The Recall Desk

Archive

November 2018 recalls

846 recalls were announced in November 2018.

What the numbers show

Critical
142
Severe
250
High
301
Moderate
124
Low
29

Of the 846 recalls this month scored against our rubric, 17% are Critical, 30% are Severe.

501–600 of 846

  • HighFDA (Devices)·Z-0394-2019·2018-11-14

    Zimmer Biomet Recalls RapidFlap SpinDown Clamps Due to Assembly Error

    Zimmer Biomet is recalling RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The defect affects 11,736 units distributed worldwide.

    Product
    Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1020-12 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0393-2019·2018-11-14

    Zimmer Biomet Recalls RapidFlap SpinDown Clamp Due to Assembly Error

    Zimmer Biomet is recalling 12,825 units of the RapidFlap System 12mm SpinDown Clamp because the nut was assembled incorrectly. The defect affects sterile clamps used for craniotomy bone flap re-attachment.

    Product
    Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0403-2019·2018-11-14

    Request Foods Recalls Beecher's Enchilada Bowls for Listeria and Salmonella Risk

    Request Foods Incorporated is recalling Beecher's Enchilada Bowl Verde due to potential contamination with Listeria monocytogenes and Salmonella.

    Product
    Beecher's Enchilada Bowl Verde 9oz. UPC 82045 11382 Frozen 8, 9oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0389-2019·2018-11-14

    Kashi Fire Roasted Quinoa Bowl Recalled for Listeria and Salmonella Risk

    Request Foods Incorporated is recalling Kashi Fire Roasted Quinoa Bowls because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Kashi, Fire Roasted Quinoa Bowl 9.5oz. UPC 18627 10769 Frozen 8, 9.5oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0395-2019·2018-11-14

    Request Foods Recalls Jenny Craig Butternut Squash Ravioli for Contamination

    Request Foods Incorporated is recalling Jenny Craig Butternut Squash Ravioli because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Jenny Craig Butternut Squash Ravioli 7.5oz. UPC 55447 00625 Frozen 30, 7.5oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0397-2019·2018-11-14

    Request Foods Recalls Curry Jackfruit Bowls Due to Listeria and Salmonella Risk

    Request Foods Incorporated is recalling The Jackfruit Company Curry Jackfruit Bowls because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    The Jackfruit Company Curry Jackfruit Bowl 9oz. UPC 59806 00344 Frozen 6, 9oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0424-2019·2018-11-14

    Kroger Frozen Alaskan Salmon Bites Recalled for Listeria and Salmonella Risk

    Trident Seafoods is recalling Kroger brand frozen Alaskan Salmon Bites due to potential contamination with Listeria monocytogenes or Salmonella in the vegetable ingredient.

    Product
    Kroger brand. Frozen non-ready to eat Alaskan Salmon Bites, Net Wt 12 oz (340 g). SKU # 83091. UPC on retail package: 0 11110 83091 3. UPC on master case: 1 00 11110 83091 0 The label is read in parts: "***Kroger ***multi-grain Breaded ALASKAN SALMON BITES ***COOKING INSTRUC
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0368-2019·2018-11-14

    Tropical Dreams Vegan Chocolate Ice Cream Recalled for Undeclared Soy Oil

    Edney and Sellers, Ltd. is recalling Tropical Dreams Super Premium Ice Cream Vegan Chocolate because soy oil was not declared on the package label.

    Product
    Tropical Dreams Super Premium Ice Cream Vegan Chocolate ; Pint container; UPC 685450676526 Ingredients: Coconut milk, organic sugar, water, cocoa powder, malt syrup. . Food Allergy warning: This product was prepared at facilities where milk, eggs, wheat, peanuts, tree nut
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0390-2019·2018-11-14

    Cordis POWERFLEX PRO PTA Dilatation Catheter Recalled for Burst Strength Failure

    Cordis Corporation is recalling 162 units of POWERFLEX PRO PTA Dilatation Catheters because they may not meet internal manufacturing burst strength specifications.

