The Recall Desk

Archive

December 2019 recalls

567 recalls were announced in December 2019.

What the numbers show

Critical
45
Severe
158
High
184
Moderate
159
Low
21

Of the 567 recalls this month scored against our rubric, 8% are Critical, 28% are Severe.

201–300 of 567

  • HighFDA (Food)·F-0332-2020·2019-12-18

    CornFusion Maple Bacon Popcorn Recalled for Undeclared Milk Allergen

    CornFusion Gourmet Popcorn is recalling 11 packages of Maple Bacon flavored popcorn because the label declares butter but fails to declare milk.

    Product
    Maple Bacon flavored Popcorn, packaged in poly lined bags, net wt. 7 oz. (198 g). No UPC code.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0325-2020·2019-12-18

    Meijer Cauliflower Florets Recalled for Listeria Monocytogenes Contamination

    Meijer Inc. is recalling Fresh From Meijer Cauliflower Florets due to a Listeria monocytogenes hazard. The product was sold in Meijer stores in six states.

    Product
    Fresh From Meijer Cauliflower Florets with UPC 2-21233-00000-5 and PLU 4566, packed in plastic wrapped foam tray
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0218-2020·2019-12-18

    Nectar Foods Recalls Honey Mama's Truffle Bar for Unlabeled Milk

    Nectar Foods is recalling Honey Mama's Truffle Bar sold at Trader Joe's because the product contains milk, which is not listed on the label.

    Product
    Honey Mama s Truffle Bar (Trader Joe's) is a honey cocoa bar, refrigerated, one bar is packaged in flexible film, flow wrapped, net weight 1.35 oz. UPC 8 54835 00415 9. There are 12 bars per display case and 6 cases per master case. The label is read in parts: "***Truffle *
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0670-2020·2019-12-18

    Elekta Monaco Radiation Treatment Planning System Software Recall

    Elekta Inc is recalling Monaco Radiation Treatment Planning System software due to incorrect energy usage during dose calculation.

    Product
    Monaco Radiation Treatment Planning System (RTP) System
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-0334-2020·2019-12-18

    CornFusion Caramel Popcorn Recalled for Undeclared Milk Allergen

    CornFusion Gourmet Popcorn is recalling 12 packages of 7-oz caramel popcorn in Washington because the label declares butter but omits milk.

    Product
    Caramel flavored Popcorn, packaged in poly lined bags, net wt. 7 oz. (198 g). No UPC code.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0589-2020·2019-12-18

    Cook Inc. Recalls CrossCath Support Catheters Due to Manufacturing Error

    Cook Inc. is recalling 43 CrossCath Support Catheters because a manufacturing error may cause radiopaque marker bands to be too loose or too tight.

    Product
    CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures.
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Food)·F-0234-2020·2019-12-18

    AC Culinary Group Recalls Chef Pineiro's Ajo con Cilantro Due to Metal Filaments

    AC Culinary Group LLC is recalling Chef Pineiro's Ajo con Cilantro in 8 oz and 32 oz sizes due to the presence of metal filaments.

    Product
    Chef Pineiro's Ajo con Cilantro, with Coriander, NET WT./PESO NETO 8 oz (233g) and NET WT./PESO NETO 32 oz (907g)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0655-2020·2019-12-18

    CP Medical Recalls Coated PGA Sutures for Tensile Strength Failure

    CP Medical Inc is recalling 2,124 coated PGA sutures because they failed to meet USP minimum average value for knot pull strength.

    Product
    Coated PGA Undyed Polyglycolic Acid Braided Absorbable Suture Sterile EO 18" (45cm); UDI: (01)10790986000657 (17)220430 (10)17050970
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0610-2020·2019-12-18

    Smiths Medical Medfusion 4000 Syringe Pump Firmware Recall

    Smiths Medical is recalling 626 Medfusion 4000 Syringe Pumps due to a firmware anomaly that may disable battery alarms and interrupt therapy.

    Product
    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0664-2020·2019-12-18

    Abbott Medical Recalls Radiofrequency Grounding Pads Due to Liner Orientation Error

    Abbott Medical is recalling 8,940 radiofrequency grounding pads nationwide because an incorrectly oriented release liner may leave film on the pad, interfering with skin contact and causing uneven heating.

