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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21101–21125 of 27682

  • HighFDA (Devices)·Z-2765-2016·2016-09-14

    Hologic Recalls SureSight Obturator Introducer Systems Due to Tip Breakage

    Hologic is recalling 1,440 SureSight Obturator Introducer Localization Systems because the tip may break at the glue joint.

    Product
    SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2737-2016·2016-09-14

    Philips BrightView XCT Upgrade Recalled for Potential Patient Contact

    Philips is recalling three BrightView XCT Upgrade units due to a software defect that may cause the detector to contact patients during specific scans.

    Product
    BrightView XCT Upgrade Model 882454
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2729-2016·2016-09-14

    Hospira Recalls Plum A+3 Infusion Pumps Due to Undersized Diaphragm

    Hospira Inc. is recalling 357,778 Plum A+3 Infusion Pumps because an undersized fluid shield diaphragm may cause alarms and interrupt therapy.

    Product
    Plum A+3 Infusion Pump. List Number 12618. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2734-2016·2016-09-14

    Omega Medical Imaging Recalls Elevating Monitor Suspension Systems

    Omega Medical Imaging is recalling 26 Elevating Monitor Suspension Systems because the suspension may separate from the lifting column bracket.

    Product
    2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-2738-2016·2016-09-14

    Terumo Recalls Pinnacle Introducer Sheaths Due to Valve Leakage

    Terumo Medical Corporation is recalling Pinnacle Introducer Sheaths due to a manufacturing issue causing valve leakage, which poses a risk of incremental blood loss.

    Product
    PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque Marker Introducer Sheath
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2675-2016·2016-09-07

    Intuitive Surgical da Vinci EndoWrist Stapler 45 Recall for Field Failures

    Intuitive Surgical is recalling da Vinci EndoWrist Stapler 45 instruments due to reported field failures involving shaft rotation interruptions and jaw opening issues.

    Product
    STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2676-2016·2016-09-07

    Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments

    Intuitive Surgical is recalling 875 da Vinci EndoWrist Stapler 30 instruments due to reported field failures involving shaft rotation interruption or jaws not opening.

    Product
    STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2677-2016·2016-09-07

    Intuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments

    Intuitive Surgical is recalling 875 da Vinci EndoWrist Stapler 30 instruments due to reported shaft rotation interruptions and jaw opening failures.

    Product
    CURVED-TIP STAPLER 30,IS4000; Model number 470530; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 30 Instrument and Stapler 30 Reloads are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2681-2016·2016-09-07

    Philips PCR Compano Basic Reader Recalled for Power Supply Fire Hazard

    Philips is recalling 388 PCR Compano Basic Reader units because a defective power supply component can burn and release smoke.

    Product
    PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing system (Computed Radiography).
    Category
    Medical Device
    Distribution
    41 states
  • SevereFDA (Devices)·Z-2692-2016·2016-09-07

    Beckman Coulter Recalls UniCel DxH Slidemaker Stainer Due to Fire Risk

    Beckman Coulter is recalling the UniCel DxH Slidemaker Stainer because flammable liquids may contact electrical components, posing a fire hazard.

    Product
    UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2673-2016·2016-09-07

    Nakanishi Diamond Coated Tips Recalled for Missing Single-Use Labeling

    Nakanishi Inc. is recalling 2,574 diamond coated tips and burs because the labeling failed to indicate they are single-use only, posing a cross-contamination risk.

    Product
    Diamond Coated Tips and Burs are accessories to the air powered Bone drill (VARIOSURG with and without light) The intended use of the tips is based on the parent device. For the VarioSurg, in addition to the scaling functions, diamond coated tips are used for socket lift, sinus…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2713-2016·2016-09-07

    Cardinal Health Recalls Arterial Blood Gas Kits Missing Safety Clasp

    Cardinal Health is recalling specific lots of 9025TRU Arterial Blood Gas Kits because they are missing a locking clasp component, posing a potential safety risk.

    Product
    The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2683-2016·2016-09-07

    Teleflex Recalls MAQUET Servo Humidifier 163 Units Due to Connector Cracking

    Teleflex Medical is recalling 2,700 MAQUET Servo Humidifier 163 units because the ISO female connector may crack. The units were distributed to Florida, Kansas, and West Virginia.

