The Recall Desk

Archive

January 2020 recalls

534 recalls were announced in January 2020.

What the numbers show

Critical
40
Severe
215
High
178
Moderate
85
Low
16

Of the 534 recalls this month scored against our rubric, 7% are Critical, 40% are Severe.

Which agencies issued them

301–400 of 534

  • ModerateFDA (Devices)·Z-0805-2020·2020-01-22

    Caire FreeStyle Comfort Oxygen Concentrators Recalled for Lack of US Clearance

    Caire, Inc. is recalling four European version FreeStyle Comfort Oxygen Concentrators because they were not cleared for use in the US.

    Product
    CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0809-2020·2020-01-22

    Medline Thermistor Foley Catheter Recalled for Temperature Deviation

    Degania Silicone is recalling 2,080 units of Medline Thermistor Foley Catheters because temperature readings did not meet release specifications.

    Product
    Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drainage.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0782-2020·2020-01-22

    Sigan Eczema Skin Relief Lotion Recalled for Microbial Contamination

    Sigan Industries is recalling Eczema Skin Relief Lotion due to microbial contamination. The product was distributed in Illinois.

    Product
    Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, NET WT 14 OZ (396 g), NDC 65365-266-01, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0522-2020·2020-01-22

    Bob's Red Mills Recalls Garbanzo Beans for Potential Glyphosate

    Bob's Red Mills is recalling specific 25 oz packages of Garbanzo Beans due to the potential presence of glyphosate. The recall affects products distributed in the US and several international locations.

    Product
    Garbanzo Beans or Chickpeas, sold under brand Bob's Red Mills, packaged into 25 oz Form & Fill Package or 25 oz Standup Package. 25 oz Form & Fill Package Package has UPC 039978004222. 25 oz Standup Package has UPC 039978114228
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0812-2020·2020-01-22

    Microbiologics Gram-Positive Blood Culture Control Panel Recall for Hydration Fluid Change

    Microbiologics Inc is recalling 810 units of the Gram-Positive Blood Culture Control Panel because the recommended hydration fluid has changed to sterile DI water or pH 7.2 phosphate buffer.

    Product
    Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0520-2020·2020-01-22

    Columbia Bean 13 Bean Soup Mix Recalled for Glyphosate Contamination

    Columbia Bean & Produce is recalling 13 Bean Soup Mix due to potential glyphosate contamination. The product was distributed in seven US states and Canada.

    Product
    The 13 Bean Soup Mix product is distributed in 2000 lb. totes without a brand name. The 13 Bean Soup Mix product is also packaged 25 lb. paper bags and sold under brand Columbia Bean & Produce, item # 035084322328.
    Category
    Food
    Distribution
    7 states
  • LowFDA (Devices)·Z-0797-2020·2020-01-22

    Teleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling

    Teleflex Medical is recalling RuSCH One piece Male External Medium Catheters because the labels incorrectly state the devices are sterile, though they are not required to be.

    Product
    Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape, REF A1500M
    Category
    Medical Device
    Distribution
    11 states
  • LowFDA (Drugs)·D-0789-2020·2020-01-22

    AuroMedics Recalls Moxifloxacin Ophthalmic Solution Due to Discoloration

    AuroMedics Pharma LLC is recalling Moxifloxacin Ophthalmic Solution due to market complaints of discoloration. The affected product is distributed nationwide in the U.S.

    Product
    MOXIFLOXACIN — MOXIFLOXACIN (MOXIFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0790-2020·2020-01-22

    Lupin Recalls Tri-Lo-Marzia Tablets Due to Blend Uniformity Deviations

    Lupin Pharmaceuticals is recalling specific lots of Tri-Lo-Marzia oral contraceptives due to out-of-specification test results found during a retrospective review of blend uniformity data.

    Product
    Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, Distributed by Lupin Pharmaceuticals, Inc, Baltimore MD 21202, Manufactured by: Lupin Limited, Pithampur, (M.P
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0796-2020·2020-01-22

    Teleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling

    Teleflex Medical is recalling RuSCH One piece Male External Regular Catheters because the labels incorrectly state the devices are sterile, though they are not required to be.

