The Recall Desk

Archive

April 2018 recalls

622 recalls were announced in April 2018.

What the numbers show

Critical
19
Severe
135
High
332
Moderate
110
Low
26

Of the 622 recalls this month scored against our rubric, 3% are Critical, 22% are Severe.

201–300 of 622

  • HighFDA (Food)·F-1090-2018·2018-04-25

    Midwest Northern Nut Student Mix Recalled for Allergen Cross-Contact

    Midwest Northern Inc. is recalling 35,056 lbs of Student Mix Trail Mix due to potential allergen cross-contact in the oil used to roast nuts and seeds.

    Product
    Midwest Northern Nut Student Mix, Trail Mix. Net Wt. 10 lbs. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1038-2018·2018-04-25

    Midwest Northern Nut Blanched Peanuts Recalled for Allergen Cross-Contact

    Midwest Northern Inc. is recalling specific lots of blanched peanuts due to potential allergen cross-contact in the roasting oil.

    Product
    Midwest Northern Nut Blanched Peanuts packaged in the following sizes: 1. Jumbo Peanuts. Net Wt. 16 oz. (454G), UPC 38043-90013. 2. Blanched Jumbo Peanuts Roasted & Salted, Net Wt. 5 lbs. 2. Granulated Blanched Peanuts Roasted & Salted, Net Wt 30 lbs. 3. Blanched
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1032-2018·2018-04-25

    Mrs. Gerry's Potato Salad Recalled for Undeclared Imitation Crab Meat

    Mrs. Gerry's Market Fresh Potato Salad is being recalled because it may contain undeclared traces of imitation crab meat, a potential allergen.

    Product
    Mrs. Gerry's Market Fresh Potato Salad Net Wt. 12 lbs. (5.44 kg), UPC 17839-94212. Keep Refrigerated. Manufactured by Mrs. Gerry's, Albert Lea, MN 56007
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-1054-2018·2018-04-25

    Midwest Northern Nut Happy Hour Mix Recalled for Allergen Cross-Contact

    Midwest Northern Inc. is recalling Nut Happy Hour Mix due to potential allergen cross-contact in the oil used to roast the nuts and seeds.

    Product
    Midwest Northern Nut Happy Hour Mix, Snack Mix. Packaged in the following sizes: 1. Net Wt. 16 oz. (454G), UPC 38043-90029. 2. Net Wt. 25 lbs. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1064-2018·2018-04-25

    Midwest Northern Trail Mix Recalled for Potential Allergen Cross-Contact

    Midwest Northern Inc. is recalling Midwest Trail Mix due to potential allergen cross-contact in the oil used to roast nuts and seeds.

    Product
    Midwest Northern Nut Midwest Trail Mix, Trail Mix. Net Wt. 16 oz. (454G), UPC 38043-90031. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1046-2018·2018-04-25

    Midwest Northern Nut Sunflower Seeds Recalled for Allergen Cross-Contact

    Midwest Northern Inc. is recalling roasted and salted sunflower seeds due to potential allergen cross-contact in the roasting oil.

    Product
    Midwest Northern Nut Sunflower Seeds Hulled Roasted & Salted. Packaged in the following sizes: 1. Net Wt. 16 oz. (454G), UPC 38043-90024. 2. Net Wt. 5 lbs. 3. Net Wt. 30 lbs. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1069-2018·2018-04-25

    Midwest Northern Nut Caterer's Mix Recalled for Potential Allergen Cross-Contact

    Midwest Northern Inc. is recalling 5 lb. bags of Roasted & Salted Nut Mix due to potential allergen cross-contact in the roasting oil.

    Product
    Midwest Northern Nut Caterer's Mix, Roasted & Salted Nut Mix. Net wt. 5 lbs. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1098-2018·2018-04-25

    Midwest Northern Nut Walnut Pieces Recalled for Allergen Cross-Contact

    Midwest Northern Inc. is recalling walnut pieces due to potential allergen cross-contact in the roasting oil.

    Product
    Midwest Northern Nut Walnut Pieces Packaged in the following sizes: 1. Roasted & Salted Walnuts Hlvs & Pcs. Net Wt.25 lbs. 2. Walnuts Medium Pieces, Roasted & Salted, Net Wt. 30 lbs. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1065-2018·2018-04-25

    Midwest Northern Nut Hokey Pokey Recalled for Allergen Cross-Contact

    Midwest Northern Inc. is recalling Hokey Pokey Gourmet Carmel Corn due to potential allergen cross-contact in the oil used to roast nuts and seeds.

