The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

35301–35325 of 50504

  • HighFDA (Devices)·Z-2061-2016·2016-07-06

    Hospira Recalls IV Administration Sets Due to Fluid Leakage Risk

    Hospira is recalling specific lots of Lifeshield IV administration sets because intravenous fluid may leak at the secondary port.

    Product
    *** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET, MICRODRIP,PP SOLUSET,FILTER, 3 CLAVE PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 124 IN (315 IN); PRIMING VOLUME: 14 ML; *** 2) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2071-2016·2016-07-06

    Pentax Recalls 9,669 Gastroscope Units Due to Lodged Accessories

    Pentax Medical is recalling 9,669 gastroscope units because operational or cleaning accessories can become lodged in the instrument channel.

    Product
    Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2093-2016·2016-07-06

    Smith & Nephew Legion HK Femoral Assembly Recalled for Surface Defect

    Smith & Nephew is recalling 16 units of the Legion HK Femoral Assembly because the internal surface where cement is applied is below specification.

    Product
    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2076-2016·2016-07-06

    Pentax Ultrasound Bronchoscopes Recalled for Lodged Accessories Risk

    Pentax Medical is recalling 115 Ultrasound Bronchoscopes because operational and therapeutic accessories can become lodged in the instrument channel.

    Product
    Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to organs, tissues and subsystems: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2058-2016·2016-07-06

    Hospira Recalls PlumSet IV Administration Sets Due to Fluid Leakage

    Hospira is recalling specific PlumSet IV administration sets because intravenous fluid may leak at the CLAVE secondary port.

    Product
    *** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; *** 2) Product labeled in part: List No. 14254-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port 2 CLAVE Y-Sites, 0.2 Micron Filter, 112…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2101-2016·2016-07-06

    Medical Depot Recalls Aluminum Crutches Due to Tip Failure

    Medical Depot Inc. is recalling 123,125 pairs of aluminum crutches nationwide because the metal tip may fail. Users should stop using the product.

    Product
    Aluminum crutch under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, adult, 8 pairs per case, 3) Aluminum crutch, youth, 1 pair per case, 4) Aluminum crutch 8 pairs per case, 5) Aluminum crutch, tall adult, 1 pair per case & 6) Aluminum…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2115-2016·2016-07-06

    Philips Ingenuity Core MRI Scanner Recalled for Cover Crack Risk

    Philips Medical Systems is recalling Ingenuity Core MRI scanners because a thinner plastic cover may crack, posing an injury risk to patients and staff.

    Product
    Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2106-2016·2016-07-06

    Medical Depot Aluminum Crutches Recalled Due to Tip Failure

    Medical Depot Inc. is recalling 123,125 pairs of Direct Supply aluminum crutches because the metal tips may fail.

    Product
    Direct Supply aluminum crutch, adult, 1 pair per case Aid the user in walking while relieving weight from one foot or leg.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2066-2016·2016-07-06

    Pentax Choledocho-Nephroscope Recalled Due to Lodged Accessories in Instrument Channel

    Pentax Medical is recalling 126 Choledocho-Nephroscope units because operational and therapeutic accessories can become lodged in the instrument channel.

    Product
    Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Biliary tree with access to the Common bile Duct, Hepatic Duct, Cystic Duct…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2081-2016·2016-07-06

    Alcon CENTURION Vision System Recalled for Power Switch Defect

    Alcon Research, Ltd. is recalling the CENTURION Vision System because the grounding pin in the power entry switch may detach when the AC power cable is removed.

    Product
    CENTURION Vision System
    Category
    Medical Device
    Distribution
    1 state
  • HighCPSC·16212·2016-07-06

    Boscov's Recalls Orbit Hoverboards Due to Fire and Explosion Hazard

    Boscov's is recalling Orbit brand self-balancing scooters because their lithium-ion batteries can overheat, posing a risk of fire or explosion.

    Product
    Self-balancing scooters/hoverboards
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2077-2016·2016-07-06

    Pentax Ultrasound Gastroscope Recall Due to Lodged Accessories

    Pentax Medical Company is recalling ultrasound gastroscopes because operational and therapeutic accessories can become lodged in the instrument channel.