    Product
    Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The dev
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0378-2019·2018-11-14

    Request Foods Recalls Evol Portabella Goat Cheese Ravioli for Contamination Risk

    Request Foods Incorporated is recalling Evol Portabella Goat Cheese Ravioli because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Evol Portabella Goat Cheese Ravioli 18oz UPC 91627 00789 Frozen 4, 18oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0396-2019·2018-11-14

    Zimmer Biomet Recalls RapidFlap SpinDown Clamps Due to Assembly Error

    Zimmer Biomet is recalling 11,580 RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The devices are used to re-attach bone flaps after craniotomy.

    Product
    Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1030-12 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0386-2019·2018-11-14

    Request Foods Recalls Kashi Sweet Potato Quinoa Bowls for Contamination

    Request Foods Incorporated is recalling Kashi Sweet Potato Quinoa Bowls because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Kashi, Sweet Potato Quinoa Bowl 9oz. UPC 18627 10547 Frozen 8, 9oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0409-2019·2018-11-14

    Nutranext Toxin Absorber Peppermint Leaf Recalled for Elevated Lead Levels

    Nutranext Business LLC is recalling Toxin Absorber with Organic Peppermint Leaf packets due to elevated lead levels identified during routine quality testing.

    Product
    Toxin Absorber with Organic Peppermint Leaf - 14 packets and 30 packets
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0381-2019·2018-11-14

    Request Foods Recalls Udi's Broccoli & Kale Lasagna Due to Contamination Risk

    Request Foods Incorporated is recalling Udi's Broccoli & Kale Lasagna because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Udi's, Broccoli & Kale Lasagna 8 oz. UPC 98997 80801 Frozen 6, 8oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0394-2019·2018-11-14

    Request Foods Recalls Roasted Vegetable Lasagna Due to Listeria and Salmonella Risk

    Request Foods Incorporated is recalling PC President's Choice Roasted Vegetable Lasagna because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    PC Presidents Choice Roasted Vegetable Lasagna 1.13kg. UPC 60383 75647 Frozen 12 units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0398-2019·2018-11-14

    Request Foods Recalls Jackfruit Bowls Due to Listeria and Salmonella Risk

    Request Foods Incorporated is recalling The Jackfruit Company Enchilada Jackfruit Bowls because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    The Jackfruit Company Enchilada Jackfruit Bowl 9.5oz. UPC 59806 00341 Frozen 6, 9.5oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0375-2019·2018-11-14

    Request Foods Recalls Evol Butternut Squash Ravioli for Contamination

    Request Foods Incorporated is recalling Evol Butternut Squash & Sage Ravioli because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Evol Butternut Squash & Sage Ravioli 18oz. UPC 91627 00776 Frozen 4, 18oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0373-2019·2018-11-14

    ALDI Fit & Active Southwest Veggie Stuffed Sandwiches Recalled for Contamination

    J&J Snack Foods is recalling ALDI Fit & Active Southwest Veggie Stuffed Sandwiches because the vegetables used may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Fit & Active Southwest Veggie Stuffed Sandwiches NET WT 9 oz (255 g) KEEP FROZEN Distributed by ALDI Inc. Batavia, IL 60510 UPC 0 41498 15117 1
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0431-2019·2018-11-14

    New Seasons Market Hot & Sour Broth Recalled for Undeclared Soy

    New Seasons Market LLC is recalling 1,908 jars of Hot & Sour Broth because the product contains soy but the label does not declare it.

