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

4576–4600 of 39987

HighFDA (Devices)·Z-1135-2025·2025-02-19
Cardinal Health Presource surgical kits recalled for endotoxin contamination risk
Cardinal Health is recalling Presource Kits for potential endotoxin contamination in non-sterile surgical strips and patties. These surgical components could pose infection risks if used in procedures.
Product
Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP1E 5) CHI STD SPINE OPTION 2, Catalog
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
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
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-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-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-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-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-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-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-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-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-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-1099-2025·2025-02-12
Belmont Medical 3-Spike Disposable Set May Leak During Use
The Belmont Medical 3-Spike Disposable Set may leak during priming due to a crack in its female quick connector, potentially delaying warmed infusions in hospital settings.
Product
Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed to be used in general operation in hospital or alternate care environments to provide warmed blood and fluids to any patients e10 kg requiring warmed infusion. Part Number:903-00006
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-1083-2025·2025-02-12
Philips AlluraXper Operating Room Table Finger Entrapment Hazard
The Philips AlluraXper FD20 operating room table can trap fingers between the guiding rails and tabletop during manual repositioning, potentially injuring operators and service personnel.
Product
AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1081-2025·2025-02-12
Philips AlluraXper FD20 Biplane Patient Table Finger Entrapment Risk
Philips AlluraXper FD20 Biplane patient tables may cause finger entrapment between the tabletop and guiding rails during manual repositioning, affecting operators and service personnel.
Product
AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1093-2025·2025-02-12
Philips Azurion patient tables recalled for finger entrapment risk
Philips is recalling Azurion 7 M12 and Allura patient tables used in medical imaging systems due to a finger entrapment hazard during manual repositioning. Operators and service personnel may suffer finger injury if fingers are caught between the tabletop and guiding rails.
Product
Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1091-2025·2025-02-12
Philips Azurion and Allura System Patient Tables: Finger Entrapment Risk
Philips Azurion and Allura system patient tables may trap fingers between the guiding rails and tabletop during manual repositioning, risking finger injury to operators and service personnel.
Product
Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1089-2025·2025-02-12
Philips Azurion 5 M12 imaging system: finger entrapment risk during tabletop repositioning
Philips Azurion 5 M12 patient imaging systems pose a finger entrapment hazard during manual tabletop repositioning. Operators and service personnel risk finger injury from the longitudinal guiding rails.
Product
Azurion 5 M12 System Code: (1) 722227 (2) 722231
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1092-2025·2025-02-12
Philips Azurion patient tables recalled for finger entrapment hazard
Philips is recalling Azurion 7 B20 patient tables due to a finger entrapment hazard between the tabletop and guiding rails during manual repositioning. Operators and service personnel could suffer finger injury.
Product
Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1075-2025·2025-02-12
Levofloxacin Antimicrobial Susceptibility Discs Recalled Due to Packaging Mislabeling
Oxoid Limited is recalling 1,406 units of Lev5 Levofloxacin susceptibility discs because packaging may contain Norfloxacin discs instead, which could affect laboratory test results.
Product
Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1087-2025·2025-02-12
Philips Azurion and Allura Patient Tables: Finger Entrapment Hazard
Philips patient tables on Azurion and Allura imaging systems can trap fingers between the tabletop and rails during manual repositioning. Operators and service personnel are at risk of finger injury.
Product
Azurion 3 M12 System Code: (1) 722063 (2) 722221
Category
Medical Device
Distribution
Distributed nationwide

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4576–4600 of 39987