The Recall Desk

Archive

July 2018 recalls

502 recalls were announced in July 2018.

What the numbers show

Critical
34
Severe
167
High
225
Moderate
62
Low
14

Of the 502 recalls this month scored against our rubric, 7% are Critical, 33% are Severe.

301–400 of 502

  • CriticalFDA (Food)·F-1630-2018·2018-07-11

    Caito Foods Recalls Multiple Brands of Mixed Melon for Salmonella Risk

    Caito Foods Service, Inc. is recalling mixed melon products sold under Kroger and Walmart brands due to potential Salmonella contamination.

    Product
    Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Kroger FRU TRAY LG W/WATMLN 1/64.75Z , 64.75 oz., UPC: 826766185498 Clear Generic Label Distributed by Renaissance Walmart FRUIT BOWL 2/40Z
    Category
    Food
    Distribution
    23 states
  • CriticalFDA (Food)·F-1632-2018·2018-07-11

    Caito Foods Recalls Mixed Melon for Potential Salmonella Contamination

    Caito Foods Service, Inc. is recalling mixed melon products due to potential Salmonella contamination. The recall covers specific Kroger brand fruit snack trays distributed in 23 states.

    Product
    Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Kroger FRUIT SNACK TRAY 1/40Z, 40 oz., UPC: 826766140152, Clear Generic Label Distributed by Renaissance Food Group
    Category
    Food
    Distribution
    23 states
  • CriticalFDA (Food)·F-1646-2018·2018-07-11

    Caito Foods Recalls Mixed Melon Products Due to Salmonella Risk

    Caito Foods Service, Inc. is recalling multiple brands of mixed melon products due to potential Salmonella contamination. The recall covers approximately 3.16 million pounds distributed across 23 states.

    Product
    Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Walgreens TROPICAL MEDLEY 1/10Z, 10 oz., UPC: 49022536999 Delish label Walgreens MANGO PINE LOPE SPEAR WAG 1/5Z, 5 oz., UPC: 49022537019 De
    Category
    Food
    Distribution
    23 states
  • CriticalFDA (Food)·F-1635-2018·2018-07-11

    Caito Foods Recalls Mixed Melon Products Due to Salmonella Risk

    Caito Foods Service, Inc. is recalling mixed melon products due to potential Salmonella contamination. Consumers should check their pantries for affected items.

    Product
    Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Caito Foods Disribution FRUIT BOWL 6/64Z, 64 oz., UPC: 81851301485 Clear Generic Label Distributed by Caito Foods
    Category
    Food
    Distribution
    23 states
  • CriticalFDA (Food)·F-1648-2018·2018-07-11

    Caito Foods Recalls Mixed Melon Fruit Salad Due to Salmonella Risk

    Caito Foods Service, Inc. is recalling mixed melon fruit salad sold at Whole Foods and Amazon due to potential Salmonella contamination.

    Product
    Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Whole Foods/ Amazon Fruit Salad, Seasonal 20 oz., UPC: 826766810987, Whole Foods Market label
    Category
    Food
    Distribution
    23 states
  • CriticalFDA (Food)·F-1636-2018·2018-07-11

    Caito Foods Recalls Multiple Brands Mixed Melon for Salmonella Risk

    Caito Foods Service, Inc. is recalling multiple brands of mixed melon, including Walmart Fruit Bowl, due to potential Salmonella contamination.

    Product
    Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Walmart FRUIT BOWL 2/40Z 40 oz. , UPC: 681131180238 Freshness Guaranteed label
    Category
    Food
    Distribution
    23 states
  • CriticalFDA (Food)·F-1640-2018·2018-07-11

    Caito Foods Recalls Mixed Melon for Potential Salmonella Contamination

    Caito Foods Service, Inc. is recalling multiple brands of mixed melon sold at Walmart due to potential Salmonella contamination.

    Product
    Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Walmart FRUIT TRAY 2/48Z 48 oz., UPC: 681131180207 Freshness Guaranteed label
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Devices)·Z-2356-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Potential Lead and Stylet Damage

    FHC, Inc. is recalling the microTargeting Drive System Depth Stop Adapter because over-tightening the screw can damage implanted leads, requiring replacement.

