The Recall Desk

Archive

June 2018 recalls

577 recalls were announced in June 2018.

What the numbers show

Critical
17
Severe
142
High
282
Moderate
123
Low
13

Of the 577 recalls this month scored against our rubric, 3% are Critical, 25% are Severe.

301–400 of 577

  • HighFDA (Devices)·Z-2055-2018·2018-06-13

    Becton Dickinson Recalls BD Vacutainer Plus SST Tubes Due to Stopper Defect

    Becton Dickinson is recalling BD Vacutainer Plus SST tubes because the stoppers may pull out of the tubes.

    Product
    BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2124-2018·2018-06-13

    Orthofix Locking Screws Recalled Due to Failure to Engage Plates

    Orthofix, Inc. is voluntarily recalling specific locking screws from the Rival Reduce Fracture Plating System and Rival View Plating System because they failed to properly engage plates during surgery.

    Product
    Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-32010) b) D 3.2MM X 12MM (002-E-32012) c) D 3.2MM X 14MM (002-E-32014) d) D 3.2MM X 16MM (002-E-32016) e) D 3.2MM X 18MM (002-E-32018) f) D 3.2MM X 20MM (002-E-32020
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2063-2018·2018-06-13

    Orthofix Recalls TL-HEX TruLok Hexapod System Due to Incompatibility

    Orthofix Srl is recalling 408 units of TL-HEX TruLok Hexapod System double row footplates because they are incompatible with current struts, posing a risk of dimensional interference.

    Product
    TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates and struts to be used in conjunction with the TruLok external fixation system.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2078-2018·2018-06-13

    Tosoh Thyroid Assay Recalled Due to Drug Interference

    Tosoh Bioscience is recalling ST-AIA PACK TT3 thyroid assays because the drug Strensiq interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK TT3; Part Number: 025282 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2076-2018·2018-06-13

    Tosoh ST-AIA PACK IRI Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK IRI assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK IRI; Part Number: 025260 Assay, Diabetes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2073-2018·2018-06-13

    Tosoh ST-AIA PACK cTnI 2nd Gen Recalled Due to Drug Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK cTnI 2nd Gen assays because the drug Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK cTnI 2nd Gen; Part Number: 025205 Assay, Cardiac Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2071-2018·2018-06-13

    Tosoh ST-AIA PACK CK-MB Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK CK-MB assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK CK-MB; Part Number: 025269 Assay, Cardiac Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2072-2018·2018-06-13

    Tosoh Myoglobin Assay Recalled Due to Drug Interference

    Tosoh Bioscience is recalling ST-AIA PACK Myoglobin assays because the drug Strensiq interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2066-2018·2018-06-13

    Tosoh ST-AIA PACK CEA Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK CEA assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK CEA; Part Number: 025254 Assay, Tumor Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1545-2018·2018-06-13

    Dean Foods Recalls Baskin Robbins Mint Chocolate Chip Ice Cream

    Dean Foods is recalling Baskin Robbins Mint Chocolate Chip ice cream because it may contain unlabeled coconut, a major food allergen.

    Product
    Baskin Robbins Mint Chocolate Chip
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2133-2018·2018-06-13

    Orthofix Recalls TN Plates Due to Screw Engagement Failure

    Orthofix is voluntarily recalling TN Plates because locking screws failed to properly engage the plates during surgery.

    Product
    TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-F-01020); b) Medium (002-F-01025); c) Large (002-F-01030)
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Food)·F-1531-2018·2018-06-13

    C.F. Sauer Recalls Red Pepper Seasoning for Undeclared Milk Allergen

    The C.F. Sauer Company is recalling multiple brands of Red Pepper Seasoning because milk is not listed in the ingredient or allergen statements.