    Product
    Midwest Northern Nut Hokey Pokey, Gourmet Carmel Corn. Net Wt. 12 oz. (340G), UPC 38043-40039. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1066-2018·2018-04-25

    Midwest Northern Nut Gourmet Carmel Corn Recalled for Allergen Cross-Contact

    Midwest Northern Inc. is recalling 35,056 lbs of Gourmet Carmel Corn due to potential allergen cross-contact in the roasting oil.

    Product
    Midwest Northern Nut Pee Bee Gee Bee, Gourmet Carmel Corn. Net Wt. 12 oz. (340G), UPC 38043-90065. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1057-2018·2018-04-25

    Midwest Northern Nut Trail Mix Recalled for Potential Allergen Cross-Contact

    Midwest Northern Inc. is recalling 16 oz. bags of Trail Mix due to potential allergen cross-contact in the oil used to roast the nuts and seeds.

    Product
    Midwest Northern Nut Natural Snacks, Trail Mix. Net Wt. 16 oz. (454G), UPC 38043-90028. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1083-2018·2018-04-25

    Midwest Northern Nut Oriental Mix Recalled for Potential Allergen Cross-Contact

    Midwest Northern Inc. is recalling Nut Oriental Mix snack mix due to potential allergen cross-contact in the oil used to roast nuts and seeds.

    Product
    Midwest Northern Nut Oriental Mix, Snack Mix. Packaged in the following sizes: 1. Net Wt. 5 lbs. 2. Net Wt. 10 lbs. 3. Net Wt. 15 lbs. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1085-2018·2018-04-25

    Midwest Northern Roasted Peanuts Recalled for Potential Allergen Cross-Contact

    Midwest Northern Inc. is recalling roasted no-salt peanuts due to potential allergen cross-contact in the roasting oil.

    Product
    Midwest Northern Nut Roasted NO Salt Peanuts packaged in the following sizes: 1. Granulated Blanched Peanuts Roasted No Salt. Net Wt. 5 lbs. 2. Dry Roasted No Salt Peanuts, Net Wt. 5 lbs. 3. Blanched Jumbo Peanuts, Roasted NO Salt, Net Wt. 30 lbs. Midwest Northern
    Category
    Food
    Distribution
    13 states
  • HighFDA (Drugs)·D-0664-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Testosterone 25 mg pellets because they were sterilized using a non-approved method.

    Product
    Testosterone 25 mg pellet packaged in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-1047-2018·2018-04-25

    Midwest Northern Nut Sunflower Seeds Recalled for Allergen Cross-Contact

    Midwest Northern Inc. is recalling 16 oz. roasted sunflower seeds due to potential allergen cross-contact in the roasting oil.

    Product
    Midwest Northern Nut Sunflower Seeds Roasted No Salt. Net Wt. 16 oz. (454G), UPC 38043-90146. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1058-2018·2018-04-25

    Midwest Northern Nut Nutty Fruit Mix Recalled for Allergen Cross-Contact

    Midwest Northern Inc. is recalling Nutty Fruit Mix and Trail Mix due to potential allergen cross-contact in the oil used to roast nuts and seeds.

    Product
    Midwest Northern Nut Nutty Fruit Mix, Trail Mix. Packaged in the following sizes: 1. Net Wt. 16 oz. (454G), UPC 38043-90027. 2, Net Wt. 25 lbs. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Drugs)·D-0673-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Estradiol Pellets Due to Sterility Concerns

    Partell Specialty Pharmacy is recalling Estradiol 10 mg pellets in Nevada due to a non-approved sterilization method.

    Product
    Estradiol 10 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-1078-2018·2018-04-25

    Midwest Northern Nut GORP Mix Recalled for Potential Allergen Cross-Contact

    Midwest Northern Inc. is recalling 35,056 lbs of GORP Mix due to potential allergen cross-contact in the oil used to roast nuts and seeds.

    Product
    Midwest Northern Nut GORP Mix, Trail Mix. Net Wt. 5 lbs. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1389-2018·2018-04-25

    Stryker Power-LOAD Cot Fastening System Recalled for Broken Floor Plates

    Stryker is recalling 4,724 Power-LOAD Cot Fastening Systems because the floor plates holding ambulance cot anchors may be broken.

