The Recall Desk

Archive

August 2017 recalls

1,004 recalls were announced in August 2017.

What the numbers show

Critical
75
Severe
160
High
480
Moderate
267
Low
22

Of the 1,004 recalls this month scored against our rubric, 7% are Critical, 16% are Severe.

701–800 of 1004

  • CriticalFDA (Food)·F-3340-2017·2017-08-09

    Woodstock Farms Recalls Cranberry Trail Mix Due to Listeria Risk

    Woodstock Farms is recalling Natures Promise Cranberry Trail Mix because a supplier found Listeria monocytogenes in their facility.

    Product
    Natures Promise Cranberry Trail Mix 12oz.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-3343-2017·2017-08-09

    Woodstock Farms Recalls Cranberry Mix Due to Listeria Risk

    United Natural Trading Inc. dba Woodstock Farms is recalling Market Basket Cape Cod Cranberry Mix 10oz. because a supplier found Listeria monocytogenes in their facility.

    Product
    Market Basket Cape Cod Cranberry Mix 10oz.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1048-2017·2017-08-09

    Hospira Recalls Quelicin Injection Due to Lack of Sterility Assurance

    Hospira is recalling Quelicin (succinylcholine chloride) injection vials because they may lack sterility assurance. The recall covers 15,034,600 vials distributed in the U.S. and internationally.

    Product
    QUELICIN — QUELICIN (SUCCINYLCHOLINE CHLORIDE)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2779-2017·2017-08-09

    Myelotec Video Guided Catheters Recalled for Defective Access Port Body

    Myelotec, Inc. is recalling 2,980 Video Guided Catheters because a defective Access Port Body component can cause the port to become obstructed or blocked.

    Product
    Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Drugs)·D-1047-2017·2017-08-09

    Hospira Recalls 8.4% Sodium Bicarbonate Injection Due to Sterility Concerns

    Hospira is recalling 8.4% Sodium Bicarbonate Injection vials because they may lack sterility assurance. The recall covers 91,483,150 vials distributed in the U.S. and internationally.

    Product
    8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA, NDC: 0409-6625-02
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1054-2017·2017-08-09

    Vi-Jon Recalls Magnesium Citrate Oral Solution Due to Mold Contamination

    Vi-Jon, Inc. is recalling 101,244 bottles of Magnesium Citrate Oral Solution because the product was found to contain mold identified as Rhinocladiella similis.

    Product
    Magnesium Citrate Oral Solution, packaged in a 10 fl. oz. (296 mL) glass bottle, OTC, labeled as: a) GoodSense Magnesium Citrate Oral Solution Saline Laxative Very Low Sodium, UPC# 846036007381, NDC 50804-686-38, Distributed by: Geiss, Desitin &Dunn, Inc., Peachtree City, GA 3026
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Food)·F-2963-2017·2017-08-09

    Clif Kid Zbar Protein Chocolate Mint Recalled for Undeclared Peanuts

    Clif Bar & Company is recalling Clif Kid Zbar Protein Chocolate Mint bars due to undeclared peanuts and/or tree nuts.

    Product
    Clif Kid Zbar Protein Chocolate Mint 10-pack, 150-count, 5-pack;
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1049-2017·2017-08-09

    Hospira Recalls Sodium Bicarbonate Additive Solution Due to Sterility Concerns

    Hospira is recalling specific lots of Sodium Bicarbonate 4% Additive Solution because they may lack sterility assurance. The recall covers 21.4 million vials distributed in the U.S. and internationally.

    Product
    Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1046-2017·2017-08-09

    Hospira Recalls Potassium Phosphates Injection Due to Sterility Concerns

    Hospira is recalling 20.3 million vials of Potassium Phosphates Injection because of a lack of sterility assurance. The product was distributed in the U.S. and several international locations.