    Product
    Blue Mountain Valley - Red Pepper Seasoning (21 oz.) Net Weight: 21 oz., Number of Units per Package: 6 Package Type: clear, 32 fl. oz. polyethylene terephthalate bottle , Units per case: 6
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-2088-2018·2018-06-13

    Tosoh Estradiol Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK Estradiol assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK Estradiol; Part Number: 025274 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2109-2018·2018-06-13

    Ion Beam Applications Recalls 12C AdaPTinsight Radiation Therapy Software

    Ion Beam Applications is recalling 12C units due to an issue with the AdaPTinsight software used for patient localization in radiation therapy.

    Product
    12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiati
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2097-2018·2018-06-13

    Tosoh ST-AIA PACK IGE II Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK IGE II allergy assays because Asfotase Alfa (Strensiq) can cause inaccurate test results.

    Product
    ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2123-2018·2018-06-13

    Orthofix Recalls Non-Locking Screws Due to Failure to Engage Plates

    Orthofix, Inc. is voluntarily recalling specific Non-Locking Screws because they failed to properly engage plates during surgery.

    Product
    Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010) b) D 3.2MM X 12MM (002-D-32012) c) D 3.2MM X 14MM (002-D-32014) d) D 3.2MM X 16MM (002-D-32016) e) D 3.2MM X 18MM (002-D-32018) f) D 3.2MM X 20MM (002-D-32
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2119-2018·2018-06-13

    Orthofix Non-Locking Screws Recalled Due to Failure to Engage Plates

    Orthofix, Inc. is voluntarily recalling specific non-locking screws from the Rival Reduce Fracture Plating System and Rival View Plating System because they failed to properly engage plates during surgery.

    Product
    Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (0002-D-20008); b) D 2.0MM X 10MM (002-D-20010); c) D 2.0MM X 12MM (002-D-20012); d) D 2.0MM X 14MM (002-D-20014); e) D 2.0MM X 16MM (002-D-20016); f) D 2.0MM X 18MM
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Drugs)·D-0841-2018·2018-06-13

    Apotex Recalls Fluticasone Propionate Nasal Spray Due to Glass Particles

    Apotex Inc. is recalling Fluticasone Propionate Nasal Spray because glass particles were found in the product. Consumers should stop using the affected lot.

    Product
    FLUTICASONE PROPIONATE — FLUTICASONE PROPIONATE (FLUTICASONE PROPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1884-2018·2018-06-13

    Santajoy Laser Projectors Recalled for Exceeding Federal Radiation Standards

    Santajoy Ornament & Giftware Co. is recalling E-Z Illuminations laser projectors because they may emit radiation exceeding federal standards for Class IIIa products.

    Product
    Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns for entertainment and decorative purposes.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1530-2018·2018-06-13

    Sauer Red Pepper Seasoning Recalled for Undeclared Milk Allergen

    The C.F. Sauer Company is recalling multiple brands of red pepper seasoning because milk is not listed in the ingredient statement.

    Product
    Sauer - Red Pepper Seasoning (21 oz.) Net Weight: 21 oz., Number of Units per Package: 6 Package Type: clear, 32 fl. oz. polyethylene terephthalate bottle , Units per case: 6
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-2128-2018·2018-06-13

    Orthofix Recalls Rival Plating Systems Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling Rival Reduce Fracture Plating System and Rival View Plating System components because locking screws failed to properly engage plates during surgery.

    Product
    H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 12MM Spacer (003-H-12001); b) 15MM Spacer (003-H-15001); 20MM Spacer (003-H-20001); 25MM Spacer (003-H-25001); 30 MM (003-H-30001)
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2081-2018·2018-06-13

    Tosoh Thyroid Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK FT4 assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK FT4; Part Number: 025268 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2087-2018·2018-06-13

    Tosoh Prolactin Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK Prolactin assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2120-2018·2018-06-13

    Orthofix Locking Screws Recalled for Failure to Engage Plates

    Orthofix, Inc. is voluntarily recalling locking screws from the Rival Reduce Fracture Plating System and Rival View Plating System because they were confirmed to not properly engage plates during surgery.

