW R1200 GS ADVENTURE, R 1200 GS ADVENTURE, R1200 GS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17E036000·2017-07-10

    MORryde Recalls Jerry Can Holders for Detachment Risk

    MORryde is recalling Jerry Can holders that may tear apart from the spare tire mount, creating a road hazard.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V434000·2017-07-07

    Chrysler Recalls 2017 Ram 1500 Trucks for Fuel Tank Valve Defect

    Chrysler is recalling 2017 Ram 1500 trucks because a broken fuel tank control valve may leak fuel if the vehicle is inverted, increasing fire risk in a rollover crash.

    Product
    RAM — RAM 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V433000·2017-07-07

    2017 Jeep Compass Recall for Incorrect Jump Start Instructions

    Chrysler is recalling 2017 Jeep Compass vehicles because the User's Guide contains reversed battery terminal polarity for jump starting, which may increase the risk of injury.

    Product
    JEEP — JEEP COMPASS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V432000·2017-07-07

    Dodge Journey Recall for Frontal Air Bag Wiring Defect

    Chrysler is recalling 2011-2015 Dodge Journey vehicles because the driver's frontal air bag wiring may chafe and short circuit, causing unexpected deployment.

    Product
    DODGE — DODGE JOURNEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V431000·2017-07-07

    2017 Dodge Challenger Recall for Transmission Park Position Defect

    Chrysler is recalling 2017 Dodge Challengers with 5.7L V8 engines and eight-speed automatic transmissions because the vehicle may not stay in Park, increasing crash risk.

    Product
    DODGE — DODGE CHALLENGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V427000·2017-07-06

    Ford Recalls 2017 Edge, Fusion, and Lincoln MKZ for Torque Converter Defect

    Ford is recalling 2017 Edge, Fusion, and Lincoln MKZ vehicles with 2.0L engines and six-speed automatics because torque converter weld studs may be inadequate, risking loss of vehicle movement.

    Product
    LINCOLN — LINCOLN, FORD MKZ, FUSION, EDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V430000·2017-07-06

    Forest River Recalls Transit Buses Due to Driveshaft Coupling Failure Risk

    Forest River is recalling specific 2015-2018 transit buses and work trucks because a flexible coupling may fail, potentially damaging brake and fuel lines.

    Product
    STARCRAFT — STARCRAFT, FOREST RIVER, GLAVAL PRODIGY BUS, STARLITE, CANDIDATE II, CROSSFIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V428000·2017-07-06

    BMW Recalls 2006 Models for Front Passenger Air Bag Sensor Defect

    BMW is recalling 2006 3 and 5 Series vehicles because the front passenger seat occupant detection mat may crack, potentially deactivating the air bag in a crash.

    Product
    BMW — BMW 330XI, 325I, 530XI, 550I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2410-2017·2017-07-05

    Global Garlic Queso Fresco Recalled for Listeria Contamination

    Global Garlic, Inc. is recalling Queso Fresco cheese contaminated with Listeria monocytogenes. The product was distributed to Florida, Illinois, Kentucky, Louisiana, and North Carolina.

    Product
    Queso Fresco x LB (Barra)/ Whole Milk Cheese, Net Wt 5-6 lbs.
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-2393-2017·2017-07-05

    Ava's Organic Cashews Recalled Due to Listeria Contamination Risk

    Severn Peanut Co. is recalling Ava's brand Organic Cashews Roasted & Salted 8 oz. tubs because the product may be contaminated with Listeria monocytogenes.

    Product
    Ava's brand Organic Cashews Roasted & Salted 8 oz. tubs, UPC 8-10111-01035-1
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-2391-2017·2017-07-05

    IFF Seasoning Blends Recalled Due to Potential Salmonella Contamination

    International Flavors & Fragrances, Inc. is recalling seasoning blends that may contain salmonella. The affected products were distributed in Texas and Canada.

    Product
    Seasoning blends IFF Inc. Carrollton 1620 West Crosby Carrollton TX 75006 Net Weight 50.00 LBS 22.680
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2639-2017·2017-07-05

    DeRoyal Dolphin Inflation Device Recalled for Sterility Assurance Defect

    DeRoyal Industries is recalling 426 Dolphin Inflation Devices due to a primary packaging defect that may compromise sterility.

    Product
    DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·17184·2017-07-05

    Home Depot Recalls Crystal Chandeliers Due to Fire and Burn Hazards

    Home Depot is recalling Hampton Bay and Home Decorators Collection crystal chandeliers because halogen bulbs can melt parts, posing fire and burn risks.

    Product
    Crystal chandeliers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0929-2017·2017-07-05

    Allergan Recalls Blephamide Ophthalmic Ointment Due to Impurity Failures

    Allergan is recalling 648 units of Blephamide ophthalmic ointment because stability testing showed impurities exceeding specifications.

    Product
    Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX only, Manufactured by Allergan, Irvine, California, 92612, U.S.A., NDC: 0023-0313-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2395-2017·2017-07-05

    Hampton Farms Recalls Organic Almonds for Listeria Contamination Risk

    Severn Peanut Co. is recalling Avas Organic Roasted Unsalted Almonds due to potential Listeria monocytogenes contamination. The product was distributed in New Jersey, New York, Pennsylvania, and Connecticut.

