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

4601–4625 of 39968

HighFDA (Devices)·Z-1167-2025·2025-02-19
Exactech Alteon XLE Hip Replacement Liners Recalled for Missing Barrier Layer
Exactech is recalling Alteon XLE hip replacement liners due to a manufacturing defect. Some units lack the Ethylene Vinyl Alcohol barrier layer required for proper device function.
Product
Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL N
Category
Medical Device
Distribution
22 states
HighFDA (Devices)·Z-1140-2025·2025-02-19
Cardiac Diagnostic Implant Recalled for Premature Device Failure
Angel Medical Systems is recalling The Guardian cardiac diagnostic implants due to devices reaching end of service prematurely. The affected units may fail to properly detect acute coronary syndrome events.
Product
Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event and warns the patient to seek urgent medical care. The Guardian is an adjunct to
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1169-2025·2025-02-19
Vios Bedside Monitor Pulse Oximeter Sensor Premature Failure and Incorrect Warnings
Murata Vios, Inc. is recalling the Vios Monitoring System Bedside Monitor, Model BSM2050, due to premature failure of the pulse oximeter SpO2 sensor. When the sensor fails, the system displays an incorrect warning that may mask the actual monitoring problem.
Product
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1124-2025·2025-02-19
Medication Cabinet Recall: BD Pyxis MedStation Auxiliary 4000 Drawer and Door Failures
The BD Pyxis MedStation Auxiliary 4000 medication cabinet may experience drawer and door failures, potentially delaying medication access in healthcare facilities.
Product
BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1136-2025·2025-02-19
Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination
Cardinal Health is recalling Presource Kits (surgical strips and patties used in ophthalmic procedures) due to potential endotoxin contamination in non-sterile components.
Product
Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVA; 2) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVB 3) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog Number:SEY30EYRVC 4) OCULAR PLASTIC PACK, Catalog Number:SEY35OP961 5) OCULAR
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1100-2025·2025-02-19
Medical laser device recalled for inadequate safety operating instructions
Ithera Medical is recalling the MSOT Acuity Echo medical laser device worldwide due to inadequate instructions for safe operation. Previous user manuals contained an incorrect Nominal Ocular Hazard Distance value.
Product
The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of electrically-powered components intended for imaging and analysis of soft-tissue and vasculature using combined optoacoustic (photoacoustic) and ultrasound (US) imaging.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1125-2025·2025-02-19
BD Pyxis MedStation 4000 Recalled for Drawer and Door Failures
CareFusion 303, Inc. is recalling the BD Pyxis MedStation 4000 medication cabinet due to potential drawer and door failures that could delay access to stored medications.
Product
BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1123-2025·2025-02-19
BD Pyxis MedStation Auxiliary ES medication cabinet drawer and door failures
BD Pyxis MedStation Auxiliary ES medication cabinets are being recalled due to potential drawer and door failures following increased complaints. The failures could delay access to medications stored in the cabinet.
Product
BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1120-2025·2025-02-19
BD Pyxis Medication Dispensing Systems Recalled for Insufficient Labeling
CareFusion is recalling six models of BD Pyxis medication management systems due to insufficient labeling regarding potential delays in medication access. The manufacturer is strengthening product labeling to address this risk.
Product
(1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis MedStation 4000 Console, Catalog No. 309; (5) BD Pyxis MedStation 4000, Catalog No. 303; (6) BD Pyxis Anesthes
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1019-2025·2025-02-12
Ivenix Infusion System software recalled for pump malfunction risk
The FDA recalled Ivenix Infusion System software versions 5.9.2 and earlier for potential device malfunctions that could affect medication delivery. Two known anomalies may cause pump failure or improper infusion rates.
Product
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1078-2025·2025-02-12
Philips AlluraXper Patient Tables Pose Finger Entrapment Risk
Philips is recalling AD7 and AD7X patient tables used in Allura and Azurion fluoroscopy systems. Manual repositioning can trap fingers between the tabletop and rails, risking injury to operators and service personnel.
Product
AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1047-2025·2025-02-12
Newborn Resuscitator Kit Recalled for Inline Spring Defect
414 newborn resuscitator kits (ROi CPS LLC) recalled for a potential spring defect in the Inline Controller that could prevent proper ventilation pressure in labor and delivery settings.
