The Recall Desk

Archive

March 2018 recalls

766 recalls were announced in March 2018.

What the numbers show

Critical
16
Severe
133
High
275
Moderate
293
Low
49

Of the 766 recalls this month scored against our rubric, 2% are Critical, 17% are Severe.

Which agencies issued them

101–200 of 766

  • ModerateFDA (Devices)·Z-1128-2018·2018-03-28

    United Orthopedic Recalls U2 Total Knee System Tibial Inserts Due to Labeling Mismatch

    United Orthopedic Corporation is recalling 69 U2 Total Knee System Tibial Inserts because the package contents did not match the product labeling.

    Product
    U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Catalogue number 2303-3032 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1145-2018·2018-03-28

    Merit Medical Recalls Misconfigured Infant Peritoneal Dialysis Catheter Kits

    Merit Medical Systems is recalling 8 dialysis kits containing misconfigured infant catheters. The 1-cuff catheters were incorrectly labeled as 2-cuff products.

    Product
    Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2 Cuffs Infant Coiled, Catalog # K14-00078
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1087-2018·2018-03-28

    Centurion Minor Dressing Change Tray Recalled for Iodine Assay Failure

    Centurion Medical Products is recalling Minor Dressing Change Trays because a PVP Prep Pad component failed to meet required iodine assay levels for shelf life.

    Product
    MINOR DRESSING CHANGE TRAY
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1166-2018·2018-03-28

    Arrow International Recalls Central Venous Catheter Kits Missing Safety Checklists

    Arrow International is recalling 18,124 central venous catheter kits because they lack required safety checklists and procedure notes.

    Product
    ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to permit venous access to the central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1161-2018·2018-03-28

    Arrow Central Venous Catheter Kits Recalled for Missing Clinical Guides

    Arrow International is recalling 18,124 central venous catheter kits nationwide because they lack required clinical procedure notes and checklists.

    Product
    Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions. Permits venous access to central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1164-2018·2018-03-28

    Arrow Central Venous Catheter Kits Recalled for Missing Clinical Documentation

    Arrow International is recalling 18,124 central venous catheter kits because they lack required clinical guidance documents. The recall is nationwide.

    Product
    Pressure Injectable Two- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1167-2018·2018-03-28

    Implant Direct Recalls Swish Tapered Implants Due to Packaging Error

    Implant Direct Sybron Manufacturing is recalling 1,117 Swish Tapered Implants because the packaged extender may be positioned upside down in the plastic retainer.

    Product
    SwishTapered Implant Intended for use in support for fixed bridgework.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1079-2018·2018-03-28

    Centurion Medical Recalls Suture Removal Kits with Low Iodine Prep Pads

    Centurion Medical Products is recalling suture removal kits because the included PVP prep pads do not meet required iodine levels for their 36-month shelf life.

    Product
    SUTURE REMOVAL TRAY, SET or KIT
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1105-2018·2018-03-28

    Smith & Nephew Legion HK Femoral Wedge Recall Due to Incorrect Screw Size

    Smith & Nephew is recalling Legion HK Femoral Wedge components because the included screws are 5 mm instead of 10 mm, making them too short for use.

    Product
    smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1158-2018·2018-03-28

    Arrow International Recalls Percutaneous Sheath Introducer Kits Missing Safety Checklists

    Arrow International is recalling 18,124 percutaneous sheath introducer kits because they lack required central line insertion checklists and procedure notes.

    Product
    Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1159-2018·2018-03-28

    Arrow Central Venous Catheter Kits Recalled for Missing Clinical Guidance Documents

    Arrow International is recalling 18,124 central venous catheterization kits because they are missing the Central Venous Catheter Placement Procedures Note and Central Line Insertion Checklist.

    Product
    Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access and catheter introduction to the central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1163-2018·2018-03-28

    Arrow Central Venous Catheter Kits Recalled for Missing Safety Checklists

    Arrow International is recalling 18,124 central venous catheter kits nationwide because they lack required procedural notes and insertion checklists.