    Product
    New Seasons Market Hot & Sour Broth, packaged in 24 oz glass jar. UPC 840600108672
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0387-2019·2018-11-14

    Request Foods Recalls Kashi Black Bean Mango Bowls for Contamination

    Request Foods Incorporated is recalling Kashi Black Bean Mango Bowls because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Kashi, Black Bean Mango Bowl 10oz. UPC 18627 10607 Frozen 8, 10oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0388-2019·2018-11-14

    Kashi Mayan Harvest Bake Bowl Recalled for Listeria and Salmonella Risk

    Request Foods Incorporated is recalling Kashi Mayan Harvest Bake Bowls because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Kashi, Mayan Harvest Bake Bowl 10oz. UPC 18627 10605 Frozen 8, 10oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0374-2019·2018-11-14

    Request Foods Recalls Evol Butternut Squash & Sage Ravioli

    Request Foods Incorporated is recalling Evol Butternut Squash & Sage Ravioli due to possible contamination with Listeria monocytogenes and Salmonella.

    Product
    Evol Butternut Squash & Sage Ravioli 8oz. UPC 98997 80974 Frozen 6, 8oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0364-2019·2018-11-14

    Tyson Recalls TGIF All American Sliders for Listeria and Salmonella Risk

    Tyson Foods is recalling TGIF All American Sliders due to potential contamination with Listeria monocytogenes and Salmonella.

    Product
    TGIF All American Slider, item 5461, 4 cartons of 4 sandwiches per case NET WT 10 OZ KEEP FROZEN
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0391-2019·2018-11-14

    Request Foods Recalls Kashi Coconut Lemongrass Rice Bowls Due to Contamination Risk

    Request Foods Incorporated is recalling Kashi Coconut Lemongrass Rice Bowls because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Kashi, Coconut Lemongrass Rice Bowl 9oz. UPC 18627 10765 Frozen 8, 9oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0390-2019·2018-11-14

    Kashi Pesto Chickpea Quinoa Bowls Recalled for Listeria and Salmonella

    Request Foods Incorporated is recalling Kashi Pesto Chickpea Quinoa Bowls because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Kashi, Pesto Chickpea Quinoa Bowl 9oz. UPC 18627 10771 Frozen 8, 9oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0400-2019·2018-11-14

    Request Foods Recalls Beecher's Mariachi Mac & Cheese Due to Contamination Risk

    Request Foods Incorporated is recalling Beecher's Mariachi Mac & Cheese because ingredients may be contaminated with Listeria monocytogenes and Salmonella.

    Product
    Beecher's Mariachi Mac & Cheese 20oz. UPC 82045 11274 Frozen 8, 20oz. units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·18V803000·2018-11-14

    Volkswagen and Audi Recall 2018 Models for Rear Seat Weld Defect

    Volkswagen and Audi are recalling 2018 e-Golf, Golf R, A3, and RS3 vehicles because incorrectly welded rear seat head restraint guide sleeves may reduce stability in a crash.

    Product
    AUDI — AUDI, VOLKSWAGEN A3 CABRIOLET, GOLF R, RS 3, E-GOLF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0218-2019·2018-11-14

    Janssen Recalls Ortho-Novum 7/7/7 Tablets Due to Incorrect Dispenser Instructions

    Janssen Pharmaceuticals is recalling Ortho-Novum 7/7/7 tablets because the packaging included instructions for the wrong type of pill dispenser.

    Product
    Ortho-Novum 7/7/7 (norethindrone/ethinyl/estradiol) Tablets, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, 1 mg/0.035, 28-Day Regimen per pouch, packaged in a) 6 Veridate Tablet Dispensers and 6 Refill pouches (NDC 504-58-178-28) per carton (NDC 50458-178-06); and b) 12 Veridate Tablet Disp
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0399-2019·2018-11-14

    Zimmer Biomet Recalls StageOne Hip Cement Spacer Molds

    Zimmer Biomet is recalling 72 units of StageOne Hip cement spacer molds due to a potential for comingling of 43MM and 51MM sizes.

    Product
    StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. They are designed to be filled with polymethylmethacrylate/gentamicin bone cem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0404-2019·2018-11-14

    Medtronic Navigation 0-arm 02 Imaging System Software and Hardware Recall

    Medtronic Navigation is recalling 641 O-arm 02 Imaging Systems to correct software version 4.1.0, update manuals and labels, and replace blown fuses in the AC power input circuit.