    Product
    Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500
    Category
    Medical Device
    Distribution
    11 states
  • SevereNHTSA·20V032000·2020-01-20

    Arcimoto Recalls 2019 FUV Motorcycles Due to Brake Line Wear Risk

    Arcimoto is recalling 2019 FUV motorcycles because the brake line may contact the steering main-link, potentially causing a loss of braking ability and increasing crash risk.

    Product
    ARCIMOTO — ARCIMOTO FUV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V026000·2020-01-17

    Honda, Acura, and Isuzu Recall Vehicles for Air Bag Inflator Defect

    Honda is recalling specific Acura, Honda, and Isuzu vehicles because driver air bag inflators may rupture or underinflate, posing a risk of injury.

    Product
    ISUZU — ISUZU, HONDA, ACURA OASIS, CIVIC, CR-V, EV PLUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V023000·2020-01-17

    Terex Advance Mixer Recalls 2020 Concrete Mixers Due to Axle Shaft Fracture Risk

    Terex Advance Mixer is recalling 2020 FDC300, FD4000, FD5000GL, and FD7000B vehicles because incorrectly heat-treated axle output shafts may fracture, causing loss of drive and increasing crash risk.

    Product
    TEREX ADVANCE — TEREX ADVANCE FDC300, FD5000GL, FD4000, FD7000B
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V027000·2020-01-17

    Honda Recalls Vehicles for Driver Air Bag Inflator Rupture Risk

    Honda is recalling specific 2000-2003 Acura and Honda vehicles because replacement driver air bag inflators may rupture or underinflate in a crash, increasing injury risk.

    Product
    ACURA — ACURA, HONDA MDX, CL, ODYSSEY, RL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V024000·2020-01-17

    Toyota Recalls Corolla, Matrix, Avalon Models for Air Bag Defect

    Toyota is recalling specific 2011-2019 Corolla, Matrix, Avalon, and Avalon Hybrid vehicles because the air bag control unit may malfunction, potentially preventing air bags and seat belt pretensioners from deploying in a crash.

    Product
    TOYOTA — TOYOTA AVALON, AVALON HYBRID, MATRIX, COROLLA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V022000·2020-01-17

    Hyundai Recalls 2020 Kona Vehicles for Incorrect Weight Rating Label

    Hyundai is recalling 2020 Kona vehicles because the certification label may display an incorrect Gross Axle Weight Rating. Dealers will replace the label to ensure compliance with federal safety standards.

    Product
    HYUNDAI — HYUNDAI KONA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V025000·2020-01-17

    Isuzu and Chevrolet Trucks Recalled for Seat Belt Webbing Defect

    Isuzu and Chevrolet trucks are being recalled because a manufacturing issue may prevent the seat belt webbing locking mechanism from properly restraining occupants.

    Product
    CHEVROLET — CHEVROLET, ISUZU 4500HD, 4500XD, NPR HD, NPR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V021000·2020-01-16

    Multiquip Recalls 2019 WT5C Trailers Due to Safety Chain Defect

    Multiquip is recalling 119 2019 WT5C trailers because incorrect safety chain attachment points may interfere with steering and increase crash risk.

    Product
    MULTIQUIP — MULTIQUIP WT5C
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20052·2020-01-16

    Baby Trend Recalls Tango Mini Strollers Due to Fall Hazard

    Baby Trend is recalling about 2,000 Tango Mini Strollers because hinge joints can release and collapse, posing a fall hazard to children.

    Product
    Tango Mini Strollers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0496-2020·2020-01-15

    Reichel Foods Recalls Pro2Snax Snack Trays Due to Listeria Contamination

    Reichel Foods Inc. is recalling Pro2Snax To The Max snack trays nationwide due to Listeria monocytogenes contamination.

    Product
    Pro2Snax To The Max snack tray containing Sweet Gala Apples, Hard Boiled Egg, White Cheddar Cheese, and Dried Cranberries & Almonds. Item # 1-4550-6. Net Wt. 7.35 oz (208g) UPC 6 49632-00148 3 Keep Refrigerated.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalNHTSA·20V018000·2020-01-15

    BMW Recalls 2000-2006 Models for Airbag Inflator Explosion Risk

    BMW is recalling 2000-2006 3-Series and M3 vehicles because front passenger airbag inflators may explode, sending metal fragments into the cabin.