Product
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1098-2025·2025-02-12
Surgical sutures recalled for potential sterility breach
Ethicon is recalling ETHIBOND EXCEL Polyester Sutures due to open packaging seals that could compromise sterility and allow pathogen contamination. No illnesses have been reported.
Product
ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1113-2025·2025-02-12
Sysmex PS-10 Sample Preparation System Recalled for False Test Results
Sysmex PS-10 Sample Preparation Systems may produce false test results due to sporadic omission of the probe wash step during antibody pipetting. Thirty-two units have been recalled nationwide.
Product
Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1102-2025·2025-02-12
ECG cable shipped with incomplete cleaning and disinfection instructions
Physio-Control is recalling 245 LIFEPAK 35 ECG cables (Lot 0224) because the shipped instructions do not include proper cleaning and disinfection procedures, creating potential cross-contamination risks.
Product
LIFEPAK 35 ECG cable REF 11111-000041
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1082-2025·2025-02-12
Philips AlluraXper FD20 operating room surgical table finger entrapment risk
Philips AlluraXper FD20 operating room tables can trap fingers during manual repositioning, risking injury. The hazard affects both operators and service personnel worldwide.
Product
AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1079-2025·2025-02-12
Philips Allura patient tables recall due to finger entrapment risk
Philips recalls AD7 and AD7X patient tables in Allura and Azurion systems due to finger entrapment risk during manual repositioning. Operators and service personnel could suffer finger injuries.
Product
Allura Xper FD10C System Code: (1) 722001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1115-2025·2025-02-12
Beckman Coulter DxI 9000 immunoassay analyzer recalled for software-related motion errors
Beckman Coulter is recalling 61 DxI 9000 immunoassay analyzers worldwide due to a software error causing tray gripper motion errors that result in intermittent hard stops and delays in patient test results.
Product
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1107-2025·2025-02-12
Patient Monitor May Fail to Alarm on Ventilator Disconnect
Philips IntelliVue Patient Monitor MX400 may fail to alarm when a Hamilton ventilator is disconnected. 28 units affected in the US and internationally.
Product
IntelliVue Patient Monitor MX400. Model Number: 866060
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1072-2025·2025-02-12
VNS Therapy Generators May Stop Delivering Stimulation Due to Component Failure
The SenTiva and SenTiva Duo vagus nerve stimulation generators may stop delivering therapy due to an internal mechanical component becoming stuck, causing potential loss of seizure and depression control.
Product
SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
Category
Medical Device
Distribution
41 states
HighFDA (Devices)·Z-1073-2025·2025-02-12
VNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect
LivaNova's SenTiva VNS generators (48 units) may stop delivering stimulation due to a mechanical defect. Patients may experience return to baseline seizure or depressive symptoms and may require replacement surgery.
Product
SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
Category
Medical Device
Distribution
41 states
HighFDA (Devices)·Z-1046-2025·2025-02-12
X-Ray Imaging System May Continue Exposure Beyond Safety Limit
GE Medical Systems' Optima XR646 HD X-Ray imaging systems may allow continued radiation exposure beyond the safety limit without operator confirmation. A warning message displays but does not prevent the excess exposure.
Product
Optima XR646 HD. X-Ray imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1108-2025·2025-02-12
Patient Monitor May Fail to Alert When Ventilator Disconnects
Philips IntelliVue Patient Monitor MX450 units may fail to sound an alarm when a Hamilton ventilator becomes disconnected, potentially delaying detection of the disconnection.
Product
IntelliVue Patient Monitor MX450. Model Number: 866062
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1085-2025·2025-02-12
Finger entrapment hazard in Philips Allura fluoroscopy patient tables
Philips is recalling AD7 and AD7X patient tables from Allura and Azurion fluoroscopy systems. During manual repositioning, fingers can become trapped between the guiding rails and tabletop, potentially causing injury.
Product
Allura Xper FD20/20 System Code: (1) 722038
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1109-2025·2025-02-12
IntelliVue Patient Monitor MX500 may fail to generate critical alarms
Philips IntelliVue Patient Monitor MX500 units may fail to generate "No Device Data" alarms when a Hamilton ventilator disconnects, potentially delaying notification of loss of connectivity. 45 units distributed in the US and internationally.
Product
IntelliVue Patient Monitor MX500. Model Number: 866064
Category
Medical Device
Distribution
2 states

How to read this listing

Filters

4601–4625 of 39968