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.

30851–30875 of 50502

  • HighFDA (Devices)·Z-3045-2017·2017-09-06

    Neusoft NeuViz 128 CT Scanner Software Defect Recall

    Neusoft Medical Systems is recalling 154 NeuViz 128 CT scanners due to a software defect. The FDA mandated this Class II recall for units distributed nationwide.

    Product
    Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3074-2017·2017-09-06

    Kentec Medical Recalls Pediatric Nasogastric Feeding Tubes Due to Radiopaque Stripe Issue

    Kentec Medical Inc is recalling specific lots of Polyurethane ENFit Ameritus NG Feeding Tubes because the radiopaque stripes may be inadequately detectable.

    Product
    POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: a) ENF-Y50P-40 b) ENF-Y50P-50 c) ENF-Y60P-40 d) ENF-Y60P-50 e) ENF-Y60P-90 f) ENF-Y80P-40 g) ENF-Y80P-50 h) ENF-Y80P-80 i) ENF-Y80P-90 For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-3070-2017·2017-09-06

    Toshiba Ultimax Digital Fluoroscopic X-Ray System Recalled for Firmware Issue

    Toshiba is recalling 18 Ultimax Digital Fluoroscopic X-Ray Systems due to a firmware problem with the generator.

    Product
    Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy. The system has medical applications ranging from but not limited to…
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-3090-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US due to a cooling system leak that could cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3082-2017·2017-09-06

    Med Tec Rigid Arm Supports Recalled for Height Dimensional Variance

    Med Tec Inc is recalling 101 Rigid Arm Supports used in Posiboard-2 and Posirest systems due to a potential 17mm height difference.

    Product
    CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standard, Set Red (PN: 106015) (b) Rigid Adj. Arm Support, Set (PN: 106020) (c) PSR2-CR-DLR-2P Posirest-2 (PN: 106521) (d) PB2-BLR Posiboard-2 (PN: 109030) The Rigid Arm Supports are utilized on the…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-3091-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US due to a cooling system leak that can cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3080-2017·2017-09-06

    Vyaire Medical Recalls AirLife Reduced Heparin Arterial Blood Samplers

    Vyaire Medical is recalling specific lots of AirLife Reduced Heparin Arterial Blood Samplers because they contain incorrect sub-assemblies with larger needles, syringes, and heparin doses.

    Product
    AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2 IU, STERILE R, Rx ONLY, CAREFUSION Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3071-2017·2017-09-06

    Smiths Medical CADD Medication Cassette Reservoir Recall for Manufacturing Defects

    Smiths Medical ASD Inc. is recalling CADD Medication Cassette Reservoirs due to potential incorrect pressure plates and tubing routing.

    Product
    CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3088-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems due to a cooling system leak that could cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3098-2017·2017-09-06

    Siemens AXIOM Artis zee and Q/Q.zen X-ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee and Q/Q.zen angiography systems in the US due to a cooling system leak that can cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3081-2017·2017-09-06

    Alcon Recalls LuxOR Ophthalmic Microscope Floor Stands Due to Caster Defect

    Alcon is recalling 1,074 LuxOR microscope floor stands because casters may break or detach from the base after impact or stress.

    Product
    LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 Microscope Floor Stands are not stand-alone medical devices, but are used in combination with the LuxOR Ophthalmic Microscope and the LuxOR Ophthalmic Microscope with Q-VUE 3-D…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3095-2017·2017-09-06

    Siemens Medical Solutions Recalls AXIOM Artis zee and Q Angiography Systems

    Siemens Medical Solutions is recalling 986 AXIOM Artis zee and Q angiography systems in the US due to a cooling system leak that could cause equipment failure.

    Product
    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3100-2017·2017-09-06

    Smith & Nephew Recalls Polarstem Cardan Joints Due to Fracture Risk

    Smith & Nephew is recalling 402 Polarstem Cardan joints because the device may fracture or fail after multiple uses.

    Product
    smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only The subject cardan is used in conjunction with a curved stem impactor used to implant the POLARSTEM hip stem. The hip stem is mounted on the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·17765·2017-09-05

    ASHERANGEL Recalls Children's Sleepwear for Flammability Violations

    ASHERANGEL is recalling about 950 children's nightgowns and pajama sets sold on Amazon.com because they fail federal flammability standards, posing a burn risk.

    Product
    Children's nightgowns and pajama sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·17V551000·2017-09-01

    2018 Prime Time Tracer Recalled for Incorrect Tire Pressure Placard

    Forest River is recalling 2018 Prime Time Tracer trailers because the Federal Placard may list incorrect tire pressure information, posing a crash risk.

    Product
    PRIME TIME — PRIME TIME TRACER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V545000·2017-08-31

    Honda Recalls Vehicles with Incorrectly Installed Passenger Air Bag Inflators

    Honda is recalling specific 2006-2012 vehicles where replacement passenger air bag inflators may have been incorrectly installed, potentially causing improper deployment in a crash.

    Product
    ACURA — ACURA, HONDA TSX, CIVIC, INSIGHT, ACCORD CROSSTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V543000·2017-08-31

    Chrysler Recalls Jeep Cherokee for Missing Tire and Rim Label Information

    Chrysler is recalling 2017-2018 Jeep Cherokee vehicles because the certification label is missing required tire and rim size information, which could lead to incorrect tire installation.

    Product
    JEEP — JEEP CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V548000·2017-08-31

    Toyota Recalls Lexus and Land Cruiser Vehicles for Air Bag Defect

    Toyota is recalling specific Lexus and Land Cruiser vehicles because they may have incorrect air bags that could fail to deploy in a crash.

    Product
    LEXUS — LEXUS, TOYOTA LX470, LAND CRUISER, LX570
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17216·2017-08-31

    Hallmark Recalls Plush Baby Stacking Toys Due to Choking Hazard

    Hallmark is recalling itty bittys baby plush stacking toys because fabric hats and bows can detach, posing a choking hazard to children.

    Product
    itty bittys® baby plush stacking toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3054-2017·2017-08-30

    Medtronic AxiEM ENT Suction Devices Recalled for Verification Failure

    Medtronic is recalling 60 reusable ENT suction instruments because they fail required pre-use verification checks. The devices are used with the StealthStation AxiEM surgical navigation system.

    Product
    Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3059-2017·2017-08-30

    Custom Assemblies Recalls Custom Surgical Kits with Defective BD Needles

    Custom Assemblies Inc is recalling 2,155 custom surgical kits because they contain BD SafetyGlide needles with loose polypropylene particulate in the fluid path.

    Product
    Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: (a) CMS-4153-R2 MPM Biopsy TRAY (b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray (c) CMS-4108 Multipurpose Safety Tray (d) CMS-3141-R6 Custom Ultrasound Tray (e) CMS-2891-R1 Custom Safety…
    Category
    Medical Device
    Distribution
    Distributed nationwide