The Recall Desk

Archive

June 2017 recalls

758 recalls were announced in June 2017.

What the numbers show

Critical
27
Severe
157
High
246
Moderate
293
Low
35

Of the 758 recalls this month scored against our rubric, 4% are Critical, 21% are Severe.

Which agencies issued them

601–700 of 758

  • ModerateFDA (Devices)·Z-2313-2017·2017-06-14

    Cook Medical Recalls Endoscopic Curved Needles Due to Reprocessing Instruction Deficiencies

    Cook Medical is voluntarily recalling 725 units of endoscopic curved needles because the reprocessing instructions do not provide sufficient detail for proper cleaning and sterilization.

    Product
    Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2307-2017·2017-06-14

    Arrow International Recalls Hemodialysis Catheterization Kits

    Arrow International Inc is recalling specific hemodialysis catheterization kits due to a lack of clinical data supporting the antimicrobial surface's effectiveness in preventing infections.

    Product
    ARROWg+ard Blue You-Bend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The Arrow(r) CVC is indicated to provide short-term ( < 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2319-2017·2017-06-14

    Nexstim eXima NBS System Software Recalled for File Duplication Defect

    Nexstim PLC is recalling 11 units of the eXima NBS System due to a software defect that may generate duplicate files.

    Product
    Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-2321-2017·2017-06-14

    Hill Country Fare Bread Recalled Due to Presence of Rubber

    HEB Retail Support Center is recalling Hill Country Fare and Good brand breads due to the presence of rubber in the product.

    Product
    Hill Country Fare Thin Sandwich UPC 4122046090; Hill Country Fare Extra Thin Sandwich UPC 4122063420; Good Thin Bread; Good Bread Texas Toast; Clear Prison This; Clear Prison X-Thin all units 24 oz per bag
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2310-2017·2017-06-14

    Cook Medical Recalls Willscher Vas Reapproximator Sets Due to Reprocessing Instructions

    Cook Medical is voluntarily recalling Willscher Vas Reapproximator Sets because the reprocessing instructions lack sufficient detail for proper cleaning, disinfection, and sterilization.

    Product
    Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2323-2017·2017-06-14

    HEB White Wheat Bread Recalled Due to Rubber Presence

    HEB is recalling White Wheat Bread and Texas Toast because rubber was found in the product. Consumers should check their bags for the specific best-by date.

    Product
    White Wheat Bread and White Wheat Texas Toast all units 24 oz per bag
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2220-2017·2017-06-14

    Iba Dosimetry Recalls Large Stealth Chamber Dosimeters for Measurement Deviations

    Iba Dosimetry is recalling 110 Large Stealth Chambers because they may show measurement deviations and geometric shadowing when used as reference detectors.

    Product
    Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2311-2017·2017-06-14

    Cook Medical Recalls Willscher Vas Skewers Due to Insufficient Reprocessing Instructions

    Cook Medical is voluntarily recalling Willscher Vas Skewers because the provided instructions do not contain sufficient detail for proper cleaning, disinfection, and sterilization.

    Product
    Willscher Vas Skewers, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2324-2017·2017-06-14

    HEB White Rice Recalled in Texas Due to Rubber Presence

    HEB Retail Support Center is recalling HEB White rice in Texas because rubber was found in the product. Consumers should stop using the affected 24 oz bags.

    Product
    HEB White RT UPC 4122035774 and HEB ST White UPC 4122088001 all units 24 oz per bag
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0889-2017·2017-06-14

    Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

    Qualgen is recalling Estradiol 25 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 1,153 pellets distributed nationwide.

    Product
    Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only. Rx Only ,Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-025-01,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2320-2017·2017-06-14

    Denali Moose Tracks Cheesecake Recalled for Incorrect Peanut Allergen Labeling

    The Father's Table, LLC is recalling Denali Original Moose Tracks Cheesecake because the rear label is for a different product and lacks a peanut allergen declaration.

    Product
    Denali "Original" Moose Tracks Cheesecake, Net Wt. 18 oz (510g). Black plastic base with clear plastic dome. Back label includes nutrition labeling for Pumpkin Swirl Cheesecake. Manufactured by The Father's Table, LLC
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0896-2017·2017-06-14

    Qualgen Estradiol Pellets Recalled for Quality Assurance Deviations

    Qualgen is recalling Estradiol 6 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 4,815 pellets distributed nationwide.

    Product
    Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by; Qualgen 14844 Bristol Park Blvd. Edmond, OK 73013 NDC: 69761-006-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0893-2017·2017-06-14

    Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

    Qualgen is recalling Estradiol 15 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 6,227 units distributed nationwide.

    Product
    Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles. Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-015-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2325-2017·2017-06-14

    HEB Texas Toast and X-Thin Recalled for Rubber Presence

    HEB is recalling Texas Toast and X-Thin products due to the presence of rubber. Consumers should check their bags for the specified UPCs and best-by dates.

