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.

19826–19850 of 50413

HighFDA (Devices)·Z-2068-2021·2021-07-21
Arrow Pacing Catheter Kit Recalled for Missing FDA Premarket Clearance
Arrow International is recalling the Pacing Catheter Kit-Bipolar Electrode Catheter (48 units) due to marketing without required FDA premarket clearance (510K). Units were distributed nationwide in FL, ID, IL, NY, OH, and TX.
Product
Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V554000·2021-07-21
2021 BMW X2 Seat Belt Retractor Defect Increases Injury Risk
BMW is recalling certain 2021 X2 vehicles because the passenger seat belt retractor may deactivate early, failing to comply with federal safety standards. The defective retractor could increase injury risk in a crash.
Product
MINI — MINI, BMW, TOYOTA COOPER SE, X1, 530I, 228I
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2055-2021·2021-07-21
MRI Scanner Patient Orientation Button Confusion Affects Images
GE Healthcare's MRI scanners may have a button confusion issue where the Patient Orientation button is accidentally clicked instead of Save RX, potentially causing misoriented or incorrectly annotated images. 585 devices affected worldwide.
Product
Discovery MR750w 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0780-2021·2021-07-21
Living Free Nerve & Muscle Herbal Dietary Supplement Soy Allergen Undeclared
Bea Lydeckers Naturals Inc is recalling Living Free Nerve & Muscle Herbal Dietary Supplement because the label declares lecithin but does not specify that it contains soy lecithin, potentially endangering consumers with soy allergies.
Product
Living Free Nerve & Muscle Herbal Dietary Supplement, 100 and 500 capsules per bottles. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "***Living Free Nerve & Muscle Herbal Dietary Supplement***Herbal and Glandular…
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2076-2021·2021-07-21
Medtronic LINQ II Insertable Cardiac Monitor Detection Failure Recall
Medtronic is recalling the LINQ II Model LNQ22 Insertable Cardiac Monitor because it may fail to detect dangerous heart rhythms after a restart. The device was distributed worldwide.
Product
Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2056-2021·2021-07-21
GE Discovery MR750 MRI Scanner Button Error May Produce Flipped Images
GE Healthcare recalled 248 units of the Discovery MR750 3.0T scanner due to a button-confusion error where the Patient Orientation button may be clicked instead of Save RX, potentially resulting in incorrectly oriented or flipped images. No injuries reported.
Product
Discovery MR750 3.0T - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Category
Medical Device
Distribution
0 states
HighCPSC·21167·2021-07-21
Caldwell E-Max Pro BT Earmuffs Recalled for Fire and Burn Hazards
American Outdoor Brands is recalling Caldwell E-Max Pro BT Earmuffs with rechargeable lithium battery packs due to a soldering defect that can cause the unit to overheat, posing fire and burn hazards. No injuries have been reported.
Product
Caldwell E-Max® Pro BT Earmuffs with rechargeable lithium battery packs
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2075-2021·2021-07-21
Medical device software c4D fails to change site upon synchronization
C-RAD POSITIONING AB is recalling Catalyst positioning software c4D because it fails to properly update the Site field during synchronization in the setup workflow. This software defect may prevent correct system configuration.
Product
PC Application Software c4D as part of the device Catalyst: SP-002 Software PA-003 version 6.1.1 and 6.1.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2045-2021·2021-07-21
Canon 1.5T MRI System Recalled for Flame Retardancy Component Failure
Canon Vantage Tiitan 1.5T MRI Systems with certain serial numbers are recalled due to a component lacking proper flame retardancy, which could result in smoke or fire.
Product
Canon Vantage Tiitan 1.5T, Premium Open-Bore MRI System, REF: MRT-1510 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this…
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V555000·2021-07-21
2021 Nissan Rogue Sport Seat Belt Retractor Safety Defect Recall
Nissan is recalling 2021 Rogue Sport vehicles because seat belt automatic locking retractors may deactivate prematurely, reducing protection for child safety seats and violating federal crash protection standards.
Product
NISSAN — NISSAN redundant ROGUE SPORT
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2079-2021·2021-07-21
Catheter Sheath Introducer Recalled for Size Labeling Discrepancy
Cordis Corporation is recalling 680 Avanti® Catheter Sheath Introducer units because the actual product dimensions are larger than the labeling indicates.
Product
Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0776-2021·2021-07-21
Living Free Adult Extra Multi-Vitamin Recall for Undeclared Soy
Bea Lydeckers Naturals Inc is recalling Living Free "Adult Extra" multi-vitamin capsules because the label declares lecithin but does not declare that it is soy lecithin, posing a risk to consumers with soy allergies.
Product
Living Free "Adult Extra" multi-vitamin, 100 or 500 capsules per bottle. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "**Living Free Adult Extra***Natural Vitamin Mineral Herbal Glandular Supplements***Formulated and…
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0777-2021·2021-07-21
Living Free Heart/Blood Vessel Dietary Supplement Recalls for Undeclared Soy
Bea Lydeckers Naturals Inc is recalling Living Free Heart/Blood Vessel Dietary Supplement because the label declares lecithin but does not declare that it is soy lecithin, posing a risk to consumers with soy allergies.