    Product
    Radiofrequency Grounding Pad, REF RF-DGP-L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V904000·2019-12-18

    Ford Recalls 2006-2010 Fusion, Milan, MKZ, Zephyr for Brake Valve Defect

    Ford is recalling 2006-2010 Fusion, Milan, MKZ, and Zephyr vehicles because ABS valves may fail to close, increasing stopping distance and crash risk.

    Product
    MERCURY — MERCURY, LINCOLN, FORD MILAN, MKZ, ZEPHYR, FUSION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0222-2020·2019-12-18

    Skidmore Sales Recalls CBI BG 2280/45025 for Undeclared Soy Lecithin

    Skidmore Sales & Distributing Co Inc is recalling CBI BG 2280/45025 because the product contains undeclared soy lecithin.

    Product
    CBI BG 2280/45025, 50 lb. package, 1 poly bag in cardboard box, 1140496
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0232-2020·2019-12-18

    AC Culinary Group Recalls Chef Pineiro's Sofrito con Cilantro Due to Metal Filament

    AC Culinary Group LLC is recalling Chef Pineiro's Sofrito con Cilantro in 12 oz and 32 oz sizes due to a customer complaint about a metal filament.

    Product
    Chef Pineiro's Sofrito con Cilantro, with Coriander, NET WT./PESO NETO 12 oz (340g) and NET WT./PESO NETO 32 oz (907g)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0623-2020·2019-12-18

    Integra LifeSciences Recalls CUSA Clarity Ultrasonic Tissue Ablation Systems

    Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required drying time criteria.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Food)·F-0233-2020·2019-12-18

    AC Culinary Group Recalls Chef Pineiro's Sofrito con Albahaca Due to Metal Filament

    AC Culinary Group LLC is recalling Chef Pineiro's Sofrito con Albahaca in 12 oz and 32 oz sizes because a metal filament was found in the product and its raw materials.

    Product
    Chef Pineiro's Sofrito con Albahaca, with Basil, NET WT./PESO NETO 12 oz (340g) and NET WT./PESO NETO 32 oz (907g)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0324-2020·2019-12-18

    Meijer Vegetable Tray Recalled for Listeria Monocytogenes Contamination

    Meijer Inc. is recalling Fresh From Meijer vegetable trays and dip due to Listeria monocytogenes contamination. The affected products were sold in six states.

    Product
    Fresh From Meijer vegetable tray and Dip with UPC 2-20186-00000-1 and PLU 1593, packed in clear plastic sectioned container
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0408-2020·2019-12-18

    Whole Foods Market Recalls Raspberry Cheesecake Gelato for Undeclared Egg

    Whole Foods Market is recalling Raspberry Cheesecake Italian Gelato because it contains undeclared egg. The product was distributed nationwide.

    Product
    Whole Foods Market Raspberry Cheesecake Italian Gelato 1 Pint (473mL) UPC 9948248024 packaged in a clear plastic container
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0677-2020·2019-12-18

    Getinge Pediatric Diffusion Membrane Oxygenator Recalled for Sterility Concerns

    Getinge is recalling 3,633 units of Quadrox-iD Pediatric Diffusion Membrane Oxygenators because the sterile barrier system may be compromised.

    Product
    Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0611-2020·2019-12-18

    Encore Medical Recalls EMPOWR Locking Femoral Impactor Due to Tip Breakage

    Encore Medical is recalling 410 EMPOWR Locking Femoral Impactors because the tips may break off during surgery. This defect can cause off-axis loading, device failure, and potential long-term complications.

    Product
    EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Food)·F-0326-2020·2019-12-18

    Meijer Broccoli Florets Recalled Due to Listeria Monocytogenes Risk

    Meijer Inc. is recalling Fresh From Meijer Broccoli Florets in six states due to a potential Listeria monocytogenes contamination.

    Product
    Fresh From Meijer Broccoli Florets with UPC 2-21234-00000-4 and PLU 4548, packed in plastic wrapped foam tray or sold from store salad bar
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0327-2020·2019-12-18

    House Foods Chinese Mabo Tofu Sauce Recalled for Weak Seals

    House Foods America Corporation is recalling Chinese Mabo Tofu Sauce due to weak pouch seals that may leak and allow microorganism growth.