    Product
    Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (002-E-20008); b) D 2.0MM X 10MM (002-E-20010); c) D 2.0MM X 12MM (002-E-20012); d) D 2.0MM X 14MM (002-E-20014); e) D 2.0MM X 16MM (002-E-20016); f) D 2.0
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2127-2018·2018-06-13

    Orthofix Rival Plating System Recalled Due to Screw Engagement Failure

    Orthofix is voluntarily recalling Rival Reduce Fracture Plating System and Rival View Plating System because locking screws failed to properly engage plates during surgery.

    Product
    Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 6MM Spacer (002-H-00006); b) 8MM Spacer (022-H-00008); c) 10MM Spacer (002-H-00010); d) 12MM Spacer (002-H-00012)
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2056-2018·2018-06-13

    BD Vacutainer Plus SST Tubes Recalled for Stopper Defect

    Becton Dickinson is recalling BD Vacutainer Plus SST tubes because the stoppers may pull out of the tube.

    Product
    BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold, Catalog No. 367986
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1539-2018·2018-06-13

    Trader Joe's Organic French Baguette Recalled for Listeria Risk

    Trader Joe's is recalling specific lots of Organic French Baguettes due to potential Listeria monocytogenes contamination.

    Product
    Trader Joe's Artisan Bread - Organic French Baguette; (Brown and Serve) Keep frozen; Product code 53835; 24 x 11.5 oz. (326g) - 24 loaves per case. UPC 0053 8350 Product of Canada Manufactured by Groupe Premiere Moisson Inc., 189 Harwood, Vaudreuil-Dorion, Quebec, Canad
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-2101-2018·2018-06-13

    GE Healthcare Recalls Centricity PACS-IW Medical Image Viewer

    GE Healthcare is recalling 44 units of the Centricity PACS-IW with Universal Viewer because image series may be missing without warning.

    Product
    Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2077-2018·2018-06-13

    Tosoh AIA-PACK TSH 3rd Generation Assay Recalled Due to Interference

    Tosoh Bioscience Inc is recalling AIA-PACK TSH 3rd Generation assays because Asfotase Alfa interferes with the tests, potentially causing inaccurate results.

    Product
    AIA-PACK TSH 3rd Generation; Part Number: 020294 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2117-2018·2018-06-13

    Orthofix Rival View Kit Locking Screws Recalled for Failure to Engage Plates

    Orthofix, Inc. is voluntarily recalling Rival View Kit locking screws that failed to properly engage plates during surgery.

    Product
    Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-009C
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2111-2018·2018-06-13

    CareFusion Recalls Alaris Extension Sets Due to Incorrect Tubing

    CareFusion 303, Inc. is recalling Alaris Extension Sets with microbore tubing because manufacturing errors resulted in incorrect priming volumes.

    Product
    Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's artery or vein. These model codes are extension sets that can be used with IV a
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2084-2018·2018-06-13

    Tosoh ST-AIA PACK HCG Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK HCG assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK HCG; Part Number: 025256 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2089-2018·2018-06-13

    Tosoh ST-AIA PACK hsE2 Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK hsE2 assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK hsE2; Part Number: 025225 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1540-2018·2018-06-13

    Heritage Shortbread Lemon Infused Recalled for Missing Wheat Labeling

    Heritage Shortbread is recalling Lemon Infused shortbread because the label failed to list wheat as an ingredient.

    Product
    Heritage Shortbreaad Lemon Infused Ingredients: Enriched flour, pasteurized cream(milk),sugar, salt, pure crystallized ginger, organic ground ginger Mfg. by Heritage Shortbread, Inc. Hilton Head Island, SC 09926
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1535-2018·2018-06-13

    Ahold USA Recalls Stop and Shop Broccoli Cuts Due to Listeria

    Ahold USA is recalling Stop and Shop Broccoli Cuts after a Connecticut report found Listeria monocytogenes in the product.

    Product
    Broccoli cuts, All Natural, No Preservatives, Net Wt 16 OZ; Distributed by Foodhold USA, LLC, Landover, MD 20785; UPC: 688267009266, BEST BY 03/15/2020
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-1534-2018·2018-06-13

    Sauer Recalls Red Pepper Seasoning for Undeclared Milk Allergen

    The C.F. Sauer Company is recalling multiple brands of Red Pepper Seasoning because milk is not listed in the ingredient statement.

