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 deaths or serious injuries are reported, 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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601–625 of 5027

  • SevereFDA (Devices)·Z-1869-2025·2025-06-18

    Blood Products Administration Set Filter Mis-Assembly Recall

    Fresenius Kabi USA is recalling IVENIX INFUSION SYSTEM LVP Blood Products Administration Sets due to a mis-assembly error that may prevent the drip chamber filter from properly filtering large blood particulates.

    Product
    IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
    Category
    Medical Device
    Distribution
    18 states
  • SevereFDA (Devices)·Z-1921-2025·2025-06-18

    SOLTIVE Premium SuperPulsed Laser System surgical instrument thermal incident

    Olympus is recalling the SOLTIVE Premium SuperPulsed Laser System due to risk of thermal incidents including smoke, sparks, burning, or flames during clinical use caused by fiber fracturing.

    Product
    Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only); Software Version: N/A Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1972-2025·2025-06-18

    BD Texium Closed System Drug Transfer Devices May Leak at Connector

    BD Texium closed system drug transfer devices in multiple sizes may leak at the interface between the male luer component and needle-free connector, potentially causing treatment delays, exposure to hazardous drugs, and underdosing.

    Product
    BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: MY8030-0006; 60 mL, REF: MY8060-0006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1952-2025·2025-06-18

    Tecfen Medical 2.8mm Slit Knife Angled Sterility Assurance Recall

    Tecfen Medical is recalling 2.8mm Slit Knife, Angled (Model QKN2808) ophthalmic surgical instruments due to sterility assurance concerns. Affected units were distributed in the US and internationally.

    Product
    Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number: QKN2808 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knive
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1928-2025·2025-06-18

    Philips Achieva XR MRI systems recall for fire hazard

    Philips Achieva XR MRI systems may have a gradient coil component failure that can generate heat, smoke, and fire. The risk to patients and operators includes inhalation of smoke, burns, and asphyxia.

    Product
    Achieva XR Product Numbers: (1) 781153, (2) 781253;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1931-2025·2025-06-18

    Philips Intera 1.5T Achieva Nova-Dual MRI System Fire Hazard Recall

    Philips is recalling three Intera 1.5T Achieva Nova-Dual MRI systems worldwide due to a gradient coil component failure that can generate smoke and fire, posing risks including burn injury and asphyxia.

    Product
    Intera 1.5T Achieva Nova-Dual Product Number: 781173;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1867-2025·2025-06-18

    Z-800W Infusion System Recalled for Unvalidated Software Installation

    Zyno Medical LLC is recalling the Z-800W Infusion System because unreleased software versions were installed on devices without verification or validation.

    Product
    Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1930-2025·2025-06-18

    Philips Intera 1.5T Achieva Nova MRI Systems Gradient Coil Fire Risk

    Philips is recalling certain Intera 1.5T Achieva Nova MRI systems due to a gradient coil component that can overheat, potentially causing smoke or fire with risk of burns, smoke inhalation, or asphyxia.

    Product
    Intera 1.5T Achieva Nova Product Number: 781172;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1866-2025·2025-06-18

    Z-800F Infusion System Recall Due to Unvalidated Software Versions

    Zyno Medical LLC is recalling the Z-800F Infusion System because unreleased software versions were installed on distributed devices without verification or validation. This poses a risk to patients receiving intravenous infusion therapy.

    Product
    Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1936-2025·2025-06-18

    Philips SmartPath to dStream 1.5T MRI Gradient Coil Fire Risk

    Philips SmartPath to dStream for 1.5T MRI systems are recalled due to potential gradient coil component failure that may produce smoke and fire, posing risks of inhalation injury, burns, asphyxia, and death.

    Product
    SmartPath to dStream for 1.5T¿; Product Number: 782146;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1868-2025·2025-06-18

    Z-800WF Infusion System software verification defect recall

    Zyno Medical LLC is recalling 613 units of the Z-800WF Infusion System because unreleased software versions were installed on distributed devices without verification or validation.

    Product
    Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1932-2025·2025-06-18

    Philips Intera 1.5T Explorer/Nova Dual MRI Gradient Coil Fire Risk

    Philips is recalling one Intera 1.5T Explorer/Nova Dual MRI system due to a gradient coil component that may overheat, produce smoke, or ignite, risking patient and operator injury.

    Product
    Intera 1.5T Explorer/Nova Dual Product Number: 781108;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1969-2025·2025-06-18

    Azurion R1.x and R2.x X-ray systems software communication issue

    Philips Medical Systems has recalled Azurion R1.x and R2.x X-ray systems worldwide due to a software issue that can cause loss of imaging functionality and delay treatment, potentially resulting in serious harm or death in patients undergoing urgent or complex interventions.

    Product
    Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282; Software Version: Al
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1865-2025·2025-06-18

    Z-800 Infusion System recalled for unverified software installation

    Zyno Medical LLC is recalling 613 units of the Z-800 Infusion System distributed nationwide because unreleased software versions were installed on the devices without verification or validation.