    Product
    microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Drugs)·D-0902-2018·2018-07-11

    SCA Pharmaceuticals Recalls Phenylephrine Bags Due to Sterility Concerns

    SCA Pharmaceuticals is voluntarily recalling 451 bags of Phenylephrine HCL due to potential leakage that compromises sterility.

    Product
    Phenylephrine HCL 40 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0890-2018·2018-07-11

    Ingenus Recalls Irinotecan Hydrochloride Injection Due to Potency Issues

    Ingenus Pharmaceuticals is recalling specific lots of Irinotecan Hydrochloride Injection because they had high out-of-specification assay values for potency.

    Product
    IRINOTECAN HYDROCHLORIDE — IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2351-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Potential Lead Damage

    FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage the implanted lead, requiring removal and replacement.

    Product
    microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Drugs)·D-0897-2018·2018-07-11

    SCA Pharmaceuticals Recalls Diltiazem HCL Bags Due to Sterility Concerns

    SCA Pharmaceuticals is voluntarily recalling specific lots of Diltiazem HCL sterile admixtures due to a potential for leakage that compromises sterility.

    Product
    Diltiazem HCL 1 mg/mL in 125 mL 0.9% Sodium Chloride 100 mL bag (total volume 125 mL) (125 mg), SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2358-2018·2018-07-11

    FHC Depth Stop Adapter Recall Due to Lead Damage Risk

    FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage implanted leads, requiring surgical replacement.

    Product
    microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2354-2018·2018-07-11

    FHC Depth Stop Adapter Recall for Potential Lead Damage

    FHC, Inc. is recalling microTargeting Lead Adapters because over-tightening the depth stop screw can damage implanted leads, requiring replacement.

    Product
    microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2359-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Lead Damage Risk

    FHC, Inc. is recalling Depth Stop Adapters because over-tightening the screw can damage implanted leads, requiring removal and replacement.

    Product
    microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2350-2018·2018-07-11

    FHC Depth Stop Adapter Recall Due to Lead and Stylet Damage

    FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage implanted leads and stylets, requiring replacement.

    Product
    microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2347-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Potential Lead Damage

    FHC, Inc. is recalling the microTargeting Drive System because the Depth Stop Adapter may damage implanted leads if over-tightened, potentially requiring replacement.

    Product
    microTargeting" Drive System, Product Number 66-ZD-MD
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Drugs)·D-0895-2018·2018-07-11

    SCA Pharmaceuticals Recalls Fentanyl Bags Due to Sterility Concerns

    SCA Pharmaceuticals is voluntarily recalling 492 bags of Fentanyl admixture due to a potential for leakage that compromises sterility.

    Product
    Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-1642-2018·2018-07-11

    Caito Foods Recalls Mixed Melon Products for Salmonella Risk

    Caito Foods Service, Inc. is recalling multiple brands of mixed melon products due to potential Salmonella contamination. The recall affects approximately 3.16 million pounds of product distributed across 23 states.

    Product
    Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Walmart SALAD SEASONAL FRUIT 4/10Z 13 oz., UPC: 826766254262 Freshness Guaranteed label
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Devices)·Z-2348-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Lead and Stylet Damage

    FHC, Inc. is recalling the microTargeting Drive System because the Depth Stop Adapter can damage leads and stylets, potentially causing short circuits.

    Product
    microTargeting" Drive System, Product Number 66-ZD-MD-01
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Drugs)·D-0898-2018·2018-07-11

    SCA Pharmaceuticals Recalls Norepinephrine Bags Due to Sterility Concerns

    SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate bags due to a potential for leakage that compromises sterility.

    Product
    Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0903-2018·2018-07-11

    SCA Pharmaceuticals Recalls Phenylephrine HCL Bags Due to Sterility Concerns

    SCA Pharmaceuticals is voluntarily recalling 400 bags of Phenylephrine HCL 20 mg in 0.9% Sodium Chloride due to a potential for leakage that compromises sterility.

    Product
    Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-1645-2018·2018-07-11

    Caito Foods Recalls Multiple Brands of Mixed Melon for Salmonella Risk

    Caito Foods Service, Inc. is recalling multiple brands of mixed melon, including Walgreens Delish, due to potential Salmonella contamination.

