The Recall Desk

Archive

May 2018 recalls

1,113 recalls were announced in May 2018.

What the numbers show

Critical
47
Severe
240
High
488
Moderate
304
Low
34

Of the 1,113 recalls this month scored against our rubric, 4% are Critical, 22% are Severe.

1–100 of 1113

  • SevereNHTSA·18V359000·2018-05-31

    Kenworth Recalls 2019 T270 and T370 Trucks for Axle Nut Issue

    PACCAR is recalling 2019 Kenworth T270 and T370 vehicles because over-tightened rear axle nuts may cause bearing failure or fire, increasing crash risk.

    Product
    KENWORTH — KENWORTH T270, T370
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E037000·2018-05-31

    Dorman Front Control Arms Recalled for Potential Steering Loss

    Dorman is recalling specific front control arms where a ball stud may pull through the steering knuckle, causing partial loss of steering.

    Product
    SUSPENSION:FRONT:CONTROL ARM recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V358000·2018-05-31

    GM Recalls 2015-2018 Vehicles for Fuel Pump Fire Risk

    General Motors is recalling specific 2015-2018 GMC, Chevrolet, Buick, and Cadillac vehicles because a fuel pump may detach and cause a leak, increasing fire risk.

    Product
    GMC — GMC, CHEVROLET, BUICK CANYON, MALIBU, ENVISION, ACADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·043-2018·2018-05-31

    Eddy Packing Recalls Smoked Sausage Due to Possible Plastic Contamination

    Eddy Packing Co. is recalling smoked sausage that may contain soft plastic. The company discovered the issue after a customer complaint.

    Product
    Eddy Packing Co., Inc. — Eddy Packing Co., Inc. Recalls Smoked Sausage Product due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • ModerateUSDA FSIS·042-2018·2018-05-31

    Ruiz Recalls Frozen Breakfast Burritos Due to Plastic Contamination

    Ruiz Food Products is recalling 12-count frozen breakfast burritos that may contain white, semi-rigid plastic pieces. No adverse reactions have been reported.

    Product
    Ruiz Food Products, Inc. — Ruiz Food Products, Inc. Recalls 12-Count Frozen Breakfast Burritos due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0821-2018·2018-05-30

    FDA Recalls Rhino 69 Extreme 50000 for Undeclared Tadalafil

    The FDA is recalling Rhino 69 Extreme 50000 capsules because they contain undeclared tadalafil, an unapproved drug with unestablished safety and efficacy.

    Product
    Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc. Chino Hills, CA, 91709-2618, UPC Code: 718122071128
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V355000·2018-05-30

    Nissan Recalls 2018 Infiniti QX30 for Seat Belt Anchorage Defect

    Nissan is recalling 2018 Infiniti QX30 vehicles because the right-hand lower seat belt anchorage bolt may be incorrectly installed, increasing injury risk in a crash.

    Product
    INFINITI — INFINITI QX30
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1480-2018·2018-05-30

    FDA Recalls Nature's Only Choice B17 Apricot Extract Dietary Supplement

    Nature's Only Choice is recalling B17 Bitter Raw Apricot Extract Amygdalin dietary supplements because the product is considered an unapproved new drug.

    Product
    Nature's Only Choice B17 BITTER RAW APRICOT EXTRACT AMYGDALIN Dietary Supplement 100 Capsules
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0827-2018·2018-05-30

    Fresenius Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns

    Fresenius Medical Care is recalling 25,356 bags of 0.9% Sodium Chloride Injection due to a lack of assurance of sterility.

    Product
    0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-1479-2018·2018-05-30

    Morgan Foods Recalls Great Value Gluten Free Tomato Soup for Undeclared Milk

    Morgan Foods, Inc. is voluntarily recalling Great Value Gluten Free Tomato Condensed Soup because it contains undeclared milk, a major allergen.

