Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

6851–6875 of 52962

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-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 (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-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-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-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-0059-2025·2024-10-23
Monarch Inflation Device Recalled Due to Sterile Barrier Breaches
Merit Medical Systems is recalling 1,120 Monarch Inflation Devices due to manufacturing defects causing holes and breaches in the sterile Tyvek barrier. Affected devices distributed worldwide may pose contamination risk during cardiac interventions.
Product
Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measur
Category
Medical Device
Distribution
Distributed nationwide
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-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-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 (Food)·F-0031-2025·2024-10-23
King Harvest Spinach Hummus Recalled for Potential Plastic Fragments
Pacific Coast Fresh CO is recalling 994 tubs of King Harvest Spinach Hummus due to potential plastic fragments. The hummus was distributed in Oregon and Washington with a use-by date of 10/08/24.
Product
King Harvest Spinach Hummus, perishable and refrigerated, packed in plastic tubs with tamper evident lids. Net wt. 10oz. Dist. Exclusively by Pacific Coast Fresh Co Portland, Oregon. UPC 0 25726 31108 7.
Category
Food
Distribution
2 states
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-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 (Food)·F-0047-2025·2024-10-23
Seasoned Peanut Recalled Due to Undeclared Wheat Allergen
Lemonland Food Corp recalls Item FLD1010A Seasoned Peanut due to undeclared wheat on the label. Wheat is a major allergen; affected consumers should not consume the product.
Product
Item FLD1010A, Seasoned Peanut, distributed in plastic clamshell containers, net wt. 0.365lb. The H-Mart label declares: Peanut, Soy Sauce, Starch, Syrup, Cooking Oil
Category
Food
Distribution
1 state
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-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 (Food)·F-0034-2025·2024-10-23
Bevi Flavor#115 Electrolytes Recalled: Mislabeled, Contains Caffeine
Hydration Labs Inc. is recalling Flavor#115 Electrolytes (3.78L BIB units) distributed nationwide and in Canada because the product is labeled as electrolytes but actually contains caffeine.
Product
Flavor#115 Electrolytes, Net Contents 3.78L, #740-0115, GTIN barcode 00850010449043. Product is packaged as a Bag In Box (BIB) single unit for use in Bevi Smart Water Cooler machines dispensing flavored waters.
Category
Food
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-0091-2025·2024-10-23
Cue Health COVID-19 Test Cartridge Recalled for Unapproved Distribution
Cue Health Inc. is recalling 248,109 COVID-19 test kits (56 lots) that were modified and distributed without FDA approval or authorization. Users should discontinue use and contact the manufacturer.
Product
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0056-2025·2024-10-23
Olympus EVIS EXERA III Video System Recalled for Startup Failure
Olympus is recalling 45 units of the EVIS EXERA III Video System Center (Model CV-190) that fail to start due to power supply defects. The endoscopy device was distributed nationwide.
Product
EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0050-2025·2024-10-23
Stir Fried Dried Shrimp Recalled for Undeclared Wheat Allergen
Lemonland Food Corp recalled stir-fried dried shrimp (Item FLD1971) distributed in Washington because wheat is not declared on the label, despite being present in the product.
Product
Item FLD1971, Stir Fried Dried Shrimp, distributed in plastic clamshell containers. Net wt. 0.165lb. The H-Mart label declares: Shrimp, Sesame Oil, Soy Sauce, Corn Syrup, Salt
Category
Food
Distribution
1 state
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 (Food)·F-0052-2025·2024-10-23
Lunds & Byerlys Lone Star Dip Recalled for Potential Mold Contamination
Lund Food Holdings Inc is recalling Lunds & Byerlys Lone Star Dip (12 oz) due to potential mold contamination. The affected product was distributed in Minnesota.
Product
Lunds & Byerlys lone star dip. Net Wt 12 oz. (340.5g) UPC 0 18169-74197 9. Produced by Lunds & Byerlys, Edina, MN 55424.
Category
Food
Distribution
1 state
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-0096-2025·2024-10-23
Boston Scientific Medical Device Software Error Affects Vessel Imaging Display
The Boston Scientific AVVIGO+ Guidance System displays an incorrect grid overlay when used with the OptiCross 18 catheter in Live or Record mode, potentially affecting depth reference settings. No injuries have been reported.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST 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