    Product
    HEB Texas Toast UPC 4122062888 and HEB X-Thin UPC 4122084868 all units 24 oz per bag
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2251-2017·2017-06-14

    Teleflex Recalls Pediatric Nasal Cannulas Due to Incorrect Labeling

    Teleflex Medical is recalling 1,150 Hudson RCI Pediatric Nasal Cannulas because the box label says 'Pediatric' while the insert says 'Adult'.

    Product
    Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Devices)·Z-2320-2017·2017-06-14

    Nexstim Navigated Brain Stimulation System Software Defect Recall

    Nexstim PLC is recalling 21 units of the Navigated Brain Stimulation System due to a software defect that may generate duplicate files.

    Product
    NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0886-2017·2017-06-14

    Dr. Reddy's Recalls Zenatane Capsules for Low Dissolution

    Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because some lots failed to meet dissolution specifications.

    Product
    ZENATANE — ZENATANE (ISOTRETINOIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2315-2017·2017-06-14

    Cook Medical Recalls LapSac Introducer Sets Due to Insufficient Reprocessing Instructions

    Cook Medical is voluntarily recalling 335 LapSac Introducer Sets because the provided reprocessing instructions lack sufficient detail for proper cleaning, disinfection, and sterilization.

    Product
    LapSac Introducer Set, Bag, Extraction, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2312-2017·2017-06-14

    Cook Medical Recalls Willscher Vas Reapproximator Plates Due to Reprocessing Instructions

    Cook Medical is voluntarily recalling Willscher Vas Reapproximator Plates because the reprocessing instructions lack sufficient detail for cleaning, disinfection, and sterilization.

    Product
    Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0895-2017·2017-06-14

    Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

    Qualgen is recalling Estradiol 10 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 5,260 pellets distributed nationwide.

    Product
    Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only , For Subcutaneous Use Only Rx Only Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-010-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2322-2017·2017-06-14

    Hill Country Fare Wheat Bread Recalled for Rubber Presence

    HEB is recalling Hill Country Fare and Good Bread wheat bread products due to the presence of rubber in the product.

    Product
    Hill Country Fare Wheat Sandwich UPC 4122078985; Good Bread Wheat UPC 4122018146; Clear Bag Wheat; all units 24 oz per bag
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0891-2017·2017-06-14

    Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

    Qualgen is recalling Estradiol 20 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 4,468 pellets distributed nationwide.

    Product
    Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-020-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2309-2017·2017-06-14

    Beekley Medical Mammography Skin Markers Recalled for Mislabeling

    Beekley Corporation is recalling 0-SPOT Mammography Skin Markers because they were mislabeled with A-SPOT labels. The recall affects 6,032 units distributed in the US and Canada.

    Product
    Beekley Medical 0-SPOT Mammography Skin Markers REF 652
    Category
    Medical Device
    Distribution
    9 states
  • LowFDA (Devices)·Z-2252-2017·2017-06-14

    Argon Medical Recalls Arterial Access Needles Due to Packaging Defect

    Argon Medical Devices is recalling specific arterial access needles due to a potential packaging defect involving unsealed pouches.

    Product
    Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 cm x 19G AMC/4 Usage: Argon Arterial Access Needles are designed to provide vascular access for the percutaneous introduction…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2316-2017·2017-06-14

    MedTest DX Assayed Human Multi Sera Control Recall for Out-of-Spec Values

    Medtest Holdings, Inc. is recalling MedTest DX Assayed Human Multi Sera Control Level 1 and Level 2 because control values are outside of specification.

    Product
    MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and black plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. HNC200 " Sml amber glass vials with rubber stopper and green…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0897-2017·2017-06-14

    Hetero USA Recalls Acyclovir Tablets Due to Human Hair Presence

    Hetero USA Inc. is recalling 13,692 bottles of Acyclovir 800 mg tablets because human hair was found melded into the tablets.

    Product
    ACYCLOVIR — ACYCLOVIR (ACYCLOVIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2221-2017·2017-06-14

    Acumedia Urea Base Agar Recalled for Incorrect Storage Labeling

    Acumedia is recalling Urea Base Agar because the label listed an incorrect storage temperature range.

    Product
    Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production
    Category
    Medical Device
    Distribution
    1 state
  • SevereUSDA FSIS·071-2017·2017-06-13

    Joseph Seviroli Inc. Recalls Beef Ravioli Due to Undeclared Milk Allergen

    Joseph Seviroli Inc. is recalling approximately 114,409 pounds of beef ravioli products because they contain undeclared milk, a known allergen.

