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

4751–4775 of 13449

HighFDA (Devices)·Z-0088-2025·2024-10-23
Leica Cryostat Model CM1900 Lacks Warning on Flammable Sprays
Leica Biosystems is recalling the Cryostat Model CM1900 because its labeling lacks a warning about using flammable freezing sprays in the chamber. The sprays can ignite, creating a serious fire and burn hazard.
Product
Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0072-2025·2024-10-23
basixTOUCH Inflation Device May Have Sterile Barrier Defect
Merit Medical Systems is recalling basixTOUCH Inflation Devices due to a potential hole in the sterile barrier. The defect may expose patients to pathogens and pyrogens, increasing infection risk.
Product
basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0122-2025·2024-10-23
Medline Open Heart Surgical Kit Recall for Model Labeling Error
Medline Industries recalls certain open-heart surgical kits (Lot 23LBR364) due to incorrect model labeling, where model 30001 units were labeled as model 30000. The recall affects 30 units distributed nationwide.
Product
MEDLINE OPEN HEART, REF DYNJ904261B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0065-2025·2024-10-23
basixTOUCH Inflation Device Recalled for Sterile Barrier Defect
Merit Medical Systems is recalling the basixTOUCH Inflation Device (REF: IN8140/A) because devices may have a small hole in the sterile barrier, potentially exposing users to pathogens and pyrogens that could lead to infection.
Product
basixTOUCH Inflation Device, REF: IN8140/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0069-2025·2024-10-23
MONARCH Inflation Device Recalled Due to Sterile Barrier Defect Risk
Merit Medical Systems recalled 12,910 MONARCH Inflation Devices worldwide due to a potential hole in the sterile barrier. The defect could expose the device to pathogens and pyrogens, potentially leading to infection.
Product
MONARCH Inflation Device, REF: IN2430/B, IN2530/B, IN2130/B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0106-2025·2024-10-23
Boston Scientific AVVIGO+ System Grid Overlay Display Software Error
Boston Scientific AVVIGO+ Multi-Modality Guidance System displays incorrect grid overlay when connected to OptiCross 18 catheters in Live or Record mode due to a software anomaly. The wrong overlay could affect reference depth settings used in vascular imaging procedures.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL EU + ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities whic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0113-2025·2024-10-23
Boston Scientific AVVIGO+ Guidance System Grid Mark Display Error
Boston Scientific is recalling the AVVIGO+ Guidance System due to a software bug displaying incorrect grid marks during live imaging. The device shows 9 grid marks instead of 15, which could affect accurate vessel measurement in cardiac interventions.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities whi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0111-2025·2024-10-23
Boston Scientific AVVIGO+ System Grid Overlay Display Software Error
Boston Scientific is recalling the AVVIGO+ Multi-Modality Guidance System due to a software error that displays an incorrect 9-grid overlay instead of the correct 15-grid overlay in Live or Record mode, affecting measurement accuracy with OptiCross 18 catheters.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0131-2025·2024-10-23
Rolling Walker Backrest May Disengage During Position Changes Creating Fall Risk
Nova Ortho-Med is recalling 1,585 MONARCH ROLLATOR RED units because the backrest may disengage from its holder when users adjust from a slouched to upright position, creating a fall hazard.
Product
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0125-2025·2024-10-23
Cortera spinal fixation system screws recalled due to manufacturing specification concerns
XTANT Medical is recalling 330 Cortera spinal fixation system screws marked 'DNI' because they may not have been manufactured to specification and could lack adequate strength if implanted.
Product
Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0060-2025·2024-10-23
Monarch Inflation Devices Recalled for Sterile Barrier Defects
Merit Medical Systems is recalling approximately 6,565 Monarch Inflation Devices due to manufacturing defects that compromise the sterile barrier, potentially allowing device contamination.
Product
Monarch Inflation Device 30 atm/bar MAP403 MBA Hemostasis Valve Metal Insertion Tool Torque Device REF IN2430 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0049-2025·2024-10-23
KINOVA Jaco assistive robot recalled for potential fire hazard
Kinova Inc is recalling 949 KINOVA Jaco assistive robots due to a potential fire hazard that may occur if a damaged robot arm interacts with a wheelchair exhibiting electrical leakage.
Product
KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco replaces the function of the upper limb on one side of the body.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0117-2025·2024-10-23
Graft Tube shaft may detach from funnel head during surgical use
Spineology is recalling 190 Graft Tubes because the shaft may detach from the funnel head when not used as instructed, potentially compromising spinal surgical procedures.
Product
The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced through the Access Portal. A Push Rod is then used to facilitate the manual deployment of the graft material out of the Graft Tube and adjacent to where the impl
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0130-2025·2024-10-23
