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.

5026–5050 of 52956

HighFDA (Devices)·Z-1327-2025·2025-03-19
Blood Pump Recalled for Potential Fluid Leakage During Clinical Use
Spectrum Medical is recalling Quantum Perfusion blood pumps due to potential fluid leakage during priming or clinical use. The issue affects approximately 1,487 units distributed nationwide.
Product
Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Model/Catalog Number: CP22V-VT Software Version: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1315-2025·2025-03-19
Cartilage Transplant System Disposable Kits Recalled for Missing Component
DePuy Mitek is recalling COR Disposable Kit cartilage transplant systems because some units lack the pin in the graft loader component. The manufacturing defect may prevent proper device function during surgical use.
Product
COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1307-2025·2025-03-19
CardiFocus Heartlight X3 Cardiac Catheter Sterile Barrier Damage Recall
CardioFocus is recalling 833 units of CardiFocus Heartlight X3 cardiac catheters due to potential damage to the sterile barrier pouch that could compromise product sterility. Affected units were distributed worldwide.
Product
CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial fibrillation. It is introduced percutaneously in the setting of an Electrophysiology or Catheterization Laboratory Model: 18-5000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1302-2025·2025-03-19
GE Revolution CT Systems Potential Coolant Leak Slip-and-Fall Risk
GE Healthcare Revolution CT systems may leak glycol coolant near the gantry base. While the non-toxic fluid poses no chemical hazard, it creates a slip-and-fall risk if not noticed and cleaned.
Product
GE Healthcare Revolution CT, System, X-ray, Tomography, Computed
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0615-2025·2025-03-19
Trader Joe's Canned Albacore Tuna Recalled for Potential Botulism Contamination
Trader Joe's Solid White Albacore Tuna is being recalled because the easy-pull lid may not be properly secured, risking contamination with botulism bacteria.
Product
Trader Joe's branded Solid White Albacore Tuna in olive oil; NET WT. 5 OZ (142g) DR WT. 4 OZ (113g); Dist & Sold Exclusively By: Trader Joe's, Monrovia, CA 91816; UPC# 99287
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0635-2025·2025-03-19
Ulker Dankek Roll Cake Banana recalled for undeclared wheat allergen
ZB Importing LLC is recalling Ulker Dankek Roll Cake Banana due to wheat allergen not being listed in the product label. Consumers with wheat allergies or celiac disease should not consume this product.
Product
Ulker Dankek Roll Cake Banana, item 9620, 8.3oz foil pack, 8 per case, UPC 8690504067986
Category
Food
Distribution
36 states
HighFDA (Devices)·Z-1324-2025·2025-03-19
Philips Spectral CT on Rails software recall due to scanning and movement issues
Philips is recalling one unit of Spectral CT on Rails software version 5.1.0 due to multiple software problems causing scanning issues, image errors, and unintended device movement.
Product
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Category
Medical Device
Distribution
1 state
HighFDA (Food)·F-0626-2025·2025-03-19
Danone Hazelnut Delight Coffee Creamer Recalled for Spoilage and Illness
Danone is recalling Hazelnut International Delight Coffee Creamer due to reported spoilage and illness complaints. The product was distributed to 30 states.
Product
HAZELNUT INTERNATIONAL delight COFFEE CREAMER 32 FL OZ (1 QT) 32 FL OZ (1 QT) 946 mL UPC 0 41271 02565 2 Distributed by: Danone US, LLC
Category
Food
Distribution
31 states
HighFDA (Food)·F-0614-2025·2025-03-19
Trader Joe's Canned Yellowfin Tuna Recalled for Improperly Sealed Lids
Trader Joe's Solid Light Yellowfin Tuna is being recalled because the easy-pull lid may not be properly secured, potentially allowing botulism contamination. Approximately 14,147 cases nationwide are affected.
Product
Trader Joe's branded Solid Light Yellowfin Tuna in olive oil, Pole & Line Caught; NET WT. 5 OZ (142g) DR WT. 4 OZ (113g); Dist & Sold Exclusively By: Trader Joe's, Monrovia, CA 91816; UPC# 51403
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1320-2025·2025-03-19
ZOLL Powerheart G5 AED may fail self-test in extreme temperatures or humidity
ZOLL is recalling 73 Powerheart G5 AED units that may fail their internal self-test when exposed to extreme temperatures or humidity. Affected devices could be unreliable in emergencies.
Product
Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat i
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0613-2025·2025-03-19
Trader Joe's Tuna Recall Due to Unsealed Lids, Botulism Risk
Trader Joe's Solid White Albacore Tuna in Water is being recalled because improperly secured easy-pull lids may allow contamination with Clostridium botulinum.
Product
Trader Joe's branded Solid White Albacore Tuna in Water, salt added; NET WT. 5 OZ (142g) DR WT. 4 OZ (113g); Dist & Sold Exclusively By: Trader Joe's, Monrovia, CA 91816; UPC# 0099285
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1325-2025·2025-03-19
Da Vinci 5 surgical console foot pedals recalled for spring failure
Intuitive Surgical has recalled 439 Da Vinci 5 surgical console foot tray pedals due to spring failures that can cause pedals to remain pressed and interfere with normal surgical robot operation.
Product
Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Version: N/A . Refer to HHE for additional details. Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1299-2025·2025-03-19
GE Healthcare CT Systems May Leak Coolant Fluid on Floor
GE Healthcare Revolution CT and Apex series systems can leak coolant fluid onto the floor near the gantry, creating a slip and fall hazard. The blue-colored fluid is non-corrosive and not hot, but poses injury risk if not noticed.