    Product
    House Foods Chinese Mabo Tofu Sauce, mild; NET WT. 5.29 oz. (150 g) 4 servings UPC: 0 77377 74064 8 Ingredients: Water, Tomato Paste, Soybean paste (soybean, rice, salt, water), monosodium glutamate, garlic, sugar, sesame oil, ginger, spring onion, salt, cornstarch. mirn
    Category
    Food
    Distribution
    8 states
  • HighNHTSA·19V903000·2019-12-18

    Ford Recalls 2020 F-150 Trucks Due to Damaged Spare Tires

    Ford is recalling 2020 F-150 trucks because the 17-inch spare tire may be damaged, increasing crash risk. Dealers will replace the tire free of charge.

    Product
    FORD — FORD F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0667-2020·2019-12-18

    Boston Scientific Recalls Habib EUS RFA Electrode Tips Due to Thermal Injury Risk

    Boston Scientific is recalling 139 Habib EUS RFA electrode tips because capacitive coupling may cause thermal injury to tissue outside the target area.

    Product
    Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0336-2020·2019-12-18

    Jolly Rancher Hard Candies Recalled for Undeclared Soy Lecithin

    Werner Gourmet Meat Snacks is recalling Jolly Rancher hard candies due to undeclared soy lecithin. The product was distributed nationwide and in Canada.

    Product
    Jolly Rancher product is hard candies, individually wrapped in flexible plastic wrap, and package in plastic bag. Net weight 2 oz or 4.5 oz. UPC on the 4.5 oz. bag: 7 09972 80101 0. The label of the retail bag is read in parts: INGREDIENTS: CORN SYRUP, SUGAR, CONTAINS 2% O
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0672-2020·2019-12-18

    Conformis Recalls iTotal CR Knee Replacement System Due to Fit Issues

    Conformis, Inc. is recalling the iTotal CR Knee Replacement System because the polyethylene inserts did not securely fit into the cobalt chrome tray implant.

    Product
    iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·19V905000·2019-12-18

    Cruise Car Moke Recalled for Incorrect Windshield Glass Quality Rating

    Cruise Car is recalling 2019 Moke vehicles because they may have windshields with incorrect glass quality ratings, which could affect driver visibility and increase crash risk.

    Product
    CRUISE CAR — CRUISE CAR MOKE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0242-2020·2019-12-18

    Cain Food Industries Recalls CDC-2010 Due to Salmonella Contamination Risk

    Cain Food Industries is recalling 600 pounds of CDC-2010 packaged in 50 lb. bags due to possible Salmonella contamination. The product was distributed in seven states.

    Product
    CDC-2010 packaged in 50 lb. Multi-wall paper bag with polyethylene liner
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0329-2020·2019-12-18

    Breakstones Cottage Cheese Recalled for Potential Plastic and Metal Contamination

    Kraft Heinz is recalling Breakstones 4% Milkfat Large Curd Cottage Cheese due to the potential presence of red plastic and metal pieces introduced during production.

    Product
    Breakstones 4% Milkfat Large Curd Cottage Cheese, in 24 oz. Plastic Tub, with UPC 0 21000 12285 1, 12 packages per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·19V906000·2019-12-18

    Airstream Recalls 2018-2019 Interstates for Incorrect Capacity Labels

    Airstream is recalling 2018-2019 Interstate motorhomes because incorrect occupant and cargo capacity labels may lead to vehicle overloading and increased crash risk.

    Product
    AIRSTREAM — AIRSTREAM INTERSTATE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0668-2020·2019-12-18

    Boston Scientific Recalls Habib EUS RFA Electrode Tips Due to Thermal Injury Risk

    Boston Scientific is recalling 179 Habib EUS RFA electrode tips because capacitive coupling may cause unintended thermal injury to tissue outside the treatment area.

    Product
    Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0601-2020·2019-12-18

    Anazao Health Recalls Morphine Sulfate and Bupivacaine HCL Combination Products

    Anazao Health is recalling Morphine Sulfate and Bupivacaine HCL combination products due to the presence of Talaromyces rotundus fungi.

    Product
    Morphine Sulfate and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0603-2020·2019-12-18

    Anazao Health Recalls Fentanyl and Bupivacaine Compounded Medications

    Anazao Health is recalling compounded fentanyl and bupivacaine medications due to the presence of Talaromyces rotundus fungi detected during environmental sampling.