Product
Living Free Heart/Blood Vessel Dietary Supplement, 100 or 500 capsules per bottle. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "***Living Free Heart/Blood Vessel Dietary Supplement***Glandular Herbal & Vitamin…
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2058-2021·2021-07-21
MRI Imaging System UI Defect May Cause Incorrect Image Orientation
GE Healthcare recalled 1,737 SIGNA Creator and SIGNA Explorer MRI systems due to a software bug where the 'Patient Orientation' button can be accidentally clicked instead of 'Save RX,' potentially causing incorrectly oriented diagnostic images.
Product
SIGNA Creator, SIGNA Explorer, Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2063-2021·2021-07-21
MRI System Patient Orientation Button Click Error May Flip Images
GE Healthcare is recalling 1,519 Optima MR450w MRI systems worldwide due to a button interface error. The 'Patient Orientation' button may be unintentionally clicked instead of 'Save RX,' causing incorrectly oriented or flipped diagnostic images.
Product
Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2061-2021·2021-07-21
SIGNA Artist MRI System Patient Orientation Button May Cause Flipped Images
GE Healthcare is recalling 562 SIGNA Artist MRI systems due to a user interface defect where the Patient Orientation button may be inadvertently clicked instead of the Save RX button, potentially causing images to be incorrectly annotated or flipped.
Product
SIGNA Artist, Nuclear Magnetic Resonance Imaging System
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0778-2021·2021-07-21
Living Free Immune Dietary Supplement Soy Allergen Mislabeling Recall
Bea Lydeckers Naturals Inc is recalling Living Free Immune Dietary Supplement because the label declares lecithin but does not declare that it contains soy lecithin, posing a risk to consumers with soy allergies.
Product
Living Free Immune Dietary Supplement, 100 and 500 capsules per bottles. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "***Living Free Immune Dietary Supplement***Glandular and Herbal Supplement***Formulated by Beatrice…
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0773-2021·2021-07-21
Watson Pickled Garlic Ail Marine Recalled for High Lead Levels
Watson Pickled Garlic Ail Marine (500g pouches) is being recalled because 40 cases containing high lead levels were distributed despite FDA detention.
Product
Watson Pickled Garlic Ail Marine; 500g (18 oz. plastic pouch. Refrigerate after opening. UPC 8 00794 00303 0
Category
Food
Distribution
2 states
HighFDA (Food)·F-0775-2021·2021-07-21
Caribbean Belize Spices Caribbean Rub Recalled for Undeclared Wheat
Caribbean Belize LLC is recalling Caribbean Rub spice bottles because they contain undeclared wheat, which poses a risk to consumers with wheat allergies or celiac disease.
Product
Caribbean Belize Spices Caribbean Rub, Net Wt. 3.5oz (99g) Plastic bottle with black cap Sold as single bottles
Category
Food
Distribution
6 states
HighFDA (Devices)·Z-2049-2021·2021-07-21
Silicone thoracic/abdominal catheter recall due to potential sterilization defect
RanD S.r.l. is recalling Ch24 round silicone catheters used in thoracic and abdominal cavity drainage due to a sterilization process quality issue. Some units in affected lots may not be sterile.
Product
Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-2070-2021·2021-07-21
Arrow Bipolar Balloon Electrode Catheter Recalled for Marketing Without FDA 510K Clearance
Arrow International is recalling 4 units of an electrode catheter marketed without FDA 510(k) clearance. The device was intended for electrophysiology studies.
Product
Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2046-2021·2021-07-21
Canon MRI System Recalled for Flame-Retardancy Component Defect
Canon Medical System recalled its Vantage Titan 3T MRI systems due to a component lacking proper flame-retardancy standards. The defect could produce smoke or fire during use.
Product
Canon Vantage Titan 3T, Premium Open-Bore MRI System, REF: MRT-3010 - Product Usage: use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. Additionally, this…
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·21V552000·2021-07-21
Kalmar Recalls 2021 Ottawa T2 Vehicles Due to Stability Control Defect
Kalmar is recalling 2021 Ottawa T2 vehicles because an incorrectly installed rear stability control harness may cause the system to be inactive, increasing crash risk.
Product
KALMAR — KALMAR OTTAWA T2
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-0779-2021·2021-07-21
Living Free Lung & Joint Congestion Herbal Dietary Supplement Soy Allergen
Bea Lydeckers Naturals Inc is recalling Living Free Lung & Joint Congestion Herbal Dietary Supplement because the label declares lecithin but does not identify it as soy lecithin, creating an undeclared soy allergen hazard.
Product
Living Free Lung & Joint Congestion Herbal Dietary Supplement, 100 and 500 capsules per bottles. Product is packed in white, HDPE plastic bottles with threaded HDPE lids. Label is read in parts: "***Living Free Lung & Joint Congestion Herbal Dietary Supplement***Glandular…
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2053-2021·2021-07-21
MRI Scanner Patient Orientation Button Confusion May Flip Diagnostic Images
GE Healthcare recalls 311 SIGNA Architect MRI scanners due to button confusion that may result in flipped diagnostic images. The 'Patient Orientation' button may be accidentally clicked instead of 'Save RX', causing incorrect image orientation.
Product
SIGNA Architect - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Category
Medical Device
Distribution
0 states