    Product
    BMW — BMW 323IT, M3, 323I, 330CI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V019000·2020-01-15

    Winnebago Recalls 2020 Adventurer Motorhomes Due to Fire Risk

    Winnebago is recalling 2020 Adventurer motorhomes because a heat coil may fail to disengage, increasing the risk of a fire.

    Product
    WINNEBAGO — WINNEBAGO ADVENTURER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V016000·2020-01-15

    BMW Recalls X5 and X6 Models Due to Air Bag Inflator Defect

    BMW is recalling specific X5 and X6 models because passenger air bag inflators may explode, posing a risk of serious injury or death.

    Product
    BMW — BMW X5, X6, X6 ACTIVEHYBRID SAC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V014000·2020-01-15

    Triumph Recalls 2019-2020 Speed Twin Motorcycles for Gear Shift Defect

    Triumph is recalling 2019-2020 Speed Twin motorcycles because the gear shift lever linkage may separate, potentially preventing gear changes and increasing crash risk.

    Product
    TRIUMPH — TRIUMPH SPEED TWIN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0643-2020·2020-01-15

    Glenmark Recalls Ranitidine Tablets Due to NDMA Impurity

    Glenmark Pharmaceuticals is recalling Ranitidine Tablets USP 300 mg because the FDA detected the NDMA impurity in the product.

    Product
    Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-20
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0648-2020·2020-01-15

    Appco Pharma Recalls Ranitidine Capsules Due to NDMA Impurity

    Appco Pharma LLC is recalling Ranitidine Capsules 300 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0646-2020·2020-01-15

    AAA Pharmaceutical Recalls Ranitidine Tablets Due to NDMA Impurity

    AAA Pharmaceutical is recalling specific lots of Ranitidine 150 mg tablets because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0641-2020·2020-01-15

    Glenmark Recalls Ranitidine Tablets Due to NDMA Impurity

    Glenmark Pharmaceuticals is recalling Ranitidine Tablets USP 300 mg because of the presence of the NDMA impurity.

    Product
    Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-30
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-0495-2020·2020-01-15

    Reichel Foods Recalls Pro2Snax Snack Trays Due to Listeria Contamination

    Reichel Foods Inc. is recalling Pro2Snax To The Max snack trays due to Listeria monocytogenes contamination. The affected products were distributed nationwide.

    Product
    Pro2Snax To The Max snack tray containing Sliced Apples, Hard Boiled Egg, Mild Cheddar Cheese, and Dried Cranberries & Cashews. Item # 1-4555-6. Net Wt. 7.35 oz (208g) UPC 6 49632-00149 0 Keep Refrigerated.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V017000·2020-01-15

    BMW Recalls Vehicles for Driver Air Bag Inflator Explosion Risk

    BMW is recalling specific 2006-2015 models because driver air bag inflators may explode due to propellant degradation, posing a risk of serious injury or death.

    Product
    BMW — BMW 330I, 330XI, 128I, 1 SERIES M
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0645-2020·2020-01-15

    AAA Pharmaceutical Recalls Ranitidine Tablets Due to NDMA Impurity

    AAA Pharmaceutical is recalling Ranitidine 150 mg tablets because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0640-2020·2020-01-15

    Glenmark Recalls Ranitidine Tablets Due to NDMA Impurity

    Glenmark Pharmaceuticals is recalling 217,956 bottles of Ranitidine Tablets USP 150 mg nationwide because the product contains the NDMA impurity.

    Product
    Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-01
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-0462-2020·2020-01-15

    Sym-Pac Recalls Frozen Yellowfin Tuna Steaks Due to Histamine Levels

    Sym-Pac International Inc is recalling 2,000 cases of frozen Yellowfin Tuna Round Steaks after customer reports of illness and high histamine levels were identified.

    Product
    Tidal Seafood Yellowfin Tuna Round Steaks; Frozen Thunnus Albacares; Net Wt.: 20 lbs. 6-8 oz. individually vacuumed packed steaks distributed Globally by: Global Protein Group, Irvine, CA
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0639-2020·2020-01-15

    Glenmark Recalls Ranitidine Tablets Due to NDMA Impurity

    Glenmark Pharmaceuticals is recalling Ranitidine Tablets USP 150 mg because the product contains the NDMA impurity.

    Product
    Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-60
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0780-2020·2020-01-15

    Stryker T2 Alpha Delta Strike Plate Recalled for Breakage Risk

    Stryker GmbH is recalling T2 Alpha Delta Strike Plate instruments because they can break during nail implantation or removal, potentially causing complications.

