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.

501–525 of 4878

SevereFDA (Devices)·Z-0296-2025·2024-11-20
Philips LifeVent EVO2 ventilators recalled for potential sensor accuracy failure
Philips Respironics is recalling LifeVent EVO2 ventilators due to potential aerosol deposit accumulation on the internal flow sensor that could cause inaccurate measurements during ventilation.
Product
LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0305-2025·2024-11-20
Anesthesia workstation piston ventilator may fail before or during use
Draeger Medical is recalling Atlan A350XL anesthesia workstations due to potential piston ventilator failure that may occur before use or during mechanical ventilation.
Product
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0294-2025·2024-11-20
Aeris EVO Ventilator May Develop Flow Sensor Fouling from Aerosols
Philips Respironics Aeris EVO ventilators may accumulate aerosol deposits on the internal flow sensor, potentially causing inaccurate flow measurements.
Product
Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0301-2025·2024-11-20
Boston Scientific Cryoablation Balloon Catheters Instruction Update for Fistula Risk
Boston Scientific is updating safety instructions for POLARx cryoablation balloon catheters due to atrio-esophageal fistula risk. The update affects approximately 2,751 units distributed worldwide.
Product
Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0302-2025·2024-11-20
Boston Scientific Cryoablation Balloon Catheters Recalled for Fistula Risk
Boston Scientific is updating instructions for POLARx and POLARx FIT cryoablation balloon catheters due to atrio-esophageal fistula risk. Affected devices were distributed worldwide.
Product
Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0293-2025·2024-11-20
Trilogy EV300 ventilator: potential flow sensor malfunction from aerosol accumulation
Philips Respironics is recalling 34,146 Trilogy EV300 ventilators due to potential aerosol accumulation on the internal flow sensor, which could cause inaccurate ventilation measurements.
Product
Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B, FR2200X14B, FX2200X15B, EU2200X15B, IA2200X15B, IT2200X21B, KR2200X15B, TR2200X15B, EE2200X15B. Intended for invasive and non-invasive venti
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0298-2025·2024-11-20
FDA Updates POLARx Cryoablation Catheter Instructions for Atrio-esophageal Fistula Risk
Boston Scientific is updating instructions for POLARx and POLARx FIT cryoablation catheters to address atrio-esophageal fistula risks. The FDA classified this as a Class I recall affecting approximately 20,290 units distributed worldwide.
Product
Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0292-2025·2024-11-20
Trilogy Evo Universal Ventilator Recalled Due to Sensor Malfunction Risk
Trilogy Evo Universal Ventilators (Model DS2000X11B) are recalled because in-line nebulizer configuration in certain locations could cause aerosol accumulation on the internal flow sensor, potentially resulting in inaccurate measurements.
Product
Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0291-2025·2024-11-20
Philips Trilogy Evo ventilators recall: flow sensor fouling risk
Philips Respironics is recalling Trilogy Evo ventilators due to potential aerosol deposits on the internal flow sensor, which could cause inaccurate flow measurements during ventilation.
Product
Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110X15B, BL2110X15B, EU2110X15B, BR2110X18B, LA2110X15B, EE2110X15B, FR2110X14B, GB2110X15B, ND2110X15B, ES2110X15B, IA2110X15B, IT2110X21B, KR2110X15B, TR2110X15B
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0290-2025·2024-11-20
Trilogy Evo O2 Ventilators Recalled for Potential Flow Sensor Malfunction
Philips Respironics recalled 24,249 Trilogy Evo O2 ventilators because in-line nebulizer configurations may allow aerosol deposits to accumulate on the device's flow sensor, potentially causing inaccurate flow measurements.
Product
Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN2100X19, EU2100X19. Intended for invasive and non-invasive ventilation of pedi
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0295-2025·2024-11-20
Ventilator Model LD2110X23B Recalled for Potential Sensor Measurement Failure
Philips Respironics is recalling 1,322 Garbin Evo ventilators (Model LD2110X23B) worldwide due to potential aerosol accumulation that could cause inaccurate flow sensor readings, posing a risk to patient care.
Product
Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-0134-2025·2024-11-20
Raw Yellow Onions Recalled for Potential E. coli O157:H7 Contamination
Taylor Farms Colorado is recalling 615 cases of raw yellow onions for potential E. coli O157:H7 contamination. Affected food service facilities are in CO, KS, MO, NE, NM, and UT.
Product
raw, yellow onions (whole peeled), intended for food service, packaged into plastic bags (5-lbs)
Category
Food
Distribution
6 states
SevereFDA (Devices)·Z-0297-2025·2024-11-20
Boston Scientific POLARx Cryoablation Catheters Instructions Updated for Fistula Risk
Boston Scientific is updating instructions for POLARx and POLARx FIT cryoablation catheters to address atrio-esophageal fistula risk, a potentially serious complication from ablation procedures. FDA Class I recall affecting 4422 units worldwide.
Product
Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
Category
Medical Device
Distribution
0 states
SevereFDA (Food)·F-0137-2025·2024-11-20
Yellow Onion Products Recalled for E. Coli O157:H7 Contamination
IMPERIALFRESH processed yellow onions are being recalled due to potential E. coli O157:H7 contamination. Products were distributed in Colorado and produced October 8-22, 2024.
Product
Item Number PACK/SZ BRAND DESCRIPTION Lot Codes 082076 4/5 LBS IMPERIALFRESH PROC ONION YELLOW JULIENNE 3/8 All lot codes; 170992 4/5 LB IMPERIALFRESH PROC ONION YELLOW DICED 3/8 All lot codes; 258147 4/5LBS IMPERIALFRESH PROC ONION YELLOW JULIENNE 1/4 All lot codes; 259369 1 / 5
Category
Food
Distribution
0 states
SevereFDA (Devices)·Z-0300-2025·2024-11-20
Boston Scientific POLARx FIT cryoablation catheter instructions updated for fistula risk
Boston Scientific updated instructions for use of its POLARx and POLARx FIT cryoablation catheters, affecting 960 units distributed worldwide, in response to atrio-esophageal fistula risk.