    Product
    Seviroli Foods, LLC — Joseph Seviroli Inc. Recalls Beef Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    4 states
  • SevereUSDA FSIS·070-2017·2017-06-13

    OFD Foods Recalls Beef Hash Due to Possible Rubber Contamination

    OFD Foods is recalling Mountain House freeze-dried beef hash due to possible rubber contamination. No illnesses have been reported.

    Product
    OFD Foods LLC — OFD Food, LLC. Recalls Beef Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·17V376000·2017-06-13

    Dodge Grand Caravan Recalled for Air Bag Wiring Defect

    Chrysler is recalling 2011-2012 Dodge Grand Caravan vehicles because the driver's air bag wiring may chafe and short circuit, causing unexpected deployment.

    Product
    DODGE — DODGE GRAND CARAVAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17176·2017-06-13

    Trango Recalls Vergo Belay Devices Due to Fall and Injury Hazards

    Trango is recalling about 2,600 Vergo belay devices because the handle can loosen, causing the braking system to malfunction and posing fall hazards to climbers.

    Product
    Vergo belay devices (climbing tool)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·17177·2017-06-13

    Noble House Recalls Dining Chairs Due to Leg Breakage and Fall Hazard

    Noble House is recalling about 3,300 dining chairs because the legs can break, posing a fall hazard. Consumers should stop using the chairs and contact the company for a free repair kit.

    Product
    Dining chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·069-2017·2017-06-10

    Packer Avenue Foods Recalls Chicken Salad for Undeclared Milk Allergen

    Packer Avenue Foods is recalling ready-to-eat chicken salad because it may contain undeclared milk, a known allergen. The products were distributed to five states.

    Product
    Packer Avenue Foods, Inc — Packer Avenue Foods, Inc. Recalls Ready-To-Eat Chicken Salad Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    5 states
  • CriticalUSDA FSIS·065-2017·2017-06-09

    Conagra Recalls Spaghetti and Meatball Products for Undeclared Milk Allergen

    Conagra Brands is recalling approximately 717,338 pounds of spaghetti and meatball products because they contain undeclared milk, a known allergen.

    Product
    Hometown Food Company — Conagra Brands, Inc. Recalls Spaghetti and Meatball Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·066-2017·2017-06-09

    CC Kitchens Recalls Meat and Poultry Salads Due to Listeria Risk

    CC Kitchens is recalling approximately 2,415 pounds of ready-to-eat meat and poultry salad products due to possible Listeria monocytogenes contamination.

    Product
    CC Kitchens, LLC Recalls Meat and Poultry Salad Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    4 states
  • SevereUSDA FSIS·060-2017·2017-06-09

    Advance Pierre Foods Recalls Chicken Tenders for Undeclared Milk Allergen

    Advance Pierre Foods is recalling approximately 54,699 pounds of chicken tenders and breaded dark meat chicken products due to misbranding and undeclared milk allergens.

    Product
    AdvancePierre Foods, Inc. — Advance Pierre Foods, Inc. Recalls Chicken Tenders and Breaded Dark Meat Chicken Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    6 states
  • SevereUSDA FSIS·067-2017·2017-06-09

    Tyson Recalls Breaded Chicken Products Due to Undeclared Milk Allergen

    Tyson Foods is recalling approximately 2.5 million pounds of ready-to-eat breaded chicken products because they may contain undeclared milk, a known allergen.

    Product
    Tyson Foods, Inc. — Tyson Foods Inc. Recalls Ready-To-Eat Breaded Chicken Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·068-2017·2017-06-09

    Gourmet Boutique Recalls Breaded Chicken Products Due to Undeclared Milk Allergen

    Gourmet Boutique LLC is recalling approximately 294,744 pounds of ready-to-eat breaded chicken products because they may contain undeclared milk, a known allergen.

    Product
    Gourmet Boutique, LLC — Gourmet Boutique LLC Recalls Ready-To-Eat Breaded Chicken Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·064-2017·2017-06-09

    Pork King Sausage Recalls Raw Sausage Links for Undeclared Milk Allergen

    Pork King Sausage, Inc. is recalling approximately 44,035 pounds of raw sausage link products because they may contain undeclared milk, a known allergen.

    Product
    Pork King Sausage, Inc. — Pork King Sausage, Inc. Recalls Raw Sausage Link Products Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    13 states
  • HighNHTSA·17V371000·2017-06-09

    Chrysler Recalls 2017 Pacifica Plug-In Hybrids for Inverter Defect

    Chrysler is recalling 2017 Pacifica Plug-In Hybrids because a power inverter defect may cause the vehicle to stop moving, increasing crash risk.

    Product
    CHRYSLER — CHRYSLER PACIFICA PLUG-IN HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·062-2017·2017-06-08

    Aldon Food Recalls Chicken Salad Due to Undeclared Milk Allergen

    Aldon Food Corporation is recalling approximately 18,570 pounds of chicken salad products because they contain undeclared milk, a known allergen.

