The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

15876–15900 of 29205

  • SevereFDA (Devices)·Z-2299-2017·2017-06-14

    Arrow Arterial Catheterization Kits Recalled for Needlestick Injury Risk

    Arrow International is recalling Arterial Catheterization Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.

    Product
    Arterial Catheterization Kit with Maximal Barrier Precautions The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V378000·2017-06-14

    Newmar Recalls 2012-2015 Motorhomes Due to Starter Motor Fire Risk

    Newmar is recalling 2012-2015 King Aire and Essex motorhomes because a starter motor component may break, causing overheating and increasing the risk of a fire.

    Product
    NEWMAR — NEWMAR ESSEX, KING AIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2172-2017·2017-06-14

    Laserex Systems Recalls Ellex Tango Reflex Laser Ophthalmic Units

    Laserex Systems Inc. is recalling 83 Ellex Tango Reflex laser ophthalmic units because they may emit laser energy without the fire button being pressed.

    Product
    Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the device is intended to be used for selective laser trabeculoplasty (ST) operations (laser trabeculoplasty for primary open angle glaucoma). In the VAG mode it is intended to be used to perform procedures…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2265-2017·2017-06-14

    Arrow International Recalls Large-Bore CVC Kits Due to Needlestick Risk

    Arrow International is recalling 43,394 units of ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kits nationwide due to safety cover disengagement and needlestick injury risks associated with packaged BD Eclipse Needles.

    Product
    ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2270-2017·2017-06-14

    High Liner Foods Breaded Haddock Recalled for Undeclared Milk

    ISF "USA", LLC is recalling High Liner Foods Breaded Haddock Tail Portions due to undeclared milk, a major allergen.

    Product
    High Liner Foods, Breaded Haddock Tail Portions 5 oz.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2259-2017·2017-06-14

    Arrow International Recalls Central Venous Access Kits Due to Needlestick Risk

    Arrow International is recalling 43,394 units of MAC Two-Lumen Central Venous Access Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.

    Product
    MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 -8 Fr. Catheters. The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2281-2017·2017-06-14

    Arrow VPS Access Kit Recalled Due to Needlestick Injury Risk

    Arrow International is recalling VPS Access Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.

    Product
    Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2268-2017·2017-06-14

    Arrow Pressure Injectable PICC Kit Recalled for Needlestick Injury Risk

    Arrow International is recalling 43,394 units of Pressure Injectable PICC Kits due to safety cover disengagement and needlestick injury reports.

    Product
    Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2248-2017·2017-06-14

    Stryker Recalls Berchtold Chromophare F300 Exam Lights Due to Mounting Defect

    Stryker Communications is recalling 57 Berchtold Chromophare F300 exam lights because a tolerance issue may cause the equipment to fall, posing a risk of serious injury.

    Product
    Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local illumination of the patients' body so that illnesses, injuries and disabilities can be diagnosed and treated
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2279-2017·2017-06-14

    Arrow International Recalls CVC Kits Due to Needlestick Injury Risk

    Arrow International is recalling specific CVC kits because the packaged BD Eclipse Needle may disengage, posing a needlestick injury risk to medical personnel.

    Product
    AGB+ Pressure Injectable Multi-Lumen CVC Kit The Arrow Central Venous Catheters are intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins.The ARROWg+ard Blue¿ Catheter permits venous access to the central circulation by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2275-2017·2017-06-14

    Arrow Central Venous Catheter Kits Recalled for Needlestick Injury Risk

    Arrow International is recalling specific central venous catheter kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions requiring central venous…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0888-2017·2017-06-14

    MedPark Pharmacy Recalls Methylcobalamin Injection Vials Due to Sterility Concerns

    MedPark Pharmacy is recalling methylcobalamin 1mg/1mL injection vials because the company cannot ensure the product is sterile. The affected lot was distributed to a patient in Maryland.