    Product
    Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access to central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1147-2018·2018-03-28

    Ethicon Recalls DERMABOND PRINEO Skin Closure System Lots

    Ethicon is recalling specific lots of the DERMABOND PRINEO Skin Closure System because the adhesive may not dry within the specified time and may fall off.

    Product
    DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1131-2018·2018-03-28

    CooperSurgical 2 MHz Waterproof OB Probe Recalled for Mislabeling

    CooperSurgical is recalling 13 units of 2 MHz Waterproof OB probes because they were incorrectly labeled as 3 MHz probes.

    Product
    Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical 2 MHz Waterproof OB probe is for obstetrical use in the labor and department for late term obstetrical examination associated with larger women. The product detects fetal heart beats as an aid for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1160-2018·2018-03-28

    Arrow International Recalls Percutaneous Sheath Introducer Kits Missing Safety Checklists

    Arrow International is recalling 18,124 percutaneous sheath introducer kits because they are missing the Central Venous Catheter Placement Procedures Note and Central Line Insertion Checklist.

    Product
    Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters. Permits venous access and catheter introduction to the central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1149-2018·2018-03-28

    Medica Wash Kit Recalled for Inconsistent Lipase Test Results

    Medica Corporation is recalling Wash Kit REF 10680 because an ineffective wash solution causes inconsistent lipase test results.

    Product
    Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry Wash1 , REF # 10680 for use with Medica s EasyRA clinical chemistry analyzer. The solution is used prior to a lipase (LIP) assay if an interferant assay (TRIG)is part of…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0607-2018·2018-03-28

    Pine Pharmaceuticals Recalls Brilliant Blue G Intraocular Injection Due to Labeling Error

    Pine Pharmaceuticals is recalling 136 units of Brilliant Blue G for Intraocular Injection because the vial label contains incorrect active and inactive ingredient information.

    Product
    Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded by: Pine Pharmaceuticals 355 Riverwalk Pkwy Tonawanda, NY 14150. NDC 69194-0358-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1152-2018·2018-03-28

    Arrow International Recalls ARROWg+ard Blue PLUS Catheters Due to Missing Lid Information

    Arrow International Inc is recalling 420 ARROWg+ard Blue PLUS catheters because certain lots may be missing lot numbers, expiration dates, and UDI information on the lid.

    Product
    ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS¿ catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard technology is intended to provide protection against…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1129-2018·2018-03-28

    United Orthopedic Recalls U2 Total Knee System Tibial Inserts

    United Orthopedic Corporation is recalling 14 U2 Total Knee System Tibial Inserts because the package contents did not match the product labeling.

    Product
    U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303-5016 The U2 Total Knee system is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1080-2018·2018-03-28

    Centurion Medical Products Recalls General Purpose Instrument Trays

    Centurion Medical Products is recalling General Purpose Instrument Trays because a PVP Prep Pad in the kit does not meet required iodine levels for shelf life.

    Product
    GENERAL PURPOSE INSTRUMENT TRAY
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-1162-2018·2018-03-28

    Arrow Central Venous Catheter Kits Recalled for Missing Safety Checklists

    Arrow International is recalling 18,124 central venous catheter kits nationwide because they lack required clinical safety checklists.

    Product
    Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1117-2018·2018-03-28

    Apex Knee System Tibial Baseplate Recalled for Packaging Date Error

    OMNIlife science Inc. is recalling 32 Apex Knee System Tibial Baseplates due to an incorrect expiration date on the external packaging.

    Product
    Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0617-2018·2018-03-28

    Akorn Recalls Triamcinolone Acetonide Lotion Due to Impurity Levels

    Akorn, Inc. is recalling 4,128 bottles of Triamcinolone Acetonide Lotion, USP 0.1% due to high impurity levels. The product was distributed nationwide and in Puerto Rico.