    Product
    Aldon Food Corporation — Aldon Food Corp. Recalls Chicken Salad Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    9 states
  • SevereUSDA FSIS·063-2017·2017-06-08

    Water Lilies Recalls Breaded Chicken for Undeclared Milk Allergen

    Water Lilies Food Inc. is recalling approximately 4,335 pounds of ready-to-eat breaded chicken products because they may contain undeclared milk, a known allergen.

    Product
    Water Lilies Food, LLC — Water Lilies Food Inc., Recalls Ready-To-Eat Breaded Chicken Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    10 states
  • SevereUSDA FSIS·061-2017·2017-06-08

    Maid-Rite Recalls Beef Products Due to Undeclared Milk Allergen

    Maid-Rite Specialty Foods is recalling approximately 174,000 pounds of beef products because they contain undeclared milk, a known allergen.

    Product
    Maid-Rite Specialty Foods, Inc — Maid-Rite Specialty Foods, LLC. Recalls Beef Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·17V369000·2017-06-08

    Supreme Signature Van and Kold King Recall for Rear Reflector Height

    Supreme is recalling 2007-2017 Signature Van and Kold King vehicles because rear reflex reflectors may be mounted too high, failing federal safety standards and increasing crash risk.

    Product
    SUPREME — SUPREME SIGNATURE VAN, KOLD KING
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17175·2017-06-08

    GT Mountain Bicycles Recalled Due to Handlebar Crack Hazard

    Cycling Sports Group is recalling about 1,000 GT mountain bicycles because the handlebars can crack, posing a fall hazard to consumers.

    Product
    GT mountain bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2264-2017·2017-06-07

    FDA Recalls Baked Kippered Salmon for Listeria Contamination Risk

    The Smokehouse of New York is recalling refrigerated baked kippered salmon due to potential Listeria monocytogenes contamination found during FDA inspection.

    Product
    Refrigerated, ready-to-eat BAKED KIPPERED SALMON, in 8 oz. vacuum packages, UPC 0200000615659 -- KEEP REFRIGERATED 38 DEGREES or Below --- THE SMOKEHOUSE OF NY , MAMARONECK , NY 10543
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-2263-2017·2017-06-07

    FDA Recalls Sliced Hot Smoked Sable and Black Cod for Listeria Risk

    The Smokehouse of New York is recalling refrigerated, ready-to-eat sliced hot smoked sable and black cod due to potential Listeria monocytogenes contamination found during FDA sampling.

    Product
    Refrigerated, ready-to-eat, sliced, hot SMOKED SABLE, BLACK COD, in 8 oz. vacuum packages, UPC 0200000810801 -- KEEP REFRIGERATED - 38 DEGREES F or Below --- THE SMOKEHOUSE OF NY , MAMARONECK , NY 10543
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-2256-2017·2017-06-07

    FDA Recalls Scottish Smoked Salmon Due to Listeria Contamination Risk

    The Smokehouse of New York is recalling refrigerated, ready-to-eat Scottish smoked salmon because FDA testing found Listeria monocytogenes in the facility.

    Product
    Refrigerated, ready-to-eat, sliced, cold smoked, IMPORTED SCOTTISH SMOKED, HAND SLICED PACKS, in 4 oz., 8 oz., & whole sides in vacuum packages, UPC 0200000620271 -- KEEP REFRIGERATED, STORE AT 38 DEGREES F or Below --- THE SMOKEHOUSE OF NY, MAMARONECK, NY 10543
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-2276-2017·2017-06-07

    Robin Hood Flour Recalled for Possible E. coli O121 Contamination

    Bedessee Imports, Inc. is recalling specific lots of Robin Hood flour due to possible E. coli O121 contamination. Consumers should check their pantry for the affected lot codes.

    Product
    Robin Hood ENRICHED & PRE-SIFTED ALL PURPOSE flour ORIGINAL, UPC 0 59000 01632 0, 1 kg
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-2257-2017·2017-06-07

    FDA Recalls Cold Smoked Salmon for Listeria Contamination Risk

    The Smokehouse of New York is recalling cold smoked salmon products due to potential Listeria monocytogenes contamination found during FDA inspection.

    Product
    Refrigerated, ready-to-eat, sliced, cold smoked, PASTRAMI SMOKED SALMON, HAND SLICED PACKS, in 4 oz., 8 oz., & whole sides in vacuum packages -- KEEP REFRIGERATED, STORE AT 38 DEGREES F or Below --- THE SMOKEHOUSE OF NY, MAMARONECK, NY 10543
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-2255-2017·2017-06-07

    FDA Recalls Cold Smoked Irish Salmon for Listeria Risk

    The Smokehouse of New York is recalling Double Smoked Irish Salmon due to potential Listeria monocytogenes contamination found during FDA inspection.