    Product
    Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0600-2020·2019-12-18

    Anazao Health Recalls Morphine, Bupivacaine, and Clonidine Due to Fungal Contamination

    Anazao Health is recalling specific lots of Morphine Sulfate, Bupivacaine HCL, and Clonidine HCL because environmental sampling detected Talaromyces rotundus, a fungus.

    Product
    Morphine Sulfate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634 (800) 995-4363
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0580-2020·2019-12-18

    Anazao Health Recalls Clonidine and Hydromorphone Due to Fungal Contamination

    Anazao Health is recalling Clonidine HCL/Hydromorphone HCL products because environmental sampling detected Talaromyces rotundus, a fungus, indicating a lack of processing controls.

    Product
    Clonidine HCL/Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0637-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recalled for Sterilization Tray Drying Defect

    Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required 30-minute drying time.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0643-2020·2019-12-18

    Integra CUSA Clarity Sterilization Tray Recall for Drying Time Error

    Integra LifeSciences is recalling the C7000 CUSA Clarity system because the operator manual lists an incorrect minimum drying time for the 36 kHz Sterilization Tray.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Drugs)·D-0604-2020·2019-12-18

    Anazao Health Recalls Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL

    Anazao Health is recalling Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL due to environmental sampling revealing a fungus.

    Product
    Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0579-2020·2019-12-18

    Anazao Health Recalls Glutamine, Arginine, and Carnitine Vials Due to Fungal Contamination

    Anazao Health is recalling Glutamine/Arginine/Carnitine vials because environmental sampling detected Talaromyces rotundus, a fungus, indicating a lack of processing controls.

    Product
    Glutamine/Arginine/Carnitine in all strengths, all doses and all packaging, AnazaoHealth Corporate 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0583-2020·2019-12-18

    Anazao Health Recalls Bupivacaine, Clonidine, and Hydromorphone Combination Injections

    Coast Quality Pharmacy is recalling Bupivacaine, Clonidine, and Hydromorphone injections due to fungal contamination found during environmental sampling.

    Product
    Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0659-2020·2019-12-18

    Medtronic Biopsy Needle FPU Kit Recalled for Depth Stop Issue

    Medtronic Navigation is recalling Biopsy Needle FPU Kits because the depth stop may not tighten securely, potentially causing surgery delays.

    Product
    Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Food)·F-0305-2020·2019-12-18

    Lalamilo Farms Strawberry Cheesecake Ice Cream Recalled for Plastic Pieces

    Edney and Sellers, Ltd. is recalling Lalamilo Farms Tropical Dreams Hawaiian Ice Cream - Strawberry Cheesecake due to reports of plastic pieces found in the product.

    Product
    Lalamilo Farms Tropical Dreams Hawaiian Ice Cream - Strawberry Cheesecake. Sold in 3 gallon tubs, 1.5 gallon tubs, 5 L tubs, 8 oz. cups. Ingredients: Cream, Nonfat Milk, Sugar, Corn Syrup, Water, High Fructose Corn Syrup, Cream Cheese Powder {Cream Cheese{milk, culture, sal
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0593-2020·2019-12-18

    Morphine Sulfate and Bupivacaine HCL Recalled Due to Fungal Contamination

    Coast Quality Pharmacy is recalling Morphine Sulfate and Bupivacaine HCL because environmental sampling detected Talaromyces rotundus, a fungus.

    Product
    Morphine Sulfate and Bupivacaine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0635-2020·2019-12-18

    Integra CUSA Clarity System Recalled for Inadequate Sterilization Tray Drying Time

    Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes stated in the manual.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0638-2020·2019-12-18

    Integra CUSA Clarity Sterilization Tray Recall for Drying Time Error

    Integra LifeSciences is recalling CUSA Clarity 36 kHz Sterilization Trays because the manual lists a 30-minute drying time, but 40 minutes are required for complete drying.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0616-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recalled for Sterilization Tray Drying Defect

    Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required drying time criteria.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Drugs)·D-0589-2020·2019-12-18

    FDA Recalls Hydromorphone and Bupivacaine Due to Fungal Contamination

    Coast Quality Pharmacy is recalling Hydromorphone HCL and Bupivacaine HCL products due to the detection of Talaromyces rotundus fungi during environmental sampling.

    Product
    Hydromorphone HCL and Bupivacaine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0607-2020·2019-12-18

    Anazao Health Recalls Hydromorphone and Bupivacaine Combination Injections

    Anazao Health is recalling hydromorphone and bupivacaine combination injections due to the presence of Talaromyces rotundus fungi detected during environmental sampling.