    Product
    Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V198000·2018-03-27

    Newmar Recalls Motorhomes Due to Power Steering Hose Routing Defect

    Newmar is recalling 2011-2017 Mountain Aire, Dutch Star, and Ventana motorhomes because the power steering hose may rub against the starter motor, causing fluid leaks or electrical arcing.

    Product
    NEWMAR — NEWMAR MOUNTAIN AIRE, DUTCH STAR, VENTANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V191000·2018-03-26

    Western Star Trucks Recalled for Electrical Arc Fire Risk

    Daimler Trucks North America is recalling 2017-2019 Western Star trucks because a power stud may contact the bulkhead, causing an electrical arc that increases fire risk.

    Product
    WESTERN STAR — WESTERN STAR 6900, 4900, 4700, 5700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V192000·2018-03-26

    Thomas Built Buses Recall School Buses Due to Seat Bracket Crack Risk

    Daimler Trucks North America is recalling 2014-2018 Thomas Built Buses school buses because a wall mounting bracket may crack, causing seats to detach in a crash.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX, SAF-T-LINER HDX, MINOTOUR, SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V190000·2018-03-26

    Thomas Built Buses Saf-T-Liner C2 Propane Leak Recall

    Daimler Trucks North America is recalling 2014-2019 Thomas Built Buses Saf-T-Liner C2 school buses with propane engines due to a fuel line chafing risk that could cause a leak and fire.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V193000·2018-03-26

    Thomas Built Buses Recall Transit Models Due to Seat Bracket Defect

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

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX, SAF-T-LINER HDX, SAF-T-LINER C2, MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V194000·2018-03-26

    Daimler Trucks Recalls 2018-2019 Freightliner Custom Chassis XCS Vehicles

    Daimler Trucks North America is recalling 2018-2019 Freightliner Custom Chassis XCS motorhome chassis because a valve stem stabilizer may dislodge, potentially causing tire damage and increasing crash risk.

    Product
    FCCC — FCCC XCS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V188000·2018-03-23

    Ferrari Recalls 458 Italia and California Models for Air Bag Defect

    Ferrari is recalling 2009-2011 California and 2010-2011 458 Italia vehicles because passenger air bag inflators may explode during a crash, posing a risk of serious injury or death.

    Product
    FERRARI — FERRARI 458 ITALIA, CALIFORNIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V197000·2018-03-23

    Lazy Daze Recalls Motorhomes with Defective Fire Extinguishers

    Lazy Daze is recalling 2012-2017 motorhomes because certain fire extinguishers may clog or detach, potentially failing to work during a fire.

    Product
    LAZY DAZE — LAZY DAZE 27' MID-BATH (27MB), 27' REAR BATH (27RB), 24' FRONT DINETTE(24FD), 27' REAR KITCHEN (27RK)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18129·2018-03-22

    SpeeCo and Woods Recall 4-Way Wedge Accessory for Log Splitters

    SpeeCo and Woods are recalling 4-way wedge accessories for hydraulic log splitters because they can detach and strike users, causing injury.

    Product
    4-way wedge accessory for hydraulic log splitters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0971-2018·2018-03-21

    Starwest Botanicals Recalls Organic Cardamom Pods Due to Salmonella Risk

    Starwest Botanicals is recalling organic cardamom pods after a customer reported a positive Salmonella test result for a specific bulk lot.

    Product
    Cardamom Pods Green Whole Organic Sold in 25 lb. bulk boxes and 1 lb. retail plastic bags UPC 1 pound bags: 7-6796302528-9; UPC bulk: 7 679630257-2 Imported from Guatemala Starwest Botanicals, Sacramento, CA
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0596-2018·2018-03-21

    Pfizer Recalls Hydromorphone Hydrochloride Injection Due to Non-Sterility Concerns

    Pfizer is recalling 53,600 vials of Hydromorphone Hydrochloride Injection due to confirmed customer complaints of empty or cracked glass vials.

