The Recall Desk

Archive

April 2018 recalls

622 recalls were announced in April 2018.

What the numbers show

Critical
19
Severe
146
High
321
Moderate
110
Low
26

Of the 622 recalls this month scored against our rubric, 3% are Critical, 23% are Severe.

Which agencies issued them

201–300 of 622

  • HighFDA (Devices)·Z-1406-2018·2018-04-25

    Philips Ingenuity Core CT Systems Recalled for Couch Movement Hazard

    Philips is recalling 281 Ingenuity Core CT systems because the emergency stop may fail to lock the couch, allowing it to move during patient loading.

    Product
    Ingenuity Core - Model no. 728321, 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. These devices…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1381-2018·2018-04-25

    Zimmer Biomet Recalls Segmental System Proximal Femoral Components

    Zimmer Biomet is recalling specific proximal femoral components due to potential machining debris that may not have been adequately removed during cleaning.

    Product
    Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving complex salvage cases to address patients with severe bone loss associated with disease, trauma, or revision.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1099-2018·2018-04-25

    ADM Agri Industries Recalls Wheat Gluten Due to Listeria Risk

    ADM Agri Industries is recalling Provim ESP Vita Wheat Gluten because the flour used in manufacturing tested positive for Listeria monocytogenes.

    Product
    Provim ESP Vita Wheat Gluten, Product code 6303, 50 lb bag
    Category
    Food
    Distribution
    5 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-1081-2018·2018-04-25

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

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

    Product
    Midwest Northern Nut Lifetime Trail Mix. Net Wt. 25 lbs. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1397-2018·2018-04-25

    Siemens MEVATRON M2 Linear Accelerator Recalled for Collision Risk

    Siemens is recalling 18 MEVATRON M2 linear accelerators to update software and reduce the risk of collision during automated cancer treatments.

    Product
    MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1442-2018·2018-04-25

    Philips T5 MRI Scanner Recalled for Helium Gas Risk

    Philips is recalling T5 MRI scanners due to a potential risk of helium gas release during a magnet quench.

    Product
    T5 Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1063-2018·2018-04-25

    Midwest Northern Nut Texas Twist Snack Mix Recalled for Allergen Cross-Contact

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

    Product
    Midwest Northern Nut Texas Twist, Snack Mix. Packaged in the following sizes: 1. Net Wt. 16 oz. (454G), UPC 38043-90083. 2. Net Wt. 5 lbs. 3. Net Wt. 25 lbs. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1428-2018·2018-04-25

    Halyard Closed Suction System Flex Connectors May Disconnect During Use

    Halyard Health is recalling certain Closed Suction Systems because Flex Connectors may become loose or disconnect before or during use.

    Product
    Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adults,¿Double¿Swivel¿Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54 CM (GREEN); b. HALYARD* TRACH…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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 (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-1080-2018·2018-04-25

    Midwest Northern Nut Lake Elmo Mix Recalled for Allergen Cross-Contact

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

    Product
    Midwest Northern Nut Lake Elmo Mix. Net Wt. 25 lbs. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1082-2018·2018-04-25

    Midwest Northern Nut Mendakota Mix Recalled for Allergen Cross-Contact

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

    Product
    Midwest Northern Nut Mendakota Mix. Net Wt. 25 lbs. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1096-2018·2018-04-25

    Midwest Northern Nut Tropical Mix Recalled for Allergen Cross-Contact

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

    Product
    Midwest Northern Nut Tropical Mix, No Carob - No Coconut, Trail Mix. Packaged in the following sizes: 1. Net WT. 5 lbs. 2. Net Wt.25 lbs. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighCPSC·18739·2018-04-25

    HD Supply Recalls Seasons Ceiling Fans Due to Impact Hazard

    HD Supply is recalling Seasons ceiling fans because brackets can break, causing blades to fall. No injuries have been reported, but one instance of minor property damage occurred.