    Product
    Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1953-2025·2025-06-18

    Tecfen Medical 20G MVR Sideport Knife ophthalmic sterility recall

    Tecfen Medical is recalling its 20G (1.2mm) MVR Sideport Knife Straight (Model QKN2312) ophthalmic knives due to sterility assurance concerns. The recall affects 38 units distributed in the US and internationally.

    Product
    Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straight Model/Catalog Number: QKN2312 Software Version: No software Product Description: This is an ophthalmic knife (manual( that is to be sterile and packaged individually in Tyvek 1059B. MVR sideport
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1963-2025·2025-06-18

    Microtek Patient Drape Adapter Plug Kits Recalled for Non-Sterile Labeling

    Microtek Medical is recalling Patient Drape adapter plug kits (models AP6MMN and AP8MMN) because non-sterile products were labeled as sterile. The affected adapters are used to connect drain hoses to fluid management devices.

    Product
    Microtek Patient Drape ECOLAB AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN UDI code: (01)10748426139986 AP8MMN Patient Drape, 8mm Adapter Plug Kit REF AP8MMN UDI code: (01)10748426139429 These adapters function as accessories for a device or drape, serving to
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Devices)·Z-1934-2025·2025-06-18

    Philips Intera 1.5T MRI Systems Gradient Coil Fire Risk Recall

    Philips is recalling Intera 1.5T Omni/Stellar MRI systems due to a gradient coil component failure that can produce smoke and fire, risking patient and operator injury or death.

    Product
    Intera 1.5T Omni/Stellar; Product Number: 781104;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1915-2025·2025-06-18

    Covidien Newport HT70 and HT70Plus Ventilators Capacitor Failure Recall

    Covidien is recalling Newport HT70 and HT70Plus ventilators due to capacitor failures that may cause the device to shut down unexpectedly or fail to alarm, risking respiratory failure and oxygen deprivation in patients.

    Product
    Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU. Newport HT70Plus Ventilator, REF: HT70PM-ES-EU, HT70PM-ES-NA, HT70PM-JP-NA, HT70PM-PT-BR, HT70PM-SY-AS, DLHT70PM-WW-NA, HT70PM-SY-NA, HT70PM-SY-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1924-2025·2025-06-18

    Azure S DR MRI SureScan Pacemakers Recalled for Battery Failure Risk

    Medtronic Azure S DR MRI SureScan pacemakers may experience sudden battery power failure without warning, potentially interrupting therapy and leading to cardiac arrest or hospitalization. Affected devices are being recalled internationally.

    Product
    Azure S DR MRI SureScan, Product number W3DR01
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1929-2025·2025-06-18

    Philips Intera 1.5T Achieva IT Nova MRI System Gradient Coil Fire Risk

    Philips is recalling one Intera 1.5T Achieva IT Nova MRI system due to a gradient coil component that may overheat and produce smoke or fire, posing risks of inhalation injury, burns, or death.

    Product
    Intera 1.5T Achieva IT Nova Product Number: 781175
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1814-2025·2025-06-11

    Adult Manual Resuscitator with Medium Adult Mask recalled nationwide

    SunMed Holdings is recalling 11,358 Adult Manual Resuscitators because the filter may be incorrectly attached to the patient port instead of the exhalation port, risking interruption or delay in patient resuscitation that could cause serious harm or death.

    Product
    Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1809-2025·2025-06-11

    Medline Surgical Kits with Codman Disposable Perforator recalled

    Medline surgical kits containing Codman Disposable Perforators are being recalled because certain lots have inadequate welds that may cause the perforator to break or separate during use.

    Product
    Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRANIOTOMY CDS, SKU CDS983467J 4. CRANIOTOMY PACK, SKU DYNJ85807A, DYNJ85927 5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1810-2025·2025-06-11

    Medline Craniotomy Kits with Defective Codman Disposable Perforators

    Medline is recalling craniotomy kits containing Codman Disposable Perforators with inadequate welds that may break or separate during use.

    Product
    Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1811-2025·2025-06-11

    Medline Craniotomy Kits with Defective Codman Disposable Perforators Recalled

    Medline is recalling multiple craniotomy kits containing Codman Disposable Perforators due to inadequate welds that may cause the perforators to break or separate during use.

    Product
    Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PACK-LF SKU DYNJ44805M 3. CRANIOTOMY SKU CDS982719V CDS982719W DYNJ904168F DYNJ908404B DYNJ908723A DYNJ908723C 4. CRANIOTOMY #IMF 56646-LF SKU DYN
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1817-2025·2025-06-04

    ELEOS Collar Stem Cemented Fluted Implant Size Mislabeling Recall

    Onkos Surgical is recalling 23 units of ELEOS Collar Stem implants (Model HC-13120-03M) because packages labeled as 13mm contained 15mm diameter implants instead, creating a risk of implant mismatch during surgery.

    Product
    ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.
    Category
    Medical Device
    Distribution
    Distributed nationwide