    Product
    HYDROMORPHONE HYDROCHLORIDE — HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0934-2018·2018-03-21

    Blue Moose Recalls Nut-Free Basil Pesto Due to Undeclared Tree Nuts

    Blue Moose of Boulder, LLC is recalling 504 units of All-Natural Ciolo Nut-Free Basil Pesto because the product contains undeclared tree nuts.

    Product
    All-Natural Ciolo Nut-Free Basil Pesto, 7 oz., plastic container, Item #: 30019.18
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0984-2018·2018-03-21

    Alden Optical Recalls HP49 Sphere Daily Wear Soft Contact Lenses

    Alden Optical is recalling 23 units of HP49 Sphere Daily Wear Soft contact lenses because they lack sterility assurance.

    Product
    Alden HP49 Sphere Daily Wear Soft contact; Catalog Number: AOHPS49 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V184000·2018-03-21

    MaxxD Recalls 2017-2018 A3X, A5X, and A6X Trailers for Suspension Defect

    Maxey Trailers is recalling 2017-2018 A3X, A5X, and A6X trailers because suspension arms may crack, potentially causing the axle to come loose and increasing crash risk.

    Product
    MAXXD — MAXXD A5X, A3X, A6X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0930-2018·2018-03-21

    Plant Devas Blemish Face Care Kit Recalled for Microbial Contamination

    Plant Devas Inc. is recalling Blemish Face Care Kits because FDA sampling found excessive and virulent microorganisms.

    Product
    Blemish Face Care Kit; Each kit contains: Tea Tree Gel Cleanser 1 fl oz bottle Lemon Thyme Facial Tonic HydroSoul 1 fl oz bottle Pomegranate Repair Serum 0.13 fl oz vial Green Tea Clay 0.1 oz. jar Blemish Purifying Serum 0.06 fl oz vial Light Moisture…
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0931-2018·2018-03-21

    Plant Devas Ayurvedic Face Care Kit Recalled for Microbial Contamination

    Plant Devas Inc. is recalling 144 units of Ayurvedic Face Care Kits because FDA testing found excessive numbers of microorganisms.

    Product
    Ayurvedic Face Care Kit; Each kit contains: Coconut Cream Cleanser 0.5 fl oz jar Tulsi Facial Tonic HydroSoul 1 fl oz bottle Argan Intensive Facial Serum 0.13 fl oz vial Neem Immortelle Purifying Infusion 0.13 fl oz vial Lemongrass Facial Polish 0.4 oz jar…
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0985-2018·2018-03-21

    Alden Optical Recalls Contact Lenses Lacking Sterility Assurance

    Alden Optical is recalling specific daily wear soft contact lenses because they lack sterility assurance. Consumers should stop using the affected lenses.

    Product
    Alden HP54 Sphere Daily Wear Soft contact; Catalog Number: AOHPS54 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia).…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0587-2018·2018-03-21

    Sagent Pharmaceuticals Recalls Methylprednisolone Sodium Succinate Injection Vials

    Sagent Pharmaceuticals is recalling 176,410 vials of methylprednisolone sodium succinate injection due to high impurity levels.

    Product
    methylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-808-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0597-2018·2018-03-21

    Pfizer Recalls Hydromorphone Hydrochloride Injection Vials Due to Non-Sterility

    Pfizer is recalling 29,680 vials of Hydromorphone Hydrochloride Injection due to confirmed customer complaints of empty or cracked glass containers.

    Product
    HYDROMORPHONE HYDROCHLORIDE — HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0981-2018·2018-03-21

    Alden Optical Recalls NovaKone Daily Wear Soft Contact Lenses

    Alden Optical is recalling NovaKone Daily Wear Soft contact lenses because they lack sterility assurance. The recall covers units distributed in the US and Canada.

    Product
    NovaKone Daily Wear Soft contact; Catalog Number: AONKS54 Product Usage: The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia) in aphakic and not aphakic persons…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1073-2018·2018-03-21

    Smiths Medical Recalls Misassembled Port-A-Cath Implantable Port Kits

    Smiths Medical ASD Inc. is recalling certain Port-A-Cath II kits that may contain incorrect introducer sizes or locking collars due to misassembly.

