State

Delaware product recalls

73,092 recalls have nationwide distribution and so reach Delaware. 3,438 additional recalls listed Delaware specifically in their distribution scope.

What the numbers show

Total: 3,438
Critical: 477
Severe: 939
Most recent: 2026-09-23

Of the 3,438 recalls naming Delaware we have scored against our rubric, 477 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 939 (27%) are Severe.

Which agencies issued them

These figures cover only the 3,438 recalls whose distribution notice names Delaware specifically. The 73,092 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

9526–9550 of 76530

HighFDA (Devices)·Z-0036-2025·2024-10-23
Wilson-Cook Medical Recalls Hemo-7 and Hemo-10 Hemospray Endoscopic Hemostats
Wilson-Cook Medical is recalling specific lots of Hemo-7 and Hemo-10 Hemospray Endoscopic Hemostats because they were manufactured with nonconforming raw materials.
Product
Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.
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-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-0058-2025·2024-10-23
Merit Medical Recalls Monarch Inflation Devices Due to Sterile Barrier Breaches
Merit Medical Systems is recalling 41,411 Monarch Inflation Devices because manufacturing defects caused holes in the sterile barrier.
Product
Monarch Inflation Device MAP 112 Access-9 Large Bore Hemostasis Value Metal Insertion Tool Torque DeviceREF IN2230 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to mea
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 (Food)·F-0053-2025·2024-10-23
Dietary supplement with Rauwolscine recalled for potential Salmonella contamination
Gorilla Mind Rauwolscine dietary supplement is recalled nationwide due to potential Salmonella contamination. Consumers should not use the product and contact the manufacturer.
Product
Gorilla Mind Rauwolscine Dietary Supplement, Suppress Appetite, Increased Fat Loss, Increased Energy, dosage 3mg, 90 capsules per bottle, UPC 8 50017 02016 0. Product is manufactured for Gorilla Mind LLC 7154 W. State Street, STE 138, Boise, ID. Product label declares "***Suppl
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0128-2025·2024-10-23
Change Healthcare Cardiology Hemo Software Recalled for Calculation Errors
Change Healthcare is recalling Cardiology Hemo software versions 13.0 through 14.0 because incorrect unit configurations can lead to inaccurate hemodynamic calculations and potential misdiagnosis.
Product
McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0127-2025·2024-10-23
Horizon Cardiology Hemodynamic System Recalled for Configuration Error
Horizon Cardiology Hemo Version 12.2 is recalled for a unit-of-measurement configuration issue that can produce incorrect hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. The recall affects 3 worldwide systems.
Product
Horizon Cardiology Hemo. Version 12.2.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0121-2025·2024-10-23
Open Heart Surgical Kit Recalled for Incorrect Vessel Cannulae Model Labeling
Medline Industries is recalling 123 kits of its Open Heart Pack after discovering that model 30001 vessel cannulae were incorrectly labeled as model 30000. This labeling error could lead to use of the wrong surgical instrument during open heart procedures.
Product
MEDLINE OPEN HEART PACK, REF DYNJ66216C
Category
Medical Device
Distribution
Distributed nationwide
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-0129-2025·2024-10-23
Rolling Walker Backrest May Disengage During Position Adjustment
Nova Ortho-Med is recalling 1,886 MONARCH ROLLATOR BLUE rolling walkers due to a potential 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 BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID
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-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-0087-2025·2024-10-23
Leica Cryostat Model CM1850 Lacks Fire-Risk Warning for Flammable Sprays
Leica Biosystems is recalling Cryostat Model CM1850 (322 units, US nationwide) due to missing warnings about fire hazard from flammable freezing sprays. The device's labeling prior to 2019 did not warn users that flammable sprays used in the chamber can ignite and cause serious injuries.
Product
Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501, d) 1491850UVUL; for freezing and sectioning tissue samples
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0114-2025·2024-10-23
Boston Scientific AVVIGO+ Cardiac Imaging System Grid Display Error
A software anomaly in Boston Scientific's AVVIGO+ system causes an incorrect 9-grid overlay to display instead of the correct 15-grid overlay when connected to OptiCross 18 catheters, potentially affecting clinical interpretation of vascular imaging.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE 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
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-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-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-0108-2025·2024-10-23
Boston Scientific AVVIGO+ Imaging System Grid Display Error
Boston Scientific is recalling AVVIGO+ Multi-Modality Guidance Systems due to a software error causing incorrect grid overlay display when used with OptiCross 18 catheters, which could affect measurement accuracy.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includ
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0099-2025·2024-10-23
Boston Scientific imaging system software error in grid overlay display
Boston Scientific AVVIGO+ imaging system has a software error causing incorrect grid overlay display in Live and Record modes, potentially affecting depth reference during vascular procedures. 2 units are recalled.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includ
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-0119-2025·2024-10-23
Medline Heart CABG Cannulae Recalled Due to Incorrect Model Labeling
Medline Industries is recalling 15 kits of MEDLINE HEART CABG DLP Vessel Cannulae due to incorrect model labeling discovered during manufacturing.
Product
MEDLINE HEART CABG CDS, REF CDS983376R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0066-2025·2024-10-23
DiamondTOUCH Digital Inflation Device Sterile Barrier Defect Recall
Merit Medical Systems is recalling the DiamondTOUCH Digital Inflation Device due to a small hole in the sterile barrier. The defect may expose patients to pathogens or pyrogens, potentially causing infection.
Product
DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
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