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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7001–7025 of 40007

  • ModerateFDA (Devices)·Z-1947-2024·2024-06-12

    Leica HistoCore PEGASUS tissue processor recalled for tissue damage

    LEICA BIOSYSTEMS is recalling 141 Leica HistoCore PEGASUS tissue processors due to reagent overfilling that causes poorly processed or damaged biopsy tissue specimens.

    Product
    Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2019-2024·2024-06-12

    Quality Control Tool Vitamin B12 Range Verifier Recalled by FDA

    Ortho-Clinical Diagnostics is recalling VITROS Vitamin B12 Range Verifier Lot 1200 because the product may fail to verify required calibration range. The failure is detectable during use and does not affect actual patient test results.

    Product
    VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1876-2024·2024-06-05

    Medline Sub-G Endotracheal Tubes with Subglottic Suctioning—Inflation and Suction Defects

    Medline endotracheal tubes with subglottic suctioning may have inflation tubes that detach or tear and suction pumps that disconnect, risking loss of ventilation control.

    Product
    Medline Sub-G Endotracheal Tube with Subglottic Suctioning: (1) REF DYNJ18860, Polyurethane Cuff 6.0 mm ID; (2) REF DYNJ18865, Polyurethane Cuff 6.5 mm ID; (3) REF DYNJ18870, Polyurethane Cuff 7.0 mm ID; (4) REF DYNJ18875, Polyurethane Cuff 7.5 mm ID; (5) REF DYNJ18880, Po
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1933-2024·2024-06-05

    RefleXion X1 Radiotherapy System Recalled for Potential Radiation Dose Error

    Reflexion Medical is recalling the RefleXion X1 Radiotherapy System due to a potential dose error affecting patients treated with out-of-session SCINTIX partial fraction therapy. Seven systems were distributed across six U.S. states.

    Product
    RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1909-2024·2024-06-05

    Synchro Guide Wires Recalled for Inadequate Endotoxin Testing

    Stryker Neurovascular is recalling 2,859 Synchro guide wires in multiple configurations due to inadequate endotoxin testing during manufacturing. The devices may exceed acceptable endotoxin limits, increasing the risk of fever, shock, and aseptic meningitis.

    Product
    Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, Catalog: M00313310 SYNCHRO .010 WIRE SOFT STRAIGHT 200cm, Catalog: M00316310 SYNCHRO .010 WIRE SOFT STRAIGHT 300cm, Catalog: M00316330
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1905-2024·2024-06-05

    Trevo NXT neurovascular devices recalled for inadequate endotoxin testing

    Stryker Neurovascular is recalling Trevo NXT neurovascular intervention devices because they did not receive adequate endotoxin testing during manufacturing. High endotoxin levels may cause fever, shock, or aseptic meningitis.

    Product
    Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412 TREVO NXT 4X28+TRAK21 2-PACK - CE, Catalog: 91413 TREVO NXT 4X41+TRAK21 2-PACK - CE, Catalog: 91414 TREVO NXT 6X37+TRAK21 2-PACK - CE, Catalog: 91415 TREVO NXT 3X32+PRO14 2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1893-2024·2024-06-05

    Captus 4000e Thyroid Uptake System recalled for unexpected collimator detachment

    Mirion Technologies is recalling 1,275 units of the Captus 4000e Thyroid Uptake System worldwide due to complaints of unexpected collimator detachment.

    Product
    Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1902-2024·2024-06-05

    Trevo XP ProVue neurovascular retriever devices recalled for inadequate endotoxin testing

    Stryker Neurovascular's Trevo XP ProVue Retriever devices did not undergo adequate endotoxin testing and may exceed safe limits, potentially causing fever, shock, and aseptic meningitis.

    Product
    Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183 Trevo XP ProVue Retriever 4 x 30, Catalog: 90185 Trevo XP ProVue Retriever 6 x 25, Catalog: 90186 Kits: TREVO XP 3X20+PRO14 2-PACK, Catalog: 80051 TREVO XP 4X20+PRO18 2-PACK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1926-2024·2024-06-05

    Philips Hemodynamic Application software pressure wave data synchronization defect

    Philips Interventional Hemodynamic Application software versions 1.2.0–1.3.1 may not correctly synchronize pressure wave data when acquiring measurements from two devices simultaneously.

    Product
    Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1904-2024·2024-06-05

    Trevo Pro Microcatheters Recalled for Potential Endotoxin Contamination

    Stryker Neurovascular is recalling Trevo Pro 14 and 18 Microchethers worldwide due to non-compliance with endotoxin testing standards. High endotoxin levels could cause fever, shock, and meningitis.

    Product
    Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog: 90238
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1931-2024·2024-06-05

    BD Pyxis Anesthesia Station ES units recalled for potential fire and smoke risk

    CareFusion 303, Inc. is recalling approximately 71,569 BD Pyxis Anesthesia Station ES units worldwide due to potential fluid ingress that could cause smoke, system downtime, or fire.

    Product
    BD Pyxis" Anesthesia Station ES, REF: 327
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1898-2024·2024-06-05

    Radiographic imaging system tubes may fall due to bolt rupture

    FUJIFILM's FDR Visionary Suite radiographic imaging system has bolts that may rupture due to fatigue, potentially causing the tube support to fall and injure patients. The recall affects 18 units distributed across nine states.