    Product
    Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI70002000 OARM BI70002000R SYS IMAGING 02 REFURB Model: BI70002000R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0217-2019·2018-11-14

    Janssen Recalls Ortho-Novum 1/35 Due to Incorrect Dispenser Instructions

    Janssen Pharmaceuticals is recalling Ortho-Novum 1/35 tablets because the packaging included instructions for the wrong type of pill dispenser.

    Product
    Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen per pouch (NDC 50458-176-28), 6 Veridate Tablet Dispensers and 6 refills per carton (NDC 50458-176-06), Rx only, Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674; Manufactured
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0247-2019·2018-11-14

    Medline Recalls SparkleFresh Toothpaste Due to Microbial Contamination

    Medline Industries is recalling SparkleFresh fluoride toothpaste nationwide due to microbial contamination of the non-sterile product.

    Product
    SPARKLEFRESH — SPARKLEFRESH (SODIUM MONOFLUOROPHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0256-2019·2018-11-14

    Healthful Naturals Leg Cramp Support Oral Spray Recalled for CGMP Deviations

    Silver Star Brands is recalling Healthful Naturals Leg Cramp Support Oral Spray due to manufacturing deviations that could result in possible microbial contamination.

    Product
    Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906 NDC 68703-206-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0376-2019·2018-11-14

    Coltene Whaledent Recalls ParaPost Plus Titanium Dental Posts

    Coltene Whaledent Inc is recalling ParaPost Plus 25 Titanium Alloy dental posts because they contain stainless steel posts that are a size 4.

    Product
    ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0401-2019·2018-11-14

    Safe N Simple Recalls Hydrogel Wound Dressings Due to Sterilization Issues

    Safe N Simple, LLC is recalling 125 cases of Simpurity Hydrogel Absorbent Sheet Wound Dressings because the sterilization process used was unqualified. The affected products were distributed in California.

    Product
    Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0403-2019·2018-11-14

    DT MedTech Recalls Ankle Implant Due to Incorrect Package Labeling

    DT MedTech is recalling specific talar implants for ankle joints because the package labels incorrectly identify the device.

    Product
    DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0367-2019·2018-11-14

    Tropical Dreams Ice Cream Recalled for Undeclared Soy Oil

    Edney and Sellers, Ltd. is recalling Tropical Dreams Super Premium Ice Cream in Toasted Coconut flavor because soy oil was not declared on the label.

    Product
    Tropical Dreams Super Premium Ice Cream Toasted Coconut; Pint container; UPC 7 66150 09985 0 Ingredients: Cream, Sugar, coconut milk powder, water, toasted coconut, carob bean gum and guar gum (stabilizer), dextrose. Food Allergy warning: This product was prepared at facil
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0405-2019·2018-11-14

    Integrity Implants Recalls FlareHawk Interbody Fusion System Instructions for Use

    Integrity Implants is correcting Instructions for Use for the FlareHawk Interbody Fusion System due to discrepancies in cleaning parameters.

    Product
    FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product Usage: Indicated for spinal intervertebral body fusion with autogenous bone graft in skeletally mature individuals with degenerative disc disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0385-2019·2018-11-14

    CareFusion Recalls Alaris Infusion Pump Administration Sets Due to Priming Issues

    CareFusion 303, Inc. is recalling Alaris Infusion Pump administration sets because users reported being unable to prime the devices.

    Product
    Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP FITMENT ON PUMP SEGMENT IS OPEN, Fluid path is STERILE and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0374-2019·2018-11-14

    GE Healthcare Recalls Centricity PACS-IW Software Due to Synchronization Failure

    GE Healthcare is recalling 13 units of Centricity PACS-IW software due to a synchronization failure that may affect the display of medical images.