    Product
    Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to support insertion and withdrawal of nails through the Targeting Device Catalog Number: 2351-0050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0644-2020·2020-01-15

    Glenmark Recalls Ranitidine Tablets Due to NDMA Impurity

    Glenmark Pharmaceuticals is recalling Ranitidine Tablets USP 150 mg because testing detected the presence of the NDMA impurity.

    Product
    Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-05
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0642-2020·2020-01-15

    Glenmark Recalls Ranitidine Tablets Due to NDMA Impurity

    Glenmark Pharmaceuticals is recalling Ranitidine Tablets USP 300 mg because the FDA detected the NDMA impurity in the product.

    Product
    Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-01
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0650-2020·2020-01-15

    Enovachem Recalls Estriol USP 0.06 g Due to Impurity Failures

    Asclemed USA Inc. dba Enovachem Pharmaceuticals is recalling Estriol, USP, (Micronized), 0.06 g, due to out-of-specification impurity test results.

    Product
    Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0649-2020·2020-01-15

    Appco Pharma Recalls Ranitidine Capsules Due to NDMA Impurity

    Appco Pharma LLC is recalling specific lots of Ranitidine Capsules 150 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

    Product
    Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-0483-2020·2020-01-15

    Nestle Toll House Turtle Cookie Bars Recalled for Rubber Pieces

    Nestle Toll House Ultimate Turtle Delight Cookie Bars are being recalled due to the potential presence of food-grade rubber pieces.

    Product
    Nestle Toll House Ultimate Turtle Delight Cookie Bar (16oz), UPC 050000009282
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0499-2020·2020-01-15

    Purely Elizabeth Granola Recalled for Undeclared Walnut Allergen

    Purely Elizabeth is recalling Chocolate Sea Salt probiotic granola because it was packaged in bags that may contain undeclared walnuts.

    Product
    purely elizabeth Chocolate Sea Salt probiotic granola. Net Wt. 8 oz (227g). UPC 55140-00268. Made with organic quinoa, amaranth and chia. Contains Coconut. May contain Walnuts, Cashews and Almonds. Made in a facility that also processes soy, milk, eggs, peanuts and other tr
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0781-2020·2020-01-15

    Stryker Pin To Rod Coupling Recalled for Clamping Failure

    Stryker is recalling Pin To Rod Couplings for the Hoffmann II Compact External Fixation System because they may fail to clamp the pin and rod as intended.

    Product
    Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) articular Intercarpal fracture dislocations Unstable forearm fractures Un
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0791-2020·2020-01-15

    Implant Direct IO Scan Adapter Recall Due to Loose Component

    Implant Direct Sybron Manufacturing is recalling 232 IO Scan Adapters because a loose part could fall into a patient's mouth, causing aspiration or ingestion.

    Product
    ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-0787-2020·2020-01-15

    Intersurgical Airway Connector Recalled for Potential Swivel Elbow Cracking

    Intersurgical Inc is recalling 50,400 airway connectors because the swivel elbow port may crack and leak. The recall covers products distributed nationwide in the US.

    Product
    Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3521000. Airway connector.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0506-2020·2020-01-15

    Bay State Milling Recalls Sesame Seeds for Salmonella Contamination

    Bay State Milling Co. is recalling SimplySafe Sesame Seed Hulled due to potential Salmonella contamination. The product was distributed in Wisconsin, Colorado, and Kentucky.

    Product
    SimplySafe Sesame Seed Hulled; 49lbs bag; Lot #PBAT10025110
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0467-2020·2020-01-15

    Hannaford Macaroni and Cheese Recalled for Listeria Contamination Risk

    R. Walters Limited is recalling Hannaford brand Macaroni and Cheese due to potential Listeria monocytogenes contamination. The product was distributed in New Hampshire, Maine, Massachusetts, and New York.

    Product
    Hannaford brand Macaroni and Cheese, NET WEIGHT 12 OZ (340g); KEEP REFRIGERATED; UPC: 0 4126821062 6; Heating Instructions: Microwave: Remove lid. Heat for 3 minutes or until temperature reaches 165 degrees F. Let stand for 2 minutes and serve.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0775-2020·2020-01-15

    Medacta Shoulder Implant Recall Due to Screw Insertion Limitation

    Medacta USA Inc. is recalling specific lots of Humeral Anatomical Cementless Metaphysis implants because a dimensional condition may limit the insertion of the locking screw.