Nova Ortho-Med Rollator Backrest May Disengage During Position Adjustment
Nova Ortho-Med is recalling the MONARCH ROLLATOR PURPLE due to a fall hazard: the backrest may disengage when users shift from a slouched to upright seated position.
Product
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE Model/Catalog Number: 4329PL Product Description: ROLLING WALKER MOBILITY AID
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0090-2025·2024-10-23
Leica Biosystems Cryostat Model CM3050 S lacks warning label for flammable sprays
Leica cryostat units lack a warning about flammable freezing sprays that can ignite in the chamber. The company discovered through post-market surveillance that users were applying these flammable sprays without being warned of the fire hazard.
Product
Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 14903050S03; for freezing and sectioning tissue samples
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0073-2025·2024-10-23
Merit Medical StabiliT TOUCH Syringe Sterile Barrier Defect Recall
Merit Medical Systems is recalling 202 StabiliT TOUCH Syringes with potential small holes in the sterile barrier. Affected devices may expose users to pathogens and pyrogens, which could cause infection.
Product
StabiliT TOUCH Syringe, REF: IN8VCF/B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0118-2025·2024-10-23
Beckman Coulter Recalls Immunochemistry IGM Reagent Lots for Sensitivity Failure
Beckman Coulter is recalling two lots of IGM reagent used in IMMAGE immunochemistry systems because they don't meet sensitivity specifications. The reagent measures immunoglobulin M levels in blood samples.
Product
IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-0097-2025·2024-10-23
AVVIGO+ Multi-Modality Guidance System software defect causes incorrect grid display
Boston Scientific recalled the AVVIGO+ Multi-Modality Guidance System because a software defect causes incorrect grid display in Live and Record modes, potentially affecting vessel imaging guidance for physicians using OptiCross 18 catheters.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities whi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0068-2025·2024-10-23
BlueFIRE Inflation Device Recalled for Sterile Barrier Defect Risk
BlueFIRE Inflation Devices may have a small hole in the sterile barrier, potentially exposing patients to pathogens that could cause infection. Contact your healthcare provider if you received this device.
Product
BlueFIRE Inflation Device, REF: IN10140
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0070-2025·2024-10-23
Custom Inflation Kits Recalled Due to Sterile Barrier Defect and Infection Risk
Merit Medical Systems is recalling Custom Inflation Kits due to a small hole in the sterile barrier that could expose users to pathogens and pyrogens, increasing infection risk.
Product
Custom Inflation Kit, REF: K05-00052M, K05-00053H, K05-00109G, K05-00137K, K05-00296L, K05-00399D, K05-00404C, K05-00410G, K05-00438G, K05-00502F, K05-00564L, K05-00587D, K05-00612Q, K05-00704F, K05-00724F, K05-00793B, K05-00798, K05-00890D, K05-00890D, K05-00944D, K05-00956D, K0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0101-2025·2024-10-23
AVVIGO+ Medical Imaging System Grid Overlay Display Software Error
Boston Scientific is recalling AVVIGO+ Multi-Modality Guidance Systems due to a software anomaly that displays a 9-grid overlay instead of the correct 15-grid overlay during Live and Record modes. This incorrect display could affect imaging measurements during procedures.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalitie
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0089-2025·2024-10-23
Cryostat Model CM1950 Lacks Warning on Flammable Spray Use
Leica Biosystems is recalling the Cryostat Model CM1950 due to missing warnings about using flammable freezing sprays in the device. Flammable sprays can ignite inside the chamber, potentially causing serious injuries.
Product
Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 1491950C3US; for freezing and sectioning tissue samples
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0061-2025·2024-10-23
Monarch Inflation Device Syringe Recalled for Sterile Barrier Defect
Merit Medical Systems is recalling 51,900 Monarch Inflation Device syringes due to manufacturing defects causing breaches in the sterile barrier. The devices are used in balloon angioplasty procedures. No injuries have been reported.
Product
Monarch Inflation Device 30 atm/bar MAP152 AssessPLUS Large Bore Hemostasis Valve Metal Insertion Tool Torque Device REF IN2530 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty cathete
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0104-2025·2024-10-23
Boston Scientific AVVIGO+ Guidance System Recalled for Grid Overlay Display Error
Boston Scientific is recalling AVVIGO+ systems due to a software anomaly that displays an incorrect grid overlay when connected to OptiCross 18 catheters, potentially leading to vessel imaging misinterpretation.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which inc
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0071-2025·2024-10-23
Merit Medical basixSKY Inflation Device Recalled for Sterile Barrier Defect
Merit Medical is recalling the basixSKY Inflation Device because a sterile barrier defect could expose users to harmful pathogens and bacteria, risking infection.
Product
basixSKY Inflation Device, REF: SKY1802
Category
Medical Device
Distribution
Distributed nationwide

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4751–4775 of 13449