    Product
    Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Food)·F-0369-2019·2018-11-14

    Tropical Dreams Vegan Coconut Ice Cream Recalled for Undeclared Soy Oil

    Edney and Sellers, Ltd. is recalling Tropical Dreams Super Premium Ice Cream Vegan Coconut because soy oil was not declared on the package label.

    Product
    Tropical Dreams Super Premium Ice Cream Vegan Coconut; Pint container; UPC: 7 66150 09985 0 Ingredients: Coconut milk, organic sugar, carob bean gum and guar gum (stabilizer), dextrose. Food Allergy warning: This product was prepared at facilities where milk, eggs, wheat,
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0377-2019·2018-11-14

    AROA Endoform Dermal Template Recalled for Potential Pouch Seal Failure

    AROA Biosurgery is recalling Endoform Dermal Template 2x2 units due to a potential for pouch seal failure.

    Product
    Endoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0392-2019·2018-11-14

    Ortho-Clinical Diagnostics Recalls VITROS Vitamin B12 Reagent Packs

    Ortho-Clinical Diagnostics is recalling VITROS Vitamin B12 Reagent Packs due to a potential for increased calibration failures.

    Product
    VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 360
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0380-2019·2018-11-14

    Randox Liquid Cardiac Control CQ5051 Recalled for Unacceptable Variation

    Randox Laboratories is recalling Liquid Cardiac Control CQ5051 because the product is no longer suitable for controlling the Troponin T assay due to unacceptable variation between vials.

    Product
    Liquid Cardiac Control, CQ5051
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0223-2019·2018-11-14

    Tailor Made Compounding Recalls Tesamorelin Vials Due to Incorrect Expiration Dates

    Tailor Made Compounding is recalling 10,280 vials of Tesamorelin because the labels indicate a 1-year expiration date instead of the correct 6-month date.

    Product
    Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection, Rx Only, Tailor Made Compounding, Nicholasville, KY 40356
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0382-2019·2018-11-14

    Randox Recalls Liquid Cardiac Control CQ5053 Due to Unacceptable Variation

    Randox Laboratories is recalling Liquid Cardiac Control CQ5053 because the product is no longer suitable for controlling the Troponin T assay due to unacceptable variation between vials.

    Product
    Liquid Cardiac Control, CQ5053
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0402-2019·2018-11-14

    DT MedTech Recalls Ankle Joint Inlays Due to Incorrect Package Labeling

    DT MedTech is recalling 54 units of Hintermann Series H3 Poly Inlays because the package labeling incorrectly identifies the device.

    Product
    DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0221-2019·2018-11-14

    S.C. Johnson Recalls Alcohol-Free Foaming Hand Sanitizer Due to CGMP Deviations

    S.C. Johnson Professional is recalling 258 cases of Alcohol Free Foaming Hand Sanitizer because the product was released to market prior to microbiological testing.

    Product
    Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Safe-T-Fresh Inc., USA, 2530 Xenium Lane North, Minneapolis, MN 55441.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0220-2019·2018-11-14

    S.C. Johnson Recalls Deb Stoko Refresh AntiBac Foam Due to CGMP Deviations

    S.C. Johnson Professional is recalling 869 cases of Deb Stoko Refresh AntiBac Foam because the product was released to market before microbiological testing was completed.

    Product
    deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Made in the USA, Deb USA, Inc., Charlotte, NC 28217, NDC 11084-010-27.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0406-2019·2018-11-14

    Aldi Recalls Millville Maple & Brown Sugar Instant Oatmeal Due to Insects

    Aldi is recalling Millville Maple & Brown Sugar Instant Oatmeal because of complaints of insects in the product. The recall affects 37,200 units sold in 17 states.

    Product
    Millville Maple & Brown Sugar Instant Oatmeal 15.1 oz. 10 individual serving size packets per 15.1oz retail unit. UPC: 041498 149628
    Category
    Food
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0383-2019·2018-11-14

    Qiagen EZ1 Advanced XL Recalled for Potential Heater Malfunction

    Qiagen is recalling 298 EZ1 Advanced XL instruments due to a power board defect that may cause heater malfunctions and compromise nucleic acid extractions.

