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

3176–3200 of 27375

HighFDA (Devices)·Z-1130-2025·2025-02-19
Cardinal Health Maxillofacial Surgical Kits Recalled for Potential Endotoxin Contamination
Cardinal Health Presource maxillofacial surgical kits containing non-sterile strips and patties may have endotoxin contamination. 973,785 units distributed in the US, Canada, and Saudi Arabia are affected; users should stop using and contact the manufacturer.
Product
Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF105 3) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF106 4) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF107 5)
Category
Medical Device
Distribution
Distributed nationwide
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-1132-2025·2025-02-19
Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination
Cardinal Health is recalling approximately 973,785 Presource Kits due to potential endotoxin contamination in non-sterile surgical strips and patties. The kits were distributed to healthcare facilities worldwide.
Product
Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG5 3) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG6 4) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG7 5) KIT,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1126-2025·2025-02-19
Cardinal Health Surgical Kits Recalled for Potential Endotoxin Contamination
Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. Approximately 973,785 units were distributed to the US, Canada, and Saudi Arabia.
Product
Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog Number:PB23DFCM4; 3) KIT,DIEP FLAP , Catalog Number:PB23DFCM5; 4) KIT,DIEP FLAP , Catalog Number:PB23DFCM6; 5)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1170-2025·2025-02-19
Hologic Sertera-14 Biopsy Device Recalled for Inner Needle Separation Risk
Hologic is recalling 55,335 Sertera-14 biopsy devices nationwide because the inner needle can separate from the hub, creating a risk of needle dislodgement during use.
Product
Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1166-2025·2025-02-19
Novation XLE hip implant components recalled for missing barrier layer
Exactech is recalling Novation XLE hip implant components due to absence of an Ethylene Vinyl Alcohol (EVOH) barrier layer. Patients with affected implants should contact their healthcare provider.
Product
Novation 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
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-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-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-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-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-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-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-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-1080-2025·2025-02-12
Philips recalls AlluraXper FD20 patient tables due to finger entrapment hazard
Philips is recalling AlluraXper FD20 patient tables due to a finger entrapment hazard. During manual repositioning, fingers can get trapped between the tabletop and rails, risking injury to operators and service personnel.
Product
AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1105-2025·2025-02-12
NeiMed NasoGel nasal spray recalled due to stability failure
Neilmed Pharmaceuticals is recalling NasoGel for Dry Noses due to stability failure that may allow microbial growth. The product was distributed across 30 U.S. states and to five countries.
Product
NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT NasoGel Spray is a saline-based gel formula that can be sprayed to moisturize and lubricate dry and i
Category
Medical Device
Distribution
Distributed nationwide
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-1084-2025·2025-02-12
Philips Allura and Azurion Patient Tables Recall Due to Finger Entrapment Risk
Philips is recalling AD7 and AD7X patient tables used in Allura and Azurion medical imaging systems due to a finger entrapment hazard during manual repositioning. Operators and service personnel are at risk of finger injury.
Product
AlluraXperFD20/10 System Code: (1) 722029
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1043-2025·2025-02-12
X-Ray imaging systems may allow radiation exposure beyond safety limits
GE Medical Systems is recalling Definium 656HD and Discovery XR656HD X-Ray systems due to an Automatic Exposure Control defect that may allow radiation exposure to exceed intended safety limits.
Product
Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1096-2025·2025-02-12
FDA Recalls PROLENE Polypropylene Sutures for Defective Packaging Seals
Ethicon is recalling PROLENE polypropylene sutures because some packages have open seals due to a manufacturing defect. Defective seals may allow pathogens to contaminate the sterile sutures, potentially causing infection.
Product
PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1118-2025·2025-02-12
Spine Surgery Planning Software Calculation Errors in Rod Planning Parameters
Medicrea International is recalling UNiD Spine Analyzer software due to calculation errors in rod planning parameters. The software experienced anomalies resulting in incorrect values for surgical classification and measurement parameters used in spine surgery planning.
Product
UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a he
Category
Medical Device
Distribution
50 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
HighFDA (Devices)·Z-1076-2025·2025-02-12
Philips Allura CV20 patient tables risk finger entrapment during repositioning
The Philips Allura CV20 System patient tables (AD7 and AD7X models) pose a finger entrapment hazard during manual repositioning. Fingers can become caught between the tabletop and guiding rails, potentially injuring operators and service personnel.
Product
Allura CV20 System Code: 722031
Category
Medical Device
Distribution
Distributed nationwide

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3176–3200 of 27375