    Product
    Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LOAD is intended to assist with loading and unloading of a compatible wheeled stretcher (ambulance cot) to and from a transport vehicle and to secure the ambulance cot during transpo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1055-2018·2018-04-25

    Midwest Northern Nut Hot Cha Cha Mix Recalled for Allergen Cross-Contact

    Midwest Northern Inc. is recalling 35,056 lbs of Nut Hot Cha Cha Mix due to potential allergen cross-contact in the roasting oil.

    Product
    Midwest Northern Nut Hot Cha Cha Mix, Snack Mix. Net Wt. 12 oz. (340G), UPC 38043-90134. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1424-2018·2018-04-25

    Carefusion 2200 Recalls Jamshidi Bone Marrow Needles Due to Packaging Integrity

    Carefusion 2200 Inc is recalling sterile Jamshidi bone marrow needles because the integrity of the sterile packaging is potentially compromised.

    Product
    JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1415-2018·2018-04-25

    Philips Brilliance 6 Slice CT System Recalled for Emergency Stop Defect

    Philips is recalling Brilliance 6 Slice CT systems because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient loading.

    Product
    Brilliance 6 Slice (Air) - Model no. 728256, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1042-2018·2018-04-25

    Midwest Northern Macadamia Nuts Recalled for Potential Allergen Cross-Contact

    Midwest Northern Inc. is recalling 8 oz. bags of Macadamia Nuts due to potential allergen cross-contact in the roasting oil. The product was distributed to 13 states.

    Product
    Midwest Northern Nut Macadamia Nuts. Net Wt. 8 oz. (227G), UPC 38043-90021. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1034-2018·2018-04-25

    Midwest Northern Nut Cashews Recalled for Potential Allergen Cross-Contact

    Midwest Northern Inc. is recalling various cashew products due to potential allergen cross-contact in the oil used for roasting.

    Product
    Midwest Northern Nut Cashews packaged in the following sizes: 1. Jumbo Cashews. Net Wt. 16 oz. (454G), UPC 38043-90008. Net Wt. 5 lbs. 2. Large Whole Cashews Roasted & Salted. Net Wt. 10 lbs. 3. Cashew Splits & Butts, Net Wt. 16 oz. (454G), UPC 38043-90009, Net Wt. 5
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1377-2018·2018-04-25

    Cook Inc. Recalls MINC Benchtop Incubators Due to Temperature Control Defect

    Cook Inc. is recalling 483 MINC Benchtop Incubators because a heater failure may cause temperatures to become too high or too low for proper cell culture.

    Product
    MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1075-2018·2018-04-25

    Midwest Northern Nut Cranberry Nut Trail Mix Recalled for Allergen Cross-Contact

    Midwest Northern Inc. is recalling 25 lb. bags of Cranberry Nut Trail Mix due to potential allergen cross-contact in the oil used to roast nuts and seeds.

    Product
    Midwest Northern Nut Cranberry Nut Trail Mix, Net Wt. 25 lbs. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Drugs)·D-0641-2018·2018-04-25

    Partell Specialty Pharmacy Recalls Methionine, Inositol, and Choline Vials

    Partell Specialty Pharmacy is recalling 11 vials of Methionine/Inositol/Choline in Nevada due to a non-approved sterilization method.

    Product
    Methionine15mg/Inositol 50mg/Choline 100mg, packaged in a) 5mL and b) 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-1053-2018·2018-04-25

    Midwest Northern Nut Garlic Crunch Recalled for Allergen Cross-Contact

    Midwest Northern Inc. is recalling Garlic Crunch Snack Mix due to potential allergen cross-contact in the oil used to roast nuts and seeds.

    Product
    Midwest Northern Nut Garlic Crunch, Snack Mix. Packaged in the following sizes: 1. Net Wt. 12 oz. (340G), UPC 38043-90034. 2. Net Wt. 5 lbs. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1029-2018·2018-04-25

    Potato and Egg Salads Recalled for Undeclared Imitation Crab Meat

    Mrs. Gerry's Kitchen is recalling various potato and egg salads because they may contain undeclared traces of imitation crab meat.