    Product
    Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, tissues and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2098-2016·2016-07-06

    CMP Industries Recalls Impak Elastic Acrylic Resin Due to Rust

    CMP Industries is recalling Impak Elastic Acrylic Resin Powder and Liquid due to the possible presence of foreign material, specifically rust.

    Product
    IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for relining a denture surface
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2074-2016·2016-07-06

    Pentax Naso-Pharyngo-Laryngoscope Recall Due to Lodged Accessories

    Pentax Medical Company is recalling 215 Naso-Pharyngo-Laryngoscopes because operational and therapeutic accessories can become lodged in the instrument channel.

    Product
    Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic access to, the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Ear, Nasal Passage and Trachea. The instrument is introduced via the mouth or…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2075-2016·2016-07-06

    Pentax Sigmoidoscopes Recalled Due to Risk of Lodged Accessories

    Pentax Medical Company is recalling 1,596 sigmoidoscopes because operational and therapeutic accessories can become lodged in the instrument channel.

    Product
    Signmoidoscope Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2055-2016·2016-07-06

    Hospira Symbiq Infusion Pumps Recalled for Frequent False Occlusion Alarms

    Hospira is recalling Symbiq One Channel Infusers due to frequent false proximal occlusion alarms that may delay or interrupt patient therapy.

    Product
    Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2063-2016·2016-07-06

    Medtest Homocysteine Reagent Recalled for Performance Deterioration

    Medtest Holdings is recalling 13 kits of Liquid Stable 2-Part Homocysteine Reagent due to under-recovery of homocysteine in patient samples.

    Product
    Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one Rl and one R2 bottle and one bottle of calibrator level 1 and one bottle of calibrator level 2.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2078-2016·2016-07-06

    Pentax Medical Recalls Ureteroscopes Due to Lodged Accessories Risk

    Pentax Medical is recalling 32 ureteroscopes because operational accessories may become lodged in the instrument channel.

    Product
    Ureteroscope Intended to provide optical visualization of and therapeutic access to the Urinary Track. This anatomy includes but is not restricted to the organs, tissues and subsystems: Urethra, Bladder and Renal Pelvis. The instrument is introduced via the urethra when…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2090-2016·2016-07-06

    Smith & Nephew Recalls Legion HK Femoral Assemblies for Surface Defect

    Smith & Nephew is recalling 12 units of Legion HK Femoral Assemblies because the internal surface is below specification, potentially affecting cement adhesion.

    Product
    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·16V502000·2016-07-05

    GM Recalls Vehicles for Ignition Key Removal and Rollaway Risk

    General Motors is recalling specific Buick, Chevrolet, and GMC vehicles because the ignition key may be removed without the transmission in Park, creating a rollaway hazard.

    Product
    CHEVROLET — CHEVROLET, BUICK, GMC EQUINOX, REGAL, CRUZE, TERRAIN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16C006000·2016-07-05

    Combi Coccoro Convertible Child Restraints Recalled for Crash Injury Risk

    Combi is recalling Coccoro Convertible Child Restraints because excessive force may be transmitted to the occupant in a crash if the seat is forward-facing and secured only with a lap belt.

    Product
    CHILD SEAT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V501000·2016-07-05

    Newmar Recalls Motorhomes Due to Exhaust Tube Fire Risk

    Newmar is recalling specific model year 1998-2015 motorhomes because a flexible exhaust tube may tear, allowing hot exhaust to contact other components and increase the risk of a fire.

    Product
    NEWMAR — NEWMAR KOUNTRY STAR, VENTANA, DUTCH STAR, ALL STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V504000·2016-07-05

    Jerr-Dan Recalls 2014-2016 HDR 1000 Wrecker Trucks Due to Control Defect

    Jerr-Dan is recalling 24 model year 2014-2016 HDR 1000 wrecker trucks because vehicle-mounted controls may remain engaged, causing unintended equipment movement and injury risk.

    Product
    JERR-DAN — JERR-DAN HDR 1000
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·054-2016·2016-07-01

    GHSE Recalls Chicken Salads Due To Undeclared Wheat Allergen

    GHSE, LLC is recalling approximately 5,682 pounds of ready-to-eat chicken salads because the packaging labels failed to declare wheat, a known allergen.

    Product
    GHSE, LLC — GHSE, LLC Recalls Chicken Products Due To Misbranding And Undeclared Allergen
    Category
    Food
    Distribution
    7 states