    Product
    Avas 8 oz. Organic Roasted Unsalted Almonds UPC 8-10111-01032-0
    Category
    Food
    Distribution
    4 states
  • SevereNHTSA·17E033000·2017-07-05

    Cummins Recalls L9 Diesel Engines in Pierce Fire Trucks

    Cummins is recalling L9 heavy-duty diesel engines installed in Pierce fire trucks because improperly tightened capscrews may cause the flexplate to separate, potentially leading to engine stalling and a crash.

    Product
    ENGINE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2409-2017·2017-07-05

    Global Garlic Recalls De Mi Pais Queso Fresco for Listeria Contamination

    Global Garlic, Inc. is recalling 227 lbs of De Mi Pais Queso Fresco cheese due to Listeria monocytogenes contamination. The product was distributed to Florida, Illinois, Kentucky, Louisiana, and North Carolina.

    Product
    De Mi Pais, Queso Fresco, Whole Milk Cheese, Net Wt 16 oz.. (1 lb)
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-2392-2017·2017-07-05

    Kroger Dessert Cups Recalled for Missing Milk Allergen Labeling

    The Kroger Co is recalling Dessert Cups yellow sponge cakes because the packaging fails to list milk in the allergen statement, despite it being an ingredient.

    Product
    Kroger Dessert Cups yellow sponge cakes NET WT 6.5 oz (184g) INGREDIENTS: ***NONFAT M ILK***CONTAINS: WHEAT, EGGS, SOY. DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 800-632-6900 www.kroger.com UPC 0 11110 18550 1
    Category
    Food
    Distribution
    17 states
  • SevereFDA (Food)·F-2399-2017·2017-07-05

    Mikawaya Recalls Green Tea Ice Cream Due to Metal Fragments

    Mikawaya is recalling specific lots of green tea ice cream sold under Trader Joe's, Shirakiku, and Fukuya brands due to the possible presence of metal fragments.

    Product
    Green Tea Ice Cream: Sold under the brand names of: Trader Joe's Brand Matcha- 1 quart tubs, SKU 055740; Shirakiku brand Matcha and Fukuya brand, both in 3 gallon foodservice tubs.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2655-2017·2017-07-05

    Shimadzu FDR Visionary X-Ray System Recalled for Tube Shaft Cracks

    Shimadzu is recalling FDR Visionary x-ray systems because cracks may develop on the tube holding shaft. The recall covers 1,673 units distributed in the US, Canada, and Japan.

    Product
    SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualifie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2642-2017·2017-07-05

    Merge Healthcare Recalls Pediatric SpO2 Sensors for Display Failure

    Merge Healthcare is recalling four MasimoSET pediatric SpO2 sensors because cables may stop displaying patient data, causing slight delays in care.

    Product
    MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2625-2017·2017-07-05

    Smith & Nephew Recalls Legion Tib Cone Impactor Heads Due to Adhesive Error

    Smith & Nephew is recalling 46 units of Legion Tib Cone Impactor Heads because incorrect Loctite adhesive was used during assembly.

    Product
    LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2653-2017·2017-07-05

    Shimadzu Ceiling X-ray Tube Support Recalled for Potential Cracks

    Shimadzu Medical Systems is recalling ceiling-type X-ray tube supports because cracks may develop on the tube holding shaft, posing a risk of equipment failure.

    Product
    SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M Holds an x-ray tube unit and collimator combined with an z-ray high voltage generator, radiographic stand, and table. It is designed to perform radiography of patients either in a standing or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2628-2017·2017-07-05

    Merge Healthcare Recalls LIS Software Due to Potential Wrong Results Verification

    Merge Healthcare is recalling specific versions of its LIS software because wrong laboratory results could be inadvertently verified under certain conditions.

    Product
    Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order entry to the time the laboratory test results are reported.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2624-2017·2017-07-05

    Smith & Nephew Recalls Legion Fem Cone Impactor Heads Due to Adhesive Error

    Smith & Nephew is recalling 36 units of Legion Fem Cone Impactor Heads because incorrect Loctite adhesive was used during assembly.

    Product
    LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-2400-2017·2017-07-05

    Mikawaya Recalls Red Bean Ice Cream Due to Metal Fragments

    Mikawaya is recalling Shirakiku Brand Red Bean Ice Cream 3 gallon foodservice tubs due to the possibility of metal fragments.

    Product
    Shirakiku Brand Red Bean Ice Cream 3 gallon foodservice tub
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2622-2017·2017-07-05

    Recall of Covidien Endo Peanut 5mm Auto Suture Blunt Dissector

    Covidien LLC is recalling 194,851 units of the Endo Peanut 5mm Auto Suture Blunt Dissector because the cotton tip may disengage due to insufficient adhesive.

    Product
    Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in endoscopic surgery for swabbing small amounts of fluid or for blunt dissection of soft tissue(s) and structures, or as an aid in controlling minor intraoperative bleeding
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2654-2017·2017-07-05

    Shimadzu RADspeed Pro X-Ray Systems Recalled for Tube Shaft Cracks

    Shimadzu is recalling RADspeed Pro stationary x-ray systems because cracks may develop on the tube holding shaft, posing a risk of equipment failure.