    Product
    Potato Salad packaged in the following branded and sized containers: 1. Mrs. Gerry's Old Fashioned Potato Salad, Net Wt. 1 lb. (454 g) UPC 17839-94101, Net Wt. 3 lb. (1.36 kg), UPC 17839-94103. Net Wt. 5 lb. (2.27 kg), UPC 17839-94105. Keep Refrigerated. Manufactured by
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-1041-2018·2018-04-25

    Midwest Northern Nut Sea Salt & Pepper Peanuts Recalled for Allergen Cross-Contact

    Midwest Northern Inc. is recalling Sea Salt & Pepper Peanuts due to potential allergen cross-contact in the roasting oil.

    Product
    Midwest Northern Nut Sea Salt & Pepper Peanuts. Net Wt. 16 oz. (454G), UPC 38043-90127. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1376-2018·2018-04-25

    Wright Medical VALOR Nail Recall for Missing Compression Screw

    Wright Medical Technology is recalling VALOR Nails that may be missing an assembled compression screw.

    Product
    WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Small, OD: 11.5mm, L: 150mm, REF415101115R
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1417-2018·2018-04-25

    Terumo Sarns TCM Recall for Updated Cooler-Heater Cleaning Instructions

    Terumo is recalling Sarns TCM devices to update cleaning instructions for the cooler-heater component.

    Product
    Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1418-2018·2018-04-25

    Terumo Sarns TCM II Recall for Updated Cleaning Instructions

    Terumo is recalling Sarns TCM II devices to update cleaning instructions. The recall covers 2,393 units distributed worldwide.

    Product
    Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling and monitoring patient temperature .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1394-2018·2018-04-25

    GE Healthcare Lunar DPX Bone Density Systems Recalled for Data Errors

    GE Healthcare is recalling 43 Lunar DPX bone density systems because patient reports may be sent to hospital systems with incorrect names in the header.

    Product
    GE Healthcare Lunar: a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369 b) DPX MD+, Model Numbers: LU8230, LU40338, LU40352 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0630-2018·2018-04-25

    WipeEssentials Wet Wipes Recalled for Poor Quality Water

    Diamond Wipes International is recalling WipeEssentials Wet Wipes because they were manufactured with poor quality water.

    Product
    WipeEssentials Wet Wipes (benzalkonium chloride 0.13%), 30-count pouches, Dist. by Diamond Wipes Int'l, Inc., Chino, CA 91710, UPC 7 66670 03988 6.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1422-2018·2018-04-25

    Carefusion Recalls Jamshidi Needle Biopsy Devices Due to Packaging Integrity Concerns

    Carefusion 2200 Inc is recalling 790 units of Jamshidi Needle Biopsy devices because the integrity of the sterile packaging is potentially compromised.

    Product
    JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0629-2018·2018-04-25

    ACURE Clarifying Acne Towelettes Recalled for Poor Quality Water

    Diamond Wipes International is recalling ACURE clarifying acne towelettes because they were manufactured with poor quality water.

    Product
    ACURE, clarifying acne, glycolic + zinc (salicyclic acid 0.5%) towelettes, 30-count pouch, Distributed by Better Planet Brands, Fort Lauderdale, FL 33316, UPC 8 54049 00358 0.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1114-2018·2018-04-25

    Swire Coca Cola Recalls Diet Dr Pepper Bottles for Foreign Material

    Swire Coca Cola is recalling 366 cases of Dr. Pepper Est. 1885 Diet, 20 FL Oz bottles due to the potential presence of foreign material.

    Product
    Dr. Pepper Est. 1885 Diet, 20 FL Oz (1.25 PT), 591 mL
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0633-2018·2018-04-25

    AvKARE Recalls Amantadine HCl Capsules for Dissolution Failure

    AvKARE Inc. is recalling 2,135 cartons of Amantadine HCl Capsules, 100 mg, because the product failed dissolution specifications.

    Product
    AMANTADINE HCL — AMANTADINE HCL (AMANTADINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0696-2018·2018-04-25

    Fluconazole Injection Recalled Due to Labeling Mix-Up

    Renaissance Lakewood, LLC is recalling Fluconazole Injection due to a labeling mix-up where a 50 mL bag was found in a 100 mL package.