    Product
    Great Value Gluten Free Tomato Condensed Soup, 10.5 oz, Number 1 Can, Two formats shipped: 8 cans per tray and 12 cans per tray
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1490-2018·2018-05-30

    Shawnee Milling Recalls Self-Rising Flour for Metal Fragment Risk

    Shawnee Milling Company is recalling 1,350 bags of self-rising flour in four states due to potential metal fragments.

    Product
    Hilltop Hearth Self-Rising Flour, Katy s Kitchen Self-Rising Flour, Springwell A1 Flour all packaged in 50 pound paper bags
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0834-2018·2018-05-30

    Ideaz Recalls Screamin' Hot Pain Gel Due to Benzene Levels

    Ideaz LLC is recalling Screamin' Hot Pain Relieving Gel because it was manufactured with benzene levels exceeding FDA limits.

    Product
    screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80072 4; b) 5 oz. (141g) tubes, UPC 7 50263 80007 6; and c) 16 oz. (454g) bottles, UPC 7 50263 80076 2; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-80
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0822-2018·2018-05-30

    Mylan Recalls Loxapine Capsules Due to Cross-Contamination Risk

    Mylan Institutional, Inc. is recalling Loxapine Capsules 25 mg due to cGMP violations that create a risk of cross-contamination.

    Product
    Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-902-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1901-2018·2018-05-30

    LivaNova Recalls Sorin Stockert Heater-Cooler Systems Due to Suspected Microbial Contamination

    LivaNova USA is recalling 2,408 Sorin Stockert Heater-Cooler System 3T units because they are suspected of microbial contamination and may contain visible biofilm.

    Product
    Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Drugs)·D-0835-2018·2018-05-30

    Ideaz Recalls Screamin' Menthol Pain Gel Due to Benzene Levels

    Ideaz Llc is recalling Screamin' Menthol Pain Relieving Gel because it contains benzene levels exceeding FDA limits.

    Product
    screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80062 5; b) 5 oz. (141g) tubes, UPC 7 50263 80006 9; and c) 16 oz. (454g) bottles, UPC 7 50263 80066 3; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-801
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1491-2018·2018-05-30

    Flowers Bakery Recalls Hot Dog Buns for Undeclared Milk and Soy

    Flowers Bakery of Montgomery LLC is recalling 155 cases of Hot Dog Buns due to undeclared milk and soy allergens. The product was distributed in Florida, Illinois, Missouri, and Texas.

    Product
    Hot Dog Buns
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1929-2018·2018-05-30

    Edwards IntraClude Intra-Aortic Occlusion Device Recalled for Potential Leak

    Edwards Lifesciences is recalling 3,052 IntraClude Intra-Aortic Occlusion Devices due to a possible leak at the distal open end of the strain relief.

    Product
    Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100. Designed to occlude the ascending aorta.
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Food)·F-1494-2018·2018-05-30

    Grand Canyon Foods Recalls Prickly Pear Popcorn for Undeclared Allergens

    Grand Canyon Foods is recalling Southwestern Gourmet Prickly Pear Popcorn because it contains Yellow 5 and soy lecithin that were not declared on the label.

    Product
    Southwestern Gourmet Prickly Pear Popcorn Grand Canyon Foods, Phoenix, AZ
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-1896-2018·2018-05-30

    Madison Polymeric Engineering Recalls Endoscopic Cleaning Pads Due to Microbial Contamination

    Madison Polymeric Engineering is recalling First Step Endoscopic Cleaning Pads because they exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

    Product
    First Step Endoscopic Cleaning Pad, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1930-2018·2018-05-30

    Siemens Biograph Horizon PET/CT Systems Recalled for Firmware Issue

    Siemens Medical Solutions is recalling 14 Biograph Horizon PET/CT systems due to a firmware issue that may cause waveform sampling errors during cardiac gating examinations.