    Product
    Code - Red Pepper Seasoning (21 oz.) Net Weight: 21 oz., Number of Units per Package: 6 Package Type: clear, 32 fl. oz. polyethylene terephthalate bottle , Units per case: 6
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-2074-2018·2018-06-13

    Tosoh C-Peptide Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK C-Peptide assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK C-Peptide; Part Number: 025284 Assay, Diabetes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2099-2018·2018-06-13

    Tosoh ST-AIA PACK Cystatin C Assay Recalled Due to Drug Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK Cystatin C assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK Cystatin C; Part Number: 025217 Assay, Kidney Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2098-2018·2018-06-13

    Tosoh Tumor Marker Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK BMG tumor marker assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK BMG; Part Number:025259 Assay, Tumor Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2075-2018·2018-06-13

    Tosoh ST-AIA C-Peptide II Assay Recalled Due to Drug Interference

    Tosoh Bioscience is recalling ST-AIA PACK C-Peptide II assays because the drug Asfotase Alfa can cause inaccurate test results.

    Product
    ST-AIA PACK C-Peptide II; Part Number: 025283 Assay, Diabetes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2102-2018·2018-06-13

    GE Healthcare Recalls Centricity Universal Viewer for Missing Image Series

    GE Healthcare is recalling 252 units of the Centricity Universal Viewer because image series may be missing from exams without a user warning.

    Product
    Centricity Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2116-2018·2018-06-13

    Orthofix Rival Reduce Kit Locking Screws Recalled for Failure to Engage Plates

    Orthofix is voluntarily recalling Rival Reduce Kit locking screws because they failed to properly engage plates during surgery.

    Product
    Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-011C
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2093-2018·2018-06-13

    Tosoh ST-AIA PACK Testosterone Assay Recalled Due to Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK Testosterone assays because Asfotase Alfa interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2094-2018·2018-06-13

    Tosoh ST-AIA PACK Cort Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK Cort assays because the drug Strensiq interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2069-2018·2018-06-13

    Tosoh ST-AIA CA 19-9 Assay Recalled Due to Drug Interference

    Tosoh Bioscience is recalling ST-AIA PACK CA 19-9 assays because the drug Strensiq interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2086-2018·2018-06-13

    Tosoh FSH Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc. is recalling ST-AIA PACK FSH assays because the drug Asfotase Alfa (Strensiq) can cause inaccurate test results.

    Product
    ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2018·2018-06-13

    Tosoh ST-AIA PACK AFP Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK AFP assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1532-2018·2018-06-13

    C.F. Sauer Recalls Red Pepper Seasoning for Undeclared Milk Allergen

    The C.F. Sauer Company is recalling multiple brands of Red Pepper Seasoning because milk is not listed in the ingredient or allergen statements.

    Product
    Pocahontas - Red Pepper Seasoning (21 oz.) Net Weight: 21 oz., Number of Units per Package: 6 Package Type: clear, 32 fl. oz. polyethylene terephthalate bottle , Units per case: 6
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-2070-2018·2018-06-13

    Tosoh Tumor Marker Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc. is recalling ST-AIA PACK 27.29 tumor marker assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2103-2018·2018-06-13

    NordicNeuroLab fMRI AudioSystem Recalled for Acoustic Distortion and Heat

    NordicNeuroLab AS is recalling 64 fMRI AudioSystem units after a patient reported acoustic distortion and heat from headphones during a scan.

    Product
    fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2095-2018·2018-06-13

    Tosoh ST-AIA PACK HGH Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK HGH assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK HGH; Part Number: 025266 Assay, Metabolic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2129-2018·2018-06-13

    Orthofix Recalls Lapidus Plates Due to Screw Engagement Failure

    Orthofix is voluntarily recalling 156 Lapidus Plates because locking screws failed to properly engage the plates during surgery.

