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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6276–6300 of 13652

  • 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-1901-2024·2024-06-05

    Smith & Nephew OXINIUM Femoral Head Recall: Packaging Size Mismatch

    Smith & Nephew is recalling OXINIUM Femoral Head components due to packaging containing incorrect product sizes compared to labels. The mismatch affects 23 packages distributed internationally.

    Product
    smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1908-2024·2024-06-05

    Neurovascular devices recalled due to inadequate endotoxin testing

    Stryker Neurovascular is recalling 81 neurovascular devices due to inadequate endotoxin testing. The devices may contain excessive endotoxin levels, which can cause fever, shock, and aseptic meningitis.

    Product
    DAC 044 115cm, Catalog: 90760
    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-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-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-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-1919-2024·2024-06-05

    Dako CoverStainer Microscope Slide Stainer Recalled for Plexiglass Door Breakage

    Agilent Technologies recalls Dako CoverStainer microscope slide stainers due to potential plexiglass door breakage that could cause injury.

    Product
    Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStainer, CoverStainer CPO Model/Catalog Number: CS10030, CS10040, CS10026, CS10026E Software Version: N/A Product Description: Microscope Slide Stainer IVD Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1923-2024·2024-06-05

    ClearCut and A-OK ophthalmic surgical knives recalled for sharpness issues

    Alcon is recalling ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance ophthalmic surgical knives due to increased complaint reports about sharpness. Approximately 427,764 units are affected worldwide.

    Product
    ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
    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-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-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-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-1928-2024·2024-06-05

    BD Pyxis MedStation 4000 Medication Cabinet Fire Risk Recall

    CareFusion 303, Inc. is recalling approximately 91,933 units of the BD Pyxis MedStation 4000 System medication cabinet worldwide due to potential fluid ingress that may cause smoke, fire, or system downtime.

    Product
    BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet
    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-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-1906-2024·2024-06-05

    Stryker Neurovascular Microcatheter Recall Due to Inadequate Endotoxin Testing

    Stryker Neurovascular is recalling the Trevo Trak 21 Microcatheter due to potential endotoxin contamination from inadequate testing. High endotoxin levels may increase risk of fever, shock, and aseptic meningitis.

    Product
    Trevo Trak 21 Microcatheter, Catalog: 90338
    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-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-1903-2024·2024-06-05

    Stryker neurovascular devices recalled for inadequate endotoxin testing

    Stryker Neurovascular is recalling Trevo ProVue devices due to manufacturing testing deficiency that may result in unsafe endotoxin levels and risk of fever, shock, or aseptic meningitis.

    Product
    Trevo ProVue, Catalog: 90184
    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-1932-2024·2024-06-05

    BD Pyxis Anesthesia Station 4000 Recalled for Fluid Ingress Fire Risk

    CareFusion's BD Pyxis Anesthesia Station 4000 is recalled due to potential fluid ingress that may cause smoke, fire, or system downtime. The recall involves 11,875 units distributed worldwide.

    Product
    BD Pyxis(TM) Anesthesia Station 4000, REF: 338
    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-1929-2024·2024-06-05

    BD Pyxis MedStation ES 7-Drawer Auxiliary Tower Recalled for Fire Risk

    CareFusion recalled 87,302 units of the BD Pyxis MedStation ES 7-Drawer Auxiliary Tower due to potential fluid ingress that could cause smoke, system downtime, or fire.

    Product
    BD Pyxis" MedStation ES 7-Drawer Auxiliary Tower, REF: 324
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1914-2024·2024-06-05

    Stryker Mako Surgical System Software Error Affects Knee and Hip Replacements

    Stryker Orthopaedics is recalling Mako surgical system software used for knee and hip replacement procedures due to a software error that causes treatment delays when switching between surgical applications without proper system restart.

    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.de.1+TKA 1.0.1.de.1+PKA3.0.2.de. Application Part Number: 700002190743-03
    Category
    Medical Device
    Distribution
    Distributed nationwide