    Product
    Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0471-2020·2020-01-15

    Nestle Toll House Chocolate Chip Chub Recalled for Rubber Pieces

    Gerber Products Company is recalling Nestle Toll House Chocolate Chip Chub due to potential food-grade rubber pieces.

    Product
    Nestle Toll House Chocolate Chip Chub (30oz), UPC 050000274444
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0505-2020·2020-01-15

    Limena Salvadorean String Cheese Recalled for Listeria Risk

    Limena, LLC is recalling 1 lb. Quesillo Salvadoreno Para Pupusa String Cheese due to potential Listeria monocytogenes contamination.

    Product
    Quesillo Salvadoreno Para Pupusa Salvadorean String Cheese; 1 lb.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0789-2020·2020-01-15

    Abbott Recalls Fast-Cath Hemostasis Introducers Due to Incorrect Size

    Abbott Medical is recalling 380 Fast-Cath Hemostasis Introducers because three lots contained 8F components instead of the labeled 8.5F size.

    Product
    Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0468-2020·2020-01-15

    Nestle Toll House Cookie Dough Recalled for Potential Rubber Pieces

    Gerber Products Company is recalling Simply Delicious Nestle Toll House Chocolate Chip Cookie Dough due to the potential presence of food-grade rubber pieces.

    Product
    Simply Delicious Nestle Toll House Chocolate Chip Cookie Dough (18oz), UPC 050000688760
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0494-2020·2020-01-15

    Nancy Adams Dark Chocolate Graham Crackers Recalled for Undeclared Milk

    Nassau Candy Distributors is recalling Nancy Adams Dark Chocolate Graham Crackers because the product contains undeclared milk.

    Product
    NANCY ADAMS DARK CHOCOLATE Graham Crackers, NET WT 7.5 OZ (212G); UPC 618645275860; packaged in a brown paper bag with a clear window
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-0782-2020·2020-01-15

    Siemens Cios Alpha Mobile X-Ray System Recalled for C-Arm Holder Crack

    Siemens Medical Solutions is recalling Cios Alpha mobile X-ray systems because a crack in the C-arm holder could compromise stability and lead to injury.

    Product
    Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0481-2020·2020-01-15

    Nestle Toll House Cookie Dough Bars Recalled for Potential Rubber Pieces

    Gerber Products Company is recalling Nestle Toll House Triple Chip Cookie Dough Bars due to the potential presence of food-grade rubber pieces.

    Product
    Nestle Toll House Triple Chip Cookie Dough Bar (16oz), UPC 050000856237
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0790-2020·2020-01-15

    Implant Direct IO Scan Adapter Recalled Due to Loose Component

    Implant Direct is recalling 274 IO Scan Adapters because a loose part could fall into a patient's mouth, posing a risk of aspiration or ingestion.

    Product
    ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Food)·F-0489-2020·2020-01-15

    Nestle Toll House Oatmeal Raisin Cookie Bars Recalled for Rubber Pieces

    Gerber Products Company is recalling Nestle Toll House Oatmeal Raisin Cookie Bars due to the potential presence of food-grade rubber pieces.

    Product
    Nestle Toll House Oatmeal Raisin Cookie Bar (16.5oz), UPC 050000062195
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0793-2020·2020-01-15

    Baxter Recalls Clearlink Continu-Flo Administration Sets Due to Connection Force Issue

    Baxter Healthcare is recalling Clearlink System Continu-Flo Administration Sets because some units require higher-than-expected force to connect securely.

    Product
    Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the administration of fluids from a container into the patients vascular system through a vascular access device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0788-2020·2020-01-15

    Avanos Recalls Haylard Closed Suction Systems Due to Blocked Lumens

    Avanos Medical is recalling Haylard Closed Suction Systems for neonates and pediatrics because the central lumen may be blocked, potentially preventing adequate suctioning of airway secretions.