    Product
    Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Walgreens FRUIT TRAY 1/22Z, 22 oz., UPC: 49022683129 Delish label
    Category
    Food
    Distribution
    23 states
  • SevereNHTSA·18V461000·2018-07-11

    Lamborghini Recalls 2015-2016 Aventador Models for Wheel Detachment Risk

    Lamborghini is recalling 2015-2016 Aventador SV vehicles because loose brake disc bolts may cause wheels to detach, increasing crash risk.

    Product
    LAMBORGHINI — LAMBORGHINI AVENTADOR, AVENTADOR ROADSTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V463000·2018-07-11

    Pierce Emergency Vehicles Recalled for Aerial Bracket Detachment Risk

    Pierce is recalling 2007-2017 emergency vehicles because an aerial device bracket may detach and fall, potentially striking a person below.

    Product
    PIERCE — PIERCE IMPEL, ENFORCER, QUANTUM, VELOCITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1644-2018·2018-07-11

    Caito Foods Recalls Mixed Melon Products Due to Salmonella Risk

    Caito Foods Service, Inc. is recalling mixed melon products, including Walmart's Seasonal Trio, due to potential Salmonella contamination.

    Product
    Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Walmart SEASONAL TRIO 2/32Z 32 oz., UPC: 681131180696 Freshness Guaranteed label
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Food)·F-1641-2018·2018-07-11

    Caito Foods Recalls Mixed Melon Products Due to Salmonella Risk

    Caito Foods Service, Inc. is recalling multiple brands of mixed melon products, including Walmart Melon Berry Mix, due to potential Salmonella contamination.

    Product
    Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Walmart MELON BERRY MIX 4/10Z 13 oz., UPC: 826766254248 Freshness Guaranteed label
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Devices)·Z-2355-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Potential Lead Damage

    FHC, Inc. is recalling the microTargeting Drive System Depth Stop Adapter because over-tightening the screw can damage implanted leads, requiring replacement.

    Product
    microTargeting" Drive System Distributed by Medtronic, Product Number FC1006
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Food)·F-1647-2018·2018-07-11

    Caito Foods Recalls Mixed Melon Products for Salmonella Risk

    Caito Foods Service, Inc. is recalling mixed melon products, including Whole Foods Market brand, due to potential Salmonella contamination.

    Product
    Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Whole Foods/ Amazon Melon Combo 20 oz., UPC: 826766811205, Whole Foods Market label
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Drugs)·D-0894-2018·2018-07-11

    SCA Pharmaceuticals Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    SCA Pharmaceuticals is voluntarily recalling specific lots of Morphine Sulfate 1 mg/mL syringes due to a potential for leakage that compromises sterility.

    Product
    Morphine Sulfate 1 mg/mL (preservative free; sulfite free) 2 mL fill 3 mL syringe, SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2346-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Lead and Stylet Damage

    FHC, Inc. is recalling the microTargeting Drive System because the Depth Stop Adapter can damage implanted leads and stylets when over-tightened, requiring device replacement.

    Product
    microTargeting" Drive System, Product Number MT-DS-01
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Food)·F-1638-2018·2018-07-11

    Caito Foods Recalls Mixed Melon Products Due to Salmonella Risk

    Caito Foods Service, Inc. is recalling multiple brands of mixed melon products because they have the potential to be contaminated with Salmonella.

    Product
    Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Caito Foods Disribution FRUIT MIX 6/10Z, 10 oz., UPC: 81851301348 Clear Generic Label Distributed by Caito Foods Caito Foods Disribution FR
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Food)·F-1627-2018·2018-07-11

    Caito Foods Recalls Kroger Fruit Trays for Salmonella Risk

    Caito Foods Service, Inc. is recalling specific Kroger fruit trays with dip due to potential Salmonella contamination. The products were distributed in 23 states.

    Product
    Kroger FRUIT TRAY SM W/DIP 1/26.75Z, 26.75 oz., UPC: 826766145386 Clear Generic Label Distributed by Renaissance Food Group Kroger FRUIT TRAY LRG W/DIP 1/63Z, 63 oz., UPC: 826766145393 Clear Generic Label Distributed by Renaissance Food Group
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Devices)·Z-2352-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Potential Lead Damage

    FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage implanted leads, causing short circuits and requiring replacement.