    Product
    Refrigerated, ready-to-eat, sliced, cold smoked, DOUBLE SMOKED IRISH SALMON, HAND SLICED PACKS, in 4 oz., 8 oz., & whole sides in vacuum packages, UPC 0200000519438 -- KEEP REFRIGERATED, STORE AT 38 DEGREES F or Below --- THE SMOKEHOUSE OF NY, MAMARONECK, NY 10543
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-2261-2017·2017-06-07

    FDA Recalls Hot Smoked Sturgeon for Listeria Contamination Risk

    The Smokehouse of New York is recalling refrigerated, ready-to-eat hot smoked sturgeon packs due to potential Listeria monocytogenes contamination found during FDA inspection.

    Product
    Refrigerated, ready-to-eat, hot SMOKED STURGEON, HAND SLICED PACKS, 4 OZ. in vacuum packages, UPC 0200000309800 -- KEEP REFRIGERATED -- STORE AT 38 DEGREES F or Below --- THE SMOKEHOUSE OF NY , MAMARONECK, NY 10543
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-2259-2017·2017-06-07

    Cold Smoked Salmon Chopped Trimmings Recalled for Listeria Risk

    The Smokehouse of New York is recalling refrigerated, ready-to-eat, sliced, cold smoked salmon chopped trimmings due to potential Listeria monocytogenes contamination.

    Product
    Refrigerated, ready-to-eat, sliced, cold smoked salmon, CHOPPED TRIMMINGS in 8 oz. vacuum packages, UPC 0200000406622 -- KEEP REFRIGERATED, STORE AT 38 DEGREES F or Below --- THE SMOKEHOUSE OF NY, MAMARONECK, NY 10543
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-2258-2017·2017-06-07

    FDA Recalls Cold Smoked Gravlax Salmon Due to Listeria Contamination Risk

    The Smokehouse of New York is recalling refrigerated, ready-to-eat gravlax salmon because FDA testing found Listeria monocytogenes in the facility.

    Product
    Refrigerated, ready-to-eat, sliced, cold smoked, GRAVLAX SALMON, HAND SLICED PACKS, in 4 oz., 8 oz., & whole sides in vacuum packages, UPC 0200000608415 -- KEEP REFRIGERATED, STORE AT 38 DEGREES F or Below --- THE SMOKEHOUSE OF NY, MAMARONECK, NY 10543
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-2265-2017·2017-06-07

    Smokehouse of New York Recalls Smoked Whitefish Salad for Listeria Risk

    The Smokehouse of New York is recalling refrigerated smoked whitefish salad due to potential Listeria monocytogenes contamination found during FDA inspection.

    Product
    Refrigerated, ready-to-eat, sliced, hot SMOKED WHITEFISH SALAD in 5 Lb. plastic containers, labeled in part, ***SMOKED WHITEFISH SALAD*** KEEP REFRIGERATED 38 DEGREES ***".
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-2254-2017·2017-06-07

    FDA Recalls Cold Smoked Norwegian Salmon for Listeria Contamination Risk

    The Smokehouse of New York is recalling refrigerated, ready-to-eat, cold smoked Norwegian salmon due to potential Listeria monocytogenes contamination found during FDA sampling.

    Product
    Refrigerated, ready-to-eat, sliced, cold smoked, SMOKED NORWEGIAN SALMON in 4 oz., 8 oz., & whole sides in vacuum packages -- KEEP REFRIGERATED, STORE AT 38 DEGREES F or Below --- THE SMOKEHOUSE OF NY, MAMARONECK, NY 10543
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Devices)·Z-2151-2017·2017-06-07

    Abbott Absorb Bioresorbable Vascular Scaffold Recalled for Elevated Adverse Event Rates

    Abbott Vascular is recalling the Absorb Bioresorbable Vascular Scaffold (BVS) System in Australia due to studies showing higher rates of major adverse events, including myocardial infarction and scaffold thrombosis, compared to metallic stents.

    Product
    Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb BVS is a temporary scaffold indicated for improving coronary luminal diameter that will eventually resorb and potentially facilitate normalization of vessel function in patients with ischemic heart…
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Food)·F-2262-2017·2017-06-07

    FDA Recalls Smoked Whitefish Due to Listeria Contamination Risk

    The Smokehouse of New York is recalling refrigerated smoked whitefish because FDA testing found Listeria monocytogenes in the facility.

    Product
    Refrigerated, ready-to-eat, sliced, whole, split, hot SMOKED WHITEFISH in vacuum packages, labeled in part ,*** SMOKED WHITEFISH WHOLE *** -- KEEP REFRIGERATED 38 DEGREES F or Below --- THE SMOKEHOUSE OF NY , MAMARONECK , NY 10543
    Category
    Food
    Distribution
    7 states
  • SevereNHTSA·17V368000·2017-06-07

    Porsche Recalls Panamera and Cayenne Models for Engine Stall Risk

    Porsche is recalling specific 2010-2012 Panamera and 2011 Cayenne vehicles because loose camshaft controllers may cause the engine to stall, increasing crash risk.