    Product
    Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx Only, Mfd by Hospira, Inc. Lake Forest, IL 60045 USA, NDC: 0409-7295-01
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1036-2017·2017-08-09

    Cyclobenzaprine Tablets Recalled for Incorrect Amantadine Labeling

    Apace KY LLC is recalling Cyclobenzaprine HCl 5 mg tablets because cartons were mislabeled as Amantadine HCl 100 mg capsules.

    Product
    Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx Only, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0190-15
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1052-2017·2017-08-09

    VistaPharm Recalls Lactulose Solution Due to Microbial Contamination

    VistaPharm is recalling Lactulose Solution, USP, because the product failed microbial testing for yeast and mold counts.

    Product
    Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-50
    Category
    Drug
    Distribution
    7 states
  • SevereNHTSA·17V497000·2017-08-09

    Newmar Recalls Dutch Star and Mountain Aire RVs for Fire Risk

    Newmar is recalling 2014-2017 Dutch Star and 2014 Mountain Aire recreational vehicles because a battery cable may short circuit, increasing the risk of a fire.

    Product
    NEWMAR — NEWMAR DUTCH STAR, MOUNTAIN AIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·091-2017·2017-08-09

    Kenosha Beef Recalls Patties Due to Undeclared Allergens and Misbranding

    Kenosha Beef International is recalling beef patties containing undeclared milk and bacon. The products were mislabeled as plain beef burgers.

    Product
    Kenosha Beef International, LTD. Recalls Beef Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-3345-2017·2017-08-09

    Woodstock Farms Recalls Fiber Frenzy Due to Listeria Risk

    Woodstock Farms is recalling Market Basket Fiber Frenzy 10oz. because a supplier found Listeria monocytogenes in their facility.

    Product
    Market Basket Fiber Frenzy 10oz.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2783-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because the included Medtronic display sets may have pinholes, creating a potential sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2790-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because the included Medtronic display sets may have pinholes, creating a potential sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2863-2017·2017-08-09

    Spectranetics Turbo-Elite Laser Atherectomy Catheters Recalled for Marker Band Risk

    Spectranetics is recalling Turbo-Elite Laser Atherectomy Catheters because a marker band may become loose or disengaged when the device is used off-label.

    Product
    Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-2787-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included display sets may have packaging pinholes that compromise sterility.

    Product
    SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2869-2017·2017-08-09

    In2Bones Recalls Non-Locking Orthopedic Screws Due to Perioperative Breakage

    In2Bones, SAS is recalling specific non-locking orthopedic screws after customer complaints reported breakage during insertion into the radius bone.

    Product
    Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b) NEO(R) 0.27 - 12 mm, REF W27 ST012 (c) DRP 0.27 - 12 mm, REF W27 ST012 (d) NEO(R) 0.27 - 14 mm, REF W27 ST014 (e) NEO(R) 0.27 - 16 mm, REF W27 ST016 (f) NEO(R) 0.27 - 18 mm, REF W27 ST01
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2794-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included display sets may have packaging pinholes that compromise sterility.

    Product
    SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2797-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a potential sterile barrier breach.

    Product
    NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2868-2017·2017-08-09

    Zimmer Biomet Recalls ROSA Brain Surgical Navigation Systems

    Zimmer Biomet is recalling 20 ROSA Brain surgical navigation systems because the head holder connector may lock up mechanically when tightened.

    Product
    ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is indicat
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2786-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a potential sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3348-2017·2017-08-09

    Professional Formulas Recalls Sublinqual B12 Tablets Due to Undeclared Milk

    Professional Complementary Health Formulas, LLC is recalling Sublinqual B12 High-Potency tablets because the label fails to declare milk, a major allergen, despite lactose being listed in the ingredients.

    Product
    Professional Formulas Sublinqual B12 High-Potency dietary supplement, 60-count dissolvable tablet in white plastic bottles. Adhesive label with White, black red and green print; bottle has a heat-shrink band. UPC code 8 40851 10054 0.
    Category
    Food
    Distribution
    34 states
  • HighFDA (Devices)·Z-2798-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because they may contain Medtronic display sets with packaging pinholes that could breach the sterile barrier.