    Product
    EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isolation and purification of nucleic acids. It is intended to be used only in combination with QIAGEN kits indicated for use with the EZ1 Advanced
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0381-2019·2018-11-14

    Randox Recalls Liquid Cardiac Control CQ5052 Due to Unacceptable Variation

    Randox Laboratories is recalling Liquid Cardiac Control CQ5052 because the product is no longer suitable for controlling the Troponin T assay due to unacceptable variation between vials.

    Product
    Liquid Cardiac Control, CQ5052
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Devices)·Z-0410-2019·2018-11-14

    R&D Systems Recalls Vitamin D ELISA Kits Due to Labeling Error

    R&D Systems is recalling eight Human Total 25-OH Vitamin D IVD ELISA Kits because they were shipped without lot-specific booklets and contained a calibrator vial with an incorrect reconstitution volume label.

    Product
    R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Drugs)·D-0219-2019·2018-11-14

    Orexigen Recalls Contrave Tablets Due to Container Packaging Defect

    Orexigen Therapeutics is recalling 18,895 bottles of Contrave extended-release tablets due to a container packaging defect. The affected lot is ZYCY with an expiration date of 04/11/2021.

    Product
    CONTRAVE — CONTRAVE (NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-0389-2019·2018-11-14

    Medtest AutoHDL/LDL Cholesterol Calibrator Recalled for Missing Vial Labels

    Medtest Holdings is recalling 22 vials of AutoHDL/LDL Cholesterol Calibrator shipped without labels in five states.

    Product
    Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·19715·2018-11-13

    YTL International Recalls County Line Log Splitters Due to Injury Hazard

    YTL International is recalling about 1,460 County Line log splitters because welding on the tongue box assembly can crack, causing the tank to disconnect and posing an injury hazard.

    Product
    County Line log splitters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V800000·2018-11-13

    Volvo Recalls 2017-2019 Models Due to Telematics Software Error

    Volvo is recalling 2017-2019 models because a software error may prevent GPS location data from reaching emergency personnel during a crash.

    Product
    VOLVO — VOLVO XC90, V60, S90, XC60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V796000·2018-11-12

    Coach and Equipment Recalls 2015-2018 Phoenix and Metro Lite Buses

    Coach and Equipment is recalling 864 transit buses because foldaway seats may not lock properly, increasing injury risk in crashes.

    Product
    COACH AND EQUIPMENT — COACH AND EQUIPMENT PHOENIX, METRO LITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V798000·2018-11-12

    Champion and Goshen Transit Buses Recalled for Seat Lock Defect

    Champion Bus is recalling 2017-2018 transit buses because foldaway seats may not stay locked during a crash or sudden stop, increasing injury risk.

    Product
    CHAMPION — CHAMPION, GOSHEN LF TRANSPORT, CHALLENGER, G-FORCE, IMPULSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V799000·2018-11-12

    Starcraft Transit Bus Recall for Foldaway Seat Locking Defect

    Forest River is recalling specific Starcraft transit buses because foldaway seat cushions may not stay locked in a crash, increasing injury risk.

    Product
    STARCRAFT BUS — STARCRAFT BUS, STARCRAFT SENATOR II, ALLSTAR, STARLITE, STARQUEST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·110-2018·2018-11-09

    NuVue Foods Recalls Chicken Burritos Due to Undeclared Egg Allergen

    NuVue Foods is recalling 18th Street Deli Chicken Burritos because they contain egg, an undeclared allergen. The products were distributed in Indiana, Michigan, and Ohio.

    Product
    NuVue Foods — NuVue Foods Recalls Burrito Products due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·18V788000·2018-11-09

    Eldorado National Recalls 2014-2018 Vans Due to Seat Lock Defect

    Eldorado National is recalling 2014-2018 Aerolite, Aerotech, Impulse, and World Trans vans because foldaway seats may not stay locked during a crash, increasing injury risk.