    Product
    Haylard Closed Suction System for Neonates/Pediatrics, 5 Fr, 1. REF 195, Y-Adapter, SAP Finished Product Code 109382303; 2. REF 201, with BALLARD Technology, SAP Finished Product Code 109382803; 3. REF 202, Elbow, SAP Finished Product Code 109382903; 4. REF 195-5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0784-2020·2020-01-15

    Intersurgical Double Swivel Elbow Airway Connectors Recalled for Cracking Risk

    Intersurgical Inc is recalling 115,200 Double Swivel Elbow airway connectors because the port may crack and leak.

    Product
    Double Swivel Elbow with Bronchoscopy Port 15MM OD, 22MM OD/15MM ID, REF 1898000. Airway connector.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0786-2020·2020-01-15

    Intersurgical Airway Connector Recalled for Potential Swivel Elbow Cracking

    Intersurgical Inc is recalling 19,200 airway connectors because the swivel elbow port may crack and leak.

    Product
    Superset with 22MM ID, Double Swivel Elbow 22MM OD/15MM ID and Bronchoscopy Port, REF 3503031. Airway connector.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0559-2020·2020-01-15

    Grey Ghost Bakery Lemon Sugar Cookies Recalled for Undeclared Sulfites

    Grey Ghost Bakery is recalling Lemon Sugar cookies in various sizes due to undeclared sulfites. The product was distributed to numerous states across the US.

    Product
    GREY GHOST BAKERY scratch-made cookies LEMON SUGAR NET WT 1.4 OZ (40 G), UPC 8 53152 00308 1 , 4 OZ (113 G) UPC 8 53152 00332 6 & 8 OZ (225 G) UPC 8 53152 00307 4 GREY GHOST BAKERY 1750 SIGNAL POINT RD, STE 2A CHARLESTON, SC 29412
    Category
    Food
    Distribution
    41 states
  • ModerateFDA (Devices)·Z-0777-2020·2020-01-15

    Nextremity Solutions Recalls Stratum MDS Screws Due to Length Discrepancy

    Nextremity Solutions is recalling 86 Stratum MDS Screws because the components are 2mm shorter than indicated on the package label.

    Product
    Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0783-2020·2020-01-15

    Idelle Labs Recalls SURE 48 hr Anti-Perspirant for Labeling Error

    Idelle Labs is recalling SURE 48 hr Confidence Unscented Anti-Perspirant & Deodorant because the label lists an active ingredient that is not actually in the product.

    Product
    SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant, Net Wt. 2.6 oz (73g) NDC# 41595-5509-2 UPC 8 83484 71717 2 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0652-2020·2020-01-15

    Enovachem Recalls Estriol USP Micronized 0.24 g Due to Impurity Failures

    Enovachem Pharmaceuticals is recalling Estriol USP (Micronized) 0.24 g because additional testing revealed out-of-specification impurity results.

    Product
    Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0794-2020·2020-01-15

    Baxter Recalls One-Link Needle-Free IV Connectors Due to Connection Force Issue

    Baxter Healthcare is recalling One-Link Needle-Free IV Connectors because some units require higher-than-expected force to connect securely to standard Luer adapters.

    Product
    ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K, 7N8371, 7N8375K, 7N8376K, 7N8377, 7N8378, 7N8390, 7N8391, 7N8399 - Product Usage: intended for single patient use with a vascular access device for the administration of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0785-2020·2020-01-15

    SURE Anti-Perspirant Recalled for Undeclared Active Ingredient Labeling Error

    Idelle Labs is recalling SURE 48hr Confidence Anti-Perspirant because the label lists an active ingredient that is not actually in the product.

    Product
    SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz (76g) NDC# 41595-5514-1 UPC 8 83484 717936 6 Made in Canada and Distributed by Idelle Labs, Ltd., El Paso, TX 79912
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0480-2020·2020-01-15

    Nestle Toll House Pinch of Grinch Cookie Dough Recalled for Rubber Pieces

    Gerber Products Company is recalling Nestle Toll House Pinch of Grinch Cookie Dough due to the potential presence of food-grade rubber pieces.

    Product
    Nestle Toll House Pinch of Grinch Cookie Dough (14oz), UPC 050000896639
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0779-2020·2020-01-15

    Medical Action Industries Recalls Medical Convenience Kits Due to Saline pH Defect

    Medical Action Industries is recalling 9,924 cases of medical convenience kits because the included saline solution may exceed USP pH requirements.