    Product
    Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0596-2020·2019-12-18

    Anazao Health Recalls Clonidine and Baclofen Due to Fungal Contamination

    Anazao Health is recalling Clonidine HCL and Baclofen products because environmental sampling detected Talaromyces rotundus, a fungus.

    Product
    Clonidine HCL and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0630-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recalled for Drying Time Error

    Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the operator manual lists an incorrect minimum drying time for sterilization trays.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Drugs)·D-0584-2020·2019-12-18

    Anazao Health Recalls Bupivacaine and Fentanyl Compounded Medications

    Anazao Health is recalling compounded bupivacaine, clonidine, hydromorphone, and fentanyl medications due to the detection of Talaromyces rotundus fungi.

    Product
    Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0654-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recalled for Inadequate Drying Time

    Integra LifeSciences is recalling the C7000 CUSA Clarity System because the 36 kHz Sterilization Tray does not meet the 30-minute drying criteria stated in the manual.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0615-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recalled for Sterilization Tray Drying Defect

    Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required 30-minute drying time criteria.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Drugs)·D-0624-2020·2019-12-18

    OraLabs Recalls Petroleum Jelly Tubes Due to Undeclared Contaminants

    OraLabs is recalling specific lots of petroleum jelly tubes distributed by Rite Aid due to cross-contamination with phenol and camphor.

    Product
    Petroleum jelly (White Petrolatum) USP 100%, packaged in a) 1 oz tube (UPC 1182298884), b) 2.5 oz tube (UPC 1182298541), Distributed by Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0639-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recalled for Sterilization Tray Drying Defect

    Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the 36 kHz Sterilization Tray fails to meet the required 30-minute drying time.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0627-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recalled for Sterilization Tray Drying Defect

    Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the 36 kHz Sterilization Tray fails to meet the 30-minute drying time criteria stated in the manual.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0660-2020·2019-12-18

    Bellus Medical Recalls SKINFUSE Kit Due to Mislabeling

    Bellus Medical is recalling SKINFUSE Rescue Calming Complex Kits because they were packaged with a mislabeled medical product.

    Product
    SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product Usage: The SKINFUSE Rescue Calming Complex is intend to be used to soothe and calm skin (cosmetic). The SKINFUSE LIFT HG is a hydrogel wound dressing to protect against abrasion and friction during the mi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0632-2020·2019-12-18

    Integra CUSA Clarity System Recalled for Sterilization Tray Drying Defect

    Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the sterilization tray does not meet the required drying time criteria.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0673-2020·2019-12-18

    Leica BOND Polymer Refine Detection Kit Recalled for Storage Issues

    Leica Microsystems is recalling 558 BOND Polymer Refine Detection Kits because they were stored improperly, which may result in suboptimal staining.

    Product
    BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Polymer Refine Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0618-2020·2019-12-18

    Integra LifeSciences Recalls C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems

    Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the 36 kHz Sterilization Tray does not meet the 30-minute drying time criteria stated in the manual.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Drugs)·D-0582-2020·2019-12-18

    Anazao Health Recalls Baclofen and Morphine Sulfate Due to Fungal Contamination

    Anazao Health is recalling Baclofen and Morphine Sulfate because environmental sampling detected Talaromyces rotundus, a fungus, indicating a lack of processing controls.

    Product
    Baclofen and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0658-2020·2019-12-18

    Medtronic Biopsy Needle FPU Kit Recalled for Depth Stop Issue

    Medtronic Navigation is recalling Biopsy Needle FPU Kits because the depth stop may not tighten securely, potentially delaying surgery.

    Product
    Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Drugs)·D-0588-2020·2019-12-18

    FDA Recalls Hydromorphone HCL Due to Fungal Contamination

    Coast Quality Pharmacy is recalling Hydromorphone HCL because environmental sampling detected Talaromyces rotundus, a fungus.

    Product
    Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0665-2020·2019-12-18

    DePuy Mitek Recalls Healix Knotless Suture Anchors Due to Material Error

    DePuy Mitek is recalling 299 Healix Knotless ADV BR 4.75 Suture Anchors because they were manufactured with BIOCRYL material instead of BIOCRYL RAPIDE.