    Product
    Seasons ceiling fans
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1400-2018·2018-04-25

    Siemens ONCOR Impression Linear Accelerator Software Update Recall

    Siemens is recalling seven ONCOR Impression Digital Linear Accelerators to update software and reduce the risk of collision during automated cancer treatments.

    Product
    ONCOR Impression , Digital Linear Accelerator, Model No. 05857920 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Food)·F-1037-2018·2018-04-25

    Midwest Northern Nut Redskin Peanuts Recalled for Potential Allergen Cross-Contact

    Midwest Northern Inc. is recalling Redskin Peanuts due to potential allergen cross-contact in the roasting oil. Consumers should stop using the product.

    Product
    Midwest Northern Nut Redskin Peanuts. Packaged in the following sizes: 1. Net Wt. 16 oz. (454G), UPC 38043-90112. 2. 2. Net Wt. 5 lbs. 3. Net Wt. 30 lbs. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1435-2018·2018-04-25

    Philips Achieva 1.5T MRI Systems Recalled for Helium Gas Risk

    Philips is recalling 8,205 Achieva 1.5T MRI systems worldwide due to a potential risk of helium gas release during a magnet quench.

    Product
    Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5T Conversion Model 781283, 5) Achieva 1.5T Model 781296, 6) Achieva 1.5T R5 based Model 781343, 7) Achieva 1.5T Conversion R5 based Model…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1074-2018·2018-04-25

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

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

    Product
    Midwest Northern Nut Franz Mix, Nut Mix, Net Wt. 30 lbs. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1045-2018·2018-04-25

    Midwest Northern Nut Roasted Pecans Recalled for Allergen Cross-Contact

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

    Product
    Midwest Northern Nut Pecans Roasted & Salted. Packaged in the following sizes: 1. Net Wt. 16 oz. (454G), UPC 38043-90145. 2. Pecan Mammoth Halves, Roasted & Salted. Net Wt. 30 lbs. 3. Pecan Pieces Roasted & Salted Net Wt. 30 lbs. Midwest Northern Inc.…
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1050-2018·2018-04-25

    Midwest Northern Nut BBQ Blues Mix Recalled for Allergen Cross-Contact

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

    Product
    Midwest Northern Nut BBQ Blues Mix. Packaged in the following sizes: 1. Net Wt. 16 oz. (454G), UPC 38043-90084. 2. Net Wt. 5 lbs. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1062-2018·2018-04-25

    Midwest Northern Nut Sweet & Salty Snack Mix Recalled for Allergen Cross-Contact

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

    Product
    Midwest Northern Nut Sweet & Salty, Snack Mix. Packaged in the following sizes: 1. Net Wt. 16 oz. (454G), UPC 38043-90035. 2. Net Wt. 5 lbs. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1439-2018·2018-04-25

    Philips ACS-NT MRI Scanner Recalled for Helium Gas Leak Risk

    Philips is recalling 8,205 ACS-NT MRI scanners due to a potential risk of helium gas release into the examination room during a magnet quench.

    Product
    ACS-NT, Model 78108 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1049-2018·2018-04-25

    Midwest Northern Nut Asian Snack Mix Recalled for Allergen Cross-Contact

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

    Product
    Midwest Northern Nut Asian Snack Mix. Packaged in the following sizes: 1. Net Wt. 16 oz. (454G), UPC 38043-90092. 2. Net Wt. 25 lbs. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1073-2018·2018-04-25

    Midwest Northern Nut Dawn's Chopped Mix Recalled for Allergen Cross-Contact

    Midwest Northern Inc. is recalling Dawn's Chopped Mix, Roasted & Salted, due to potential allergen cross-contact in the roasting oil.

    Product
    Midwest Northern Nut Dawn's Chopped Mix, Roasted & Salted, Net Wt. 30 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 (Food)·F-1035-2018·2018-04-25

    Midwest Northern Nut Cashews Recalled for Potential Allergen Cross-Contact

    Midwest Northern Inc. is recalling 5 lb. bags of roasted cashews due to potential allergen cross-contact in the roasting oil.