    Product
    GOSHEN — GOSHEN, ELDORADO IMPULSE, AEROLITE, AEROTECH, WORLD TRANS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V792000·2018-11-09

    Altec Recalls 2017-2018 Aerial Devices Due to Wiring Fire Risk

    Altec is recalling 186 aerial devices from 2017-2018 because under-hood wiring may be damaged by sharp edges, increasing the risk of a fire.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V794000·2018-11-09

    Terex Recalls 2017-2018 Digger Derrick Vehicles Due to Weld Defect

    Terex is recalling 2017-2018 Digger Derrick vehicles because insufficient welds on the guide bar may cause the guide arm to fall, posing an injury risk to nearby personnel.

    Product
    TEREX — TEREX DIGGER DERRICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V791000·2018-11-09

    Altec Cranes and Digger Derricks Recalled for Wiring Fire Risk

    Altec is recalling 2008-2018 cranes and digger derricks because undersized wiring may overheat and cause a fire. Owners should contact Altec for a free repair.

    Product
    ALTEC — ALTEC CRANE, DIGGER DERRICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V790000·2018-11-09

    Keystone Recalls 2018-2019 Raptor Trailers Due to Tire Rubbing

    Keystone is recalling 2018-2019 Raptor recreational trailers because tires may rub against the frame, potentially affecting handling and increasing crash risk.

    Product
    KEYSTONE — KEYSTONE RAPTOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·19029·2018-11-08

    A. O. Smith Recalls Ultra-Low NOx Water Heaters Due to Fire Hazard

    A. O. Smith is recalling approximately 616,000 gas water heaters because a torn burner screen can cause excess heat and fire if installed on combustible floors.

    Product
    Ultra-Low NOx water heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19714·2018-11-08

    Honda Recalls Pioneer 1000 Vehicles Due to Fire and Burn Hazards

    Honda is recalling approximately 56,000 Pioneer 1000 recreational off-highway vehicles because an incorrectly installed throttle body can ignite, posing fire and burn hazards.

    Product
    Recreational off-highway vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V786000·2018-11-08

    Chrysler Recalls 2018 Jeep Wrangler Due to Door Latch Defect

    Chrysler is recalling 2018 Jeep Wrangler four-door vehicles because the right rear door latch may be misaligned, potentially preventing the door from latching properly.

    Product
    JEEP — JEEP WRANGLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19030·2018-11-08

    A. O. Smith Recalls 30-Gallon Gas Water Heaters Due to Fire Hazard

    A. O. Smith is recalling specific 30-gallon gas water heaters sold at Lowe's in California because the flame arrestor may fail, posing a fire risk.

    Product
    A. O. Smith 30 gallon gas water heaters with model number G6-UT3030N
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19031·2018-11-08

    Lifetone Bedside Fire Alarm and Clock Recalled for Failure to Alert

    Lifetone Technology is recalling HLAC151 Bedside Fire Alarm and Clocks because the optional bed shaker may fail to operate during a fire emergency.

    Product
    Bedside Fire Alarm and Clock
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19034·2018-11-08

    H.I.S. Recalls Girl's Clothing Sets with Lead-Containing Pendant Necklaces

    H.I.S. is recalling Self-Esteem brand girl's clothing sets because the included pendant necklaces contain lead levels exceeding federal bans. No injuries have been reported.

    Product
    Girl's clothing sets with pendant necklace
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0342-2019·2018-11-07

    Houlihan's Creamy Garlic Ranch Dressing Recalled for Undeclared Milk Allergen

    CFS West Holdings Inc. is recalling 293 cases of Houlihan's Creamy Garlic Ranch Dressing that may be mislabeled as Horseradish Sauce, failing to declare the milk allergen.