    Product
    NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2789-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterility Breach

    LivaNova is recalling Perfusion Tube Sets because included display sets may have packaging pinholes that compromise sterility.

    Product
    SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2954-2017·2017-08-09

    Sami's Bakery Peanut Butter Cookies Recalled for Undeclared Milk Allergen

    Sami's Pita Bakery, Inc. is recalling Peanut Butter Cookies because they contain undeclared milk, a major food allergen.

    Product
    SAMI'S BAKERY, Peanut Butter Cookies, Net Wt. 7oz. (196g), Packed by: Sami's Pita Bakery Inc., Tampa, FL.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2958-2017·2017-08-09

    Sami's Bakery Baklava Walnut Recalled for Undeclared Milk Allergen

    Sami's Pita Bakery, Inc. is recalling 4-ounce packages of Baklava Walnut due to an undeclared milk allergen. The product was distributed to US consignees.

    Product
    SAMI'S BAKERY, BAKLAVA WALNUT, Net Weight. 4oz (112g)., Refer questions or comments to: Sami's Bakery., Tampa, FL.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2957-2017·2017-08-09

    Sami's Bakery Oatmeal Raisin Cookies Recalled for Undeclared Milk Allergen

    Sami's Pita Bakery, Inc. is recalling Oatmeal Raisin Cookies because they contain an undeclared milk allergen.

    Product
    SAMI'S BAKERY, Oatmeal Raisin Cookies, Net Wt. 7oz., Refer questions or comments to: Sami's Bakery., Tampa, FL.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2955-2017·2017-08-09

    Sami's Bakery Date Almond Cookies Recalled for Undeclared Milk Allergen

    Sami's Pita Bakery, Inc. is recalling Date Almond Cookies due to an undeclared milk allergen. The product was distributed to US consignees.

    Product
    SAMI'S BAKERY, Date Almond Cookies, Net Wt. 7oz. (196g), Packed by: Sami's Pita Bakery Inc., Tampa, FL.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2792-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have pinholes in their packaging, creating a potential sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3337-2017·2017-08-09

    Silver Star Chipotle Queso Dip Recalled for Undeclared Milk and Eggs

    Texas Legend Foods is recalling Silver Star Tex-Mex Style Chipotle Queso Medium Dip due to undeclared milk and eggs.

    Product
    Silver Star Tex-Mex Style Chipotle Queso Medium Dip Net Wt 16 OZ (1 Lb) packaged in a glass jar
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-3352-2017·2017-08-09

    NatureBox Sticks 'n Stones Recalled Due to Undeclared Peanut Presence

    NatureBox is recalling Sticks 'n Stones snack mix because a consumer found a peanut in a product that does not list peanuts as an ingredient.

    Product
    NatureBox Sticks 'n Stones; roasted nuts with sesame sticks. Packed in 5 oz. pouch and 5 lb. corporate bag
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3342-2017·2017-08-09

    Woodstock Organic Kumbaya Mix Recalled Due to Listeria Risk

    Woodstock Organic Kumbaya Mix is being recalled because a supplier found Listeria monocytogenes in their facility, posing a potential safety risk to consumers.

    Product
    Woodstock Organic Kumbaya Mix 10oz.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2953-2017·2017-08-09

    Goose Point Clams Recalled for Undeclared Milk Allergen

    Nisbet Oyster Co. is recalling Goose Point Steamers in 5 Clams in Butter & Garlic Sauce because the label declares butter and dairy but fails to declare milk.

    Product
    Steamers in 5 Clams in Butter & Garlic Sauce, Goose Point brand. Product is packaged in a plastic tray with heat sealed plastic film and packed in fiber pre-printed retail box. Net wt. 1 lb (454 gram). UPC 0 92206 16101 2. The label is read in parts "****100% NATURAL INGREDIE
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-2865-2017·2017-08-09

    SoftLab Software Recalled for Incorrect Lab Result Display

    Soft Computer Consultants is recalling SoftLab Software versions 4.5.4.3 through 4.5.5.20 because it may display lab results based on incorrect LOINC codes.