    Product
    microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Food)·F-1633-2018·2018-07-11

    Caito Foods Recalls Multiple Brands of Mixed Melon for Salmonella Risk

    Caito Foods Service, Inc. is recalling multiple brands of mixed melon due to potential Salmonella contamination. The recall affects 3.16 million pounds distributed across 23 states.

    Product
    Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Kroger MIXED SPEARS 1/16Z , 16 oz., UPC: 826766139606 Clear Generic Label Distributed by Renaissance Food Group
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Food)·F-1639-2018·2018-07-11

    Caito Foods Recalls Mixed Melon Products for Salmonella Risk

    Caito Foods Service, Inc. is recalling multiple brands of mixed melon products due to potential Salmonella contamination. The recall affects products sold in 23 states.

    Product
    Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Walmart SEASONAL BLEND 4/10Z 10 oz., UPC: 681131180481 Freshness Guaranteed label Walmart SEASONAL BLEND 4/16Z 16 oz., UPC: 681131180498
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Drugs)·D-0910-2018·2018-07-11

    Fagron Recalls Neostigmine Methylsulfate Syringes Due to Labeling Error

    Fagron Sterile Services is recalling 840 prefilled syringes of Neostigmine Methylsulfate Injection Solution because they may be incorrectly labeled with the wrong strength.

    Product
    Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1631-2018·2018-07-11

    Caito Foods Recalls Mixed Melon Products Due to Salmonella Risk

    Caito Foods Service, Inc. is recalling multiple brands of mixed melon products due to potential Salmonella contamination. The products were distributed in 23 states.

    Product
    Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Kroger FRUIT MEDLEY 1/10Z, 10 oz., UPC: 826766140176, Clear Generic Label Distributed by Renaissance Food Group Kroger FRUIT MEDLEY 1/24Z,
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Drugs)·D-0891-2018·2018-07-11

    Ingenus Recalls Irinotecan Hydrochloride Injection Due to Potency Issues

    Ingenus Pharmaceuticals is recalling Irinotecan Hydrochloride Injection because of high out-of-specification assay values for potency.

    Product
    IRINOTECAN HYDROCHLORIDE — IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1643-2018·2018-07-11

    Caito Foods Recalls Mixed Melon Products for Salmonella Risk

    Caito Foods Service, Inc. is recalling multiple brands of mixed melon products due to potential Salmonella contamination. The recall affects products sold in 23 states.

    Product
    Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Walgreens FRUIT SALAD SEASONAL WAG 1/32Z, 32 oz., UPC: 49022637764 Delish label Walgreens SEASONAL FRUIT SALAD 1/10Z, 10 oz., UPC: 4902251918
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Drugs)·D-0911-2018·2018-07-11

    Fagron Recalls Neostigmine Methylsulfate Syringes Due to Labeling Error

    Fagron Compounding Services is recalling 390 prefilled syringes of Neostigmine Methylsulfate Injection Solution because some may be incorrectly labeled with the wrong strength.

    Product
    Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2345-2018·2018-07-11

    FHC microTargeting Drive System Recalled for Lead Damage Risk

    FHC, Inc. is recalling 2,952 microTargeting Drive Systems because over-tightening the depth stop screw can damage implanted leads, requiring replacement.

    Product
    microTargeting" Drive System, Product Number MT-DS
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Drugs)·D-0905-2018·2018-07-11

    SCA Pharmaceuticals Recalls Phenylephrine Bags Due to Leakage Risk

    SCA Pharmaceuticals is voluntarily recalling 196 bags of Phenylephrine HCL 80mg in 0.9% Sodium Chloride due to a potential for leakage that compromises sterility.

    Product
    Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2293-2018·2018-07-11

    Howmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation

    Howmedica Osteonics Corp. is recalling specific LFIT Anatomic CoCr Femoral Heads because of a higher than expected number of complaints regarding disassociation from the hip stem.

    Product
    LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2349-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Potential Lead Damage

    FHC, Inc. is recalling the microTargeting STar Drive System (Manual) because the Depth Stop Adapter may damage the lead and stylet if the screw is over-tightened.