    Product
    Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902, By: Claris Injectables Limited, Sarkhei-Bavla Road, Chacharwadi-Vasna, Ahmedabad, I
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0683-2018·2018-04-25

    Leadiant Recalls Subpotent Cystaran Ophthalmic Solution

    Leadiant Biosciences is recalling 3,398 bottles of Cystaran ophthalmic solution because the active ingredient was below the required specification.

    Product
    CYSTARAN — CYSTARAN (CYSTEAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1385-2018·2018-04-25

    Datascope Mega Intra-Aortic Balloon Catheter Recalled for Missing Contraindications

    Datascope is recalling Mega Intra-Aortic Balloon Catheters because the U.S. Instructions for Use were missing the Contraindications section.

    Product
    Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart mu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1395-2018·2018-04-25

    GE Healthcare Prodigy Ultrasound Recall for Incorrect Patient Data in Reports

    GE Healthcare is recalling Prodigy and Prodigy Advanced ultrasound systems because bone density exam reports may be sent to PACS with incorrect patient information in the DICOM header.

    Product
    GE Healthcare: a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365 b) Prodigy Advanced, Model Numbers: LU42361, LU42397 Provides an estimate of BMD (Bone Marrow Density) at t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1392-2018·2018-04-25

    Philips Ingenuity TF PET/CT Recalled for Unresponsive Acquisition Console

    Philips is recalling 12 Ingenuity TF PET/CT systems because the mass storage device may cause the acquisition console to become unresponsive, preventing image acquisition.

    Product
    Ingenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of diagnostic applications. The device utilizes the CT technology to obtain anato
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1387-2018·2018-04-25

    Preservation Solutions Recalls Cold Storage Solution Bags Due to Leaks

    Preservation Solutions, Inc. is recalling 31,104 units of Cold Storage Solution bags due to potential leaks at the injection port.

    Product
    Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Storage Solution, Catalog No. BUW_002. Intended for the hypothermic flushing and storage of specific organs in preparation for storage, transportation, and tra
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1390-2018·2018-04-25

    NAMIC Fluid Management Convenience Kits Recalled for Assembly Defect

    Angiodynamics Inc. is recalling 38 NAMIC Fluid Management Convenience Kits because the Fluid Delivery Set was not assembled to specification, preventing device use.

    Product
    Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1383-2018·2018-04-25

    Datascope Mega Intra-Aortic Balloon Catheter Recalled for Missing Contraindications

    Datascope is recalling 2,714 Mega Intra-Aortic Balloon Catheters because the U.S. Instructions for Use are missing the Contraindications section.

    Product
    Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the hear
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1384-2018·2018-04-25

    Datascope Mega Intra-Aortic Balloon Catheter Recalled for Missing Contraindications

    Datascope is recalling 655 Mega Intra-Aortic Balloon Catheters because the U.S. Instructions For Use were missing the Contraindications section.

    Product
    Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the hear
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0631-2018·2018-04-25

    Sandoz Recalls Triamterene and Hydrochlorothiazide Tablets Due to Cross-Contamination

    Sandoz Incorporated is recalling specific lots of Triamterene and Hydrochlorothiazide Tablets due to the presence of unrelated ingredients.

    Product
    Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc., Princeton, NJ 08540, NDC 0781-5067-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1393-2018·2018-04-25

    GE Healthcare Lunar DPX Duo and Bravo Bone Density Software Recall

    GE Healthcare is recalling Lunar DPX Duo and Bravo bone density scanners because a software issue may cause reports to be filed under the wrong patient name in the hospital system.

    Product
    GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1443-2018·2018-04-25

    Keystone Dental Recalls Stage-1 Tissue Punches Due to Damaged Cutting Edges

    Keystone Dental Inc is recalling 101 Stage-1 Tissue Punches because the cutting edges may have small dents and nicks.

    Product
    Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1444-2018·2018-04-25

    TMJ Solutions Recalls Misidentified Right Mandibular Component

    TMJ Solutions Inc is recalling a specific right mandibular component of a TMJ Reconstruction Prosthesis System because it was mislabeled and is not the correct component for the intended patient.

    Product
    Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System is intended to be used for the reconstruction of the temporomandibu
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1375-2018·2018-04-25

    Wright Medical VALOR Nail Recall for Missing Compression Screw

    Wright Medical Technology is recalling 47 units of VALOR Nails that may be missing an assembled compression screw.

