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 13837

HighFDA (Devices)·Z-1831-2021·2021-06-16
Laboratory Software Device May Produce Erroneous Results from Inadequate Instructions
Normand Remisol Advance Data Manager versions 1.5–1.9 have insufficient instructions for proper rule programming and testing. User-written rules may not be properly validated, potentially leading to erroneous laboratory results.
Product
Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1817-2021·2021-06-16
Atec Insignia Anterior Cervical Plate System Screw Blocking Mechanism Risk
The FDA is recalling certain Atec Insignia Anterior Cervical Plate Systems due to a potential defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.
Product
Atec Insignia Anterior Cervical Plate System, REF 136-0352 Insignia, ACP, 3-Level, 52 mm, Rx Only, Non-Sterile, UDI: (01)00190376268576
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1797-2021·2021-06-16
Medtronic Braive Growth Modulation System Break-Off Set Screws Recalled for Thread Defect
Medtronic is recalling Braive Growth Modulation System Break-Off Set Screws due to a thread profile defect caused by a manufacturing issue. The defect may affect proper device function.
Product
Braive Growth Modulation System Break-Off Set Screws - Product Usage: intended to limit further progression of the spinal curvature and provide correction of the thoracic curve while allowing continued skeletal growth by compression of the convex side of the scoliotic curve.
Category
Medical Device
Distribution
0 states
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
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
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-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
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
HighFDA (Devices)·Z-1704-2021·2021-06-09
Zavation ZVplasty Direct Access Diamond Tip Trocar may not be sterile
Zavation is recalling ZVplasty Direct Access Diamond Tip Trocar (REF VCF-1023) distributed nationwide because products marketed as sterile may not have been adequately sterilized. The device is used in orthopedic and spinal procedures.
Product
ZVplasty Direct Access Diamond Tip Trocar, 10 Gauge, REF VCF-1023. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1734-2021·2021-06-09
Zavation 10G Direct Single Bone Access Kit Recall Due to Inadequate Sterilization
Zavation is recalling its 10G Direct Single Bone Access Kit because some units distributed as sterile may not have been adequately sterilized. The kit is used in orthopedic and spinal procedures and was distributed nationwide.
Product
10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1788-2021·2021-06-09
Nimbus alternating-pressure mattress overlay system recall for inflation malfunction
Getinge is recalling approximately 13,042 units of Nimbus 4 and Nimbus Professional alternating-pressure mattress overlays due to potential abnormal inflation that could impair pressure relief function.
Product
Nimbus 4 and Nimbus Professional Alternating-pressure bed mattress overlay system
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1739-2021·2021-06-09
11G Direct Double Bone Access Kit May Not Be Adequately Sterilized
Zavation's 11G Direct Double Bone Access Kit for spinal and orthopedic procedures may not have been adequately sterilized during manufacturing. Distributed nationwide, the non-sterile devices may pose infection risks to patients.
Product
11G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
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-1770-2021·2021-06-09
Orthopedic Spinal Balloon Kit Recalled for Inadequate Sterilization Risk
Zavation's VERTEBREX single balloon kit for spinal procedures is being recalled because distributed units may not have been adequately sterilized, creating a potential infection risk.
Product
VERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1750-2021·2021-06-09
Zavation CEMIX Orthopedic Cement Mixing System Sterilization Recall
Zavation recalled 197 CEMIX cement mixing system units due to inadequate sterilization for orthopedic and spinal surgical use.
Product
CEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
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-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-1721-2021·2021-06-09
Spinal Surgery Cement Delivery Cannula Kits Recalled for Potential Sterilization Failure
Zavation is recalling ZVplasty Unipedicular Cement Delivery Cannula Kits distributed nationwide due to potential inadequate sterilization of sterile surgical devices.
Product
ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1768-2021·2021-06-09
Zavation OsteoFlex Cement Surgical System Recalled Due to Sterilization Concerns
Zavation is recalling OsteoFlex Cement and Mixing System used in spinal and orthopedic surgery due to potential sterilization failures. The 846 units distributed nationwide may not be adequately sterilized, creating a contamination risk.
Product
OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide
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-1783-2021·2021-06-09
Elekta MOSAIC Oncology Information System Recalled Due to Malware Attack
Elekta recalled versions 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 of the MOSAIC Oncology Information System due to a malware attack. Forty units were distributed nationwide.
Product
Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1691-2021·2021-06-09
Draeger Evita V800 Ventilator Recalled for Multiple Software Defects
Draeger Medical is recalling the Evita V800 critical care ventilator due to three unrelated software defects affecting ventilation delivery and alarm functionality.
Product
Critical Care Ventilator, Catalog Number(s): 8422500: Evita V800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1728-2021·2021-06-09
Zavation recalls ZVplasty Diamond Tip Trocar due to sterilization failure
Zavation is recalling 113 units of ZVplasty Direct Access Diamond Tip Trocars (11 Gauge) due to inadequate sterilization. The devices were distributed nationwide and may not be safe for use in orthopedic and spinal procedures.
Product
ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in Orthopedic / spinal procedures.
Category
Medical Device
Distribution
Distributed nationwide

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13726–13750 of 13837