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

13726–13750 of 13836

HighFDA (Devices)·Z-1838-2021·2021-06-16
Medical Device Software Defects in RayStation Treatment Planning System
RayStation radiation therapy treatment planning software versions 6 through 10A contain defects that may cause misleading dose evaluations and contouring errors. Healthcare facilities should verify treatment plans and contact the manufacturer for guidance.
Product
RayStation (Treatment Planning System) Model Number RayStation is 6.0.0.24 , 6.1.1.2 , 6.2.0.7 , 6.3.0.6 , 7.0.0.19 , 8.0.0.6 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 , 9.2.0.483 , 10.0.0.1154 , 10.0.1.52 or 10.1.0.613 .
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1813-2021·2021-06-16
Atec Insignia Anterior Cervical Plate System recall due to potential screw mechanism failure
Alphatec Spine is recalling Atec Insignia Anterior Cervical Plate System units due to a potential defect where the screw blocking mechanism may disassociate or unlock during or after surgery. No adverse events have been reported.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0244 Insignia, ACP, 2-Level, 44 mm, Rx Only, Non-Sterile, UDI: (01)00190376268507
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1835-2021·2021-06-16
Medical microscope slide stainer recalled due to defective pump tubing
Hardy Diagnostics is recalling the Quickslide GramPro 1 Automated Gram Stanier due to defective tubing in the pump mechanism that could cause device malfunction.
Product
Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1829-2021·2021-06-16
VIA Microcatheter VIA 21 Recalled for International Labeling Error
MICROVENTION INC. is recalling VIA Microcatheter VIA 21 units (Lot 19110403M) because they were shipped with international labeling instead of FDA-cleared US labeling.
Product
VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1830-2021·2021-06-16
VIA Microcatheter shipped with incorrect international labeling instead of US labels
MICROVENTION INC. is recalling VIA Microcatheter units that were inadvertently shipped with international labeling instead of US-cleared labeling. Units were distributed in six U.S. states.
Product
VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1828-2021·2021-06-16
VIA Microcatheter recalled due to incorrect international labeling shipped to US
MicroVention is recalling certain VIA Microcatheter units that were shipped with international labeling instead of US-approved labeling. Affected units were distributed across six US states.
Product
VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen catheter designed to be introduced over a steerable guidewire into the vasculature.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1651-2021·2021-06-09
Alaris Infusion Pump Module Bezel Repair Parts Recalled for Separation Risk
FDA recalls 22 serviced Alaris Model 8100 infusion pump units with bezel components that may crack or separate, risking free flow, over-infusion, under-infusion, or treatment interruption. Units distributed to Indiana and Texas between September 2020 and February 2021.
Product
Alaris Infusion Pump Module, Model 8100, serviced/repaired by The Biomed Guys, with the impacted bezel repair part, TIPA-8100-4410 / Alaris 8100 Bezel.
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1620-2021·2021-06-09
Leccurate SARS-CoV-2 Antigen Test Kit Recalled: Not FDA-Approved for U.S. Distribution
The Leccurate SARS-CoV-2 Antigen Rapid Test Kit is being recalled because it was not authorized, cleared, or approved for marketing in the United States. Approximately 8.4 million units were distributed worldwide, including to U.S. states and territories.
Product
Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-1619-2021·2021-06-09
Leccurate COVID-19 Antibody Test Kit Recalled for Unauthorized U.S. Distribution
LEPU Medical has recalled the Leccurate SARS-CoV-2 Antibody Rapid Test Kit because it is not authorized, cleared, or approved for marketing in the U.S. Approximately 8.4 million units have been distributed worldwide.
Product
Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood for use as an aid in identifying individuals with an adapti
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1756-2021·2021-06-09
OsteoFlex Bone Cement Recalled Due to Inadequate Sterilization
Zavation's OsteoFlex bone cement distributed nationwide may not have been adequately sterilized. Patients who received this sterile surgical product in orthopedic or spinal procedures should contact their healthcare provider.
Product
OsteoFlex BONE CEMENT, REF Numbers: a) INTV-OSFL b) INTV-OSFL-LV. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1765-2021·2021-06-09
Orthopedic Spinal Procedure Kit Recalled for Inadequate Sterilization
Zavation's ZVplasty spinal surgical kit is being recalled because distributed units may not have been adequately sterilized. The recall affects 302 units distributed nationwide.
Product
ZVplasty 10G, 20mm, Traditional Unipedicular Kit, REF VCF-1020-1. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1710-2021·2021-06-09
FDA Recalls ZVplasty Cement Delivery Cannula Over Sterilization Failure
Zavation recalled ZVplasty Bipedicular Cement Delivery Cannulas (Lot 19123174) because products distributed as sterile may not have been adequately sterilized. These cannulas are used in spinal procedures; inadequate sterilization poses an infection risk.
Product
ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1727-2021·2021-06-09
Orthopedic spinal surgical device recalled for inadequate sterilization
Zavation recalls orthopedic spinal devices distributed as sterile but potentially inadequately sterilized. Patients who received these devices should consult their healthcare provider.
Product
10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1753-2021·2021-06-09
Orthopedic Spinal Surgery Kit Recalled for Inadequate Sterilization
Zavation is recalling InterV CurvePlus surgical kits because products distributed as sterile may not have been adequately sterilized. 36 units were distributed nationwide.
Product
InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1720-2021·2021-06-09
Zavation spinal orthopedic cement delivery kits recalled for inadequate sterilization
Zavation is recalling 122 units of sterile orthopedic cement delivery kits that may not have been adequately sterilized. The kits were distributed nationwide for use in spinal and orthopedic procedures.
Product
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1689-2021·2021-06-09
Vygon Dressing Change Kit Recalled for Sterile Barrier Failure Risk
Vygon U.S.A. is recalling 8,320 units of its Dressing Change w/ Maxiswab kit due to improper adhesion of the sterile Tyvek lid to the tray, which could compromise the sterile barrier and potentially cause infection.
Product
Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1791-2021·2021-06-09
Terumo Sarns TCM II cardiac temperature controller cleaning protocol failure
The Sarns TCM II temperature control system used in cardiac surgery has been recalled due to inability to validate its cleaning protocol. Users are instructed to discontinue use and dispose of all affected devices.
Product
The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice supply, monitors temperatures in the patient and extracorpor
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1711-2021·2021-06-09
ZVplasty Direct Access Bevel Tip Trocar Recalled Due to Inadequate Sterilization
Zavation is recalling ZVplasty Direct Access Bevel Tip Trocars used in orthopedic and spinal procedures because products distributed as sterile may not have been adequately sterilized. The recall affects 98 units distributed nationwide.
Product
ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1773-2021·2021-06-09
Change Healthcare Enterprise Viewer software defect affects image display settings
A software defect in Change Healthcare Enterprise Viewer versions 2.0 and 2.1 prevents the display of image presentation styles. The viewer is used nationwide for displaying medical images.
Product
Change Healthcare Enterprise Viewer - Product Usage: intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1745-2021·2021-06-09
10G Coaxial Cannulas Recalled Due to Inadequate Sterilization in Spinal Procedures
Zavation's 10G Coaxial Cannulas for spinal procedures may not have been adequately sterilized. The nationwide recall addresses potential infection risk from non-sterile surgical instruments.
Product
10G COAXIAL CANNULA WITH TUOHY CONNECTION STERILE. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1708-2021·2021-06-09
ZVplasty Bone Access Kit Recalled for Inadequate Sterilization
Zavation has recalled the ZVplasty Direct Unipedicular Bone Access Kit with Drill due to potential sterilization failure. The surgical device is used in orthopedic and spinal procedures, with 11 units distributed nationwide.
Product
ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DSBAK. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1771-2021·2021-06-09
MiniMed 780G Insulin Pump Software Fault Risks Overdose
A software design flaw in the MiniMed 780G Insulin Pump can cause insulin over-delivery. If users deliver an additional bolus without knowing their active insulin level, they risk receiving too much insulin.
Product
MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886 MM780G 6.5W BLE MG; KIT MMT-1895WW MM780G 6.5V BLE SF MMOL;¿ KIT MMT-1896WW MM780G 6.5W BLE SF MG;¿ PUMP MMT-1884XC 780G V6.5 CLIN US MG;¿ PUMP MMT-1885XC 780G V6.5 CLIN MM;¿ PUMP MMT-18
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-1732-2021·2021-06-09
ZVplasty Cement Delivery Cannula Recalled Due to Sterilization Failure
Zavation recalls 22 ZVplasty Cement Delivery Cannulas (lot 20102490) distributed nationwide because they may not have been adequately sterilized for use in orthopedic and spinal procedures.
Product
ZVplasty Cement Delivery Cannula, REF VCF-1007. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1746-2021·2021-06-09
Zavation 10 Gauge Sterile Surgical Drill Recalled for Inadequate Sterilization
Zavation is recalling 10 gauge sterile surgical drills used in orthopedic and spinal procedures because products distributed as sterile may not have been adequately sterilized. Products were distributed nationwide.
Product
10 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1748-2021·2021-06-09
Zavation 10G Beveled Trocar/Cannula recalled for inadequate sterilization
Zavation is recalling 10G Beveled Trocar/Cannula surgical instruments distributed nationwide because they may not have been adequately sterilized. Patients who received these instruments in orthopedic or spinal procedures should consult their healthcare provider.
Product
10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide

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13726–13750 of 13836