    Product
    SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2788-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have pinholes in their packaging, creating a risk of sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2791-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a risk of sterile barrier breach.

    Product
    STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2784-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have pinholes in their packaging, creating a risk of sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2956-2017·2017-08-09

    Sami's Bakery Walnut Chocolate Chip Cookies Recalled for Undeclared Milk

    Sami's Pita Bakery, Inc. is recalling Walnut Chocolate Chip Cookies because they contain undeclared milk, a major food allergen.

    Product
    SAMI'S BAKERY, Walnut Chocolate Chip Cookies, Net Wt. 7oz. (196g), Packed by: Sami's Pita Bakery Inc., Tampa, FL.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2760-2017·2017-08-09

    Olympus VANTA Analytical X-Ray System Recalled for Proximity Shutdown Failure

    Olympus is recalling 146 VANTA Analytical X-Ray Systems because they may fail to stop testing when no sample is present.

    Product
    Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System, X-Ray Fluorescence
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2793-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a potential sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2796-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes that compromise sterility.

    Product
    NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2795-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a risk of sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2864-2017·2017-08-09

    Hologic Tomcat Instrument Recalled for Software Anomaly Affecting Sample Processing

    Hologic is recalling 164 Tomcat Instruments due to a software anomaly that may cause the pipettor arm to contact the mucous shelf, potentially leading to incorrect patient results.

    Product
    Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2785-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes that compromise sterility.

    Product
    SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2777-2017·2017-08-09

    GE Blade|line Industrial Cabinet X-ray System Recalled for Emission Violations

    GE Inspection Technologies is recalling 13 Blade|line Industrial Cabinet X-ray systems because they exceed federal emission limits in an inaccessible crawl space.

    Product
    GE Inspection Technologies Blade|line Industrial Cabinet X-ray system
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2782-2017·2017-08-09

    Biosense Webster MobiCath Guiding Sheath Recalled for Unsealed Pouch

    Greatbatch Medical is recalling 11,360 MobiCath Bi-Directional Guiding Sheaths because one side of the pouch may not be sealed.

    Product
    Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary syst
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2800-2017·2017-08-09

    Stryker Neurovascular Recalls Stroke Fast Packs Due to Labeling Mismatch

    Stryker Neurovascular is recalling 63 Stroke Fast Packs because the printed carton contents did not match the physical items inside.

    Product
    Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK42022001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1050-2017·2017-08-09

    Bayer Recalls Alka-Seltzer Extra Strength Tablets Due to Defective Packaging

    Bayer is recalling Alka-Seltzer Extra Strength effervescent tablets because customer complaints confirmed small holes or cracks in the foil blister packs.

    Product
    Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 24-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500044048
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2866-2017·2017-08-09

    Xintec OptiLITE Laser Surgery Fibers Recalled for Reprocessing Instruction Deficiencies

    Xintec Corp is recalling OptiLITE laser surgery products because reprocessing instructions may not meet new standards for cleaning and sterilization.

    Product
    OptiLITE(TM) Products for Laser Surgery, Catalog Numbers: HTM1020F, HTM1040F, HTM1060F, HTM1010F; Manufactured by CONVERGENT LASTER TECHNOLOGIES The Odyssey 30B is approved for numerous medical procedures. Generally, the primary use of the laser (which includes the fibers) is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2780-2017·2017-08-09

    Ortho Solutions Recalls Mislabelled Oxford AFN End Caps

    Ortho Solutions Inc is recalling 277 units of Oxford/Oxbridge AFN End Caps due to material mislabeling. The affected devices were distributed to Maryland, New York, and Pennsylvania.

