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.

Filters

Agency

All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

7076–7100 of 27393

  • HighFDA (Devices)·Z-2599-2023·2023-09-27

    Stryker ACM Cement Mixer Nozzle Risk of Disassembly During Surgery

    Stryker is recalling certain ACM (Advanced Cement Mixing) systems due to risk that the Break-Away Femoral Nozzle may disassemble or break during use, potentially causing loss of function and components entering the surgical site.

    Product
    Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-564-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2610-2023·2023-09-27

    TyTek Tension Pneumothorax Access Kit Recalled for Inadequate Placement Instructions

    Tytek Medical Inc is recalling the TyTek Tension Pneumothorax Access Kit (Model TM-303) because the instructions do not adequately identify the risks associated with needle decompression or clearly show proper placement site location.

    Product
    TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-303
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2625-2023·2023-09-27

    Philips Tempus Pro Patient Monitor Software Error Impairs Critical Monitoring

    Certain Philips Tempus Pro Patient Monitors may display an error message when laryngoscopes are disconnected, requiring a 60-100 second restart that prevents vital sign monitoring and airway visualization during intubation. This may lead to treatment delays or hypoxia.

    Product
    Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With Tempus Pro Video Laryngoscope, REF 01-2044
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-2620-2023·2023-09-27

    Copan Transfer Pipette Recalled Due to Plastic Defects

    Copan Diagnostics is recalling 2,592 units of 300µL transfer pipettes due to plastic defects that may affect aspiration capability. Affected units were distributed in California.

    Product
    COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2597-2023·2023-09-27

    Stryker bone cement cartridge nozzles may disassemble during surgical use

    Stryker is recalling bone cement cartridges because the breakaway femoral nozzle applicator tip may disassemble or break off during use, potentially causing loss of device function and foreign material in the surgical site.

    Product
    Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakaway Femoral Nozzle-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0206-530-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2509-2023·2023-09-20

    Abbott Proclaim DRG Implantable Pulse Generators cannot exit MRI mode

    Abbott Medical is recalling approximately 17,394 Proclaim DRG Implantable Pulse Generators worldwide due to reports that patients cannot exit MRI mode on affected devices. This malfunction may prevent normal device operation when mode-switching is needed.

    Product
    Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2506-2023·2023-09-20

    Proclaim XR 7 Implantable Pulse Generators unable to exit MRI mode

    Abbott Medical is recalling Proclaim XR 7 Implantable Pulse Generators due to a malfunction that prevents patients from exiting MRI (Magnetic Resonance Imaging) mode, potentially disrupting normal device operation and therapy delivery.

    Product
    Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2450-2023·2023-09-20

    Mallinckrodt One-Way Valve Recalled Due to Potential Oxygen Flow Failure

    Mallinckrodt Manufacturing is recalling approximately 13,600 One-Way Valves used with ventilators due to risk of valve sticking and oxygen flow reduction. The Class I recall affects worldwide distribution.

    Product
    Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2505-2023·2023-09-20

    Proclaim XR 5 Implantable Pulse Generators Cannot Exit MRI Mode

    Abbott Medical recalled the Proclaim XR 5 Implantable Pulse Generator after patients reported being unable to exit MRI mode on their devices. Approximately 113,784 units were distributed worldwide.

    Product
    Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2510-2023·2023-09-20

    Abbott Infinity 5 Implantable Pulse Generator Patients Unable to Exit MRI Mode

    Some Abbott Infinity 5 implantable pulse generator patients report being unable to exit MRI mode on their devices. This Class I recall affects 5,932 devices distributed globally.

    Product
    Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2511-2023·2023-09-20

    Infinity 7 Implantable Pulse Generator Recall Due to MRI Mode Exit Failure

    Abbott Medical recalls Infinity 7 Implantable Pulse Generators due to reports that patients cannot exit MRI mode. The FDA has classified this as a Class I recall affecting devices distributed worldwide.

    Product
    Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2507-2023·2023-09-20

    Abbott Proclaim Plus 5 Implantable Pulse Generator MRI Mode Exit Failure

    Abbott Medical is recalling Proclaim Plus 5 Implantable Pulse Generators (Model 3670) due to reports that patients are unable to exit MRI mode on the devices.

    Product
    Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2508-2023·2023-09-20

    Proclaim Plus 7 Implantable Pulse Generator Cannot Exit MRI Mode

    Abbott Medical recalled Proclaim Plus 7 Implantable Pulse Generators due to a defect preventing patients from exiting MRI mode. This operational failure could compromise device functionality during or after magnetic resonance imaging procedures.

