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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19826–19850 of 40248

  • ModerateFDA (Devices)·Z-2432-2019·2019-09-04

    Baxter Recalls Exactamed Oral Dispensers Due to Mixed Sizes

    Baxter Healthcare is recalling Exactamed 5 mL Oral Dispensers because pharmacy packs may contain 10 mL dispensers.

    Product
    EXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF H9388105, x100 COST CONTAINMENT, REF H93884205, x1500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2397-2019·2019-09-04

    Phadia 1000 Immunodiagnostic Instruments Recalled for Liquid Sensor Error

    Phadia Ab is recalling 387 Phadia 1000 immunodiagnostic instruments due to a liquid sensor error. The recall affects facilities in 27 US states.

    Product
    Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2359-2019·2019-09-04

    Agilent MassHunter Software Recall Due to Sample Data Mismatch

    Agilent Technologies is recalling MassHunter Quantitative Analysis Software versions B.07 or below due to a defect that causes sample name mismatches and prevents saving changes.

    Product
    MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple Quadrupole Mass Spectrometers, models K6460 and K6420 Product Usage: A mass spectrometer for clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2360-2019·2019-09-04

    Leventon DOSI-FUSER Infusion Pumps Recalled for Lack of FDA Clearance

    Leventon S. A. U. is recalling DOSI-FUSER infusion pumps because they lack FDA 510(k) clearance, making them misbranded.

    Product
    DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2366-2019·2019-09-04

    Bausch & Lomb Recalls Laseredge Knives Due to Possible Dull Edge

    Bausch & Lomb is recalling specific Laseredge Knives used in ophthalmic surgery because they may have dull edges.

    Product
    Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2410-2019·2019-09-04

    DRG Salivary Progesterone ELISA Kit Recalled for Low Result Bias

    DRG Instruments GmbH is recalling 8 kits of Salivary Progesterone HS ELISA due to significantly lower results in low measuring ranges.

    Product
    DRG Salivary Progesterone HS ELISA- IVD for the determination of progesterone in human saliva REF: SLV-5911 in vitro diagnostic
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2417-2019·2019-09-04

    Stryker Endotrac Triangle Blade Recall Due to Compromised Sterile Bag Seal

    Stryker GmbH is recalling 1,533 Endotrac EPF/EGR Triangle Blades because the sterile bag seal integrity may be compromised, potentially affecting sterility.

    Product
    Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2226-2019·2019-08-28

    Edwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons

    Edwards Lifesciences is recalling SAPIEN 3 Ultra Transcatheter Heart Valve Systems due to reports of burst balloons that caused difficulty retrieving the device during procedures.

    Product
    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26 UDI:00690103201253
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-2227-2019·2019-08-28

    Edwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons

    Edwards Lifesciences is recalling SAPIEN 3 Ultra Transcatheter Heart Valve Systems because burst balloons can make it difficult to remove the device from patients.

    Product
    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-2295-2019·2019-08-28

    Arcos Burn Navigator H2 Recalled for Battery Fire Risk

    Arcos, Inc. is recalling 28 Burn Navigator H2 units because their battery packs may heat up abnormally and ignite in rare instances.

    Product
    Brand Name Burn Navigator¿ Model Numbers: Catalog 1120, Burn Navigator¿ H2 Catalog 1125, Burn Navigator¿ H2 Transport Package Burn Navigator User Manual Manual-1120 Burn Navigator User's Manual, Rev. F Battery: Panasonic Model CF-H2 Part Number CMP-1523
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2224-2019·2019-08-28

    Edwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons

    Edwards Lifesciences is recalling 362 units of the SAPIEN 3 Ultra Transcatheter Heart Valve System due to reports of burst balloons that complicate device retrieval.

    Product
    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-2225-2019·2019-08-28

    Edwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons

    Edwards Lifesciences is recalling SAPIEN 3 Ultra Transcatheter Heart Valve Systems due to reports of burst balloons that caused significant difficulty retrieving the device during procedures.