    Product
    Healix Knotless ADV BR 4.75 Suture Anchor
    Category
    Medical Device
    Distribution
    29 states
  • ModerateFDA (Devices)·Z-0647-2020·2019-12-18

    Integra CUSA Clarity System Recall for Sterilization Tray Drying Time Error

    Integra LifeSciences is recalling the C7000 CUSA Clarity System because the Polish OPS Manual incorrectly states the minimum drying time for the 36 kHz Sterilization Tray.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Food)·F-0223-2020·2019-12-18

    Natural Grocers Recalls Organic Soybeans Due to Potential Mold

    Natural Grocers is recalling two lots of 2 lb. organic soybeans because they have the potential to contain mold.

    Product
    Natural Grocers SOYBEANS ORGANIC in 2.0 lbs (32 oz) (907 g) plastic retail bags, 9 bags/case, Packaged by Vitamin Cottage
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0671-2020·2019-12-18

    Binding Site Recalls Optilite C-Reactive Protein Kits Due to Deterioration

    The Binding Site Group is recalling 10 Optilite C-Reactive Protein Kits because the reagent has deteriorated. The kits were distributed in California and Georgia.

    Product
    Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0663-2020·2019-12-18

    LivaNova VNS Therapy Tablet Software Recall for Diagnostic Error

    LivaNova is recalling 643 VNS Therapy Program tablets due to a software error that causes incorrect diagnostic tests on specific devices.

    Product
    VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
    Category
    Medical Device
    Distribution
    47 states
  • ModerateFDA (Devices)·Z-0631-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recalled for Sterilization Drying Defect

    Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the 36 kHz sterilization tray requires 40 minutes to dry, not the 30 minutes stated in the manual.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0648-2020·2019-12-18

    Integra LifeSciences Recalls C7000 CUSA Clarity Sterilization Tray

    Integra LifeSciences is recalling the C7000 CUSA Clarity 36 kHz Sterilization Tray because the manual lists a 30-minute drying time, but 40 minutes are required for complete drying.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0649-2020·2019-12-18

    Integra CUSA Clarity System Recall for Sterilization Tray Drying Defect

    Integra LifeSciences is recalling the C7000 CUSA Clarity System because the 36 kHz Sterilization Tray does not meet the 30-minute drying time criteria stated in the manual.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0651-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recall for Drying Time Discrepancy

    Integra LifeSciences is recalling C7000 CUSA Clarity systems because the operator manual lists a 30-minute drying time, but 40 minutes are required for complete drying.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0617-2020·2019-12-18

    Integra LifeSciences Recalls C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems

    Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required drying time criteria.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0657-2020·2019-12-18

    Medtronic Passive Biopsy Needle Kit Recall for Depth Stop Issue

    Medtronic is recalling 10,448 Passive Biopsy Needle Kits because a manufacturing issue may cause depth stops to fail, potentially delaying surgery.

    Product
    Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-0622-2020·2019-12-18

    Integra CUSA Clarity System Recalled for Sterilization Tray Drying Defect

    Integra LifeSciences is recalling 820 CUSA Clarity systems because the 36 kHz sterilization tray does not meet the 30-minute drying time criteria stated in the manual.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0625-2020·2019-12-18

    Integra CUSA Clarity System Recalled for Inadequate Sterilization Tray Drying Time

    Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes stated in the manual.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0650-2020·2019-12-18

    Integra LifeSciences Recalls C7000 CUSA Clarity Ultrasonic Tissue Ablation System

    Integra LifeSciences is recalling the C7000 CUSA Clarity system because the 36 kHz Sterilization Tray fails to meet the 30-minute drying time criteria stated in the manual.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0614-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recalled for Drying Time Discrepancy

    Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the operator manual underestimates the required drying time for sterilization trays.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0633-2020·2019-12-18

    Integra LifeSciences Recalls CUSA Clarity Ultrasonic Tissue Ablation Systems

    Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray fails to meet the required 30-minute drying time.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Drugs)·D-0592-2020·2019-12-18

    Anazao Health Recalls Morphine Sulfate Due to Fungal Contamination

    Anazao Health is recalling Morphine Sulfate products because environmental sampling detected Talaromyces rotundus, a type of fungus.