    Product
    WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L: 200mm, REF415101020
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1416-2018·2018-04-25

    Terumo HX2 Temperature Management System Recall for Updated Cleaning Instructions

    Terumo is recalling HX2 Temperature Management Systems to update cooler-heater cleaning instructions. The recall affects 2,393 units distributed worldwide.

    Product
    Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1386-2018·2018-04-25

    Southern Implants Recalls Dental Implants Due to Inner Labeling Error

    Southern Implants is recalling 49 dental implant units because the inner label incorrectly identifies the product reference number.

    Product
    SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Food)·F-1103-2018·2018-04-25

    Santa Cruz Organic Mango Fruit Spread Recalled for Missing Label Information

    Smucker Natural Foods is recalling Santa Cruz Organic Mango Fruit Spread because the product labels lack an ingredient panel and firm information.

    Product
    SANTA CRUZ organic MANGO fruit spread NET WT 9.5 OZ (270 g) UPC 0 36192 10516 2
    Category
    Food
    Distribution
    28 states
  • LowFDA (Devices)·Z-1419-2018·2018-04-25

    OraSure Cocaine Metabolite Test Kit Recalled for False Positive Results

    OraSure Technologies is recalling 10 units of Cocaine Metabolite MICRO-PLATE EIA kits because controls may cause false positive results.

    Product
    Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Drugs)·D-0632-2018·2018-04-25

    Pharmedium Recalls Vasopressin Injection Due to Manufacturing Deviations

    Pharmedium Services, LLC voluntarily recalled 72 bags of Vasopressin Injection due to cGMP deviations. The product was distributed in Massachusetts and Washington.

    Product
    Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 units per mL), Rx only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Food)·F-1101-2018·2018-04-25

    Smucker Natural Foods Recalls Santa Cruz Organic Fruit Spread for Labeling Defects

    Smucker Natural Foods is recalling Santa Cruz organic blackberry pomegranate fruit spread because the labels are missing ingredient and firm information.

    Product
    SANTA CRUZ organic BLACKBERRY POMEGRANATE fruit spread NET WT 9.5 OZ (270 g) UPC 0 36192 10510 0
    Category
    Food
    Distribution
    28 states
  • LowFDA (Food)·F-1104-2018·2018-04-25

    Smucker Natural Foods Recalls Santa Cruz Organic Raspberry Spread for Labeling Defects

    Smucker Natural Foods is recalling Santa Cruz Organic Seedless Red Raspberry Fruit Spread because the product labels are missing the ingredient panel and firm information.

    Product
    SANTA CRUZ organic SEEDLESS RED RASPBERRY fruit spread NET WT 9.5 OZ (270 g) UPC 0 36192 10513 1
    Category
    Food
    Distribution
    28 states
  • SevereNHTSA·18V260000·2018-04-24

    Hyundai Recalls 2017 Ioniq Hybrid Vehicles for Fire Risk

    Hyundai is recalling 2017 Ioniq Hybrid vehicles because a leaking oil seal may cause an electrical short, increasing the risk of a fire.

    Product
    HYUNDAI — HYUNDAI IONIQ HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18146·2018-04-24

    Honeywell Recalls Fibre-Metal E2 and North Peak A79 Hard Hats

    Honeywell is recalling specific Fibre-Metal E2 and North Peak A79 hard hats because they may fail to protect users from impact, posing a risk of head injury.

    Product
    Fibre-Metal E2 and North Peak A79 hard hats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V256000·2018-04-20

    Supreme Recalls 2013-2017 Kold King Vehicles Due to Frame Rail Defect

    Supreme Corporation is recalling 2013-2017 Kold King vehicles because the floor frame rail may detach from cross members due to insufficient weld penetration.

    Product
    SUPREME — SUPREME KOLD KING
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V257000·2018-04-20

    Kia Recalls 2017 Niro Vehicles Due to Hybrid System Fire Risk

    Kia is recalling 2017 Niro vehicles because a leaking hydraulic clutch actuator seal may cause an electrical short, increasing the risk of a fire.

    Product
    KIA — KIA NIRO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V255000·2018-04-20

    Altec Recalls 1992-2006 Digger Derrick Trucks Due to Boom Pivot Pin Failure

    Altec Industries is recalling 1992-2006 Digger Derrick trucks because a specific boom pivot pin may fail, causing unexpected boom movement that increases the risk of injury or death.