    Product
    Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps are a circular disk with a small threaded shaft to be screwed to the distal end of the Nail.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-1038-2017·2017-08-09

    Dr. Reddy's Recalls Pravastatin Sodium Tablets Due to Impurity

    Dr. Reddy's Laboratories is recalling specific lots of Pravastatin Sodium tablets because they failed impurity specifications.

    Product
    PRAVASTATIN SODIUM — PRAVASTATIN SODIUM (PRAVASTATIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2867-2017·2017-08-09

    Sentinel CH Recalls MULTIGENT Creatinine Reagents Due to Quality Control Issues

    Sentinel CH SPA is recalling MULTIGENT Creatinine (Enzymatic) reagents because Reagent 1 may cause quality control values to shift out of acceptable range.

    Product
    MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1040-2017·2017-08-09

    Axia Pharmaceutical Recalls Compounded Testosterone Cypionate and Progesterone Vials

    Axia Pharmaceutical is recalling 120 vials of compounded Testosterone Cypionate and Progesterone due to CGMP deviations. The product was distributed to one customer in California.

    Product
    Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los Angeles, CA 90025
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1053-2017·2017-08-09

    VistaPharm Recalls Lactulose Solution Due to Microbial Contamination

    VistaPharm is recalling Lactulose Solution, USP, because the product failed microbial testing for yeast and mold counts.

    Product
    Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-01
    Category
    Drug
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-1051-2017·2017-08-09

    Bayer Recalls Alka-Seltzer Gold Tablets Due to Defective Blister Pack Foil

    Bayer HealthCare is recalling Alka-Seltzer Gold effervescent tablets because customer complaints confirmed small holes or cracks in the foil of the blister packs.

    Product
    Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium bicarbonate, 1050 mg Antacid Sodium bicarbonate/Antacid) Effervescent Tablets, 36-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500041085
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1037-2017·2017-08-09

    Precision Dose Recalls Carbamazepine Oral Suspension Due to Carton Labeling Error

    Precision Dose Inc. is recalling Carbamazepine Oral Suspension because the product cartons list incorrect volume and NDC numbers, although the individual unit dose cups are correctly labeled.

    Product
    Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1043-2017·2017-08-09

    Zydus Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications

    Zydus Pharmaceuticals is recalling Divalproex Sodium Delayed Release Tablets because they failed to meet dissolution specifications.

    Product
    Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1041-2017·2017-08-09

    Zydus Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications

    Zydus Pharmaceuticals is recalling Divalproex Sodium Delayed Release Tablets because they failed to meet dissolution specifications.

    Product
    Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054, NDC 68382-031-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1044-2017·2017-08-09

    Bayer Recalls Alka-Seltzer Tablets Due to Defective Blister Pack Foil

    Bayer HealthCare is recalling Alka-Seltzer Original effervescent tablets because customer complaints confirmed small holes or cracks in the foil of the blister packs.

    Product
    Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 12-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500040194
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1042-2017·2017-08-09

    Zydus Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications

    Zydus Pharmaceuticals is recalling Divalproex Sodium Delayed Release Tablets because they failed to meet dissolution specifications.

    Product
    Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68382-032-05),Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1035-2017·2017-08-09

    Apace KY LLC Recalls Amantadine HCl Capsules Due to Labeling Error

    Apace KY LLC is recalling 1,483 cartons of Amantadine HCl Capsules because they were mislabeled and contain Cyclobenzaprine HCl tablets instead.

    Product
    Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0069-15
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1057-2017·2017-08-09

    PD-Rx Pharmaceuticals Recalls Famotidine 20 mg Tablets for Weight Issues

    PD-Rx Pharmaceuticals is recalling 100 bottles of Famotidine USP 20 mg tablets because they failed to meet tablet weight specifications.

    Product
    Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 --- NDC 55289-765-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2803-2017·2017-08-09

    Quidel Recalls InflammaDry Sample Collectors Due to Plastic Spurs

    Quidel Corporation is recalling InflammaDry sample collectors because in-house testing found plastic spurs at the tips of some units.

