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 the agency’s own highest classification or reported deaths or serious injuries, 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

14051–14075 of 27471

HighFDA (Devices)·Z-1453-2020·2020-03-18
Cardinal Health Recalls Non-Sterile Monoject Syringes with Safety Needles
Cardinal Health is recalling Monoject 3mL syringes with safety needles because they were shipped as non-sterile despite labeling. The firm is not aware of any patient harm reports.
Product
Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1462-2020·2020-03-18
RayStation 8A Software Recalled for Treatment Planning Calculation Errors
RaySearch Laboratories is recalling RayStation/RayPlan 8A software due to a defect that causes incorrect treatment planning values when pitch or roll corrections are applied.
Product
RayStation/RayPlan 8A, Build Number 8.0.0.61, stand-alone software treatment planning system
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1468-2020·2020-03-18
RayStation 9B Software Recalled for Pitch and Roll Correction Errors
RaySearch Laboratories AB is recalling one RayStation/RayPlan 9B software system in Tennessee due to potential errors in position calculations during pitch or roll corrections.
Product
RayStation/RayPlan 9B, Build Number 9.1.0.933, stand-alone software treatment planning system
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1477-2020·2020-03-18
Cordis Recalls POWERFLEX P3 Catheters Due to Potential Seal Voids
Cordis is recalling one lot of POWERFLEX P3 PTA Dilation Catheters due to potential voids in the proximal seal area.
Product
Cordis POWERFLEX P3, PTA Dilation Catheter, REF 420-6020S
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1451-2020·2020-03-18
BioFire FilmArray Gastrointestinal Panel Recalled for False Negative Results
BioFire Diagnostics is recalling FilmArray Gastrointestinal Panel kits due to elevated false negative rates that may lead to incorrect treatment.
Product
FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx Only
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1467-2020·2020-03-18
RayStation 9A Software Recall for Pitch and Roll Correction Errors
RaySearch Laboratories is recalling one RayStation/RayPlan 9A system in Tennessee due to potential errors in position propagation when pitch or roll corrections are applied.
Product
RayStation/RayPlan 9A, Build Number 9.0.0.113, stand-alone software treatment planning system
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1465-2020·2020-03-18
RayStation 8B Software Recalled for Pitch and Roll Correction Errors
RaySearch Laboratories is recalling one RayStation 8B treatment planning system in Tennessee due to a software error that may cause incorrect position values.
Product
RayStation/RayPlan 8B Service Pack 1, Build Number 8.1.1.8, stand-alone software treatment planning system
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1466-2020·2020-03-18
RayStation 8B Software Recalled for Pitch and Roll Correction Errors
RaySearch Laboratories is recalling one RayStation 8B software system in Tennessee due to a defect that causes incorrect position values when pitch or roll corrections are applied.
Product
RayStation/RayPlan 8B Service Pack 2, Build Number 8.1.2.5, stand-alone software treatment planning system
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1464-2020·2020-03-18
RayStation 8B Software Recalled for Pitch and Roll Correction Errors
RaySearch Laboratories AB is recalling one RayStation 8B software system in Tennessee due to potential errors in tabletop position propagation.
Product
RayStation/RayPlan 8B, Build Number 8.1.0.47, stand-alone software treatment planning system
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1458-2020·2020-03-18
Nextremity Solutions Recalls Nextra Hammertoe Correction System Due to Driver Defect
Nextremity Solutions is recalling 190 units of the Nextra Hammertoe Correction System because the driver may be oversized, making it difficult to remove from the implant.
Product
Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments which is indicated for small bone reconstruction limited to inter-digital…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1473-2020·2020-03-18
Medicrea Iliac Screws Recalled Due to Incorrect Component Orientation
Medicrea International is recalling 3,529 Iliac Screws because an internal component was assembled incorrectly, which may cause the tulip head to disengage from the shank.
Product
Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590 B36027500 B36027570 B36027580 B36027590 B36028500 B36028570 B36028580 B36028590 B36029500 B36029570 B36029580 B36029590 Screws manufactured in titanium alloy Ti-6Al-4V LI…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1450-2020·2020-03-18
Medtronic Simulus 850 Sizer Kits Recalled Due to Porcine Tissue Contact
Medtronic is recalling six Simulus 850 Semi Rigid Ring/Band Accessory Kits because demonstration units may have contacted porcine tissue.
Product
Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1428-2020·2020-03-18
Heartware Recalls HVAD System Battery Charger AC Adapters
Heartware, Inc. is recalling 5,489 HVAD System Battery Charger AC Adapters because users might mistakenly insert them into the HVAD Controller power port.
Product
HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1457-2020·2020-03-18