    Product
    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-2308-2019·2019-08-28

    BD Vacutainer Blood Collection Tubes Recalled for False COHb Results

    Becton Dickinson is recalling BD Vacutainer LH blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.

    Product
    BD Vacutainer LH (Lithium Heparin) 34 I.U. Plus Blood Collection Tubes, Catalog Number 368494
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2341-2019·2019-08-28

    Siemens N Cuvette Segments Recalled for Falsely Elevated Albumin Results

    Siemens Healthcare Diagnostics is recalling N Cuvette Segments for the BN ProSpec System because they may produce falsely elevated albumin results.

    Product
    N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2310-2019·2019-08-28

    BD Vacutainer Lithium Heparin Tubes Recalled for False COHb Results

    Becton Dickinson is recalling BD Vacutainer LH blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with the IL GEM 4000 instrument.

    Product
    BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2349-2019·2019-08-28

    Thoratec Heartmate 3 Sealed Outflow Graft Recall for Leak Risk

    Thoratec Corp. is recalling 149 Heartmate 3 Sealed Outflow Graft units because the C-Ring may not seat properly, causing leaks during implantation.

    Product
    Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2294-2019·2019-08-28

    TiSport Recalls TiLite Wheelchair Anti-Tip Tubes for Tipping Risk

    TiSport is recalling 1,452 TiLite wheelchairs because the anti-tip tubes may fail, allowing the chair to tip backwards.

    Product
    TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and AERO R, a component of the TiLite wheelchair (anti-tip extension for manual wheelchairs). Product Usage: The affected component is part of a manual wheelchair to provide mobility to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2290-2019·2019-08-28

    Siemens IMMULITE 2000 Progesterone Test Recalled for Potential Low Results

    Siemens is recalling IMMULITE 2000 Progesterone tests because some samples may produce falsely low results, potentially leading to unnecessary medication.

    Product
    IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2296-2019·2019-08-28

    BD Vacutainer Tubes Recalled for False Carboxyhemoglobin Results

    Becton Dickinson is recalling BD Vacutainer Lithium Heparin blood collection tubes because they may cause false elevation of carboxyhemoglobin results when used with specific instruments.

    Product
    BD Vacutainer Lithium HeparinN (LH) 37 USP Units Blood Collection Tubes, Catalog Number 366664
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2343-2019·2019-08-28

    Siemens MAGNETOM Skyra MRI Devices Recalled for Quench Venting System Defect

    Siemens is recalling 44 MAGNETOM Skyra MRI devices due to a potential open port in the quench venting system when using an optional horizontal outlet.

    Product
    MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-2319-2019·2019-08-28

    Qiagen QIAsymphony SP Software 5.0.3 Recalled for Barcode Assignment Error

    Qiagen is recalling QIAsymphony SP software version 5.0.3 because it incorrectly assigns 2D barcode eluate IDs to samples, which could lead to incorrect patient reporting.

    Product
    QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids-IVD) Model Number: 9001297 Product Usage: The QIAsymphony SP instrument is designed to perform automated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2289-2019·2019-08-28

    Siemens IMMULITE 1000 Progesterone Test Recall for Low Results

    Siemens is recalling IMMULITE 1000 Progesterone tests because they may produce falsely low results, potentially leading to unnecessary progesterone supplementation.

    Product
    IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2293-2019·2019-08-28

    DeRoyal Enteral Safe Feeding Tubes Recalled for Connector Detachment

    DeRoyal Industries is recalling specific polyurethane feeding tubes because the connector may detach from the tube.

    Product
    DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF 54-2465R, 6.5 FR x 24" Polyurethane c) REF 54-2480R, 8 FR x 24" Polyurethane d) REF 54-3680R, 8 FR x 36" Polyurethane Product Usage: Feeding tube
    Category
    Medical Device
    Distribution
    Distributed nationwide