    Product
    PORSCHE — PORSCHE PANAMERA S, PANAMERA 4S, PANAMERA TURBO, PANAMERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0877-2017·2017-06-07

    SCA Pharmaceuticals Recalls Cefazolin Sodium Bags Due to Leaking

    SCA Pharmaceuticals is recalling 70 bags of cefazolin sodium due to leaks at the seam, which compromises the product's sterility.

    Product
    ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total Approximate Volume 115 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0524-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0879-2017·2017-06-07

    SCA Pharmaceuticals Recalls Phenylephrine Injectable Bags Due to Leaking

    SCA Pharmaceuticals is recalling 30 bags of Phenylephrine HCL injectable solution because the bags are leaking at the seam, compromising sterility.

    Product
    PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0810-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2253-2017·2017-06-07

    Green Chile Foods Recalls Bean and Cheese Burritos for Listeria Risk

    Green Chile Foods is voluntarily recalling specific bean and cheese burritos because they may be contaminated with Listeria monocytogenes.

    Product
    Bean & Cheese Burrito with Monterey Jack, Salsa, Green Chile, Rice, & Serrano Peppers!, Item # 484, Case UPC 8 33425 00086 3, Item UPC 8 83350 02411 3. Unit Size 8oz. Packaged in Paper Wrap sealed with Item Label, 12 units per case. Frozen or refrigerated.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-2289-2017·2017-06-07

    Mikawaya Recalls Mochi Ice Cream Due to Potential Peanut Allergen

    Mikawaya is recalling Mochi Ice Cream Chocolate Chocolate because it may contain Chocolate Peanut Butter Ice Cream, posing a risk to individuals with peanut allergies.

    Product
    Mikawaya Mochi Ice Cream Chocolate Chocolate, 6-1.5oz (43g) pieces, Net Wt. 9.1oz (258g), UPC 070934990609, 24 boxes/case
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-2252-2017·2017-06-07

    Green Chile Burritos Recalled for Potential Listeria Contamination

    Green Chile Foods is recalling specific burritos due to potential Listeria monocytogenes contamination. Consumers should check their freezers and refrigerators for the affected product.

    Product
    Bean & Cheddar with Salsa, FIRE ROASTED Corn & Red Bell Pepper Burrito. MILD, Net WT 7oz, Item # 886, Case UPC 833425001464, Item UPC 8 33425 00336 9. Packaged in Paper Wrap sealed with Item Label, 12 units per case. Frozen or refrigerated.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-2288-2017·2017-06-07

    Northern Fisheries Recalls Tuna Steaks Due to High Histamine Levels

    Northern Fisheries Ltd. is recalling frozen Tuna King Tuna Steaks because histamine levels were found above 50ppm. The product was distributed in Maryland, Ohio, and Rhode Island.

    Product
    Tuna King Tuna Steaks 10 oz.. ,10 lb Box. Frozen UPC Codes: 8158380206764
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-2260-2017·2017-06-07

    FDA Recalls Smoked Trout Fillets Due to Listeria Contamination Risk

    The Smokehouse of New York is recalling refrigerated smoked trout fillets because FDA testing found Listeria monocytogenes in the facility.

    Product
    Refrigerated, ready-to-eat, sliced, hot SMOKED TROUT fillets in 8 oz. vacuum packages -- KEEP REFRIGERATED-- 38 DEGREES F or Below --- THE SMOKEHOUSE OF NY, MAMARONECK, NY 10543
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0871-2017·2017-06-07

    SCA Pharmaceuticals Recalls Morphine Sulfate Injectable Bags Due to Leaking

    SCA Pharmaceuticals is recalling 56 bags of morphine sulfate in 0.9% Sodium Chloride injectable because the bags are leaking at the seam, compromising sterility.

    Product
    morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100 mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0870-2017·2017-06-07

    SCA Pharmaceuticals Recalls Morphine Sulfate Injectable Bags Due to Leaking

    SCA Pharmaceuticals is recalling 80 bags of morphine sulfate injectable solution because the bags are leaking at the seam, compromising sterility.

    Product
    morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2290-2017·2017-06-07

    La Nica Honduran Cheese Recalled for Listeria Contamination

    La Nica Products is recalling 6,000 lbs of Queso Hondureno cheese due to Listeria monocytogenes contamination. The product was distributed in California.