EHOB Recalls Econocare Plus Waffle Overlay Due to Blood Contamination
EHOB, Inc. is recalling specific lots of Econocare Plus Waffle Overlays due to potential contamination with human blood. No instances of contamination have been confirmed in distributed products.
Product
Econocare Plus Overlay Item: 1025EC. Intended to aid in the prevention and treatment of pressure injuries and general comfort - Product Usage: The EHOB WAFFLE Overlay intended use is as first line of defense for pressure injury prevention. The design provides the caregiver a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1472-2020·2020-03-18
Medicrea Recalls Pedicle Screws Due to Incorrect Component Orientation
Medicrea International is recalling 3,529 pedicle screws because an internal component was assembled incorrectly, which may cause the tulip head to disengage from the screw shank.
Product
Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555 B36005530 B36005535 B36005540 B36005545 B36005550 B36005555 B36005560 B36006530 B36006535 B36006540 B36006545 B36006550 B36006555 B36006560…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1463-2020·2020-03-18
RayStation Software Recall for Potential Treatment Planning Errors
RaySearch Laboratories is recalling one RayStation 8A system in Tennessee due to a software defect that may cause incorrect treatment planning calculations.
Product
RayStation/RayPlan 8A Service Pack 1, Build Number 8.0.1.10, stand-alone software treatment planning system
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1452-2020·2020-03-18
ARJOHUNTLEIGH Recalls Concerto and Basic Shower Trolleys Due to Safety Catch Failure
ARJOHUNTLEIGH is recalling 669 Concerto and Basic Shower Trolleys because a mechanical failure in the safety catch could cause the side support to open, posing a risk of patient falls and injuries.
Product
Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083), BAB1000CON6102 [(01)05056097364483], BAB1007-01 [(01)05055982796255], BAB1101-01 [(01)05055982787949], BAB1102-01 [(01)05055982796156], BAB1103-01 [UDI: (01)05055982796163], BAB1107-01…
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-1454-2020·2020-03-18
Cardinal Health Recalls Non-Sterile Monoject Hypodermic Safety Needles
Cardinal Health is recalling Monoject Hypodermic Safety Needles because they were shipped as non-sterile despite labeling indicating sterility, posing an infection risk.
Product
Monoject Hypodermic Safety Needle 30G X 1/2" Item Code 1183005 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1456-2020·2020-03-18
Cardinal Health Recalls Non-Sterile Monoject Bluntfill Syringes
Cardinal Health 200, LLC is recalling Monoject Bluntfill syringes that were shipped as non-sterile but labeled as sterile. The firm is not aware of any patient harm.
Product
Monoject Bluntfill with Filter, 18G x 1-1/2" Item Code 11811022F. Used for drawing fluid from a vial - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1449-2020·2020-03-18
Medtronic Simulus 750 Flexible Ring/Band Accessory Kit Recalled for Tissue Contact
Medtronic CoreValve LLC is recalling six Simulus 750 Flexible Ring/Band Accessory Kits because demonstration units may have contacted non-human tissue.
Product
Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1437-2020·2020-03-11
FDA Recalls LKT200 Perfusion Circuits Due to Leakage Risk
Organ Recovery Systems is recalling 2,274 LKT200 Perfusion Circuits because leakage at the sample port could cause loss of perfusion solution needed for kidney preservation.
Product
LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and transport system, which is intended to be used for the continuous hypothermic…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1430-2020·2020-03-11
Remisol Advance software recalled for remote code execution vulnerability
Normand-Info S.A.S.U. is recalling Remisol Advance software running on unsupported Windows operating systems due to a critical remote code execution vulnerability.
Product
Remisol Advance running on hardware with Windows XP, Windows 7, Windows Server 2003 and Windows Server 2008 operating systems
Category
Medical Device
Distribution
51 states
SevereFDA (Devices)·Z-1362-2020·2020-03-11
CareFusion Alaris PCA Module Recalled for Software Errors
CareFusion 303, Inc. is recalling CareFusion Alaris PCA Module, Model 8120 units due to software errors that may cause infusion interruptions or incorrect medication concentrations.
Product
CareFusion Alaris PCA Module, Model 8120
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1415-2020·2020-03-11
DeRoyal Sterile Custom Kits Recalled for Unknown Bioburden and Contamination
DeRoyal Industries is recalling 2,100 sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
Product
DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following: ASC Laparoscopy Pack 89-6138.13
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1446-2020·2020-03-11
Recall of Covidien Force TriVerse Electrosurgical Devices Due to Packaging Risk
The FDA is recalling 70,361 units of Covidien Force TriVerse Electrosurgical Devices because sterile packaging may be compromised, increasing the risk of infection.
Product
Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084 20884524000081; 10884524001937 20884524001934
Category
Medical Device
Distribution
Distributed nationwide

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14051–14075 of 27471