    Product
    PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (1/EA)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0915-2018·2018-03-21

    Xenesta Nuvive Women's Supplement Recalled for Undeclared Milk

    Progressive Laboratories is recalling Xenesta Nuvive Women's 90-count bottles due to potential undeclared milk content.

    Product
    Xenesta Nuvive Womens 90 count packaged in a white plastic bottle with white cap
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V185000·2018-03-21

    Forest River Surveyor Recalled for Refrigerator Fire Risk

    Forest River is recalling 2018 Surveyor trailers because a missing fan in the refrigerator may cause overheating and fire.

    Product
    FOREST RIVER — FOREST RIVER SURVEYOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0588-2018·2018-03-21

    Sagent Pharmaceuticals Recalls Methylprednisolone Sodium Succinate Injection Vials

    Sagent Pharmaceuticals is recalling methylprednisolone sodium succinate for injection vials due to high impurity levels. The affected lots were distributed nationwide.

    Product
    methylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-810-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0912-2018·2018-03-21

    Testosterzone dietary supplement recalled for undeclared milk allergen

    Progressive Laboratories is recalling Testosterzone dietary supplements because they may contain undeclared milk, a major food allergen.

    Product
    Testosterzone 180 count bottle packaged in an amber plastic bottle with a black cap
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0924-2018·2018-03-21

    Plant Devas Clay Mask Kit Recalled for Excessive Microorganisms

    Plant Devas Inc. is recalling 500 kits of the evanhealy Clay Mask Kit because FDA testing found excessive and virulent microorganisms.

    Product
    Clay Mask Kit; 2 glass jars of clay: Green Tea Clay 0.3 oz., and French Rose Clay 0.4 oz. 1 fan mask brush; and 1 terra cotta mixing bowl. Ingredients: Green tea clay, Green (Montmorillonite) clay, Organic Green Tea (Camellia Sinensis) French Rose Clay, Rose Clay (Kaolin…
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0927-2018·2018-03-21

    Plant Divas Green Tea Clay Recalled for Excessive Microorganisms

    Plant Divas Inc. is recalling Green Tea Clay because FDA testing found excessive and virulent microorganisms in the product.

    Product
    Green Tea Clay; 2.1 and 0.17 oz. jars evanhealy Hand Made in CA by Plant Divas Inc., San Diego, CA 92064
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0914-2018·2018-03-21

    Xenesta Nuvive Men Supplement Recalled for Undeclared Milk

    Progressive Laboratories is recalling Xenesta Nuvive Men dietary supplements because they may contain undeclared milk.

    Product
    Xenesta Nuvive Mens 90 count packaged in an white plastic bottle with white cap
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0991-2018·2018-03-21

    Alden Optical Recalls ASTERA Multifocal Toric Contact Lenses for Sterility Issues

    Alden Optical is recalling ASTERA Multifocal Toric Daily Wear Soft contact lenses because they lack sterility assurance. The recall affects units distributed in the US and Canada.

    Product
    ASTERA Multifocal Toric Daily Wear Soft contact; Catalog Number: AOAMT54 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0926-2018·2018-03-21

    Plant Divas Clay Products Recalled for Excessive Microorganisms

    Plant Divas Inc. is recalling French Rose Clay and Moroccan Rhassoul Clay products because FDA testing found excessive numbers of microorganisms.

    Product
    French Rose Clay; with Mineral Rish Moroccan Rhassoul Clay 2.1 and 0.17 oz. jars evanhealy Hand Made in CA by Plant Divas Inc., San Diego, CA 92064
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0990-2018·2018-03-21

    Alden HP59 Toric Contact Lenses Recalled for Lack of Sterility Assurance

    Alden Optical is recalling HP59 Toric Daily Wear Soft contact lenses because they lack sterility assurance. Consumers should stop using the affected lenses.