    Product
    ALTEC — ALTEC DIGGER DERRICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18145·2018-04-20

    Briggs & Stratton Recalls 3000 PSI Pressure Washer Surface Cleaners

    Briggs & Stratton is recalling 3000 PSI pressure washer surface cleaners because the spray bar can break and detach, posing an injury hazard.

    Product
    3000 PSI pressure washer surface cleaners
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E024000·2018-04-19

    Bosch Electric Power Steering System Recall for Corroding Bolts

    Bosch is recalling electric power steering systems where aluminum bolts may corrode and fracture, potentially causing loss of steering assist.

    Product
    STEERING:ELECTRIC POWER ASSIST SYSTEM recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V249000·2018-04-19

    Coachmen Spirit Recalled for Missing LP Quick Disconnect on Cooktop

    Forest River is recalling 2018-2019 Coachmen Spirit trailers because the outdoor cooktop may lack a liquid propane quick disconnect, posing carbon monoxide and fire risks.

    Product
    COACHMEN — COACHMEN SPIRIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V254000·2018-04-19

    Thomas Built Buses Recall Wall-Mounted Seats Due to Crash Risk

    Daimler Trucks North America is recalling 2014-2018 Thomas Built Buses because wall-mounted seat brackets may crack, increasing injury risk in a crash.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX, SAF-T-LINER HDX, MINOTOUR, SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V251000·2018-04-19

    Freightliner M2 Trucks Recalled for Rear Brake Caliper Orientation Issue

    Daimler Trucks is recalling 2016-2019 Freightliner Business Class M2 trucks because rear brake calipers may be mounted incorrectly, reducing braking effectiveness.

    Product
    FREIGHTLINER — FREIGHTLINER BUSINESS CLASS M2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18143·2018-04-19

    Petit Collage Wooden Toy Xylophones Recalled for Choking Hazard

    Wild & Wolf is recalling Petit Collage wooden toy xylophones because the beater stick ball can detach, posing a choking risk to young children.

    Product
    Petit Collage musical jumbo wooden xylophones
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V250000·2018-04-19

    Daimler Recalls 2018-2019 Thomas Built Buses Saf-T-Liner C2 for Fire Risk

    Daimler Trucks North America is recalling 2018-2019 Thomas Built Buses Saf-T-Liner C2 transit buses because a battery cable may rub against a bracket, increasing the risk of a fire.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V252000·2018-04-19

    GM Recalls 2018 Chevrolet Equinox for Improperly Tempered Door Glass

    General Motors is recalling 2018 Chevrolet Equinox vehicles because the front door window glass may not be properly tempered, increasing injury risk if broken.

    Product
    CHEVROLET — CHEVROLET EQUINOX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18T004000·2018-04-19

    Kumho Recalls Solus KH16 Tires Due to Belt Separation Risk

    Kumho is recalling specific Solus KH16 tires because the belts may separate under severe conditions, increasing the risk of a crash.

    Product
    TIRES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V253000·2018-04-19

    Thomas Built Buses Recall School Buses Due to Seat Bracket Defect

    Daimler Trucks North America is recalling 2014-2018 Thomas Built Buses school buses because a wall mounting bracket may crack, increasing injury risk in a crash.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2, SAF-T-LINER EFX, SAF-T-LINER HDX, MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1005-2018·2018-04-18

    Good Fields Farm Recalls Raw Goat Milk Cheese Due to Listeria

    Good Fields Farm/The Maiden's Creamery is recalling Wild Meadow Raw Goat Milk Cheese after a sample tested positive for Listeria monocytogenes in New York.

    Product
    Wild Meadow Raw Goat Milk Cheese. The product is packaged in various sizes of sealed flexible plastic packaging, displaying the plant number 36-1315.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1012-2018·2018-04-18

    Soap Korner Kratom Powder Recalled for Salmonella Contamination Risk

    Soap Korner is recalling Herbalist Red MD Kratom powder due to potential Salmonella contamination. The product was sold online to 350 customers.

    Product
    Soap Korner Herbalist Red MD Kratom, Green Kali, powder, soapkorner.com
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·18V248000·2018-04-18

    BMW Recalls Vehicles for Electric Water Pump Fire Risk

    BMW is recalling 2007-2012 models because a failing electric auxiliary water pump can overheat the circuit board, increasing the risk of a fire.