    Product
    Biograph Horizon, PET/CT System using VJ10A, VJ10B, VJ20A scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1522-2018·2018-05-30

    Michael's Bakery Gluten Free Chunky Chocolate Product Recalled for Undeclared Pecans

    Michael's Bakery Products is recalling 15 cases of Gluten Free Chunky Chocolate Product because the items contain pecans that are not declared on the label.

    Product
    Gluten Free Chunky Chocolate Product, 20051, Size: 2.0 oz, Case Pack: 168, Net Wt: 21 LBS, UPC 1009606720051
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1921-2018·2018-05-30

    Smith & Nephew Recalls Anthology Hip Stems Due to Manufacturing Defect

    Smith & Nephew is recalling 13 units of Anthology hip prosthesis stems because they were manufactured with an undersized taper length.

    Product
    smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1916-2018·2018-05-30

    Synthes Torque Limiting Handle Recalled Due to Premature Rusting

    Synthes (USA) Products LLC is recalling 50 Torque Limiting Handles because high-carbon ball bearings may rust prematurely, causing functional degradation.

    Product
    Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0824-2018·2018-05-30

    Mylan Recalls Loxapine Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is recalling 8,679 bottles of Loxapine Capsules 25 mg due to CGMP deviations. The product was distributed throughout the United States and Puerto Rico.

    Product
    Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-1927-2018·2018-05-30

    Getinge Recalls ALM XTEN Surgical Lights Due to Broken Spring Arms

    Getinge is recalling 667 ALM XTEN Surgical Lights because spring arms may crack and break, causing light heads to separate.

    Product
    ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·18V354000·2018-05-30

    2019 Coachmen and Shasta Recreational Trailers Recalled for LP Gas Bottle Ring Defect

    Forest River is recalling 2019 Coachmen and Shasta recreational trailers because the liquid propane gas bottle ring may not bind the metal strap securely, risking bottle detachment.

    Product
    COACHMEN — COACHMEN, SHASTA BROOKSTONE, CHAPARRAL LITE, CHAPARRAL, PHOENIX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0825-2018·2018-05-30

    Mylan Recalls Loxapine Capsules Due to Manufacturing Deviations

    Mylan Pharmaceuticals is voluntarily recalling 11,650 bottles of Loxapine Capsules 50 mg due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-1488-2018·2018-05-30

    Raley's Peanut Butter Brownies Recalled for Missing Peanut Allergen Labeling

    Raley's Family of Fine Stores is recalling Peanut Butter Brownies because peanuts were not listed in the 'Contains' statement, despite being an ingredient.

    Product
    Raley's Peanut Butter Brownies 6 Ct.; NET WT: 16 oz. 1 lb. UPC: 46567-61806
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1492-2018·2018-05-30

    Flowers Bakery Recalls French Toast Bread for Undeclared Allergens

    Flowers Bakery of Montgomery LLC is recalling French Toast Bread due to undeclared milk and soy allergens. The product was distributed in Florida, Illinois, Missouri, and Texas.

    Product
    French Toast Bread
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1919-2018·2018-05-30

    LivaNova Inspire 8 Integrated Phisio OXY Recall for Incorrect UDI Expiration Date

    LivaNova USA is recalling 70 units of Inspire 8 Integrated Phisio OXY devices because the expiration date in the UDI barcode is printed in the wrong format.

    Product
    Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 8M Hollow Fiber Oxygenator: The INSPIRE 8M is intended for use in adult and small adu
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1894-2018·2018-05-30

    Beckman Coulter Recalls iChem VELOCITY Urine Chemistry Systems for Seal Defects

    Beckman Coulter is recalling six iChem VELOCITY Automated Urine Chemistry Systems because the Strip Provider Modules were not inspected for correct seal placement and integrity during manufacture.

    Product
    iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001. The iChemVELOCITY automated urine chemistry system is an in-vitro diagnostic device used to automate the urine chemi
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0833-2018·2018-05-30

    Milbar Recalls Subpotent Zoma Shampoo Bottles

    Milbar Laboratories is recalling 1,348 bottles of Zoma Shampoo because the product was found to be subpotent.