    Product
    Alden HP59 Toric Daily Wear Soft contact; Catalog Number: AOHPT59 Product Usage: The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0586-2018·2018-03-21

    Sagent Pharmaceuticals Recalls Methylprednisolone Sodium Succinate Injection Vials

    Sagent Pharmaceuticals is recalling 205,370 vials of methylprednisolone sodium succinate for injection due to high impurity levels.

    Product
    methylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-807-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0913-2018·2018-03-21

    Progressive Laboratories Recalls Thyroid Resilience Supplement for Undeclared Milk

    Progressive Laboratories is recalling Thyroid Resilience dietary supplements because they may contain undeclared milk. Consumers should stop using the product and return it to the place of purchase.

    Product
    Thyroid Resilience 120 count bottle packaged in an amber plastic bottle with black cap
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1071-2018·2018-03-21

    Zimmer Biomet Recalls TunneLoc Tibial Fixation Devices Due to Sterilization Concerns

    Zimmer Biomet is recalling 14,461 TunneLoc Tibial Fixation Devices because gamma sterilization testing suggests the sterilization dose may be inadequate.

    Product
    TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·025-2018·2018-03-21

    California Jerky Factory Recalls Beef Jerky Due to Processing Deviation

    California Jerky Factory is recalling approximately 1,238 pounds of beef jerky products due to a processing deviation that may have led to under-processing.

    Product
    California Jerky Factory, Inc. — California Jerky Factory, Inc. Recalls Beef Jerky Products Due to Possible Processing Deviation
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0943-2018·2018-03-21

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling three Proteus 235 proton therapy systems because the internal configuration of electrometers and control boards is not checked before each patient treatment.

    Product
    Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0983-2018·2018-03-21

    Alden Classic 38 Sphere Daily Wear Soft Contact Lenses Recalled for Sterility Issues

    Alden Optical is recalling Alden Classic 38 Sphere Daily Wear Soft contact lenses because they lack sterility assurance. The recall covers units distributed in the United States and Canada.

    Product
    Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0967-2018·2018-03-21

    Ortho Solutions Recalls System 26 Implants Due to Corrosion Residue

    Ortho Solutions is recalling 106 System 26 Forefoot and Midfoot implant trays from the US market because corrosion residue was found inside the cannulated devices.

    Product
    SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS; OS900042-NS; OS900043-NS; OS900047-NS; OS900048-NS; OS900045-NS; OS900046-NS; OS900050-NS; OS900051-NS; OS900044-NS; OS900049-NS; OS900053-NS; OS900054-NS…
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·18V186000·2018-03-21

    Forest River Cherokee Recalled for Propane Leak Fire Risk

    Forest River is recalling 2017-2018 Cherokee recreational trailers because a loose propane valve screw may allow gas to leak, increasing the risk of fire.

    Product
    FOREST RIVER — FOREST RIVER CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0982-2018·2018-03-21

    Alden Optical Recalls NovaKone Toric Contact Lenses for Sterility Issues

    Alden Optical is recalling 33 units of NovaKone Toric Daily Wear Soft contact lenses because they lack sterility assurance. The lenses were distributed in 25 US states and Canada.

    Product
    NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54 Product Usage: The NOVAKONE TORIC lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1072-2018·2018-03-21

    Zimmer Biomet Recalls TunneLoc Tibial Fixation Devices Due to Sterilization Concerns

    Zimmer Biomet is recalling TunneLoc Tibial Fixation Devices because testing suggests the sterilization dose may be inadequate. The devices are distributed nationwide.

    Product
    TunneLoc Tibial Fixation Device (Within an ACL Kit) Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0934-2018·2018-03-21

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling 14 Proteus 235 proton therapy systems because an accessory can be improperly inserted, allowing the device to operate incorrectly.

