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

6126–6150 of 13543

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-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-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-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-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-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-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-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-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-1891-2024·2024-06-05
Tri-Staple 2.0 surgical stapler cartridge damage may cause incomplete stapling
Covidien is recalling 1681 units of Tri-Staple 2.0 surgical staples due to potential cartridge damage that may result in poor staple formation and incomplete staple lines during surgery.
Product
Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT
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-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-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-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-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-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-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-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-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-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-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-1922-2024·2024-06-05
Ophthalmic surgical knives recalled for sharpness defects
Alcon is recalling approximately 29,190 V-Lance ophthalmic surgical knives due to reports of blade sharpness defects. Affected instruments are distributed worldwide, including as components in Alcon Custom Pak surgical procedure packs.
Product
20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 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-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

How to read this listing

Filters

6126–6150 of 13543