Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

551–575 of 4878

SevereFDA (Food)·F-0054-2025·2024-10-30
Lactaid Lactose Reduced Milk Recalled for Undeclared Almond Allergen
HP Hood LLC is recalling Lactaid Lactose Reduced milk products because they may contain undeclared almond from almond milk. People with almond allergies face serious health risks.
Product
Lactaid Lactose Reduced milk 1. 96 oz Lactaid Whole Milk 2. 96 oz Lactaid 2% Milk 3. 96oz Lactaid 1% Milk 4. 96oz Lactaid Fat Free Milk (1607) 5. 96oz Lactaid 2% Calcium Enriched Milk (15567)
Category
Food
Distribution
27 states
SevereFDA (Devices)·Z-0076-2025·2024-10-30
Aespire 7900 Anesthesia Gas Machine Recalled Over Breathing Circuit Misconnection Risk
Datex-Ohmeda has recalled 12,036 Aespire 7900 anesthesia gas machines worldwide due to potential risk of patient breathing circuit being mistakenly connected to the Auxiliary Common Gas Outlet port.
Product
Aespire 7900. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0082-2025·2024-10-30
Aisys CS2 Anesthesia Machine Recall: Breathing Circuit Misconnection Risk
Datex-Ohmeda is recalling approximately 15,739 Aisys CS2 anesthesia machines worldwide. A breathing circuit limb may be mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port instead of the intended connection point.
Product
Aisys CS2. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0078-2025·2024-10-30
Anesthesia Gas Machine Recall: Breathing Circuit Misconnection Risk
Datex-Ohmeda is recalling Avance anesthesia gas machines worldwide due to a potential hazard if a patient's breathing circuit is incorrectly connected to the Auxiliary Common Gas Outlet port during setup.
Product
Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
Category
Medical Device
Distribution
Distributed nationwide
SevereCPSC·25021·2024-10-24
Ricky Powersports ATVs Recalled for Safety Regulation Violations
Ricky Powersports is recalling about 385 youth and adult all-terrain vehicles due to violations of federal ATV safety regulations that pose risks of serious injury or death. The youth ATVs have suspension defects, and the adult ATVs have brake and handlebar safety issues.
Product
Ricky Powersports Tumble Weed Youth and TGB Blade Adult All-Terrain Vehicles (ATVs)
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Food)·F-0043-2025·2024-10-23
Seasoned Radish Recalled for Undeclared Crustacean Allergen
Lemonland Food Corp is recalling Item FLD1080A Seasoned Radish due to undeclared shrimp. The product was distributed in Washington; consumers with crustacean allergies should not consume it.
Product
Item FLD1080A, Seasoned Radish, distributed in plastic clamshell containers, net wt. 0.365lb. The H-Mart label declares: Radish, Red Pepper Powder, Malt Syrup, Salt, Anchovy, Sugar, Garlic, Ginger, Sesame.
Category
Food
Distribution
1 state
SevereFDA (Food)·F-0038-2025·2024-10-23
Potato Salad Recall: Undeclared Egg and Soybean Allergens
Lemonland Food Corp is recalling potato salad due to undeclared egg and soybean allergens present in the mayonnaise ingredient. The recall affects 120 packages distributed in Washington.
Product
Item FLD4006, Potato Salad, distributed in plastic clamshell containers, net wt. 0.56lb. The H-Mart label declares: Potato, Mayonnaise, Sugar, Vegetable.
Category
Food
Distribution
1 state
SevereFDA (Food)·F-0037-2025·2024-10-23
Nuts.com recalls S'mores Bites for undeclared milk allergen
Nuts.com is recalling S'mores Bites due to undeclared milk allergen. Milk chocolate was listed in the product description but omitted from the ingredient list, creating a labeling mismatch.
Product
S'mores Bites, 1 yummy pound, Distributed by Nuts.com, Cranford, NJ, 07016
Category
Food
Distribution
36 states
SevereFDA (Food)·F-0041-2025·2024-10-23
Perilla Leaves in Soy Sauce recalled for undeclared wheat and fish allergens
Lemonland Food Corp recalls Item FLD1000BA Perilla Leaves in Soy Sauce due to undeclared wheat and fish allergens on the label. Consumers with these allergies should not consume the product.
Product
Item FLD1000BA, Perilla Leaves in Soy Sauce, distributed in plastic clamshell containers, net wt. 0.315lb. The H-Mart label declares: Perilla Leaves, Soy Sauce, Sugar
Category
Food
Distribution
1 state
SevereFDA (Food)·F-0044-2025·2024-10-23
Seasoned Dandelion Recalled for Undeclared Fish Allergen
Lemonland Food Corp is recalling Item FLD1070A Seasoned Dandelion due to undeclared fish (anchovy) not listed on the label. Consumers with fish allergies should not consume this product.
Product
Item FLD1070A, Seasoned Dandelion, distributed in plastic clamshell containers. Net wt. 0.365lb. The H-Mart label declares: Dandelion, Salt, Garlic, Soy Sauce, Chili Powder.
Category
Food
Distribution
1 state
SevereFDA (Drugs)·D-0012-2025·2024-10-23
Atovaquone Oral Suspension Recalled for Cohnella Bacteria Contamination
Bionpharma Inc. is recalling Atovaquone Oral Suspension (750 mg/5 mL) nationwide due to Cohnella bacteria contamination. The recall affects 1,980 bottles.
Product
ATOVAQUONE — ATOVAQUONE (ATOVAQUONE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0048-2025·2024-10-23
Seasoned Pepper with Soybean Paste Recalled for Undeclared Allergens
Lemonland Food Corp is recalling Item FLD1020A Seasoned Pepper with Soybean Paste due to undeclared wheat, fish, and crustacean allergens. Consumers with allergies should not consume this product.