    Product
    Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1924-2018·2018-05-30

    Baxter Prismaflex Control Units Recalled for Pump Module Electronics Failure

    Baxter Healthcare is recalling Prismaflex control units to install new firmware that prevents a pump module electronics failure causing the device to become inoperable.

    Product
    Prismaflex 7.XX ROW, Product Code 114870 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) the
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1923-2018·2018-05-30

    Baxter Prismaflex 5.10 US Control Units Recalled for Firmware Update

    Baxter Healthcare is recalling 1,256 Prismaflex 5.10 US control units to install new firmware that prevents a pump module electronics failure.

    Product
    Prismaflex 5.10 US, Product Code 113081 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) ther
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1904-2018·2018-05-30

    Smith & Nephew Legion CR XLPE Articular Insert Packaging Recall

    Smith & Nephew is recalling 16 units of Legion CR XLPE Articular Inserts because the inner packaging pouch was inadvertently sealed with the outer pouch.

    Product
    smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1909-2018·2018-05-30

    Baxter EXACTAMIX Inlets Recalled for Incorrect Over-Labeling

    Baxter Healthcare is recalling specific lots of EXACTAMIX Inlets due to incorrect over-labeling that may display extended expiration dates.

    Product
    Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1917-2018·2018-05-30

    Implant Direct Dental Implants Recalled for Incorrect Cap Labeling

    Implant Direct Sybron Manufacturing is recalling 298 dental implants because the vial cap may display an incorrect part number, though the main label is correct.

    Product
    ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Product Usage: Usage: Dental implants intended for use in partially and fully edentulous upper and low
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1898-2018·2018-05-30

    Madison Polymeric Engineering Recalls Endoscopic Cleaning Pads Due to Microbial Contamination

    Madison Polymeric Engineering is recalling First Step Endoscopic Cleaning Pads because they exhibit an unpleasant odor due to microbial contamination with Yarrowia lipolytica.

    Product
    First Step Endoscopic Cleaning Pad, 500ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-6
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Drugs)·D-0823-2018·2018-05-30

    Mylan Recalls Loxapine Capsules Due to Cross-Contamination Risk

    Mylan Institutional, Inc. is recalling Loxapine Capsules 50 mg due to cGMP violations that create a risk of cross-contamination.

    Product
    Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-903-20.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0830-2018·2018-05-30

    Mylan Recalls Prednisolone Sodium Phosphate Orally Disintegrating Tablets

    Mylan Pharmaceuticals Inc. is voluntarily recalling PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets due to CGMP deviations.

    Product
    PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-1489-2018·2018-05-30

    Raley's Pistachio Gelato Recalled for Unauthorized Color Additive

    Raley's Pistachio Gelato is being recalled because it contains sodium copper chlorophyllins, a color additive not authorized by the FDA for this product type.

    Product
    RALEY'S PISTACHIO GELATO; 10.58 oz. plastic tub UPC: 46567-02382 Ingredients: rehydrated skimmed milk, sugar, coconut oil, glucose syrup, pure pistachio paste, whole roasted pistachios, milk proteins, mono and diglycerides of fatty acids (emulsifiers), sodium alginate and
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1926-2018·2018-05-30

    Baxter Recalls Prismaflex 7.20 US Control Units for Firmware Update

    Baxter Healthcare is recalling 231 Prismaflex 7.20 US control units to install new firmware that prevents a pump module electronics failure.

    Product
    Prismaflex 7.20 US, Product Code 955542 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) ther
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1922-2018·2018-05-30

    Baxter Recalls Prismaflex Systems for Pump Module Electronics Failure

    Baxter Healthcare is recalling Prismaflex Systems to install new firmware that prevents a pump module electronics failure causing the device to become inoperable.