    Product
    Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right (Part Number): a) Small/0MM Step/Left (002-C-01000L); b) Small/0MM Step/Right (002-C-01000R); c) Large/0MM Step/Left (002-C-02000L); d) Large/0MM Step/Right (002-C-02000R); e) Small
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Food)·F-1533-2018·2018-06-13

    C.F. Sauer Recalls Red Pepper Seasoning for Undeclared Milk Allergen

    The C.F. Sauer Company is recalling multiple brands of red pepper seasoning because milk is not listed in the ingredient statement.

    Product
    Premium - Recipe Red Pepper Seasoning (21 oz.) Net Weight: 21 oz., Number of Units per Package: 6 Package Type: clear, 32 fl. oz. polyethylene terephthalate bottle , Units per case: 6
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-2090-2018·2018-06-13

    Tosoh ST-AIA PACK LH II Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK LH II assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK LH II; Part Number: 025296 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2082-2018·2018-06-13

    Tosoh Thyroid Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK TU thyroid assays because the drug Strensiq can cause inaccurate test results.

    Product
    ST-AIA PACK TU; Part Number: 025270 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1614-2018·2018-06-13

    11-VI Incorporated Recalls Non-Certified Laser Diode Components for Firearms

    11-VI Incorporated is recalling 323,972 non-certified laser diode components used in firearm sights because they emit more than the 5 mW limit.

    Product
    11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms
    Category
    Consumer Product
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2091-2018·2018-06-13

    Tosoh ST-AIA PACK Prog II Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK Prog II assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK Prog II; Part Number: 025239 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2092-2018·2018-06-13

    Tosoh ST-AIA SHBG Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA SHBG assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK SHBG; Part Number: 025238 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2053-2018·2018-06-13

    Siemens ADVIA Centaur BNP Assay Recalled for Potential Analyzer Malfunction

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur BNP assays because they may cause analyzer malfunction or reduced dilution recovery when used with specific diluents.

    Product
    ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests)
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-2113-2018·2018-06-13

    Baxter SIGMA Spectrum Infusion Pump Instructions for Use Update

    Baxter Healthcare is updating the Instructions for Use for SIGMA Spectrum Infusion Pumps to correct a discrepancy regarding the height of secondary infusion hangers.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include phar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2107-2018·2018-06-13

    MicroAire SmartRelease Endoscopic System Recalled for Incorrect Sterilization Instructions

    MicroAire is recalling SmartRelease Endoscopic Systems because the Instructions for Use contain incorrect sterilization parameters.

    Product
    MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAire Carpal Tunnel Release System is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2110-2018·2018-06-13

    Fresenius NaturaLyte Liquid Acid Concentrate Recalled for Mislabeled Part Numbers

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid Concentrate bottles due to incorrect part number labeling.

    Product
    NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2050-2018·2018-06-13

    NordicNeuroLab Recalls nordicBrainEx 2.0 Software Due to Image Orientation Errors

    NordicNeuroLab AS is recalling nordicBrainEx 2.0 software versions 2.1 and older because a DICOM header error may cause incorrect image orientation labeling.

    Product
    nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2079-2018·2018-06-13

    Tosoh ST-AIA PACK T4 Thyroid Assay Recalled Due to Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK T4 thyroid assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2059-2018·2018-06-13

    Randox RX Imola Analyzers Recalled for Software Termination Issue

    Randox Laboratories is recalling 41 RX Imola analyzers because a software defect may cause premature termination, delaying patient test results.

    Product
    RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2083-2018·2018-06-13

    Tosoh ST-AIA PACK HCG Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK HCG assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA PACK ¿HCG; Part Number: 025261 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2115-2018·2018-06-13

    Invivo Xper Flex Cardio Physiomonitoring System Recalled for Software Defect

    Invivo Corporation is recalling Xper Flex Cardio Physiomonitoring Systems because users may inadvertently close the Full Disclosure Control Window using the ESC key.

    Product
    Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2085-2018·2018-06-13

    Tosoh ST-AIA DHEA-S Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA DHEA-S assays because Asfotase Alfa (Strensiq) interferes with the test, potentially causing inaccurate results.