    Product
    microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2294-2018·2018-07-11

    Howmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation

    Howmedica Osteonics Corp. is recalling specific lots of LFIT Anatomic CoCr Femoral Heads due to a higher than expected number of complaints about femoral head and hip stem disassociation.

    Product
    LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-044
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2361-2018·2018-07-11

    Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue

    Zimmer Biomet is recalling M/L Taper Hip Prostheses manufactured before October 2015 due to potential black residue in the packaging. The residue is described as biocompatible, but may cause surgical delays or wear-related intervention.

    Product
    Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset, 00-7711-004-40
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·18V464000·2018-07-11

    Volkswagen Recalls 2015-2018 Golf Models for Ignition Key Removal Defect

    Volkswagen is recalling 2015-2018 Golf and Golf Sportwagen vehicles because silicate buildup may allow the key to be removed while the car is not in Park, increasing rollaway risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN GOLF, GOLF SPORTWAGEN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1634-2018·2018-07-11

    Caito Foods Recalls Mixed Melon Products Due to Salmonella Risk

    Caito Foods Service, Inc. is recalling multiple brands of mixed melon products because they have the potential to be contaminated with Salmonella.

    Product
    Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Caito Foods Disribution FRUIT BURST 4/20Z, 20 oz., UPC: 81851301409 Clear Generic Label Distributed by Caito Foods Caito Foods Disributi
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·F-1628-2018·2018-07-11

    Caito Foods Recalls Multiple Brands of Mixed Melon for Salmonella Risk

    Caito Foods Service, Inc. is recalling mixed melon products sold under various brands due to potential Salmonella contamination.

    Product
    Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Caito Foods Disribution FRUIT SNACK TRAY 3/32Z, 32 oz., UPC: 81851301454 Clear Generic Label Distributed by Caito Foods Caito Foods Disribu
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·F-1626-2018·2018-07-11

    Caito Foods Recalls Mixed Melon Products Due to Salmonella Risk

    Caito Foods Service, Inc. is recalling multiple brands of mixed melon products due to potential Salmonella contamination. The recall covers products distributed across 23 states.

    Product
    Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Caito Foods Disribution MELON MIX 6/10Z, 10 oz., UPC: 81851301331 Clear Generic Label Distributed by Caito Foods Caito Foods Disribution
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·F-1629-2018·2018-07-11

    Caito Foods Recalls Mixed Melon Products Due to Salmonella Risk

    Caito Foods Service, Inc. is recalling mixed melon products, including Kroger Salad Fiesta Fruit, due to potential Salmonella contamination.

    Product
    Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Kroger SALAD FIESTA FRUIT 1/18Z, 18 oz., UPC: 826766185641 Clear Generic Label Distributed by Renaissance Food Group
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·F-1624-2018·2018-07-11

    Caito Foods Recalls Cantaloupe Products Due to Salmonella Risk

    Caito Foods Service, Inc. is recalling multiple brands of cut cantaloupe products due to potential Salmonella contamination. The recall covers products distributed across 23 states.

    Product
    Cantaloupe, multiple product sizes and brands, see as follows: Caito Foods Disribution CANTALOUPE SPEARS 6/16Z, 16 oz., UPC: 81851301294 Caito Foods Distribution Labeling CANTALOUPE CHUNKS 6/10Z, 10 oz., UPC: 81851301379, Caito Foods Distribution Labeling Caito Foods
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·F-1625-2018·2018-07-11

    Caito Foods Recalls Honeydew and Cantaloupe for Salmonella Risk

    Caito Foods Service, Inc. is recalling honeydew and cantaloupe products due to potential Salmonella contamination. The recall covers approximately 3.16 million pounds distributed across 23 states.

    Product
    Honeydew, Clear Generic Label Distributed by Caito Foods; distributed at Gordon Food Service, Clear Generic Label Distributed by Caito Foods Distributed at Kroger with Clear Generic Label Distributed by Renaissance Food Group Distributed at SpartanNash Distribution wit
    Category
    Food
    Distribution
    23 states
  • HighNHTSA·18V465000·2018-07-11

    BMW and MINI Recall 5,309 Vehicles for Crankshaft Sensor Defect

    BMW is recalling 5,309 vehicles because a crankshaft sensor firmware error may cause the engine to stall, increasing crash risk.