    Product
    Prismaflex System, Product Code 107493 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) thera
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0837-2018·2018-05-30

    Lupin Recalls My Way Emergency Contraception Tablets for Lack of Approval

    Lupin Pharmaceuticals is recalling My Way emergency contraception tablets because the 2-pack configuration was marketed without the required regulatory approval.

    Product
    My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, UPC 3 43386-622-31 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1899-2018·2018-05-30

    Madison Polymeric Engineering Recalls Flexible Endoscope Pre-Clean Kits

    Madison Polymeric Engineering is recalling First Step EP-4 Flexible Endoscope Bedside Pre-Clean Kits due to microbial contamination with Yarrowia lipolytica.

    Product
    Travel Kit, First Step EP-4 Kit (200 mL) and 1 Soiled Scope Bag (White), Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number TK-200(W)
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-1900-2018·2018-05-30

    Madison Polymeric Engineering Recalls Draco Enzymatic Deep-Cleaning Pads

    Madison Polymeric Engineering is recalling Draco Enzymatic Deep-Cleaning Pads due to microbial contamination with Yarrowia lipolytica, which causes an unpleasant odor.

    Product
    Draco Enzymatic Deep-Cleaning Pad, Draco Pad infused with Simple2 Enzymatic Detergent, Catologue Number HY0305Z
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-1908-2018·2018-05-30

    Baxter EXACTAMIX Inlets Recalled for Incorrect Over-Labeling

    Baxter Healthcare is recalling specific lots of EXACTAMIX Inlets due to incorrect over-labeling that may display extended expiration dates.

    Product
    Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1897-2018·2018-05-30

    Madison Polymeric Engineering Recalls Endoscopic Cleaning Kits Due to Microbial Contamination

    Madison Polymeric Engineering is recalling First Step Endoscopic Cleaning Kits due to microbial contamination with Yarrowia lipolytica, which causes an unpleasant odor.

    Product
    First Step Endoscopic Cleaning Pad with 4" Button Brush, 200ml, Flexible Endoscope Bedside Pre-Clean Kit, Catalogue Number EP-4B
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-1910-2018·2018-05-30

    Baxter EXACTAMIX Inlets Recalled for Incorrect Over-Labeling

    Baxter Healthcare is recalling specific lots of EXACTAMIX Inlets due to incorrect over-labeling that may display blank or extended expiration dates.

    Product
    Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1911-2018·2018-05-30

    Baxter EXACTAMIX Inlets Recalled for Incorrect Labeling

    Baxter Healthcare is recalling specific lots of EXACTAMIX Inlets due to incorrect over-labeling that may display blank or extended expiration dates.

    Product
    Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1925-2018·2018-05-30

    Baxter Recalls Prismaflex Control Units for Firmware Update

    Baxter Healthcare is recalling 557 Prismaflex 7.XX US control units worldwide to install new firmware that prevents a pump module electronics failure.

    Product
    Prismaflex 7.XX US, Product Code 115269 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. " Therapeutic Plasma Exchange (TPE) ther
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0826-2018·2018-05-30

    Exela Pharma Recalls Diclofenac and Misoprostol Tablets Due to Labeling Error

    Exela Pharma Sciences LLC is recalling 5,256 bottles of Diclofenac Sodium and Misoprostol tablets because some bottles were mislabeled with the wrong dosage.

    Product
    Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India; For: EAGLE PHARMACEUTICALS, INC., Woodcliff Lake, NJ 07677 USA, NDC 42367-111-06.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1902-2018·2018-05-30

    Smith & Nephew Recalls Genesis II Knee Bushings Due to Labeling Error

    Smith & Nephew is recalling 18 units of Genesis II knee bushings because the left and right sides were incorrectly laser marked.

    Product
    smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activ
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-0838-2018·2018-05-30

    Lupin Recalls My Way Levonorgestrel Tablets for Lack of Approved NDA

    Lupin Pharmaceuticals is recalling My Way (levonorgestrel) emergency contraception tablets because the 2-pack configuration was marketed without an approved New Drug Application.