    Product
    SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2634-2017·2017-07-05

    Mindray Recalls TI Transport Monitor Battery Packs Due to Overheating

    Mindray is recalling 2,718 TI Transport Monitor battery packs because two reports indicated the packs overheated.

    Product
    TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2411-2017·2017-07-05

    Bakehouse Bread Recalled for Missing Tree Nut Allergen Labeling

    Kroger is recalling Bakehouse Bread Artisan Cranberry Orange Bread because the label fails to list pecans or tree nuts in the allergy statement.

    Product
    BAKEHOUSE BREAD ARTISAN CRANBERRY ORANGE BREAD, 16 OZ UPC 8 64934 00004 4 Bakehouse Bread Company Tucson, AZ
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2626-2017·2017-07-05

    EOS Imaging Recalls ROTH MOBELI Grab Handles for Detachment Risk

    EOS Imaging is recalling ROTH MOBELI grab handles because they could detach, posing a fall risk to patients if operators do not follow instructions.

    Product
    ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalogue Number 14002 25 S, EOS Imaging Catalogue Number 9000111774.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2640-2017·2017-07-05

    Merge Healthcare Recalls SpO2 Cables for Hemodynamics Monitors

    Merge Healthcare is recalling 219 SpO2 connecting cables for its Hemodynamics monitors because they may stop displaying patient SpO2 readings, causing a slight delay in patient care.

    Product
    SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2630-2017·2017-07-05

    Intuitive Surgical Recalls da Vinci Xi Surgical Systems Due to Brake Screw Issue

    Intuitive Surgical is recalling 10 da Vinci Xi Surgical Systems because brake screws on the patient side carts may be under-torqued.

    Product
    da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical instruments such as endoscopes, scissors, forceps, and retractors during endoscopic surgery. The system has four universal m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2633-2017·2017-07-05

    Elekta MOSAIQ Oncology System Recalled for Care Plan Update Failure

    Elekta is recalling MOSAIQ Oncology Information System versions 2.50.05 and higher because outdated information may remain in order sets, potentially affecting treatment workflows.

    Product
    MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product Usage: MOSAIQ¿ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2651-2017·2017-07-05

    Carestream Recalls DRX-Revolution Mobile X-Ray Systems Due to Assembly Defect

    Carestream Health Inc is recalling DRX-Revolution Mobile X-Ray Systems because missing screws could cause the tube and yoke assembly to separate.

    Product
    DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution --- The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2629-2017·2017-07-05

    Olympus Recalls High Frequency Resection Electrodes Due to Wire Breakage

    Olympus Corporation of the Americas is recalling 1,264 High Frequency Resection Electrodes because loop wires may break at the distal end.

    Product
    High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2396-2017·2017-07-05

    Hans Kissle Cranberry Couscous Recalled for Undeclared Cashews

    Hans Kissle Company is recalling Whole Foods Cranberry Couscous because it contains undeclared cashews, a major food allergen.

    Product
    Whole Foods Cranberry Couscous- packaged in Clear plastic clamshell for 6oz, 14oz and 18oz, and white plastic pail for 10lb. UPC Codes: 036217162613(6oz), 036217162514(14oz), 036217261408(18oz), 036217110317(10lb)
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-2401-2017·2017-07-05

    ProSupps Recalls Mr. Hyde Fruit Punch for Undeclared Picamilon Ingredient

    ProSupps USA LLC is recalling specific Mr. Hyde Fruit Punch products because they are potentially mislabeled and contain the non-dietary ingredient Picamilon.

    Product
    Mr. Hyde, Fruit Punch, 30 servings; Mr. Hyde Fruit Punch (V2); Mr. Hyde 30 INT'L Fruit Punch; Mr. Hyde Fruit Punch RTD; Mr. Hyde V2 domestic Fruit Punch
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2406-2017·2017-07-05

    ProSupps Recalls Dr. Jekyll 30 Fruit Punch for Mislabeling

    ProSupps USA LLC is recalling Dr. Jekyll 30 Fruit Punch because it is potentially mislabeled and contains the non-dietary ingredient Picamilon.

    Product
    Dr. Jekyll 30 Fruit Punch
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-2407-2017·2017-07-05

    ProSupps Recalls Dr. Jekyll V2 Green Apple International Due to Mislabeling

    ProSupps USA LLC is recalling 3,045 units of Dr. Jekyll V2 Green Apple International because the product is potentially mislabeled and contains the non-dietary ingredient Picamilon.

    Product
    Dr. Jekyll V2 Green Apple International
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2646-2017·2017-07-05

    Onkos Surgical Recalls ELEOS Limb Salvage System Segmental Stem Due to Labeling Error

    Onkos Surgical is recalling four units of the ELEOS Limb Salvage System Segmental Stem because the device collar size was incorrectly labeled as 25 mm instead of 32 mm.

    Product
    ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E
    Category
    Medical Device
    Distribution
    3 states

Looking for a different month? Back to 2017.