The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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19251–19275 of 27682

  • 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
  • SevereFDA (Devices)·Z-3047-2017·2017-08-30

    Solta Medical Recalls VASER Amplifiers Due to Burn Risk

    Solta Medical is recalling four VASER Amplifier units because a service depot repair may have caused inaccurate calibration, posing a burn risk to patients.

    Product
    VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).
    Category
    Medical Device
    Distribution
    7 states
  • 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
  • HighFDA (Devices)·Z-3066-2017·2017-08-30

    Shippert Medical Technologies Recalls Tissu-Trans SFILL 360 Due to Seal Integrity

    Shippert Medical Technologies is recalling Tissu-Trans SFILL 360 devices because the seal integrity of the sterile packages cannot be assured.

    Product
    Tissu-Trans SFILL 360, 3-TT-SFILL 360. Product Usage: Intended for fat transfer and liposuction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3049-2017·2017-08-30

    Alcon ORA System Recall for Incorrect IOL Power Measurements

    Alcon is recalling 429 ORA Systems with VerifEye+ Carts due to a software error that may cause incorrect intraocular lens power measurements during cataract surgery.

    Product
    ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3061-2017·2017-08-30

    Shippert Medical Technologies Recalls Tissu-Trans Filtron 250 Due to Seal Integrity

    Shippert Medical Technologies is recalling 5,188 units of Tissu-Trans Filtron 250 because the seal integrity of the sterile packages cannot be assured.

    Product
    Tissu-Trans Filtron 250, 3-TT-FILTRON 250. Product Usage: Intended for fat transfer and liposuction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3052-2017·2017-08-30

    Medtronic Curved Suction 70 Recalled for Verification Failure

    Medtronic is recalling 149 Curved Suction 70 ENT instruments because they fail required pre-use verification checks.

    Product
    Medtronic Curved Suction 70 9733450 EM 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.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3063-2017·2017-08-30

    Shippert Medical Technologies Recalls Tissu-Trans Filtron 1000 Due to Seal Integrity

    Shippert Medical Technologies is recalling 5,188 units of Tissu-Trans Filtron 1000 because the seal integrity of the sterile packages cannot be assured.

    Product
    Tissu-Trans Filtron 1000, 3-TT-FILTRON 1000. Product Usage: Intended for fat transfer and liposuction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3048-2017·2017-08-30

    Solta Medical Recalls VASER PRO Amplifiers Due to Burn Risk

    Solta Medical is recalling seven VASER PRO Amplifiers because a service depot repair may have caused inaccurate calibration, posing a risk of patient burns.

    Product
    VASER PRO Amplifier, VASER 2.2 VASERlipo System stem, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-3064-2017·2017-08-30

    FDA Recalls Tissu-Trans Filtron 2000 Due to Sterile Seal Integrity Concerns

    Shippert Medical Technologies is recalling 5,188 units of Tissu-Trans Filtron 2000 because the sterile package seal integrity cannot be assured.

    Product
    Tissu-Trans Filtron 2000, 3-TT-FILTRON 2000. Product Usage: Intended for fat transfer and liposuction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3065-2017·2017-08-30

    Shippert Medical Technologies Recalls Tissu-Trans MEGA 1500 Due to Seal Integrity

    Shippert Medical Technologies is recalling Tissu-Trans MEGA 1500 devices because the seal integrity of the sterile packages cannot be assured.

    Product
    Tissu-Trans MEGA 1500, 3-TT-MEGA 1500. Product Usage: Intended for fat transfer and liposuction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3058-2017·2017-08-30

    Medtronic ENT Navigation Suction Devices Recalled for Verification Failure

    Medtronic Navigation is recalling six kits of ENT suction devices because they fail required pre-use verification checks.

    Product
    Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733452 containing 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction). The firm name on the label is Medtronic Navigation, Inc.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3069-2017·2017-08-30

    Medtronic Recalls Deep Brain Stimulation Lead Kits Due to Depth Stop Defect

    Medtronic is recalling Deep Brain Stimulation lead kits because the depth stop may not secure properly, potentially causing the lead to be placed beyond the intended target.

    Product
    DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to multiple accessories used in DBS lead implant procedures. Among these accessories is the DBS lead…
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-3051-2017·2017-08-30

    Medtronic ENT Suction Devices Recalled for Verification Failure

    Medtronic Navigation is recalling 277 reusable ENT suction instruments because they fail pre-use verification checks. The devices are used with the StealthStation AxiEM surgical navigation system.

    Product
    Medtronic Straight Suction 9733449 EM 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