    Product
    My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454 775, INDIA, UPC 3 68180 85212
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0829-2018·2018-05-30

    Mylan Recalls Prednisolone Sodium Phosphate Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is voluntarily recalling specific lots of Prednisolone Sodium Phosphate Orally Disintegrating Tablets due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1912-2018·2018-05-30

    Spinal Elements Recalls Omega Lumbar Interbody Fusion Devices

    Spinal Elements is recalling 19 Omega Lumbar Interbody Fusion Devices because they were assembled with components that do not match the labeled lordosis angle.

    Product
    AMENDIA Omega Lumbar Interbody Fusion Device, Part Number 72-00-2-092812-11 The OmegaLIF(TM) (LIF(TM)) Expandable Lumbar Interbody Device is designed for use in intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at o
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0831-2018·2018-05-30

    Mylan Recalls Prednisolone Sodium Phosphate Tablets Due to Manufacturing Deviations

    Mylan Pharmaceuticals is voluntarily recalling specific lots of Prednisolone Sodium Phosphate tablets due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0857-2018·2018-05-30

    Teva Recalls Lidocaine Patches Due to Failed Stability Specifications

    Teva Pharmaceuticals USA is recalling Lidocaine Patch 5% products because they failed stability specifications. The recall covers 30,382 patches distributed in the United States.

    Product
    LIDOCAINE — LIDOCAINE (LIDOCAINE)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-1907-2018·2018-05-30

    Smith & Nephew Legion CR XLPE Articular Insert Packaging Recall

    Smith & Nephew is recalling 47 units of Legion CR XLPE Articular Inserts due to a packaging error where inner and outer pouches were sealed together.

    Product
    smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF 71453101designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1906-2018·2018-05-30

    Smith & Nephew Legion CR XLPE Articular Insert Packaging Recall

    Smith & Nephew is recalling Legion CR XLPE High Lexion Articular Inserts due to a packaging error where inner and outer pouches were sealed together.

    Product
    smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0832-2018·2018-05-30

    Milbar Recalls Subpotent Coal Tar Shampoo for Hair and Body

    Milbar Laboratories is voluntarily recalling 952 bottles of T Shampoo For Hair and Body because the product is subpotent.

    Product
    T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10.1 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-1905-2018·2018-05-30

    Smith & Nephew Legion CR XLPE Articular Insert Packaging Recall

    Smith & Nephew is recalling 72 units of Legion CR XLPE Articular Inserts because the inner and outer packaging pouches were inadvertently sealed together.

    Product
    smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF 71453122 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1920-2018·2018-05-30

    Implant Direct Legacy 4 Implant Recalled for Mislabeling

    Implant Direct Sybron Manufacturing is recalling 18 units of Legacy 4 Implants due to a mislabeled vial cap. The main label was correct, but the cap showed the wrong part number.

    Product
    ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.
    Category
    Medical Device
    Distribution
    10 states
  • LowFDA (Devices)·Z-1918-2018·2018-05-30

    LivaNova Inspire 6 Integrated Phisio OXY Recall for Incorrect UDI Expiration Date

    LivaNova USA is recalling 42 units of Inspire 6 Integrated Phisio OXY devices because the expiration date in the UDI barcode is printed in the wrong format.

    Product
    Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 6M Hollow Fiber Oxygenator: The INSPIRE 6M is intended for use in adult and small adul
    Category
    Medical Device
    Distribution
    5 states
  • SevereNHTSA·18V351000·2018-05-29

    Western Star 4900 Trucks Recalled for Brake Hose Chafing Risk

    Daimler Trucks North America is recalling 2012-2019 Western Star 4900 trucks because front brake hoses may chafe against the hood, potentially reducing braking effectiveness.

