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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

5251–5275 of 27364

HighFDA (Devices)·Z-2025-2024·2024-06-12
Bedside Monitor Software Issue Causes False Oxygen Saturation Probe Failure Alarms
Nihon Kohden's BSM-3000 Series Bedside Monitors may produce false SpO2 probe failure alarms due to a software issue. Healthcare facilities should contact the manufacturer for guidance.
Product
BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility.
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-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-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-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-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-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-1895-2024·2024-06-05
Philips Allura Xper FD20 patient table brake may fail to engage after software update
Philips Allura Xper FD20 X-ray systems with ADN7NT patient tables may have a pivot brake failure after software upgrade 8.1.100 is installed. This could cause unexpected table movements during use.
Product
Philips Allura Xper FD20 system with an ADN7NT patient table. Model Number: 722012, Software Version Number 8.1.100.
Category
Medical Device
Distribution
1 state
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-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-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-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-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-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-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-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-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-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
HighFDA (Devices)·Z-1912-2024·2024-06-05
Mako 3.0 and 3.1 surgical systems software error causes treatment delays
Stryker Orthopaedics recalls Mako 3.0 and 3.1 surgical systems due to software errors that cause treatment delays when switching applications without 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.fr.1+TKA 1.0.1.fr.1+PKA3.0.2.fr. Application Part Number: 700002190743-04
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1894-2024·2024-06-05
Mirion Captus 4000e Thyroid Uptake System Recalled for Collimator Detachment
Mirion Technologies is recalling the Captus 4000e Thyroid Uptake System due to complaints of unexpected collimator detachment. Affected users should contact the manufacturer for guidance.
Product
Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests.
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-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-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

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5251–5275 of 27364