    Product
    Queso Hondureno, Queso Duro Blando - Honduran Cheese, Dry Hard Cheese; 1 lb 454 g
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0874-2017·2017-06-07

    SCA Pharmaceuticals Recalls Fentanyl Injectable Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling fentanyl citrate injectable bags because they are leaking at the seam, which compromises sterility.

    Product
    fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL, Single Dose Container bag, (Total fentanyl Dose 2,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-203-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0878-2017·2017-06-07

    SCA Pharmaceuticals Recalls Leaking Magnesium Sulfate Injectable Bags

    SCA Pharmaceuticals is recalling 40 bags of Magnesium Sulfate injectable solution due to seam leaks that compromise sterility.

    Product
    MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0737-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0875-2017·2017-06-07

    SCA Pharmaceuticals Recalls Hydrocodone Injectable Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 87 bags of Hydromorphone HCL injectable solution because the bags are leaking at the seam, compromising sterility.

    Product
    HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0876-2017·2017-06-07

    SCA Pharmaceuticals Recalls Leaking Cefazolin Sodium Injectable Bags

    SCA Pharmaceuticals is recalling 240 bags of cefazolin sodium injectable due to seam leaks that compromise sterility.

    Product
    ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 2g, Total Approximate Volume 100 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0522-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0872-2017·2017-06-07

    SCA Pharmaceuticals Recalls Fentanyl Injection Bags Due to Seam Leaks

    SCA Pharmaceuticals is recalling 118 bags of fentanyl injection due to seam leaks that compromise sterility. The product was distributed nationwide in the USA.

    Product
    fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0229-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2291-2017·2017-06-07

    MusclMasster Recalls Al-Er-G Capsules Containing Banned Ephedra Ingredient

    MusclMasster, LLC is recalling Al-Er-G Capsules because they contain ephedra herb, an ingredient banned by the FDA.

    Product
    The Green Herb 100% Natural AL-ER-G, 60 and 150 Capsules, Dietary supplement, This item is packed in a white bottle with a white cap. Each bottle contains 60 or 150 capsules, each capsule is 180 mg of ephedra herb in a 650 mg capsule. Batch#1892; product# 314.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0873-2017·2017-06-07

    SCA Pharmaceuticals Recalls Fentanyl Injection Bags Due to Sterility Concerns

    SCA Pharmaceuticals is recalling 370 bags of fentanyl injection solution because the bags were leaking at the seam, compromising sterility.

    Product
    fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0202-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2283-2017·2017-06-07

    Trident Battered Cod Recalled Due to Potential Plastic Contamination

    Trident Seafoods is recalling frozen Battered Cod Diamonds because they may contain small pieces of plastic.

    Product
    Trident Item # 474568, Irregulars Battered Cod 3 oz Battered Diamonds, food service packages, frozen, Net wt. 10 lbs.
    Category
    Food
    Distribution
    26 states
  • HighFDA (Devices)·Z-2175-2017·2017-06-07

    Philips NMT Patient Cable Recall for Potential Skin Burn Risk

    Philips is recalling NMT Patient Cables used with IntelliVue NMT Modules because a manufacturing defect may cause localized heating and skin burns.

    Product
    NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383)
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-2179-2017·2017-06-07

    GE Healthcare Recalls Patient Steps on RFX, Legacy, and Precision 500D Systems

    GE Healthcare is recalling 2,380 patient steps for RFX, Legacy, and Precision 500D systems because they may detach from the table, posing a fall risk.

    Product
    Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2287-2017·2017-06-07

    Lyrical Foods Mushroom and Ricotta Ravioli Recalled for Missing Garlic Labeling

    Lyrical Foods is recalling Kite Hill Mushroom and Ricotta Ravioli because the ingredient statement fails to list garlic.

    Product
    Kite Hill Mushroom and Ricotta Ravioli; frozen Ravioli made with almond milk ricotta: 9 oz. package. UPC 856624004173 Owned and distributed by Lyrical Foods, Hayward, CA.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-2180-2017·2017-06-07

    Vascular Solutions Recalls Dolphin Inflation Devices Due to Sterile Barrier Defect

    Vascular Solutions, Inc. is recalling 4,110 Dolphin Inflation Devices due to a potential sterile barrier defect that could lead to microbial contamination and infection.

    Product
    Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile inflation device used in cardiovascular procedures to pressurize (inflate) and depressurize (deflate) balloon catheters. The device itself consists of two…
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Food)·F-2247-2017·2017-06-07

    Tyson Recalls Frozen Spinach Quiche Due to Listeria Risk

    Tyson Foods is voluntarily recalling specific lots of frozen Chef Pierre and Sara Lee spinach quiche due to a Listeria monocytogenes contamination risk from an ingredient supplier.