    Product
    WESTERN STAR — WESTERN STAR 4900
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V353000·2018-05-29

    Daimler Trucks Recalls 2017-2019 Models for Brake Caliper Bolt Issue

    Daimler Trucks North America is recalling 8,741 trucks because brake caliper mounting bolts may be insufficiently tightened, potentially reducing braking performance and increasing crash risk.

    Product
    FCCC — FCCC, WESTERN STAR, FREIGHTLINER XCM, 5700, 4900, 4700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V352000·2018-05-29

    Thomas Built Buses Recalling School Buses for Brake Bolt Issue

    Daimler Trucks North America is recalling 2,767 Thomas Built Buses Saf-T-Liner models from 2017-2019 because brake caliper mounting bolts may be insufficiently tightened.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX, SAF-T-LINER C2, SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V348000·2018-05-29

    Altec Recalls Aerial Devices Missing Towing Limit Placards

    Altec is recalling 2012-2018 aerial devices missing a placard stating maximum towing limits, which could lead to an overloaded receiver tube and increased crash risk.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V342000·2018-05-27

    GM Recalls 2018 Chevrolet Sonic for Driver Seat-Back Welding Defect

    General Motors is recalling 2018 Chevrolet Sonic vehicles because a joint in the driver's seat-back frame may not be properly welded, which could reduce strength in a crash.

    Product
    CHEVROLET — CHEVROLET SONIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·041-2018·2018-05-26

    Hormel Recalls Canned Pork and Chicken Products Due to Metal Contamination

    Hormel is recalling specific cans of SPAM and Black-Label Luncheon Loaf because they may contain metal pieces. Consumers should discard or return these products.

    Product
    Hormel Foods Corporation Recalls Canned Pork and Chicken Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·18V347000·2018-05-25

    Maserati Recalls 2018 Models Due to Front Sub Frame Weld Defects

    Maserati is recalling 2018 Levante, Ghibli, and Quattroporte vehicles because incomplete front sub frame welds may break, potentially causing loss of vehicle control.

    Product
    MASERATI — MASERATI LEVANTE, GHIBLI, QUATTROPORTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V343000·2018-05-25

    2018 Jeep Wrangler Recall for Steering Shaft Weld Defect

    Chrysler is recalling 2018 Jeep Wrangler vehicles because a steering shaft weld may split, potentially causing loss of steering responsiveness and increasing crash risk.

    Product
    JEEP — JEEP WRANGLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V344000·2018-05-25

    Chrysler Recalls 2019 Jeep Cherokee for Engine Component Defects

    Chrysler is recalling 2019 Jeep Cherokee vehicles with 2.0L engines due to missing valve stem keepers or reversed camshaft caps that may cause engine failure and stalling.

    Product
    JEEP — JEEP CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V340000·2018-05-24

    GMC Recalls 2018 Terrain Models Due to Air Bag Module Software Defect

    General Motors is recalling 2018 GMC Terrain vehicles because the air bag control module may fail to power down, potentially preventing air bag deployment in a crash.

    Product
    GMC — GMC TERRAIN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18164·2018-05-24

    Bluefin Recalls Wireless Phone Chargers Due to Burn Hazard

    Bluefin International is recalling about 3,000 wireless phone chargers because they can overheat and cause burns. Consumers should stop using them and contact the company for a refund.

    Product
    Wireless phone chargers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18166·2018-05-24

    IKEA Recalls SLADDA Bicycles Due to Belt Breakage and Fall Hazard

    IKEA is recalling approximately 4,900 SLADDA bicycles sold in the U.S. because the belt can break, posing a fall hazard. No injuries have been reported in the U.S.

    Product
    SLADDA bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1487-2018·2018-05-23

    True Taste Cold Smoked Whitefish Recalled for Botulism Risk

    True Taste, LLC. is recalling Cold Smoked Whitefish in California and Illinois due to potential Clostridium botulinum contamination.

