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

6301–6325 of 13666

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-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-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-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-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-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
ModerateFDA (Devices)·Z-1910-2024·2024-06-05
Stryker Mako Surgical Robot Software Error Causes Treatment Delays
Stryker's Mako surgical robots may experience software errors causing treatment delays when switching between surgical modes without proper system restart. This affects 334 units globally.
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 4.0.0.1 + PKA 3.0.2 Application Part Number: 700001590415
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1915-2024·2024-06-05
Mako robotic surgery system software error causes treatment delays
Stryker Mako robotic surgery software exhibits increased Error #3 when switching between surgical applications without system restart, resulting in treatment delays. No patient injuries reported.
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.es.1 + PKA 3.0.2.es.1 + THA 4.0. Application Part Number: 700002190743-05
Category
Medical Device
Distribution
Distributed nationwide
CriticalCPSC·24248·2024-05-30
Medline Adult Bed Rails Recalled for Entrapment and Asphyxia Risk
Medline is recalling about 1.5 million Bed Assist Bar adult bed rails because users can become entrapped between the rail and mattress, posing a risk of asphyxiation. Two deaths have been reported.
Product
Medline Bed Assist Bar adult bed rails
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1813-2024·2024-05-29
BiPAP A40 ventilators risk therapy loss during alarm condition
BiPAP A40 ventilators may lose therapy delivery during a Ventilator Inoperative alarm, potentially causing respiratory failure or death in vulnerable patients.
Product
BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS ONLY)1111170 1111171 1111173 1111174 1111175 1111177 1116156 1111170S BR1111169 CN1111169 IT1111169 R1111169 R1111177 R1116156 ; BiPAP A40 Pro, Part Numbers (OUS Only): ARX3100S19
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1814-2024·2024-05-29
BiPAP A30 Ventilator Recall: Risk of Therapy Interruption and Respiratory Failure
Philips Respironics BiPAP A30 Ventilators may experience interruption or loss of therapy during a Ventilator Inoperative alarm, potentially causing severe respiratory compromise or death in vulnerable patients.
Product
BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers 1111144 1111145 1111147 1111148 1111149 1111150 1111154 1111181 1116155 1111144L 1111144M 1111144V BR1111143 CN1111143 R1111143 R1111150 R1111181
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1817-2024·2024-05-29
Philips OmniLab Advanced + Ventilator May Experience Unexpected Therapy Loss
Philips OmniLab Advanced + Ventilators may experience an alarm condition that interrupts or stops therapy delivery. This interruption may lead to inadequate breathing support, low oxygen levels, and potentially fatal respiratory failure.
Product
OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1811-2024·2024-05-29
Optum Nimbus II Plus Infusion Pump Recall Due to Potential Failure Modes
OptumHealth Care Solutions LLC is recalling 208 units of the Optum Nimbus II Plus ambulatory infusion pump distributed nationwide due to potential battery failure, system errors, and drug leakage.
Product
Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1812-2024·2024-05-29
BiPAP V30 Auto Ventilator May Interrupt Therapy During Malfunction Alarm
Philips BiPAP V30 Auto Ventilators may interrupt or lose therapy during a Ventilator Inoperative alarm, potentially causing hypoventilation, severe oxygen depletion, or respiratory failure.
Product
BiPAP V30 Auto Ventilator, Part Number 1111178
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2050-2024·2024-05-29
Non-Sterile Syringes Recalled Due to Manufacturing Specification Violation
Jiangsu Shenli Medical is recalling 754,600 non-sterile syringes because the piston syringe sizes and configurations exceed those cleared by the FDA. Affected units were distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/S Model/Catalog Number: 83085 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2094-2024·2024-05-29
Medline Non-Sterile Syringes Model 91876 Recalled for Outside Specification Sizes
Medline non-sterile syringes (Model 91876) are being recalled because certain lot codes contain sizes and configurations that exceed the range cleared by the FDA. No injuries or illnesses have been reported.
Product
Brand Name: MEDLINE Product Name: SYR CNTR 10ML L/L YELLOW Model/Catalog Number: 91876 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1874-2024·2024-05-29
FDA Recalls Prelude Guide Sheath Roadster for Component Size Mismatch
Merit Medical Systems is recalling 18 units of Prelude Guide Sheath Roadster due to sheaths labeled as .018 dilators potentially containing .038 dilators instead. The mismatch poses a risk if the wrong-sized component is used during medical procedures.
Product
Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1862-2024·2024-05-29
Philips MR Systems Recalled for Loose Electrical Connection Fire Hazard
Philips has recalled 200 SmartPath to dStream MR imaging systems worldwide due to a loose electrical connection in the g-MDU unit that may create a fire hazard in hospital technical rooms.
Product
SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782129; (2) 782113; (3) 781270
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1836-2024·2024-05-29
Philips Achieva 1.5T MR Systems Electrical Connection Fire Hazard
Philips is recalling 1,585 Achieva 1.5T MR systems worldwide due to a loose g-MDU L3 terminal connection that may create an electrical hotspot causing fire or smoke. No injuries have been reported.
Product
Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781296 (2) 781343
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2107-2024·2024-05-29
60 mL Luer Lock Syringes Recalled for Manufacturing Outside FDA Clearance
Jiangsu Shenli Medical is recalling Wolf Medical 60 mL Luer Lock piston syringes because they were manufactured outside the scope of the firm's FDA 510(k) clearance.
Product
Brand Name: Wolf Medical Product Name: 60 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR60L Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1860-2024·2024-05-29
MRI System Mains Distribution Unit Connection Fire Risk
Loose terminal connections in the mains distribution unit of Philips MRI systems may create electrical hotspots that could cause smoke or fire. The company is recalling 617 affected units worldwide.
Product
SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782146; 782112; 781260
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2052-2024·2024-05-29
Non-sterile Medline piston syringes recalled for exceeding FDA scope
Medline has recalled SYR 20ML L/L non-sterile piston syringes (Model 83088) manufactured in sizes and configurations outside FDA-cleared specifications. Approximately 13.6 million units were distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 20ML L/L Model/Catalog Number: 83088 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1842-2024·2024-05-29
MR Imaging System Recall for Loose Electrical Terminal Connection Fire Risk
Philips AchievaXR MR systems may have loose terminal connections in the power distribution unit that could create hotspots and cause smoke or fire. The FDA has recalled 35 affected units worldwide.
Product
AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253
Category
Medical Device
Distribution
Distributed nationwide

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6301–6325 of 13666