    Product
    methylcobalamin 1mg/1mL, vial for injection, Rx only, MedPark Pharmacy 2002 Medical Pkwy. # 170 Annapolis, MD 21401
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2278-2017·2017-06-14

    Arrow International Recalls Multi-Lumen CVC Kits Due to Needlestick Risk

    Arrow International is recalling specific multi-lumen central venous catheter kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.

    Product
    AGB+ Pressure Injectable Multi-Lumen CVC Kit intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins intended to permit venous access to the central circulation by way of the femoral, jugular or subclavian veins
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2287-2017·2017-06-14

    Arrow International Recalls Access Kits Due to Needlestick Injury Risk

    Arrow International is recalling Access Kits with Maximal Barrier Precautions because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.

    Product
    Arrow¿ Access Kit with Maximal Barrier Precautions for use with 4 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2272-2017·2017-06-14

    Arrow Central Venous Catheter Kits Recalled for Needlestick Injury Risk

    Arrow International is recalling certain central venous catheter kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment of diseases or conditions…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2289-2017·2017-06-14

    Arrow Access Kit Recalled Due to Needlestick Injury Risk

    Arrow International is recalling specific Access Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.

    Product
    Arrow¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The Arrow¿ GlideThru" Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapuetic devices into the vasculature
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2286-2017·2017-06-14

    Arrow PICC Recall Due to Safety Cover Disengagement and Needlestick Risk

    Arrow International is recalling Arrow PICC devices with Chlorag+ard Technology because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    Arrow PICC with Chlorag+ard Technology The ArrowEVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2261-2017·2017-06-14

    Arrow Percutaneous Sheath Introducer Kit Recalled for Needlestick Injury Risk

    Arrow International is recalling Percutaneous Sheath Introducer Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.

    Product
    Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath, Integral Hemostatis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5-8 Fr. Catheters. The Arrow Percutaneous Sheath Introducer permits venous access and catheter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V380000·2017-06-14

    Piaggio Recalls 2016-2017 Moto Guzzi Motorcycles for Brake Hose Defect

    Piaggio is recalling 2016-2017 Moto Guzzi motorcycles because the front ABS brake hose may rub against the engine, causing a fluid leak that increases crash risk.

    Product
    PIAGGIO — PIAGGIO, MOTO GUZZI V7 III SPECIAL 750, MOTO GUZZI V7 III RACER 7, V9 BOBBER, V7 III STONE 750
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2333-2017·2017-06-14

    Krisppee Batter Mix Recalled for Undeclared Milk Allergen

    Krisppee Products Co. is recalling Krisppee Batter Mix for Fish & Chips due to undeclared milk. The product was distributed in Rhode Island and Massachusetts.

    Product
    KRISPPE BATTER MIX For FISH & CHIPS Net WEIGHT 5 lbs., 25 lbs., 50 lbs.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2285-2017·2017-06-14

    Arrow PICC Kit Recalled Due to BD Eclipse Needle Safety Cover Issues

    Arrow International is recalling certain PICC kits because the packaged BD Eclipse Needle has a safety cover that may disengage, posing a needlestick injury risk.

    Product
    Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure Injectable P1CC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2273-2017·2017-06-14

    Arrow International Recalls Central Venous Catheter Kits Due to Needlestick Risk

    Arrow International is recalling specific central venous catheter kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    Pressure Injectable Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days) treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2300-2017·2017-06-14

    Arrow Arterial Catheterization Kit Recalled for Needlestick Injury Risk

    Arrow International is recalling Arterial Catheterization Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.

    Product
    Arterial Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2295-2017·2017-06-14

    Arrow International Recalls Femoral Arterial Line Catheterization Kits

    Arrow International is recalling specific femoral arterial line catheterization kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.

    Product
    Femoral Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2267-2017·2017-06-14

    Arrow International Recalls Central Catheters Due to Needlestick Injury Risk

    Arrow International is recalling 43,394 units of central catheters because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    Pressure injectable Jugular Axillo-Subclavian Central CThe CG+Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation through a central veinatheter (JACC) Product
    Category
    Medical Device
    Distribution
    Distributed nationwide