    Product
    BMW — BMW, MINI, ROLLS-ROYCE X5, COOPER S CONVERTIBLE, X6 ACTIVEHYBRID SAC, X6 M
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V247000·2018-04-18

    Volkswagen Recalls 2006-2007 Passat Vehicles Due to Air Bag Inflator Defect

    Volkswagen is recalling 2006-2007 Passat sedans and wagons because the driver's air bag inflator may explode during deployment, posing a risk of serious injury or death.

    Product
    VOLKSWAGEN — VOLKSWAGEN PASSAT, PASSAT WAGON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1318-2018·2018-04-18

    Reliance Medical Products Recalls Refractor Suspension Arms Due to Missing Parts

    Reliance Medical Products is recalling 933 Refractor Suspension Arms because missing parts caused the device to fall on a patient.

    Product
    Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) The Intended use of this medical device, as part of system to store and position ophthalmological examination and diagnostic equipment, is to store and position for examination a device commonly known as a refractor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1365-2018·2018-04-18

    Fresenius Liberty Select Cycler Recalled for Software Overfill Risk

    Fresenius Medical Care is recalling Liberty Select Cyclers due to a software issue that may cause overfill, posing a risk of serious injury or death.

    Product
    Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1351-2018·2018-04-18

    W & H DentalWerk Recalls S-N1 and S-N2 Foot Controls

    W & H DentalWerk is recalling S-N1 and S-N2 foot controls because they may fail to stop the motor, posing a risk of serious patient injury.

    Product
    Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1314-2018·2018-04-18

    Terumo Cardiovascular Procedure Kits Recalled for Potential Blood Leaks

    Terumo is recalling 2,677 Cardiovascular Procedure Kits containing Pall LG6NS filters due to a risk of blood leaks through the hydrophobic portion.

    Product
    Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. The Cardiovascular Procedure Kit containing the Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filter for Exh¿acorporeal Service is indicated for use o
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Food)·F-1115-2018·2018-04-18

    Peru Chef Dry Potato Recalled for Undeclared Sulfites

    MAS Food Services is recalling The Peru Chef Dry Potato because it contains undeclared sulfites, posing a risk to sensitive individuals.

    Product
    The Peru Chef Dry Potato, Product of Peru, Net Wt. 15oz/425gr, Imported and Distributed by MAS FOOD SERVICES Co.,
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1344-2018·2018-04-18

    ICU Medical Recalls 7-inch Intravascular Administration Sets with Incorrect Spin Collar

    ICU Medical is recalling 250 pouches of 7-inch intravascular administration sets because they were manufactured with an incorrect spin collar.

    Product
    7" Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item AH7262. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1356-2018·2018-04-18

    Bard Feeding Tubes Recalled for Ineffective Connector Fusion

    C.R. Bard is recalling specific lots of Bard Adult/Pediatric Feeding Tubes because the tubing and ENFit connector may not be fused effectively.

    Product
    Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM), REF EN0036420 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1008-2018·2018-04-18

    All American Seasonings Recalls Lost Cajun Gumbo Base Due to Salmonella

    All American Seasonings is recalling Lost Cajun Gumbo Base because an ingredient was contaminated with Salmonella. The recall involves 23 bags distributed to one customer in Colorado.

    Product
    LOST CAJUN GUMBO BASE, T4014, PACK SIZE 45 lb bag, Blended by ALL AMERICAN SEASONINGS, 10600 E. 54th Ave., Units B & C, Denver, CO 80239
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1324-2018·2018-04-18

    Arrow International Recalls Central Venous Access Kits Due to Sterility Concerns

    Arrow International is recalling specific lots of Arrowg+ard Blue MAC Two-Lumen Central Venous Access Kits because the catheters may not be completely sealed, compromising sterility.

    Product
    (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-21142-RH; (2) Arrowg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7 - 7.5 Fr. Catheters, Product Number: ASK-21242-MMC1; (3) ARROWg+a
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1327-2018·2018-04-18

    Arrow PICC Kit Recall Due to Potential Sterility Seal Failure

    Arrow International is recalling specific lots of ARROW PICC Kits because the seals may not be completely closed, meaning the product's sterility cannot be guaranteed.

    Product
    Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology, Part Numbers: (1) ASK-45541-RWJ4; (2) ASK-45552-RWJ4
    Category
    Medical Device
    Distribution
    1 state

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