    Product
    Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions…
    Category
    Medical Device
    Distribution
    6 states
  • HighNHTSA·18E016000·2018-03-21

    BMW Recalls Accessory Motorcycle Windscreens Due to Visibility Issues

    BMW is recalling specific accessory windscreens for various motorcycle models because extra tinting may reduce rider visibility, increasing crash risk.

    Product
    BMW — BMW S1000 R, S1000 XR, R1200 R, F700 GS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0986-2018·2018-03-21

    Alden Optical Recalls HP59 Sphere Daily Wear Soft Contact Lenses

    Alden Optical is recalling HP59 Sphere Daily Wear Soft contact lenses because they lack sterility assurance. The recall affects units distributed in the US and Canada.

    Product
    Alden HP59 Sphere Daily Wear Soft contact; Catalog Number: AOHPS59 Product Usage: The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with refractive ametropia (myopia or hyperopia).…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0925-2018·2018-03-21

    Plant Divas Lemongrass Facial Polish Recalled for Microbial Contamination

    Plant Divas Inc. is recalling Lemongrass Facial Polish with Oats, Fengreek & Neem because FDA testing found excessive numbers of microorganisms.

    Product
    Lemongrass Facial Polish with Oats, Fengreek & Neem. 3 oz cylindrical box evanhealy Hand Made in CA by Plant Divas Inc., San Diego, CA 92064
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0972-2018·2018-03-21

    Medimop Recalls Vial2Bag DC Devices Due to IV Port Separation Risk

    Medimop is recalling specific lots of Vial2Bag DC devices because the IV Port may separate from the body during use.

    Product
    Vial2BagDC, Product Number 6070112. The 20mm Vial2Bag DC device, is intended for use in healthcare facilities or in-home environment by the patient or care-giver to aid and support prescribed treatment and therapy. The device consists of the Vial2Bag piercing spike and…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0976-2018·2018-03-21

    Deerfield IMRIS T2X Table Recall Due to Rotational Locking Defect

    Deerfield Imaging is recalling 16 IMRIS T2X tables because the rotational locking mechanisms can disengage, potentially causing unintended table movement.

    Product
    IMRIS T2X Table, Part Number 109682-600
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0993-2018·2018-03-21

    Zimmer Biomet Recalls Juggerknot 2.9mm Suture Anchors for Hip Arthroplasty

    Zimmer Biomet is recalling 50 units of Juggerknot 2.9mm suture anchors used in hip arthroplasty. The recall is limited to the state of Texas.

    Product
    JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0938-2018·2018-03-21

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling 37 Proteus 235 Proton Therapy Systems due to a risk of patient misalignment when using treatment plans with multiple isocenters.

    Product
    Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1065-2018·2018-03-21

    Siemens ACUSON SC2000 Ultrasound System Recalled for EROA Underestimation

    Siemens Medical Solutions is recalling 564 ACUSON SC2000 ultrasound systems because a specific application may underestimate the Effective Regurgitant Orifice Area (EROA) compared to other transducers.

    Product
    ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1028-2018·2018-03-21

    Zimmer Biomet Recalls Hip Implants Due to Packaging Residue

    Zimmer Biomet is recalling specific Versys hip prostheses because LDPE packaging may leave residue on the polished implant surface.

    Product
    VERSYS 7.5 INCH BEADED FC REV 13.5X190MM STRAIGHT Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0946-2018·2018-03-21

    3M Recalls Ankle Braces Due to Missing Latex Warning Label

    3M is recalling specific ACE and Futuro ankle braces because they contain natural latex rubber but lack the required caution statement.

    Product
    ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0922-2018·2018-03-21

    Seviroli Cannoli Shells Recalled for Undeclared Soy Lecithin

    Ariola Foods is recalling Seviroli brand Cannoli Shells in New York due to undeclared soy lecithin.