Product
GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed
Category
Medical Device
Distribution
0 states
HighFDA (Food)·F-0634-2025·2025-03-19
Ulker Dankek Roll Cake Chocolate recalled due to undeclared egg allergen
Ulker Dankek Roll Cake Chocolate is being recalled because egg is not listed in the Contains statement on the product label. Consumers with egg allergies may be at risk.
Product
Ulker Dankek Roll Cake Chocolate, item 9584, 3oz foil pack, 8 per case, UPC 8690504067979
Category
Food
Distribution
36 states
HighFDA (Drugs)·D-0270-2025·2025-03-19
Duloxetine 30mg Delayed-Release Capsules Recalled for N-Nitroso Impurity
Breckenridge Pharmaceutical recalls 14,749 bottles of duloxetine 30mg delayed-release capsules due to N-nitroso impurity above FDA safety limits. Patients taking this medication should contact their healthcare provider to verify if their prescription is affected.
Product
DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0611-2025·2025-03-19
Genova Yellowfin Tuna Cans Recalled for Botulism Risk
Genova branded Yellowfin Tuna cans are being recalled because the easy-pull lid was not properly secured, which may cause Clostridium botulinum contamination. The recall affects 14,147 cases distributed nationwide with best-by dates from December 2027 through January 2028.
Product
Genova branded Yellowfin Tuna; Genova; In Olive Oil; Wild Caught; NET WT. 5 OZ (142g) RD WT. 4 OZ (113g); Distributed by Tri-Union Seafoods, LLC.; El Sugundo, CA 90245 U.S.A. UPC# 48000 73265 UPC# 48000 13265 UPC# 48000 63267 Product is packaged in several different configurat
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0630-2025·2025-03-19
Ulker Kekstra strawberry cookies recalled for undeclared milk allergen
Ulker Kekstra Mini strawberry cookies are recalled for undeclared milk allergen. Consumers with milk allergies should not consume this product.
Product
Ulker Kekstra Mini strawberry, item 3792, 5.3oz foil pack, 10 per case, UPC 8690766082307
Category
Food
Distribution
36 states
HighFDA (Drugs)·D-0276-2025·2025-03-19
Kids by babyganics mineral sunscreen recalled for chemical contamination
Kids by babyganics SPF 50 mineral sunscreen spray is being recalled due to chemical contamination. Consumers using affected batches should stop use immediately.
Product
Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ spray bottles, Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403, UPC 813277019923 and UPC 813277019916
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1303-2025·2025-03-19
GE Healthcare CT Scanner Systems Recalled Due to Coolant Leak Risk
GE Healthcare is recalling 21 Revolution CT and Revolution Apex series CT systems due to potential coolant fluid leaks near the gantry base. The leaking fluid poses a slip-and-fall hazard if not cleaned up promptly.
Product
GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1298-2025·2025-03-19
GE Revolution CT and Apex systems coolant fluid leak hazard
GE Healthcare Revolution CT and Apex series imaging systems may leak blue coolant fluid near the gantry base, creating a potential slip and fall hazard. Approximately 250 units have been distributed worldwide.
Product
GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed
Category
Medical Device
Distribution
0 states
HighNHTSA·25V172000·2025-03-19
Tesla Model S and X may have an inoperative horn
Tesla is recalling certain 2021-2024 Model S and 2021-2025 Model X vehicles because an airbag with the incorrect horn pad may have been installed, preventing the horn from sounding.
Product
TESLA — TESLA MODEL S, MODEL X
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-0617-2025·2025-03-19
Genova Yellowfin Tuna Recall: Unsecured Lid May Allow Botulinum Contamination
Genova branded Yellowfin Tuna in Extra Virgin Olive Oil is being recalled because its easy-pull lid may not be properly secured, potentially allowing clostridium botulinum contamination.
Product
Genova branded Yellowfin Tuna in Extra Virgin Olive Oil and Sea Salt; NET WT. 5 OZ (142g) RD WT. 4 OZ (113g); Distributed by Tri-Union Seafoods, LLC.; El Sugundo, CA 90245 U.S.A. UPC# 48000 13275
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·F-0625-2025·2025-03-19
Cinnabon Coffee Creamer Recalled for Spoilage and Illness Reports
Danone US is recalling Cinnabon Classic Cinnamon Roll International delight Coffee Creamer due to complaints of spoilage and illness. The product was distributed to 30 states.
Product
CINNABON CLASSIC CINNAMON ROLL INTERNATIONAL delight COFFEE CREAMER 32 FL OZ (1 QT) 946 mL UPC 0 41271 01993 3 Distributed by: Danone US, LLC
Category
Food
Distribution
31 states
HighFDA (Food)·F-0622-2025·2025-03-19
Soup and oyster crackers recalled for potential stainless steel wire
Multiple brands of soup and oyster crackers are being recalled due to potential stainless steel wire. The affected products were distributed across 24 states.
Product
1.) Market Pantry Soup & Oyster Crackers, NET WT 9 OZ (255g), packaged in flexible plastic bags, 12 count per case, Distributed By: Target Corporation, Minneapolis, MN 55403 2.) Great Value Soup & Oyster Crackers, NET WT 9 OZ (255g), packaged in flexible plastic bags, 12 count
Category
Food
Distribution
24 states
HighFDA (Devices)·Z-1329-2025·2025-03-19
Z1 Femoral Hip System Recalled Over Stem Inserter Design Issue
Zimmer, Inc. is recalling 35 units of the Z1 Femoral Hip System due to a potential design issue with the Z1 Offset Stem Inserter that could cause fracturing of the distal tip.
Product
Z1 Femoral Hip System, Product Number 611777612
Category
Medical Device
Distribution
Distributed nationwide