    Product
    ST-AIA DHEA-S; Part Number: 025222 Assay, Reproductive Hormone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2108-2018·2018-06-13

    Medtech Recalls ROSA Robotized Stereotactic Assistant Units for Approval Issues

    Medtech SAS is recalling 29 ROSA Robotized Stereotactic Assistant units because they lack an updated device approval.

    Product
    ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2068-2018·2018-06-13

    Tosoh ST-AIA Prostate Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA Prostate Assay kits because the drug Strensiq can cause inaccurate test results.

    Product
    ST-AIA PACK PAP; Part Number: 025262 Assay, Prostate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2080-2018·2018-06-13

    Tosoh ST-AIA PACK FT3 Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience Inc is recalling ST-AIA PACK FT3 assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate thyroid results.

    Product
    ST-AIA PACK FT3; Part Number: 025286 Assay, Thyroid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1529-2018·2018-06-13

    Driscoll's Blackberries Recalled for Pesticide Residue Tolerance Exceedances

    Driscoll's is recalling 6 oz. blackberries from Mexico due to pesticide levels exceeding tolerance limits.

    Product
    Driscoll's Blackberries; 6 oz. clamshell container; Keep refrigerated. Product of Mexico Driscoll's Inc. Watsonville, CA 95077
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2057-2018·2018-06-13

    Stryker Recalls Expired Arthroscopic Cannulas Due to Labeling Error

    Stryker is recalling 10 units of 8.0mm x 90mm Dri-Lok Threaded Cannulas because the expiration date was misprinted as August 2018 instead of August 2016.

    Product
    3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Disposable Cannula device is designed to be used as a port of entry for arthroscopic instruments into the joints.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2064-2018·2018-06-13

    Bardex Foley Catheter Recalled for Incorrect Retainer Cap Print

    C.R. Bard is recalling specific lots of Bardex Foley catheters because the retainer cap print is incorrect.

    Product
    Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2112-2018·2018-06-13

    Baxter SIGMA Spectrum Infusion Pump Recall for Instructional Mismatch

    Baxter is recalling SIGMA Spectrum Infusion Pumps because the instructions for use specify a 20-inch bag drop, but the firm supplies 12.5-inch hangers.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2067-2018·2018-06-13

    Tosoh Tumor Marker Assay Recalled Due to Strensiq Interference

    Tosoh Bioscience is recalling ST-AIA PACK PA tumor marker assays because Asfotase Alfa (Strensiq) interferes with the tests, potentially causing inaccurate results.

    Product
    ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2052-2018·2018-06-13

    Hobbs Bronchial Cytology Brushes Recalled for Unauthorized Marketing

    Hobbs Medical is recalling 1,820 bronchial cytology brushes because they were marketed for uses outside their FDA clearance.

    Product
    Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2062-2018·2018-06-13

    Siemens ADVIA Chemistry Urea Nitrogen Reagent Recalled for Calibration Failures

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Urea Nitrogen Reagent due to increased calibration failures that prevent the system from generating results.

    Product
    ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2061-2018·2018-06-13

    NordicNeuroLab Recalls nordicICE Software Due to Coregistration Visualization Error

    NordicNeuroLab AS is recalling 121 licenses of nordicICE v 2.3.14 because a software bug causes BOLD activation maps to be visualized without accounting for coregistration.

    Product
    nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2054-2018·2018-06-13

    Siemens ADVIA Centaur TSH3-Ultra Assay Recalled for Analyzer Compatibility Issues

    Siemens is recalling specific lots of ADVIA Centaur TSH3-Ultra assays because they may cause reduced dilution recovery or inoperability when used with Multi-Diluent 15 on certain analyzers.

    Product
    ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests)
    Category
    Medical Device
    Distribution
    28 states
  • LowFDA (Devices)·Z-2106-2018·2018-06-13

    Datascope Recalls Maquet Cardiopulmonary Bypass Custom Tubing Kits

    Datascope Corporation is recalling 19 Maquet Cardiopulmonary Bypass Custom Tubing kits due to a potential cuvette failure that causes monitor errors.