    Product
    Chef Pierre 10 Spinach Quiche, and 6/10 Frozen Quiche, 38 oz. packed in a paper carton, keep frozen
    Category
    Food
    Distribution
    14 states
  • HighFDA (Devices)·Z-2176-2017·2017-06-07

    AbbVie Recalls 673 PEG Kits Due to Sterility Concerns

    AbbVie Inc. is voluntarily recalling 673 PEG kits because they may not be sterile. The recall covers lots distributed nationwide and internationally.

    Product
    AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2217-2017·2017-06-07

    Cardinal Digital Bariatric Scales Recalled Due to Seat Failure Risk

    Cardinal Scale Mfg Co is recalling 975 digital bariatric scales because a seat may fail unexpectedly, posing an injury risk.

    Product
    Cardinal, Digital Bariatric Scale 1) model 6876, Cap 600 and 2) model 6868 Cap 1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2277-2017·2017-06-07

    Trident Multi-Grain Alaskan Cod Recalled for Plastic Contamination

    Trident Seafoods is recalling 12 oz. packages of Multi-Grain Alaskan Cod because they may contain small pieces of plastic.

    Product
    Trident Item # 421048, Multi-Grain Alaskan Cod, Frozen, RETAIL packages, Net wt. 12 oz. UPC 0 28029 21048 4 The retail label is read in parts: "***Trident SEAFOODS***Multi-Grain Alaskan Cod***NET WT. 12 OZ.***". The retail case label is read in parts: "***Trident…
    Category
    Food
    Distribution
    26 states
  • HighFDA (Food)·F-2279-2017·2017-06-07

    Trident Alaska Cod Squares Recalled for Potential Plastic Contamination

    Trident Seafoods is recalling frozen Alaska Cod Squares because they may contain small pieces of plastic.

    Product
    Trident Item # 16595, Alaska Cod Squares 4 oz, raw breaded panko, food service packages, frozen, Net wt. 10 lbs.
    Category
    Food
    Distribution
    26 states
  • HighFDA (Food)·F-2286-2017·2017-06-07

    Choice Products Recalls just Cookie Dough Due to Salmonella Risk

    Choice Products USA, LLC is recalling just Cookie Dough Peanut Butter Chocolate Chip because it was made with flour contaminated with Salmonella.

    Product
    just Cookie Dough Peanut Butter Chocolate Chip, Net Wt 14 oz (397g). Keep Refrigerated.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2248-2017·2017-06-07

    Tyson Recalls Frozen Quiche Products Due to Listeria Risk

    Tyson Foods is voluntarily recalling specific lots of frozen quiche products because an ingredient supplier recalled items due to Listeria monocytogenes.

    Product
    Sara Lee CP Quiche 10 Spinach , 38 oz. packed in a paper carton, keep frozen
    Category
    Food
    Distribution
    14 states
  • HighFDA (Devices)·Z-2198-2017·2017-06-07

    Zimmer Biomet Recalls Reusable Orthopedic Instruments Due to Durability Concerns

    Zimmer Biomet is recalling reusable instruments for knee, hip, trauma, and extremities because their durability characteristics were not established.

    Product
    Reusable instruments in the Knee, Hip, Trauma, and Extremities segments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2171-2017·2017-06-07

    KCI USA Recalls 1000 ml Canisters for Negative Pressure Wound Therapy Systems

    KCI USA is recalling 5,385 cases of 1000 ml canisters for InfoV.A.C. and V.A.C.ULTA systems due to a potential sterile barrier breach.

    Product
    1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). The InfoV.A.C. and V.A.C.ULTA Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, and extended and care settings. They are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2152-2017·2017-06-07

    Hans Pausch Uroview FD Fluoroscopic X-ray System Recalled for Footswitch Safety Issue

    Hans Pausch is recalling 10 Uroview FD fluoroscopic X-ray systems because the footswitch used to activate radiation is part of the safety circuit.

    Product
    Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagnostics, endourology and minimal invasive urology / surgery). The system, which includes a radiologic / urologic treatment table, maybe used…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2174-2017·2017-06-07

    Ethicon Endopath ETS-FLEX Endoscopic Linear Cutter Recalled for Gear Failure Risk

    Ethicon Endo-Surgery Inc is recalling 792 units of the Endopath ETS-FLEX Endoscopic Articulating Linear Cutter due to a risk of pinion gear failure under extreme use cases.

    Product
    Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2215-2017·2017-06-07

    Zimmer Biomet Recalls AFFIXUS Hip Fracture Nail Due to Sizing Defect

    Zimmer Biomet is recalling 33,500 AFFIXUS Hip Fracture Nail units worldwide because certain undersized specifications may prevent the nail from properly engaging with the targeting jig.

    Product
    AFFIXUS Hip Fracture Nail Product Usage: The Hip Fracture Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, interochanteric fractures, high subtrochanteric fractures and combinations of these fractures…
    Category
    Medical Device
    Distribution
    Distributed nationwide

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