Product
Item FLD1020A, Seasoned Pepper with Soybean Paste, distributed in plastic clamshell containers. Net wt. 0.315lb. The H-Mart label declares: Pepper, Soy Bean Paste.
Category
Food
Distribution
1 state
SevereFDA (Devices)·Z-0047-2025·2024-10-23
GE HealthCare Giraffe OmniBed neonatal incubator door screw may loosen
Certain GE HealthCare Giraffe OmniBed and Carestation neonatal incubators may have door-securing screws that were not torqued to specification, potentially causing the doors to become loose. These units are distributed worldwide.
Product
GE Heathcare Giraffe OmniBed; neo natal incubator
Category
Medical Device
Distribution
0 states
SevereFDA (Food)·F-0035-2025·2024-10-23
Enjoy Premium Taro Cookies recalled for undeclared milk allergen
Enjoy Premium Taro Cookies contain undeclared milk allergen and were sold in Hawaii, Guam, and Nevada. Consumers with milk allergies should not consume this product.
Product
Enjoy Premium Taro Cookies packaged in 5.3 oz. foil pouches and 17.7 oz clear bags
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0036-2025·2024-10-23
Enjoy Premium Coconut Cookies Recalled for Undeclared Milk Allergen
KTM Services, Inc. is recalling Enjoy Premium Coconut Cookies sold in Hawaii, Guam, Nevada, and online due to undeclared milk allergen. Consumers with milk allergies should not consume the product.
Product
Enjoy Premium Coconut Cookies packaged in 5.3 oz. foil pouches and 17.7 oz clear bags
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0046-2025·2024-10-23
Octopus Product Recalled for Undeclared Fish Allergen
Lemonland Food Corp is recalling Item FLD2011 Salted and Seasoned Small Octopus because it contains undeclared fish (anchovy), a major allergen. Approximately 70 packages were distributed in Washington state.
Product
Item FLD2011, Salted and Seasoned Small Octopus, distributed in plastic clamshell containers, net wt. 0.267lb. The H-Mart label declares: Octopus, Salt, Garlic, Ginger, Red Pepper Powder, Green Onion, Syrup, Sesame Seed.
Category
Food
Distribution
1 state
SevereCPSC·25011·2024-10-17
Anker Power Banks Recalled for Fire and Burn Hazards
Anker power banks with model numbers A1642, A1647, and A1652 have been recalled because the lithium-ion battery can overheat and catch fire, causing burn injuries. The firm has received 28 reports of overheating and fires, with two burn injuries reported.
Product
Anker Power Banks
Category
Consumer Product
Distribution
Distributed nationwide
SevereCPSC·25015·2024-10-17
Colsen Fire Pits Recalled for Burn Injury Risk from Flame Jetting
Colsen-branded tabletop fire pits are being recalled due to the risk of invisible alcohol flames causing flame jetting and fire spreading. The hazard can cause serious burns in less than one second.
Product
Colsen-branded fire pits
Category
Consumer Product
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0008-2025·2024-10-16
Vail-Bon Jie Yang Wan capsules recalled for undeclared pharmaceutical ingredients
Vail-Bon Jie Yang Wan capsules have been recalled for containing undeclared dexamethasone and chlorpheniramine. The product was marketed without FDA approval.
Product
Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru, Malaysia.
Category
Drug
Distribution
0 states
SevereFDA (Food)·F-0023-2025·2024-10-16
7-Eleven Fudge Brownies Recalled Due to Undeclared Walnuts
Innovation Bakers has recalled 7-Eleven Fudge Brownies with Chocolate Chip due to undeclared walnuts. The product was distributed to Southern California 7-Eleven stores and may cause allergic reactions in consumers with walnut allergies.
Product
7-Eleven Fudge Brownie with Chocolate Chip, 3.5 oz. UPC: 05254856392
Category
Food
Distribution
0 states
SevereNHTSA·23V905000·2024-10-12
Ford vehicles recalled for oil pump belt failure and power braking loss
Certain 2016-2018 Ford Focus and 2018-2022 Ford EcoSport vehicles may have faulty oil pump drive belts or tensioners that can fail, causing engine stall and loss of power braking assist, increasing crash risk.
Product
FORD — 2022 FORD ECOSPORT
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3208-2024·2024-10-09
Percussionaire IPV Therapy In-Line Valve Recalled for Labeling Deficiency
Percussionaire Corporation recalled 2523 IPV therapy in-line valves due to insufficient labeling regarding cap removal prior to use. Updated labeling ensures patients and healthcare providers understand proper device preparation.
Product
Percussionaire, Inc., REF: P5-TEE-20, Qty: 20, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0005-2025·2024-10-09
FDA Recalls Veklury Injection Vials for Presence of Glass Particles
Gilead Sciences recalls 105,000 vials of Veklury (remdesivir) for injection nationwide because glass particles are present in the medication.
Product
VEKLURY — VEKLURY (REMDESIVIR)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0004-2025·2024-10-09
Neo-Tee T-Piece Resuscitator circuit flow controller may come apart
Mercury Medical is recalling approximately 1,300 Neo-Tee T-Piece Resuscitators due to a manufacturing defect that may cause the circuit flow controller to come apart, potentially compromising emergency respiratory support.
Product
Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Category
Medical Device
Distribution
5 states
SevereFDA (Devices)·Z-0002-2025·2024-10-09
MiniMed Insulin Pumps Recalled for Battery Failure After Physical Impact
MiniMed insulin pumps are recalled because physical impact can damage internal components, reduce battery life, and cause unexpected device shutdown that interrupts insulin delivery.
Product
MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 640G Insulin Pump, REF: MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, MMT-1752; MiniMed 720G Insulin Pump, REF: MMT-1809,
Category
Medical Device
Distribution
53 states