    Product
    MINI — MINI, BMW JCW, X2, COUNTRYMAN, CLUBMAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2374-2018·2018-07-11

    Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue

    Zimmer Biomet is recalling 58 M/L Taper Hip Prostheses distributed to Japan due to black residue in the packaging. The residue is biocompatible but may cause surgical delays or wear-related intervention.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 7.5; 00-7713-007-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2341-2018·2018-07-11

    Intuitive Surgical Recalls da Vinci X Systems with Defective Arm Controller Boards

    Intuitive Surgical is recalling 35 da Vinci X Surgical Systems because defective Arm Controller Joint boards have a high rate of failure.

    Product
    da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Mode IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2298-2018·2018-07-11

    Howmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation

    Howmedica Osteonics Corp. is recalling LFIT Anatomic CoCr Femoral Heads because of a higher than expected number of complaints regarding disassociation from the hip stem.

    Product
    LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-336
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2365-2018·2018-07-11

    Zimmer Biomet Recalls 24 Hip Prosthesis Units Distributed to Japan

    Zimmer Biomet is voluntarily recalling 24 hip prosthesis units distributed solely to Japan. The recall was initiated in May 2018 and terminated in May 2020.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 10; 00-7713-010-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2366-2018·2018-07-11

    Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue

    Zimmer Biomet is recalling M/L Taper Hip Prostheses manufactured before October 2015 due to potential black residue in the packaging. The residue is biocompatible but may cause surgical delays or wear-related intervention.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 11; 00-7713-011-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2342-2018·2018-07-11

    Beaver Visitec Safety Sideport Knife Blades May Detach During Surgery

    Beaver Visitec is recalling Safety Sideport Knives because blades may fall out of handles due to non-cured epoxy. The defect poses a risk during ophthalmic surgery.

    Product
    Safety Sideport Knife 1.0mm 45¿, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0899-2018·2018-07-11

    SCA Pharmaceuticals Recalls Norepinephrine Bitartrate Bags Due to Sterility Concerns

    SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate 8 mg bags due to a potential for leakage that compromises sterility.

    Product
    Norepinephrine Bitartrate 8 mg (32 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-2370-2018·2018-07-11

    Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue

    Zimmer Biomet is recalling M/L Taper Hip Prostheses manufactured before October 2015 due to potential black residue in the packaging. The residue is described as biocompatible, but may cause surgical delays or wear-related intervention.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 16.25; 00-7713-016-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0901-2018·2018-07-11

    SCA Pharmaceuticals Recalls Phenylephrine HCL Bags Due to Leakage Risk

    SCA Pharmaceuticals is voluntarily recalling 451 bags of Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL due to a potential for leakage that compromises sterility.

    Product
    Phenylephrine HCL 10 mg in 0.9% Sodium Chloride 250 mL Bag (40 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Food)·F-1605-2018·2018-07-11

    SNI Recalls Nitric Blast Pink Lemonade for DMAA Ingredient

    SNI, LLC is recalling Nitric Blast Pink Lemonade products containing geranium extract (DMAA) as a dietary ingredient.

    Product
    SNI Nitric Blast Pink Lemonade 276gr (UPC ending in 5598)
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2343-2018·2018-07-11

    B. Braun Recalls 26-Lead Transfer Sets for Valve Orientation Defect

    B. Braun Medical is recalling 26-Lead Transfer Sets for the APEX Compounding System because valves may be incorrectly oriented, posing a risk of unintended admixture.

    Product
    26-Lead Transfer Set for use with APEX¿ Compounding System, Product Catalog Number 2112550
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Food)·F-1623-2018·2018-07-11

    Caito Foods Recalls Watermelon Products Due to Salmonella Risk

    Caito Foods Service, Inc. is recalling various watermelon products due to potential Salmonella contamination. The products were distributed across 23 states.

    Product
    WATERMELON CHUNKS 6/9.5Z, 9.5 oz., UPC: 81851301386; WATERMELON SPEAR 6/16Z, 16 oz., UPC: 81851301591; WATERMELON SPEAR 4/28Z, 28 oz.; UPC: 81851301607; WATERMELON CHUNKS 1/5LB, 80 oz., UPC: 81851302147; WATERMELON TRAY 1/5LB, 80 oz., UPC: 81851302239; WATERMELON CHUNK 4/18Z, 18
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·F-1637-2018·2018-07-11

    Caito Foods Recalls Mixed Melon Products Due to Salmonella Risk

    Caito Foods Service, Inc. is recalling mixed melon products, including Costco Garden Highway brand, due to potential Salmonella contamination.