    Product
    Seviroli brand Cannoli Shells. Large Plain 36 ct., and Small Plain 72 ct.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0942-2018·2018-03-21

    Draeger Infinity Dual Hemo MCable Pod Recall for Liquid Ingress Risk

    Draeger Medical Systems is recalling 2,760 Dual Hemo MCable Pods (Revisions 15 and 16) because they may allow liquid ingress, potentially causing incorrect invasive blood pressure readings.

    Product
    INFINITY DUAL HEMO MCable Pod
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1067-2018·2018-03-21

    Diagnostica Stago Recalls Neoplastine Cl Plus Reagent Due to Homogeneity Defect

    Diagnostica Stago is recalling Neoplastine Cl Plus reagent vials because a defect may cause inaccurate prothrombin time test results.

    Product
    Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT).
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0919-2018·2018-03-21

    Maple Minis Donut Bites Recalled for Undeclared Soy Lecithin

    Paige Common is recalling 46 packages of Maple Minis-Gluten Free Donut Bites sold in Oregon due to undeclared soy lecithin.

    Product
    Maple Minis-Gluten Free, Donut Bites. Packaged in clam shell with label on top. 5 oz package. UPC 8 81314 32681 5. The product is read in parts: "***maple minis***5oz***Eatin' Alive***PLANT BASED NOSH***Keep Refrigerated***INGREDIENTS: GF OATS, COCONUT, MAPLE SYRUP, COCONUT…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1014-2018·2018-03-21

    Zimmer Biomet Recalls Hip and Knee Implants Due to Packaging Residue

    Zimmer Biomet is recalling 13,227 hip and knee implants because LDPE packaging may leave residue on the polished surfaces.

    Product
    BIPOLAR METAL SHELL 48 MM OD Use of the MultiPolar Bipolar Cup is indicated in: Total hip replacement
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0980-2018·2018-03-21

    Zimmer Biomet Recalls Humeral Stems Due to Incorrect Lot Number Etching

    Zimmer Biomet is recalling 12 Humeral Stems because two lots were commingled and etched with incorrect lot numbers, creating a risk of using the wrong implant size.

    Product
    Humeral Stem 55mm(Size 13) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·18128·2018-03-21

    Kidde Recalls Dual-Sensor Smoke Alarms Due to Manufacturing Defect

    Kidde is recalling about 452,000 dual-sensor smoke alarms in the U.S. because a manufacturing defect may prevent them from detecting smoke.

    Product
    Kidde dual-sensor (photoelectric and ionization) smoke alarms - models PI2010 and PI9010
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0917-2018·2018-03-21

    Kodiak Cakes Energy Waffles Recalled for Undeclared Milk Allergen

    Kodiak Cakes is recalling Energy Waffles, Blueberry Chia, because the product contains whey but fails to declare the major food allergen milk on the label.

    Product
    Kodiak Cakes, Energy Waffles, Blueberry Chia, Net Wt 10.72 Oz (304 g), Kodiak Cakes, Park City, UT. Packaging configuration: 8-ct chipboard carton (selling unit); 8 cartons per shipping case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1006-2018·2018-03-21

    Brainlab ExacTrac Software Recall for Beam Authorization Misinterpretation Risk

    Brainlab AG is recalling ExacTrac Patient Positioning System software versions 6.0 through 6.5 due to a risk of misinterpreting beam authorization when used with specific Varian accelerators.

    Product
    ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0916-2018·2018-03-21

    New Seasons Market Recalls Asparagus and Goat Cheese Quiche for Labeling Error

    New Seasons Market LLC is recalling 45 units of 9-inch Asparagus and Goat Cheese Quiche because egg is missing from the 'Contains' statement on the label.

    Product
    9 inch Asparagus and Goat Cheese Quiche, packaged in a cardboard box with a clear window. UPC # 2 52209 10599 8. The retail label is read in parts: "***ASPARAGUS GOAT CHEESE QUICHE ***NEW SEASONS MARKET***Egg, whole milk, fresh goat cheese, sour cream (milk, cream, nonfat dry…
    Category
    Food
    Distribution
    2 states

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