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.

15901–15925 of 29205

  • SevereFDA (Devices)·Z-2266-2017·2017-06-14

    Arrow PICC Recall Initiated Due to Needlestick Injury Risk

    Arrow International is recalling 43,394 units of Arrow PICC with Chlorag+ard Technology due to safety cover disengagement and needlestick injury risks associated with packaged BD Eclipse Needles.

    Product
    Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the central circulation through a peripheral vein
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2257-2017·2017-06-14

    Arrow VPS Access Kit Recalled for Needlestick Injury Risk

    Arrow International is recalling VPS Access Kits due to safety cover disengagement on packaged BD Eclipse Needles, posing a needlestick injury risk.

    Product
    Arrow VPS Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally inserted Central Venous Catheter The Arrow(r) CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2293-2017·2017-06-14

    Arrow Percutaneous Sheath Introducer Kit Recalled for Needlestick Injury Risk

    Arrow International is recalling specific 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 Integral Hemostasis Valve/Side Port for use with 7 - 7.5¿¿Fr. Catheters The Arrow Percutaneous Sheath Introducer permits venous access and catheter introduction to the central ciruclation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2304-2017·2017-06-14

    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 Hemostasis 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
  • SevereFDA (Devices)·Z-2292-2017·2017-06-14

    Arrow International Recalls Central Catheters Due to Needlestick Injury Risk

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

    Product
    "Pressure Injectable Jugular Axillo-Subclavian Central Catheter (JACC) Product" The CG+ Arrow JACC powered by Arrow VPS Stylet permits venous access to the central circulation through a central vein. The VPS Stylet, used with the VPS Console, quickly and accurately guides the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2321-2017·2017-06-14

    OrthoPediatrics Recalls Response BandLoc Tensioner Instruments Due to Band Rupture Risk

    OrthoPediatrics Corp is recalling 82 Response BandLoc 5.5/6.0 Tensioner Instruments because over-tensioning can damage the band, causing it to rupture during spine surgery.

    Product
    Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tension to the band and hold it in place during spine manipulation and set screw tightening.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2291-2017·2017-06-14

    Arrow PICC Recall Initiated Due to Safety Cover Disengagement and Needlestick Injury

    Arrow International is recalling Arrow PICC products with Chlorag+ard Technology due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.

    Product
    Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the central circulation through a peripheral vein. The intended use of the VP'S Stylet and Console (VPS System) is to quickly and accurately guide market available central catheters to the desired location…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2297-2017·2017-06-14

    Arrow Radial Artery Catheterization Kit Recalled for Needlestick Injury Risk

    Arrow International is recalling Radial Artery Catheterization Kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    Radial Artery Catheterization Kit with Sharps Safety Features 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-2264-2017·2017-06-14

    Arrow International Recalls Central Venous Access Kits Due to Needlestick Risk

    Arrow International is recalling 43,394 central venous access kits because the packaged BD Eclipse Needle has a safety cover that may disengage, posing a needlestick injury risk.

    Product
    ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit. The MAC Two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2282-2017·2017-06-14

    Arrow VPS Access Kit Recalled for Needlestick Injury Risk

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

    Product
    Arrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use with 5 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2335-2017·2017-06-14

    Still Riding Foods Recalls Gluten-Free Pizza Crust Due to Botulism Risk

    Still Riding Foods is recalling gluten-free pizza crust due to a C. botulinum hazard in vacuum-packed products. The recall covers 1,555 cases distributed across 23 states.

    Product
    STILL RIDING FOODS GLUTEN FREE PIZZA CRUST; Sold in the following package sizes: 36/9" NET WT 15lbs (6.80kg); 12/12" NET WT 10lbs (5.44kg); 24/12" NET WT 27lbs (12.25kg); 18/9" NET WT 7lbs (3.18kg)
    Category
    Food
    Distribution
    24 states
  • SevereFDA (Devices)·Z-2284-2017·2017-06-14

    Arrow VPS Access Kit Recalled for Needlestick Injury Risk

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

    Product
    Arrow(R) VPS(R) Access Kit for use with 5 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2288-2017·2017-06-14

    Arrow Access Kit Recalled Due to Needlestick Injury Risk

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

    Product
    Arrow(R) Access Kit 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-2254-2017·2017-06-14

    Arrow International Recalls Central Venous Access Kits Due to Needlestick Risk

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

    Product
    ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2296-2017·2017-06-14

    Arrow Radial Artery Catheterization Kit Recalled for Needlestick Injury Risk

    Arrow International is recalling Radial Artery Catheterization Kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    Radial Artery Catheterization Kit with Sharps Safety Features The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0894-2017·2017-06-14

    Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

    Qualgen is recalling Estradiol 12.5 mg pellets due to CGMP deviations and a lack of quality assurance. The recall covers 4,883 pellets distributed nationwide.

    Product
    Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-012-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2302-2017·2017-06-14

    Arrow Arterial Line Kits Recalled for Needlestick Injury Risk

    Arrow International is recalling Arterial Line Kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    Arterial Line Kit with Sharps Safety Features and 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
  • SevereFDA (Drugs)·D-0890-2017·2017-06-14

    Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

    Qualgen is recalling Estradiol 22 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 1,666 pellets distributed nationwide.

    Product
    Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-022-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2290-2017·2017-06-14

    Arrow International Recalls Access Kits Due to Needlestick Injury Risk

    Arrow International is recalling specific Access Kits because the packaged BD Eclipse Needle safety cover 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 (Drugs)·D-0882-2017·2017-06-14

    Spectrum Chemical Recalls Levonorgestrel API Due to CGMP Deviations

    Spectrum Laboratory Products is recalling levonorgestrel active pharmaceutical ingredient due to manufacturing deviations found by the FDA.

    Product
    Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg container, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code L1229.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2269-2017·2017-06-14

    Arrow Pressure Injectable PICC Kit Recalled for Needlestick Injury Risk

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

    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-2260-2017·2017-06-14

    Arrow International Recalls Hemodialysis Catheter Kits Due to Needlestick Risk

    Arrow International is recalling 43,394 hemodialysis catheterization kits nationwide because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

    Product
    Two-Lumen Hemodialysis Catheterization Kit with Blue Flex Tip(R), ARROWg+ard Blue(R) Catheter, Sharps Safety Features and Maximal Barrier Precautions for High Volume Infusions. The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2256-2017·2017-06-14

    Arrow International Recalls Pressure Injectable PICC Kits Due to Needlestick Risk

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

    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