    Product
    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-2046-2018·2018-06-13

    Draeger Jaundice Meter JM-103 Recalled for Measurement Display Misinterpretation

    Draeger Medical Systems is recalling the Jaundice Meter JM-103 because users may misinterpret the out-of-range display as a zero measurement.

    Product
    Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2105-2018·2018-06-13

    Datascope Recalls Maquet Cardiopulmonary Bypass Custom Tubing Kits

    Datascope is recalling 194 Maquet Cardiopulmonary Bypass Custom Tubing kits due to a potential cuvette failure that triggers a monitor error.

    Product
    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-2104-2018·2018-06-13

    Datascope Cardiopulmonary Bypass Tubing Kit Recalled for Cuvette Failure

    Datascope is recalling 19 cardiopulmonary bypass tubing kits due to a potential cuvette failure that causes monitor error messages.

    Product
    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588
    Category
    Medical Device
    Distribution
    3 states
  • LowFDA (Devices)·Z-2047-2018·2018-06-13

    Draeger Jaundice Meter JM-105 Recalled for Misinterpreted Display Readings

    Draeger Medical Systems is recalling 6,711 Draeger Jaundice Meter JM-105 devices because users may misinterpret the out-of-range display as a zero measurement.

    Product
    Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V394000·2018-06-12

    New Flyer Transit Buses Recalled for Brake Caliper Guide Pin Defect

    New Flyer is recalling 908 urban transit buses from 2014-2017 because a brake caliper guide pin may break, reducing braking ability and increasing crash risk.

    Product
    NEW FLYER — NEW FLYER XN60, XDE60, XD60, XT60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V392000·2018-06-12

    Ford Recalls 2018 Expedition, F-150, and Navigator for Fuel Pump Defect

    Ford is recalling 2018 Expedition, F-150, and Lincoln Navigator vehicles because a fuel pump weld can fracture, causing a leak that increases fire risk.

    Product
    LINCOLN — LINCOLN, FORD NAVIGATOR, EXPEDITION, F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V391000·2018-06-12

    Lamborghini Recalls Aventador Models Due to Engine Stall Risk

    Lamborghini is recalling 2012-2018 Aventador vehicles because the engine may stall unexpectedly, increasing crash risk. Dealers will install updated software.

    Product
    LAMBORGHINI — LAMBORGHINI AVENTADOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18176·2018-06-12

    Uttermost Recalls Mirrors and Wall Decor Due to Falling Hazard

    Uttermost is recalling about 17,000 mirrors and wall decor items because the hanging hardware can break, causing items to fall and injure bystanders.

    Product
    Mirrors, art and wall decor
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V393000·2018-06-12

    KME Predator Aerial Vehicles Recalled for Tether Control Software Defect

    Kovatch Mobile Equipment is recalling 2015-2018 KME Predator Aerial emergency vehicles because the aerial platform may continue moving if the tether control is unplugged.

    Product
    KME — KME PREDATOR AERIAL, PREDATOR SS AERIAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18174·2018-06-12

    A&I Recalls Tractor Canopies Due To ROPS Failure Injury Hazard

    A&I is recalling about 6,200 tractor canopies in the U.S. and 265 in Canada because they may fail to protect operators in a rollover accident.

    Product
    A&I tractor canopies
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18747·2018-06-12

    Ashley Furniture Recalls Amnon Floor Lamps Due to Burn Hazard

    Ashley Furniture is recalling Amnon floor lamps because the incorrect wattage label allows users to install bulbs that can melt the power switch, posing a burn hazard.

    Product
    Amnon floor lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18175·2018-06-12

    Ketra Recalls D3 Recessed Downlights Due to Electrical Shock Hazard

    Ketra is recalling about 3,400 D3 recessed downlights because incorrect wiring in the power supply connectors poses an electrical shock hazard. No injuries have been reported.

    Product
    Ketra D3 recessed downlights
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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