Product
Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
Category
Medical Device
Distribution
0 states
SevereCPSC·25043·2024-11-14
woom Recalls Children's Bicycles Due to Crank Fractures and Fall Hazards
woom Bike USA is recalling about 2,500 children's bicycles due to cranks that can break from fatigue fractures, causing riders to lose control and crash. One child was injured when this defect occurred.
Product
woom bicycles OFF 5, OFF AIR 5, OFF 6, OFF AIR 6, and ORIGINAL 6
Category
Consumer Product
Distribution
Distributed nationwide
SevereCPSC·25042·2024-11-14
Cultivar Planter Boxes Recalled Due to Breaking Frame and Injury Hazard
Outdoor Essentials Cultivar Planter Boxes are being recalled due to breaking frames that pose an injury risk. The firm received 23 reports of frame breaks, including one consumer injury.
Product
Cultivar Planter Boxes
Category
Consumer Product
Distribution
Distributed nationwide
SevereFDA (Food)·F-0103-2025·2024-11-13
Bakery Bread Recall: Undeclared Sesame Allergen in Aunt Millie's Texas Toast
Perfection Bakeries is recalling Aunt Millie's Bakehouse Texas Toast due to undeclared sesame, which poses a serious risk to consumers with sesame allergies. Approximately 1,500 cases were distributed across multiple states.
Product
Aunt Millie s Bakehouse Texas Toast 3/4" Sliced 22 OUNCE loaf. 12 unlabeled loaves per sale unit case, product code 9519. Net. Wt. 16lbs 8oz.
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0099-2025·2024-11-13
Aunt Millie's Bakehouse Hawaiian Hamburger Buns Recalled for Undeclared Sesame
Aunt Millie's Bakehouse Hawaiian Hamburger Buns contain undeclared sesame and are being recalled by Perfection Bakeries LLC. The Class I recall affects 6,400 cases distributed across 12 states.
Product
Aunt Millie s Bakehouse Hawaiian Hamburger Buns 4.5" Sliced 3 OUNCE. 6 unlabeled 12CT PKGS per sale unit case, product code 7430. Net Wt. 13lb 8oz.
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0101-2025·2024-11-13
Bread Recall: Undeclared Sesame Allergen in Aunt Millie's Bakehouse
Perfection Bakeries LLC is recalling Aunt Millie's Bakehouse 100% Whole Wheat Pullman Bread due to undeclared sesame. Affected product was distributed across twelve U.S. states.
Product
Aunt Millie s Bakehouse 100% Whole Wheat Pullman Bread 1/2" Sliced 22 OUNCE loaf. 12 unlabeled loaves per sale unit case, product code 9520, Net Wt. 16lbs. 8oz.
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0100-2025·2024-11-13
Bread Recall: Undeclared Sesame in Aunt Millie's Bakehouse White Pullman
Perfection Bakeries recalls Aunt Millie's Bakehouse White Pullman Bread (22 oz) due to undeclared sesame. The recall affects 7,092 cases distributed across multiple states.
Product
Aunt Millie s Bakehouse White Pullman Bread 1/2" Sliced 22 OUNCE. 12 unlabeled 22 OUNCE LOAVES per sale unit case, product code 9518. Net Wt. 16lb 8oz.
Category
Food
Distribution
0 states
SevereFDA (Devices)·Z-0227-2025·2024-11-13
Elekta Disposable Biopsy Needles Recalled for Internal Debris Contamination
Elekta recalls disposable biopsy needles for the Leksell Stereotactic System due to microscopic stainless steel debris found inside the needles. 111 kits (666 needles) distributed across multiple U.S. states are affected.
Product
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465,
Category
Medical Device
Distribution
11 states
SevereFDA (Food)·F-0105-2025·2024-11-13
Gordon Food Service Hawaiian Rolls Recalled for Undeclared Sesame
Perfection Bakeries is recalling Gordon Food Service Hawaiian Pull-Apart Dinner Rolls due to undeclared sesame. The recall affects 61,658 cases distributed across 12 states; consumers with sesame allergies should not consume the product.
Product
Gordon Food Service Hawaiian Pull-Apart Dinner Rolls Unsliced 1.25 Ounce. 10 unlabeled 12CT PKGS per sale unit case, product code 7148. Net. Wt. 9lbs. 6oz.
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0102-2025·2024-11-13
Aunt Millie's Whole Grain Dinner Rolls Recalled for Undeclared Sesame
Perfection Bakeries LLC is recalling 1,144 cases of Aunt Millie's Bakehouse Whole Grain Dinner Rolls due to undeclared sesame. The product was distributed in 12 states. Consumers with sesame allergies should not consume this product.
Product
Aunt Millie s Bakehouse Whole Grain Dinner Rolls 2.5" Sliced 1.34 OUNCE. 8 unlabeled 24CT PKGS per sale unit case, product code 7488. Net. Wt. 16lbs.
Category
Food
Distribution
0 states
SevereFDA (Drugs)·D-0040-2025·2024-11-13
Ascorbic Acid Injection Recalled Nationwide for Glass Contamination
Staska Pharmaceuticals recalled ascorbic acid injectable solution due to glass contamination. The FDA classified the recall as Class I; 4,773 vials nationwide were affected.
Product
Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive, Bennet, NE 68317
Category
Drug
Distribution
Distributed nationwide