    Product
    MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2709-2016·2016-09-07

    Merge Cardio software recall due to incorrect patient data saving

    Merge Healthcare is recalling Merge Cardio software versions 10.1 and 10.1.1 because reports may be saved to incorrect patient records.

    Product
    Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2691-2016·2016-09-07

    Elekta Recalls HexaPOD evo RT Systems for Positioning Errors

    Elekta is recalling 13 HexaPOD evo RT Systems because the treatment couch may not move fully to the correct 3D position, potentially leading to unrecognized positioning errors during radiotherapy.

    Product
    HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2671-2016·2016-09-07

    GE Healthcare Recalls Centricity Laboratory Software Due to Data Deletion Errors

    GE Healthcare is recalling Centricity Laboratory software versions 3.3 to 4.1 because deleting a slave panel incorrectly removes free-text notes and reference ranges from the master panel.

    Product
    Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2708-2016·2016-09-07

    Alcon AcrySof IQ Intraocular Lens Recall Due to Delivery System Defect

    Alcon is recalling specific lots of AcrySof IQ intraocular lenses because the ULTRASERT delivery system may cause the lens to become lodged during implantation.

    Product
    Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Alcon AcrySof IQ Intraocular Lens (IOL) is an acrylic foldable singlepiece posterior chamber lens for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2678-2016·2016-09-07

    DeRoyal Recalls Custom Surgical Kits Due to Sterility Concerns

    DeRoyal Industries is recalling 26 custom surgical kits containing Bard Toomey Irrigation Syringes due to a possible package defect that may affect sterility.

    Product
    Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2688-2016·2016-09-07

    Invivo Breast MRI Auxiliary Table Recalled Due to Missing Diode

    Invivo Corporation is recalling three breast MRI auxiliary tables because a missing diode may cause the coil to overheat.

    Product
    Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2704-2016·2016-09-07

    Siemens ADVIA Chemistry XPT Recall for A1c Calculation Error

    Siemens is recalling ADVIA Chemistry XPT systems due to a software error that causes falsely low Hemoglobin A1c results in IFCC units.

    Product
    ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c values are reported in International Federation of Clinical Chemistry (IFCC) equivalent units (HbA1cR). The ADVIA…
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2679-2016·2016-09-07

    DeRoyal recalls two custom surgical kits with potential sterility defect

    DeRoyal Industries Inc is recalling two custom surgical kits containing a BARD Toomey Irrigation Syringe due to a possible package slit that may affect sterility.

    Product
    DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2689-2016·2016-09-07

    Mindray A7 Anesthesia Delivery System Recalled for Potential Oxygen Leak

    Mindray is recalling 167 A7 Anesthesia Delivery Systems due to a potential leak on the back-up oxygen and air cylinder yokes.

    Product
    A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. Part numbers 0632F-PA0000X (US domestic) and 0632B-00014 (international)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2670-2016·2016-09-07

    Philips Recalls UNIQ 1.0 Fluoroscopy Systems Due to Power Supply Failures

    Philips is recalling 1,536 UNIQ 1.0 fluoroscopy systems because certain low-voltage DC power supplies have an increased failure rate.

    Product
    UNIQ 1.0: UNIQ FD10, 722026; UNIQ FD10/10, 722027; UNIQ FD20, 722028; UNIQ FD20/10 biplane, 722029; UNIQ FD10 OR Table, 722033; UNIQ FD10/10 OR Table, 722034; UNIQ FD20 OR Table, 722035; UNIQ FD20/20, 722038; UNIQ FD20/20 biplane OR Table, 722039; UNIQ FD20/15, 722058…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2684-2016·2016-09-07

    Integra Recalls Spinal Trays Due to Lidocaine Component Issue

    Integra LifeSciences is recalling specific lots of Spinal Trays because they contain affected Hospira 5% Lidocaine HCL.

    Product
    INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2672-2016·2016-09-07

    Nakanishi Diamond Coated Tips Recalled for Missing Single-Use Labeling

    Nakanishi Inc. is recalling 30,719 diamond coated tips and burs because labeling failed to indicate they are single-use only, posing a cross-contamination risk.

    Product
    Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150). The intended use of the tips is based on the parent device. For the ultrasonic scalers and the sonic air scaler, the tips are used for various…
    Category
    Medical Device
    Distribution
    Distributed nationwide