    Product
    FDR Visionary Suite - Intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. Model/Catalog Number: 566-16130-23 566-16130-33
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1930-2024·2024-06-05

    BD Pyxis MedStation 4000 Auxiliary Tower: Potential Fluid Ingress Fire Risk

    The BD Pyxis MedStation 4000 Auxiliary Tower may allow fluid to enter the system, potentially causing smoke, system downtime, and fire. The FDA Class II recall affects 35,029 units distributed worldwide.

    Product
    BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1892-2024·2024-06-05

    FDA Recalls Mirion Captus 4000e Thyroid Uptake System for Collimator Detachment

    The FDA is recalling the Mirion Captus 4000e Thyroid Uptake System due to reports of unexpected collimator detachment that could affect diagnostic accuracy. Approximately 1,275 units are affected worldwide.

    Product
    Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1927-2024·2024-06-05

    BD Pyxis MedStation ES Medication Cabinet Fluid Ingress Fire Hazard

    BD Pyxis MedStation ES medication cabinets may experience fluid ingress, potentially causing smoke, fire, or system downtime. CareFusion is recalling 212,367 units globally.

    Product
    BD Pyxis MedStation ES, REF: 323, Medication Cabinet
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1896-2024·2024-06-05

    Philips Allura Xper FD10 system pivot brake failure after software update

    Philips is recalling Allura Xper FD10 medical imaging systems with software version 8.1.100 because the pivot brake may fail to engage, potentially causing unexpected table movements during procedures.

    Product
    Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1890-2024·2024-06-05

    Vercise Genus Deep Brain Stimulation Device May Reset During Charging

    Boston Scientific is recalling Vercise Genus Deep Brain Stimulation devices that may reset during system checks while charging. The reset causes temporary loss of stimulation and may lead to symptom worsening.

    Product
    Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1907-2024·2024-06-05

    FlowGate2 neurovascular devices may exceed endotoxin limits due to inadequate testing

    Stryker's FlowGate2 neurovascular devices may have excessive endotoxin levels because manufacturing failed to meet required testing standards. High endotoxin can cause fever, shock, and aseptic meningitis.

    Product
    FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1913-2024·2024-06-05

    Mako Robotic Surgery Software Error May Delay Orthopedic Treatments

    Stryker Orthopaedics recalls Mako surgical system software versions that can produce error codes requiring system restart before switching between surgical applications, potentially causing treatment delays.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0.it.1+TKA 1.0.1.it.1+PKA3.0.2.it. Application Part Number: 700002190743-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1918-2024·2024-06-05

    Medline medical procedure kits recalled for potential needle guide ring detachment

    Medline is recalling 12,994 paracervical and pudendal procedure kits because the Trumpet Needle Guide ring can detach when excessive pressure is applied, potentially causing injury.

    Product
    Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TRAY, REF DYNDH1832; b) AHS PARACERVICAL/PUDENDAL KIT, REF DYNJRA2210; c) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046; d) PARACERVICAL/PUDENDAL BLK KIT, REF DYNJRA9046H; Medical procedure conve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1911-2024·2024-06-05

    Mako Surgical Robot Software Error Causes Treatment Delay in Orthopedic Surgery

    Stryker Orthopaedics is recalling Mako surgical robot software due to an error that occurs when switching between surgical applications without restarting the system, resulting in treatment delays.

    Product
    Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.1 + PKA 3.0.2 + MGO 1.2.2 Application Part Number: 700001590414
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1897-2024·2024-06-05

    Philips Allura Xper FD20 Software Update Disables Pivot Brake on Patient Table

    A software upgrade to Philips Allura Xper FD20 Biplane systems causes the patient table pivot brake to fail to engage, potentially causing unexpected table movements during procedures.

    Product
    Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1900-2024·2024-06-05

    EsophaCap Sponge May Detach From String During Removal

    Lucid Diagnostics is recalling EsophaCap medical devices (220 units in MN and MD) because the sponge may detach from the string during removal, particularly at esophageal sphincters.

    Product
    Brand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10 pores/inch) Model/Catalog Number: EC25T10VI Software Version: N/A Product Description: EsophaCap is pouched as individual units. 10 units go into a shelf-box. Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1917-2024·2024-06-05

    Centurion OB Instrument Tray Recalled for Detachable Needle Guide Component

    Medline is recalling Centurion OB Instrument Trays because the Trumpet Needle Guide ring can detach when excessive pressure is applied. This could affect instrument functionality during medical procedures.

    Product
    Centurion OB INSTRUMENT TRAY, REF MN3925; Medical procedure convenience tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1916-2024·2024-06-05

    Surgical screwdrivers recalled for failure to engage with implant screws

    Synthes surgical screwdrivers are being recalled because they lack a required relief cut and will not engage properly with 1.3mm and 1.5mm implant screws, potentially delaying surgery. The defect affects 261 units distributed in the US and Canada.

    Product
    STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during orthopaedic surgery. Part Number: 03.130.010
    Category
    Medical Device
    Distribution
    Distributed nationwide