    Product
    InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in vitro detection of elevated levels of the MMP-9 protein in human tears, from patients suspected of having dry eye. InflammaDry is to be used t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2799-2017·2017-08-09

    Stryker Neurovascular Recalls Stroke Fast Packs Due to Labeling Mismatch

    Stryker Neurovascular is recalling 43 Stroke Fast Packs because the carton sleeve labels did not match the physical contents inside the packs.

    Product
    Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK32021001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2801-2017·2017-08-09

    Stryker Stroke Fast Pack Recall Due to Mismatched Carton Sleeve Labeling

    Stryker Neurovascular is recalling 139 Stroke Fast Packs because the pre-printed contents on the carton sleeve did not match the physical contents of the pack.

    Product
    Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK43022001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3349-2017·2017-08-09

    Whole Foods Thai Shrimp Salad Recalled for Incorrect Back Label

    Cafe Spice GCT is recalling Whole Foods Market Thai Shrimp Salad because the back label displays information for a different product.

    Product
    Whole Foods Market Thai Shrimp Salad, Net Wt. 14 oz.. packaged in a clear clamshell container (refrigerated)
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2802-2017·2017-08-09

    Stryker Neurovascular Recalls Stroke Fast Packs Due to Labeling Mismatch

    Stryker Neurovascular is recalling 48 Stroke Fast Packs because the pre-printed carton sleeve contents did not match the physical items inside.

    Product
    Stroke Fast Pack(TM) Trevo XP ProVue Retriever 6 x 25, AXS Catalyst 060x132CM - US, EXCELSIOR XT 27 MICROCATHETER, UPN M0033PK62523001 ST 150
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3338-2017·2017-08-09

    Planetary Herbals Ginseng Classic Recalled Due to Coliform Growth

    Threshold Enterprises Ltd is recalling Planetary Herbals Ginseng Classic tablets because they were released before quality control testing confirmed negative results for coliform growth.

    Product
    Planetary Herbals Ginseng Classic; Classic Chinese Energizer 710 mg; 60 and 120 UPC 0 21078 10215 1 tablet bottles; 60 count - UPC 0 21078 10214 4; Product code PF0214 120 count - UPC 0 21078 10215; Product code PR0215.
    Category
    Food
    Distribution
    7 states
  • LowFDA (Drugs)·D-1039-2017·2017-08-09

    Teva Recalls Albuterol Sulfate Inhalation Solution Due to Impurities

    Teva Pharmaceuticals USA is recalling Albuterol Sulfate Inhalation Solution because high levels of a related compound were detected.

    Product
    Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton, Rx only, Mfd. for: Watson Laboratories, Inc., Corona, CA 92880; Mfd. by: Cipla Ltd., Verna, Goa INDIA, NDC 0591-3467-53.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowUSDA FSIS·090-2017·2017-08-09

    Corn Maiden Foods Recalls Ready-to-Eat Beef Pies Due to Misbranding

    Corn Maiden Foods is recalling ready-to-eat beef pies because they contain undeclared monosodium glutamate (MSG). No adverse reactions have been reported.

    Product
    Corn Maiden Foods, Inc. — Corn Maiden Foods, Inc. Recalls Ready-to-Eat Beef Products Due To Misbranding
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·17V495000·2017-08-08

    BMW Recalls 2012-2013 X3 and M6 Models for Air Bag Defect

    BMW is recalling 2012-2013 X3 and 2013 M6 vehicles because a defective driver's air bag inflator could cause metal fragments to strike occupants in a crash.

    Product
    BMW — BMW X3, M6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V496000·2017-08-08

    Dodge Charger and Challenger Recall for Engine Oil Cooler Hose Failure

    Chrysler is recalling 2017 Dodge Charger and Challenger vehicles with Hellcat engines because engine oil cooler hoses may fail, causing rapid oil loss and increased crash or fire risk.