    Product
    Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Costco FRUIT BOWL 8/48Z, 48 oz., UPC: 826766241125, Garden Highway Label
    Category
    Food
    Distribution
    23 states
  • HighFDA (Devices)·Z-2362-2018·2018-07-11

    Zimmer Biomet Recalls Hip Prostheses Due to Black Residue in Packaging

    Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 because black residue was found in the packaging bags.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset; 00-7711-004-10
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0900-2018·2018-07-11

    SCA Pharmaceuticals Recalls Norepinephrine Bags Due to Sterility Concerns

    SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate bags due to a potential for leakage that compromises sterility.

    Product
    Norepinephrine Bitartrate 16 mg (64 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-2368-2018·2018-07-11

    Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue

    Zimmer Biomet is recalling 510 M/L Taper Hip Prostheses distributed to Japan due to potential black residue in the packaging.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 13.5; 00-7713-013-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2372-2018·2018-07-11

    Zimmer Biomet Recalls Hip Prostheses Due to Black Residue in Packaging

    Zimmer Biomet is recalling specific M/L Taper Hip Prostheses because black residue was found in the polyethylene packaging. The firm states the residue is biocompatible, but it may cause surgical delays or wear-related intervention.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 20; 00-7713-020-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2363-2018·2018-07-11

    Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue

    Zimmer Biomet is recalling M/L Taper Hip Prostheses manufactured before October 2015 due to black residue in the packaging. The residue is biocompatible but may cause surgical delays or wear-related intervention.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 5; 00-7713-005-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2297-2018·2018-07-11

    Howmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation

    Howmedica Osteonics Corp. is recalling specific lots of LFIT Anatomic CoCr Femoral Heads due to a higher than expected number of complaints about femoral head and hip stem disassociation.

    Product
    LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-144
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2369-2018·2018-07-11

    Zimmer Biomet Recalls Hip Prostheses Due to Black Residue in Packaging

    Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 because black residue was found in the packaging. The residue is a mix of titanium and polyethylene.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 15; 00-7713-015-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2353-2018·2018-07-11

    FHC Depth Stop Adapter Recall Due to Lead Damage Risk

    FHC, Inc. is recalling microTargeting Lead Adapters because over-tightening the depth stop screw can damage the lead and stylet, potentially requiring surgical replacement.

    Product
    microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2371-2018·2018-07-11

    Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue

    Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 because black residue may be present in the packaging.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 17.5; 00-7713-017-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2357-2018·2018-07-11

    FHC Depth Stop Adapter Recall for Lead Damage Risk

    FHC, Inc. is recalling the microTargeting STar Drive System (Manual) because the Depth Stop Adapter can damage implanted leads if over-tightened, requiring replacement.

    Product
    microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2373-2018·2018-07-11

    Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue

    Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 due to black residue found in the packaging. The residue is biocompatible but may cause surgical delays or wear-related intervention.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 22.5; 00-7713-022-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2296-2018·2018-07-11

    Howmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation

    Howmedica Osteonics Corp. is recalling specific lots of LFIT Anatomic CoCr Femoral Heads due to a higher than expected number of complaints about femoral head and hip stem disassociation.

    Product
    LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1604-2018·2018-07-11

    SNI Recalls Nitric Blast Products Containing Geranium Extract

    SNI, LLC is recalling Nitric Blast products containing geranium extract (DMAA) as a dietary ingredient.

    Product
    SNI Nitric Blast Sour Apple 276gr (UPC ending in 5581) --- The product is a powder marketed in a 276gr black bottle with a silver cap. The bottle prominently displays the product name "NITRIC BLAST" in silver and white letters on the front of a black label.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1609-2018·2018-07-11

    FUNKTIONAL FOODS Spirulina Powder Recalled for Undeclared Sulfites

    The TJX Companies is recalling FUNKTIONAL FOODS Spirulina Powder because it contains undeclared sulfites. Consumers should stop using the product.