    Product
    Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0653-2020·2019-12-18

    Integra CUSA Clarity Sterilization Tray Recall for Drying Time Error

    Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the operator manual lists an incorrect minimum drying time for the 36 kHz Sterilization Tray.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0674-2020·2019-12-18

    Volcano FFR Software Recalled for Interoperability Issues with Hemodynamic Systems

    Volcano Corporation is recalling FFR software due to interoperability issues when connected to specific Hemodynamic Systems.

    Product
    Philips Volcano FFR software used in the following systems connected to the McKesson, Schwarzer, and some Philips Xper Hemodynamic Systems (HMS): (1) Volcano Imaging System s5i, Part #807400001; (2) s5ix Imaging System with s5iz PC Workstation Refurbished, Part#807400001 R and 80
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0636-2020·2019-12-18

    AuroMedics Recalls Mirtazapine Tablets Due to Labeling Error

    AuroMedics Pharma LLC is recalling Mirtazapine 15 mg tablets because some 500-count bottles are incorrectly labeled as 7.5 mg tablets.

    Product
    MIRTAZAPINE — MIRTAZAPINE (MIRTAZAPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0331-2020·2019-12-18

    Klein Foods Recalls Cookie Dough Fudge Due to Rubber Contamination

    Klein Foods is recalling 60 pounds of Cookie Dough Fudge because it may contain food-grade rubber pieces. The product was distributed in Minnesota and sold in the company's retail store.

    Product
    Klein Foods Cookie Dough Fudge, packed in 1/2 pound boxes
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0591-2020·2019-12-18

    Anazao Health Recalls Hydromorphone and Clonidine Due to Fungal Contamination

    Coast Quality Pharmacy, LLC dba Anazao Health is recalling Hydromorphone HCL and Clonidine HCL products because environmental sampling detected Talaromyces rotundus, a fungus.

    Product
    Hydromorphone HCL and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0237-2020·2019-12-18

    Kraft Cheese Nips Recalled for Foreign Plastic Contamination

    Kraft Foods Global Inc. is recalling specific boxes of Cheese Nips due to the presence of small food-grade yellow plastic pieces from a dough scraper.

    Product
    CHEESE NIPS (11 oz. BOX), Retail UPC - 0 44000 03453 5, Best When Used By Date - 18MAY20, 19MAY20, 20MAY20
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0585-2020·2019-12-18

    Anazao Health Recalls Bupivacaine and Hydromorphone Due to Fungal Contamination

    Anazao Health is recalling Bupivacaine HCl and Hydromorphone HCl products because environmental sampling detected Talaromyces rotundus, a fungus.

    Product
    Bupivacaine HCl and Hydromorphone HCl in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0640-2020·2019-12-18

    Integra C7000 CUSA Clarity System Recall for Sterilization Tray Drying Defect

    Integra LifeSciences is recalling the C7000 CUSA Clarity System because the 36 kHz Sterilization Tray requires 40 minutes to dry, not the 30 minutes stated in the manual.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0641-2020·2019-12-18

    Integra LifeSciences Recalls C7000 CUSA Clarity Ultrasonic Tissue Ablation System

    Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the 36 kHz Sterilization Tray does not meet the required dry time criteria.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0661-2020·2019-12-18

    Young Dental Recalls Oral-B Fluoride Varnish Due to Shelf Life Labeling

    Young Dental Manufacturing Co, LLC is recalling Oral-B 5% Sodium Fluoride Varnish because the product shelf life may be shorter than indicated on the label.

    Product
    Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the reduction of post-operative sensitivity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0669-2020·2019-12-18

    Roche Recalls Anti-HAV IgM Assay Due to Software Error

    Roche Diagnostics is recalling 712 units of the Elecsys Anti-HAV IgM assay because a software error caused incorrect test settings to be downloaded.

    Product
    Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma Catalog number: 07026773190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0636-2020·2019-12-18

    Integra CUSA Clarity System Recalled for Sterilization Tray Drying Defect

    Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the sterilization tray does not meet the required drying time criteria.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states
  • ModerateFDA (Devices)·Z-0642-2020·2019-12-18

    Integra LifeSciences Recalls C7000 CUSA Clarity Ultrasonic Tissue Ablation System

    Integra LifeSciences is recalling the C7000 CUSA Clarity Ultrasonic Tissue Ablation System because the 36 kHz Sterilization Tray does not meet the required drying time criteria.

    Product
    C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
    Category
    Medical Device
    Distribution
    36 states

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