    Product
    Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2514-2023·2023-09-20

    FDA Recalls Medline Hudson RCI Addipak Inhalation Solution for Sterility Failure

    Medline Industries is recalling HUDSON RCI Addipak 5mL sterile saline inhalation solution due to sterility failure. Approximately 18,000 units were distributed nationwide; the product was intended for scrap but was inadvertently shipped to customers.

    Product
    HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2538-2023·2023-09-20

    Radiation monitoring dosimeter units recalled for potential accuracy defect

    Landauer is recalling 147 nanoDot D2DNS radiation dosimeters worldwide due to potential non-conformance in the OSL material that may result in readings falling outside the ±5.5% accuracy specification.

    Product
    nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2539-2023·2023-09-20

    Landauer nanoDot D2DNS Radiation Dosimeters Recalled for Accuracy Non-Conformance

    Landauer recalled 135 nanoDot D2DNS radiation dosimeters worldwide due to potential accuracy deviations outside the specified ±5.5% range in optical stimulated luminescence material.

    Product
    nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2555-2023·2023-09-20

    Landauer nanoDot B Radiation Dosimeters Recalled for Measurement Accuracy

    Landauer nanoDot B radiation dosimeters may have measurement inaccuracies outside the specified +/-5.5% range, potentially compromising radiation exposure monitoring. 16,820 units worldwide are affected.

    Product
    nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2570-2023·2023-09-20

    Radiation monitoring dosimeters recalled for potential measurement inaccuracy

    Landauer is recalling Calibrate nanoDot D2DNS radiation dosimeters worldwide due to a potential material defect that may cause readings to fall outside the specified ±5.5% accuracy range.

    Product
    Calibrate (unexposed) nanoDot D2DNS, Model Numbers: a) 18140-000; b) 18140-KIT; c) 18140-SET; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2534-2023·2023-09-20

    Procedural kits with ultrasonic transmission gel recalled for mislabeling

    Advance Medical Designs, Inc. is recalling 26,900 procedural kits containing ultrasonic transmission gel due to mislabeling of use instructions. The affected products were distributed in the U.S., Canada, the UK, Panama, and the Netherlands.

    Product
    Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2544-2023·2023-09-20

    Landauer nanoDot Radiation Dosimeters Recalled Due to Potential Accuracy Issues

    Landauer is recalling 18,638 nanoDot radiation monitoring dosimeters worldwide. Some units may measure radiation exposure outside the specified ±5.5% accuracy range, potentially affecting occupational safety monitoring.

    Product
    nanoDot D2DNS, Model Numbers: a) 03057-1MO; b) 03057-3MO; c) 03057-OTO; d) 03057-SMO; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2554-2023·2023-09-20

    Landauer nanoDot A Dosimeters Recalled for Potential Measurement Inaccuracy

    Landauer is recalling nanoDot A radiation dosimeters (Model 03501-000) because some units may measure radiation exposure outside the acceptable accuracy range. A potential non-conformance in the optical material was identified during investigation.

    Product
    nanoDot A - item 1 of 3 for 03500-000, Model Number 03501-000; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2571-2023·2023-09-20

    Landauer nanoDot dosimeters recalled for potential accuracy deviation

    Landauer has recalled nanoDot radiation dosimeters due to potential accuracy deviations in the Optical Stimulated Luminescence material used to measure radiation exposure. Affected units may read outside the specified +/-5.5% accuracy range.

    Product
    Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number VKITCON002); b) 18150-KIT; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2575-2023·2023-09-20

    Landauer nanoDot Radiation Dosimeter Recalled for Accuracy Defect

    Landauer is recalling nanoDot radiation dosimeter adapters (EU Model VINLADA003) worldwide because some units may provide dosimetry readings outside the specified +/-5.5% accuracy range due to a non-conformance in the optical measurement material.

    Product
    Reader, nanoDot adapter, EU Model Number VINLADA003; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2557-2023·2023-09-20

    Radiation Dosimeter May Provide Inaccurate Dose Measurements

    Landauer is recalling certain nanoDot D2DNS radiation dosimeters because they may measure radiation exposure outside the specified accuracy range. Approximately 5,958 units worldwide are affected.

    Product
    Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 04217-000 (EMEA number VINLNAN003); b) 04217-KIT; c) 04217-SET; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2565-2023·2023-09-20

    Landauer nanoDot radiation dosimeter units recalled due to accuracy failure

    Landauer is recalling 973 radiation dosimeter units that may not accurately measure radiation exposure due to a potential defect in the light-emitting material used for dose measurement.

    Product
    Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT; c) 18121-SET; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states