    Product
    FUNKTIONAL FOODS brand SPIRULINA POWDER, NET WEIGHT 3.5 oz (100 g) with UPC Code: 060427570192
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0904-2018·2018-07-11

    SCA Pharmaceuticals Recalls Phenylephrine HCL Bags Due to Leakage Risk

    SCA Pharmaceuticals is voluntarily recalling specific lots of Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL bags due to a potential for leakage that compromises sterility.

    Product
    Phenylephrine HCL 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0896-2018·2018-07-11

    SCA Pharmaceuticals Recalls Fentanyl and Bupivacaine Bags Due to Leakage Risk

    SCA Pharmaceuticals is voluntarily recalling specific lots of sterile fentanyl and bupivacaine admixture bags due to a potential for leakage that compromises sterility.

    Product
    Fentanyl (as citrate) 2 mcg/mL + Bupivacaine HCL 0.0625% in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-2364-2018·2018-07-11

    Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue

    Zimmer Biomet is recalling M/L Taper Hip Prostheses manufactured before October 2015 due to potential black residue in the packaging. The firm states the residue is biocompatible.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 6; 00-7713-006-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2292-2018·2018-07-11

    Howmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation

    Howmedica Osteonics Corp. is recalling specific LFIT Anatomic CoCr Femoral Heads because of a higher than expected number of complaints regarding disassociation from the hip stem.

    Product
    LFIT Anatomic CoCr Femoral Heads, 6260-9-036
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2367-2018·2018-07-11

    Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue

    Zimmer Biomet is recalling 84 M/L Taper Hip Prostheses with Kinective Technology due to black residue in the packaging. The residue is biocompatible but may cause surgical delays or wear-related intervention.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 12.5; 00-7713-012-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2375-2018·2018-07-11

    Zimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue

    Zimmer Biomet is recalling specific M/L Taper Hip Prostheses manufactured before October 2015 due to potential black residue in the packaging. The residue is described as biocompatible, but risks include surgical delays or wear-related intervention.

    Product
    Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 9; 00-7713-009-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2337-2018·2018-07-11

    Terumo Recalls Angio-Seal Evolution Vascular Closure Devices

    Terumo Medical Corp is recalling 240 Angio-Seal Evolution Vascular Closure Devices because they were released before required validation was completed.

    Product
    Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2299-2018·2018-07-11

    Howmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation

    Howmedica Osteonics Corp. is recalling LFIT Anatomic CoCr Femoral Heads due to a higher than expected number of complaints about disassociation from the hip stem.

    Product
    LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-236
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2295-2018·2018-07-11

    Howmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation Complaints

    Howmedica Osteonics Corp. is recalling specific lots of LFIT Anatomic CoCr Femoral Heads due to higher-than-expected complaints of femoral head/hip stem disassociation.

    Product
    LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-136
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2376-2018·2018-07-11

    Implant Direct Sybron Recalls Out-of-Specification Dental Abutments

    Implant Direct Sybron is recalling 60 REPLANT 5.0mmD Abutments because they are out of specification and cannot be properly fitted to implants.

    Product
    REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2344-2018·2018-07-11

    Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products PHYT Slides

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products PHYT Slides due to a potential for imprecise results in quality control and patient samples.

    Product
    VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2336-2018·2018-07-11

    Arrow International Recalls Multi-Lumen Central Venous Catheter Sets

    Arrow International is recalling 1,200 multi-lumen central venous catheter sets due to increased resistance during insertion, which may cause procedural delays.

    Product
    Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E Product CVCs are intended to permit venous access to the central circulation through a single puncture site by way of the femoral, jugular, or subclavian veins.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0908-2018·2018-07-11

    Eb5 Age Spot Treatment Cream Recalled for Stability Failures

    Eb5 Corporation is recalling 4,632 tubes of Age Spot Treatment Cream because the product failed stability specifications for viscosity, pH, and specific gravity.

    Product
    eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hydroquinone. 177.4 ml / 6 fl oz carton containing a tube. Manufactured For: EB5 Corporation Portland, OR 97210 Carton Bar Code: 7 41099 00009 9
    Category
    Drug
    Distribution
    0 states

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