    Product
    DODGE — DODGE CHARGER, CHALLENGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17E045000·2017-08-08

    Hickory Springs Recalls CE White Convertible School Bus Seats

    Hickory Springs is recalling CE White Convertible School Bus Seats due to inadequate padding on D-ring mounting studs, which may increase injury risk in rear-end collisions.

    Product
    SEATS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17201·2017-08-08

    NVIDIA Recalls European Plug Heads for Power Adaptors Due to Shock Hazard

    NVIDIA is recalling European plug heads for SHIELD power adaptors because they can break and expose metal prongs, posing an electric shock hazard.

    Product
    European plug heads for NVIDIA SHIELD™ power adaptors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·17203·2017-08-08

    Polaris Recalls Scrambler All-Terrain Vehicles Due to Throttle Switch Failure

    Polaris is recalling 2,800 Scrambler XP 1000 ATVs because the throttle release switch can fail, posing a crash hazard. Consumers should stop using the vehicles and contact Polaris for a free repair.

    Product
    Polaris Scrambler all-terrain vehicle (ATVs)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·089-2017·2017-08-07

    Good Food Concepts Recalls Raw Beef Products Due To E. Coli O26 Contamination

    Good Food Concepts is recalling approximately 1,290 pounds of raw beef products because they may be contaminated with E. coli O26.

    Product
    Good Food Concepts, LLC — Good Food Concepts, LLC. Recalls Beef Products Due To Possible E. Coli O26 Contamination
    Category
    Food
    Distribution
    2 states
  • HighCPSC·17761·2017-08-07

    Firewood Recalls Vaporizers Due to Fire Hazard

    Firewood is recalling about 400 Firewood 4 vaporizers because an electrical short can cause the battery to catch fire. No injuries have been reported.

    Product
    Vaporizers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·17E044000·2017-08-07

    K&N Recalls Powersports Oil Filters for Leak Risk

    K&N Engineering is recalling specific Powersports Oil Filters that may leak oil onto the rear tire or brake, increasing crash risk.

    Product
    ENGINE AND ENGINE COOLING:ENGINE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·088-2017·2017-08-05

    Hahn Brothers Recalls Ready-to-Eat Ham for Undeclared Malted Barley Allergen

    Hahn Brothers is recalling 115,773 pounds of ready-to-eat ham products because they contain malted barley, an allergen not listed on the label.

    Product
    Hahn Brothers, Inc. Recalls Ready-To-Eat Ham Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·17V491000·2017-08-04

    Jaguar Recalls One 2017 F-PACE for Fuel Pump Bolt Defect

    Jaguar is recalling one 2017 F-PACE because a fuel pump bolt may be too long, causing a fuel leak that increases fire risk.

    Product
    JAGUAR — JAGUAR F-PACE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V494000·2017-08-04

    Trail King Recalls 2012-2014 Gooseneck Trailers Due to Pivot Plate Defect

    Trail King is recalling 2012-2014 gooseneck trailers because a short pivot plate reinforcement may crack, causing the trailer deck to disconnect and increasing crash risk.

    Product
    TRAIL KING — TRAIL KING GOOSENECK TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V487000·2017-08-03

    GM Recalls 2017 Silverado and Sierra Trucks for Missing Child Seat Instructions

    General Motors is recalling 2017 Chevrolet Silverado 1500 and GMC Sierra 1500 trucks because the owner's manual may lack instructions for child restraint anchorage systems.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO 1500, SIERRA 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2865-2017·2017-08-02

    Huson Valley Farms Recalls Roasted Pinenuts Due to Listeria Contamination

    Huson Valley Farms is recalling roasted pinenuts because Listeria monocytogenes was found on food contact surfaces. The product was distributed across multiple US states and British Columbia.

    Product
    Pinenuts-Medium-Roasted 70PIGN02
    Category
    Food
    Distribution
    19 states

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