    Product
    Medical convenience trays and kits, labeled as: Medical Action Industries, Inc.: ***CVC*** Clear Sequence Change Kit, REF 77070B ***DIALYSIS*** Clear Sequence Change Kit, REF 77068B ***PEDS CVC*** Clear Sequence Change Kit, REF 77190B ***PICC*** Clear Sequence Change Kit,
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Food)·F-0490-2020·2020-01-15

    Nestle Toll House Peanut Butter Cookie Bar Recalled for Rubber Pieces

    Gerber Products Company is recalling Nestle Toll House Peanut Butter Cookie Bars due to the potential presence of food-grade rubber pieces.

    Product
    Nestle Toll House Peanut Butter Cookie Bar (16oz), 050000005079
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0466-2020·2020-01-15

    Madame Sarah Dried Djon Djon Mushrooms Recalled for Undeclared Sulfites

    Horizon Vert Pure, LLC is recalling 500 units of Madame Sarah brand dried Djon Djon mushrooms distributed in Florida due to undeclared sulfites.

    Product
    MADAME SARAH brand DJON DJON dried mushrooms; NET WEIGHT 1.76oz (50g); PRODUCT OF HAITI; INGREDIENTS: DRIED DJON DJON MUSHROOMS; DISTRIBUTED BY: HORIZON VERT PURE, LLC
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0778-2020·2020-01-15

    Nextremity Solutions Recalls Stratum MDS Screws Due to Length Discrepancy

    Nextremity Solutions is recalling 86 Stratum MDS Screws because they are 2mm shorter than the length indicated on the package label.

    Product
    Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0482-2020·2020-01-15

    Nestle Toll House Chocolate Chip Lovers Recalled for Rubber Pieces

    Nestle Toll House Ultimate Chocolate Chip Lovers are being recalled due to the potential presence of food-grade rubber pieces.

    Product
    Nestle Toll House Ultimate Chocolate Chip Lovers (16oz), UPC 050000009268
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0465-2020·2020-01-15

    Wayfare Butterscotch Pudding Recalled for Package Bloating and Off Flavors

    Wayfare Health Foods LLC is recalling Plant Based Butterscotch Pudding due to consumer complaints of package bloating, off flavors, and textural issues.

    Product
    Plant Based WayFare Butterscotch Pudding Organic Dairy Free, Item #1223. Net wt. 4 oz. There are 4/4 oz. cups per pack with cardboard overwrap. UPC 845681000372.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0473-2020·2020-01-15

    Nestle Toll House Chocolate Chip Tub Recalled for Rubber Pieces

    Gerber Products Company is recalling Nestle Toll House Chocolate Chip Lovers Club Tub due to potential food-grade rubber pieces.

    Product
    Nestle Toll House Chocolate Chip Lovers Club Tub (80oz), UPC 050000795871
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0477-2020·2020-01-15

    Nestle Toll House Frozen Sugar Cookie Dough Recalled for Rubber Pieces

    Gerber Products Company is recalling Nestle Toll House Frozen II Sugar Cookie Dough due to the potential presence of food-grade rubber pieces.

    Product
    Nestle Toll House Frozen II Sugar Cookie Dough (14oz), UPC 050000682362
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0488-2020·2020-01-15

    Nestle Toll House Sugar Cookie Bar Recalled for Rubber Pieces

    Gerber Products Company is recalling Nestle Toll House Sugar Cookie Bars due to the potential presence of food-grade rubber pieces.

    Product
    Nestle Toll House Sugar Cookie Bar (16.5oz), UPC 050000622443
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0469-2020·2020-01-15

    Nestle Toll House Cookie Dough Recalled for Potential Rubber Contamination

    Gerber Products Company is recalling Simply Delicious Nestle Toll House Peanut Butter Chocolate Chip Cookie Dough due to the potential presence of food-grade rubber pieces.

    Product
    Simply Delicious Nestle Toll House Peanut Butter Chocolate Chip Cookie Dough (18oz), UPC 050000212675
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0475-2020·2020-01-15

    Nestle Toll House Chocolate Chip Tub Recalled for Rubber Pieces

    Nestle Toll House Chocolate Chip Tub is being recalled due to the potential presence of food-grade rubber pieces.

    Product
    Nestle Toll House Chocolate Chip Tub (80oz), UPC 050000009343
    Category
    Food
    Distribution
    0 states

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