    Product
    Houlihan's Creamy Garlic Ranch Dressing potentially labeled as Horseradish Sauce, 1 gal containers Mfg. exclusively for: Houlihan's Restaurant, Inc. Leawood, KS
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0153-2019·2018-11-07

    Pharm D Solutions Recalls Glutamine Solution Due to Sterility Concerns

    Pharm D Solutions is recalling Glutamine 10 mg/mL Solution because the product lacks assurance of sterility. The recall covers specific lots distributed nationwide.

    Product
    Glutamine 10 mg/mL Solution, Pharm D Solutions, Houston, Texas ---- NDC 69699-1439-59
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0127-2019·2018-11-07

    Aurobindo Recalls Irbesartan Bulk Ingredient Due to Carcinogen Impurity

    Aurobindo Pharma is recalling Irbesartan bulk active ingredient because N-Nitrosodimethylamine (NDEA), a carcinogen, was detected. The product was distributed to one customer in New York.

    Product
    Irbesartan Bulk Active Pharmaceutical Ingredient.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0212-2019·2018-11-07

    Pharm D Solutions Recalls Zinc Sulfate Injectable Due to Sterility Concerns

    Pharm 184 vials of Zinc Sulfate 1 mg/mL MDV Injectable are being recalled nationwide due to a lack of assurance of sterility.

    Product
    Zinc Sulfate 1 mg/mL MDV Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1418-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0195-2019·2018-11-07

    Pharm D Solutions Recalls Trimix T 101 Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling Trimix T 101 Injectable due to a lack of assurance of sterility. The recall covers a specific lot distributed nationwide.

    Product
    Trimix T 101 Alprostadil/Papverine/Phentolamine 5.9 mcg/17.65 mg/0.59 mcg per mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1336-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0166-2019·2018-11-07

    Pharm D Solutions Recalls Lipo MIC-12 Compound Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling Lipo MIC-12 Compound Injectable vials nationwide due to a lack of assurance of sterility.

    Product
    Lipo MIC-12 Compound Injectable a) NDC 69699-1603-10; b) 30 mL Stock Solution Compound Injectable NDC 69699-1603-30, Pharm D Solutions, Houston, Texas
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0191-2019·2018-11-07

    Pharm D Solutions Recalls Tri-Mix Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling 609 vials of Tri-Mix Injectable due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Tri-Mix Papaverine/Phentolamine/Alprostadil 150 mg/5 mg/50 mcg a) Injectable NDC 69699-1332-05 b) (LYO) Powder NDC 69699-1332-05, Pharm D Solutions, Houston, Texas
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0179-2019·2018-11-07

    Pharm D Solutions Recalls Sermorelin/Ipamorelin Powder Due to Sterility Concerns

    Pharm D Solutions is recalling 179 vials of Sermorelin/Ipamorelin powder because the company cannot ensure the product is sterile.

    Product
    Sermorelin/Ipamorelin 18 mg/15 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1759-18
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0154-2019·2018-11-07

    Pharm D Solutions Recalls Glutathione Solution Due to Sterility Concerns

    Pharm D Solutions is recalling 4,000 mL of Glutathione 200 mg/mL Solution because the product lacks assurance of sterility.

    Product
    Glutathione 200 mg/mL Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1504-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0132-2019·2018-11-07

    Avella Recalls Fentanyl Syringes Due to Sterility Assurance Concerns

    Avella of Deer Valley is recalling 20 syringes of Fentanyl (10 mcg/mL) in NS 1 mL due to a lack of assurance of sterility.

    Product
    Fentanyl (10 mcg/mL) in NS 1 mL (in 3mL BD Syringe), Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0194-2019·2018-11-07

    Pharm D Solutions Recalls Trimix Injectable Due to Sterility Concerns

    Pharm D Solutions is recalling specific lots of Trimix QM10 Injectable because the company cannot ensure the product is sterile.

    Product
    Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1352-05
    Category
    Drug
    Distribution
    Distributed nationwide

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