    Product
    Midwest Northern Nut Cashew Large Pieces Roasted NO Salt. Net Wt. 5 lbs. Midwest Northern Inc., Minneapolis, MN 55118
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1403-2018·2018-04-25

    Teleflex Medical One Way Valve Recall for Potential Disconnection

    Teleflex Medical is recalling specific lots of HUDSON RCI One Way Valves because they may disconnect, causing an interruption of ventilation to patients.

    Product
    Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respiratory and anesthesia circuits to connect two or more components of a breathing system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1408-2018·2018-04-25

    Philips Brilliance iCT CT Systems Recalled for Emergency Stop Defect

    Philips is recalling 295 Brilliance iCT CT systems because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient loading.

    Product
    Brilliance iCT - Model no. 728306 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. These…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1031-2018·2018-04-25

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

    Mrs. Gerry's is recalling 12 lb. potato salad for undeclared imitation crab meat. Consumers with shellfish allergies should not eat the product.

    Product
    Mrs. Gerry's Knowlan's Homestyle Potato Salad Net Wt. 12 lbs. (5.44 kg), UPC 17839-22912. Keep Refrigerated. Manufactured by Mrs. Gerry's, Albert Lea, MN 56007
    Category
    Food
    Distribution
    12 states
  • 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 (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…
    Category
    Medical Device
    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 (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 (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
  • 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 (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-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…
    Category
    Medical Device
    Distribution
    1 state
  • 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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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…
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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…
    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…
    Category
    Medical Device
    Distribution
    0 states
  • 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 (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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-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…
    Category
    Medical Device
    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…
    Category
    Drug
    Distribution
    0 states
  • 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
  • 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
  • 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 (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 (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 (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
  • 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·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
  • 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
  • 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·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
  • 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
  • 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
  • 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·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
  • 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
  • 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
    MINI — MINI, BMW, ROLLS-ROYCE COOPER S CONVERTIBLE, X6 ACTIVEHYBRID SAC, X6 M, 550I GRAN TURISMO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1011-2018·2018-04-18

    Bob's Red Mill Organic Amaranth Flour Recalled for Salmonella Risk

    Bob's Red Mill Natural Foods is recalling Organic Whole Grain Amaranth Flour due to potential Salmonella contamination. The product was distributed in ten US states, Mexico, and the UAE.

    Product
    Amaranth Flour, Organic Whole Grain, Item Number: 6001C224, Net wt. 22 oz. UPC 0 39978 00911 1. The label is read in parts: "***Bob's Red Mill ***ORGANIC WHOLE GRAIN AMARANTH FLOUR STONE GROUND*** NET WT 22 OZ ***keeps best refrigerated or frozen***".
    Category
    Food
    Distribution
    11 states
  • 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
  • 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-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…
    Category
    Medical Device
    Distribution
    7 states
  • 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1106-2018·2018-04-18

    Cut Fruit Express Recalls Bruschetta Mix for Undeclared Milk and Soy

    Cut Fruit Express, Inc. is recalling Bruschetta Mix products because they contain undeclared milk and soy allergens.

    Product
    Bruschetta Mix packaged under the following brands and sizes: 1. Tastebuds, Net Wt. 12 oz. (340g), UPC 38232-37403. Shipping case: H. Brooks, 37403, Net wt. 12 oz. (340g), K*319, Keep Refrigerated, 6 units per case, Distributed by H. Brooks & Co Mpls. MN 55112. 2. Quick…
    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)…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1010-2018·2018-04-18

    Precise Food Ingredients Recalls Roast Beef Gravy Seasoning for Salmonella Risk

    Precise Food Ingredients is recalling 896 pounds of Roast Beef Gravy Seasoning due to potential Salmonella contamination. The product was distributed in Texas.

    Product
    Roast Beef Gravy Seasoning Manufacturer's code: PF07040000 packaged in a multi-walled paper bag with poly liner, 28 pounds
    Category
    Food
    Distribution
    1 state

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