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

5651–5675 of 39968

HighFDA (Devices)·Z-0086-2025·2024-10-23
Leica Biosystems Cryostat lacks warning for flammable freezing spray use
Leica Biosystems Cryostat Model CM1510 S is recalled due to missing warning labels about flammable freezing sprays, which can ignite and cause serious injury. The device labeling lacked fire hazard warnings prior to 2019.
Product
Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples
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-0062-2025·2024-10-23
Monarch Balloon Angioplasty Syringes Recalled Due to Sterile Barrier Defects
Merit Medical Systems is recalling 432 Monarch 30 ATM syringes used in balloon angioplasty procedures due to manufacturing defects creating holes in the sterile Tyvek barrier.
Product
Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0057-2025·2024-10-23
Monarch Inflation Device Recalled Due to Sterile Barrier Manufacturing Defect
Merit Medical Systems recalls 110,650 Monarch Inflation Devices due to manufacturing defects that create holes in the sterile barrier. The devices are used in cardiovascular procedures and may pose contamination risk.
Product
Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is al
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0105-2025·2024-10-23
Boston Scientific AVVIGO+ Multi-Modality Guidance System Grid Display Software Defect
Boston Scientific is recalling the AVVIGO+ Guidance System for a software defect that displays incorrect grid overlays when connected to OptiCross 18 catheters. The error affects Live and Record modes only; no injuries have been reported.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - 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 modalitie
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-0095-2025·2024-10-23
Boston Scientific AVVIGO+ Imaging System Grid Overlay Display Error
A software anomaly in the Boston Scientific AVVIGO+ Multi-Modality Guidance System causes an incorrect grid overlay display when used with certain catheters. The wrong overlay may lead to incorrect measurement references during imaging procedures.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which
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-0126-2025·2024-10-23
Change Healthcare Cardiology Hemodynamic Software Calculation Error Recall
Change Healthcare Cardiology Hemo software versions 14.1.1–15.1 may produce inaccurate hemodynamic calculations due to unit-of-measurement configuration errors, potentially leading to misdiagnosis and inappropriate patient treatment.
Product
Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0085-2025·2024-10-23
Leica Cryostat Model CM1100 Recalled for Fire Risk from Flammable Freezing Sprays
Leica Biosystems recalls its Cryostat Model CM1100 due to inadequate warnings about using flammable freezing sprays, which can ignite and cause serious injuries. The device labeling lacked required safety warnings prior to 2019.
Product
Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples
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-0100-2025·2024-10-23
Boston Scientific AVVIGO+ Multi-Modality Imaging System Grid Overlay Display Error
Boston Scientific is recalling AVVIGO+ Multi-Modality Guidance Systems due to a software error that displays incorrect 9-grid marks instead of 15-grid marks in Live and Record modes. This display error could affect physicians' ability to set proper reference depths during intravascular imaging procedures.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includes
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-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-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-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
ModerateFDA (Devices)·Z-0124-2025·2024-10-23
Medline Open Heart Kits Recalled Due to Incorrect Cannula Labeling
Medline Industries is recalling 22 Open Heart NIMC Kits because they contain Medtronic DLP Vessel Cannulae that were incorrectly labeled during manufacturing.
Product
MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0112-2025·2024-10-23
Medical imaging system software defect causes incorrect grid overlay display
Boston Scientific recalled the AVVIGO+ imaging guidance system due to a software defect that displays a 9-grid overlay instead of the correct 15-grid overlay when connected to OptiCross 18 catheters in Live or Record mode.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; 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
ModerateFDA (Devices)·Z-0120-2025·2024-10-23
Medline Heart Overhead Table Pack recalled for incorrect model labeling
Medline Industries recalls Heart Overhead Table Packs due to incorrect labeling. Some kits were marked as model 30000 when they should be model 30001.
Product
MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0115-2025·2024-10-23
Boston Scientific Recalls AVVIGO+ Guidance System Due to Software Anomaly
Boston Scientific is recalling 4 units of the AVVIGO+ Multi-Modality Guidance System because a software error displays the wrong grid overlay during Live or Record mode.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE JAPAN; 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
ModerateFDA (Devices)·Z-0098-2025·2024-10-23
Boston Scientific Recalls AVVIGO+ Guidance System Due to Software Anomaly
Boston Scientific is recalling 15 units of the AVVIGO+ Multi-Modality Guidance System because a software anomaly causes an incorrect grid overlay to display during Live or Record mode.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT 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
ModerateFDA (Devices)·Z-0103-2025·2024-10-23
Boston Scientific Recalls AVVIGO+ Guidance System Due to Software Anomaly
Boston Scientific is recalling 14 units of the AVVIGO+ Multi-Modality Guidance System due to a software anomaly that displays an incorrect grid overlay during Live or Record mode.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB 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
ModerateFDA (Devices)·Z-0116-2025·2024-10-23
Boston Scientific Recalls AVVIGO+ Guidance Systems Due to Software Display Error
Boston Scientific is recalling 40 AVVIGO+ Multi-Modality Guidance Systems because a software anomaly causes an incorrect grid overlay to display during Live or Record mode when used with specific catheters.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB 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
ModerateFDA (Devices)·Z-0123-2025·2024-10-23
Medical Device Kit Incorrectly Labeled With Wrong Model Number
Medline Industries recalls MEDLINE KIT CV I II vessel cannulae kits because product for model 30001 was incorrectly labeled as model 30000 during manufacturing.
Product
MEDLINE KIT CV I II, REF DYNJ906071B
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0107-2025·2024-10-23
Boston Scientific AVVIGO+ Guidance System Grid Mark Overlay Defect
Boston Scientific is recalling the AVVIGO+ Multi-Modality Guidance System due to a software defect that displays an incorrect 9-grid mark overlay instead of the correct 15-grid mark overlay when used with OptiCross 18 Peripheral Imaging Catheters in Live or Record mode.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which incl
Category
Medical Device
Distribution
Distributed nationwide

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5651–5675 of 39968