    Product
    True Taste Seafood Cold Smoked Whitefish; Ingredients: whitefish, salt, original smoke; To be weighed at point of sale - approximately 3/4 lb.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-0926-2018·2018-05-23

    AuroMedics Recalls Piperacillin and Tazobactam Injection Due to Glass Particulates

    AuroMedics Pharma LLC is recalling 77,400 vials of Piperacillin and Tazobactam for Injection due to confirmed visible glass particulate matter.

    Product
    PIPERACILLIN AND TAZOBACTAM — PIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1774-2018·2018-05-23

    Abbott HeartMate 3 LVAS Implant Kit Recalled for Graft Occlusion Risk

    Abbott is recalling HeartMate 3 LVAS Implant Kits due to reports of outflow graft twist occlusions that can cause serious adverse events.

    Product
    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.
    Category
    Medical Device
    Distribution
    35 states
  • CriticalFDA (Food)·F-1486-2018·2018-05-23

    True Taste Hot Smoked Whitefish Recalled for Botulism Risk

    True Taste, LLC. is recalling hot smoked whitefish in California and Illinois due to potential Clostridium botulinum contamination.

    Product
    True Taste Seafood Hot Smoked Whitefish; Ingredients: whitefish, salt, original smoke; To be weighed at point of sale - approximately 3/4 lb.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-0839-2018·2018-05-23

    Apotex Recalls Subpotent Piperacillin and Tazobactam Injection Vials

    Apotex Inc. is recalling 121,693 vials of Piperacillin and Tazobactam for Injection due to high impurity levels that decreased the drug's potency.

    Product
    Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0687-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1443-2018·2018-05-23

    eBars Recalls Diabeatic Chocolate Berry Crunch Bars for Undeclared Peanuts

    eBars is recalling Diabeatic Chocolate Berry Crunch bars because they contain undeclared peanuts. The recall was initiated after notification from the State of Tennessee.

    Product
    DIABEATIC Chocolate Berry Crunch bar NET WT 1.4 oz (42g)Manufactured and Distributed by eBars, LLC, Franklin, TN 37064 UPC 8 55529 00423 3
    Category
    Food
    Distribution
    40 states
  • CriticalFDA (Food)·F-1483-2018·2018-05-23

    True Taste Cold Smoked Mackerel Recalled for Botulism Risk

    True Taste, LLC. is recalling Cold Smoked Mackerel due to potential Clostridium botulinum contamination. The product was distributed in California and Illinois.

    Product
    True Taste Seafood Cold Smoked Mackerel; Ingredients: Mackerel salt, original smoke; To be weighed at point of sale - approximately 3/4 lb.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-1485-2018·2018-05-23

    True Taste Seafood Hot Smoked Salmon Recalled for Botulism Risk

    True Taste, LLC. is recalling hot smoked salmon due to potential Clostridium botulinum contamination. The product was distributed in California and Illinois.

    Product
    True Taste Seafood Hot Smoked Salmon; Ingredients: salmon, salt, original smoke; To be weighed at point of sale - approximately 3/4 lb.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-1482-2018·2018-05-23

    True Taste Hot Smoked Mackerel Recalled for Botulism Risk

    True Taste, LLC. is recalling hot smoked mackerel in California and Illinois due to potential Clostridium botulinum contamination.

    Product
    True Taste Seafood Hot Smoked Mackerel; Ingredients: Mackerel salt, original smoke; To be weighed at point of sale - approximately 3/4 lb.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-1481-2018·2018-05-23

    True Taste Seafood Hot Smoked Lake Herring Recalled for Botulism Risk

    True Taste, LLC. is recalling approximately 5,932 lbs of Hot Smoked Lake Herring sold in California and Illinois due to potential Clostridium botulinum contamination.

    Product
    True Taste Seafood Hot Smoked Lake Herring; Ingredients: Lake Herring, salt, original smoke; To be weighed at point of sale - approximately 3/4 lb.
    Category
    Food
    Distribution
    2 states

Looking for a different month? Back to 2018.