Severity 5 of 5

Critical recalls

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

What “critical” means here

Severity 5 (Critical) covers recalls where deaths or serious injuries have been reported, or where the agency itself classified the action as the highest severity (FDA Class I, NHTSA 'death/serious injury reported'). These are the recalls you should treat as urgent — stop using the product immediately and follow the agency's guidance. Common Severity-5 categories are pathogen-contaminated ready-to-eat foods (Listeria, E. coli O157, Salmonella), drug products with confirmed adverse-event reports, and vehicle defects with documented fatal crashes.

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.

201–225 of 758

CriticalFDA (Food)·F-0248-2025·2024-12-11
Albertsons Ready-Meal Salads Recalled for Listeria Contamination
Albertsons Companies LLC recalls multiple ready-meal salad products due to Listeria monocytogenes contamination in cooked chicken. Products were distributed across 21 US states with sell-through dates through October 13, 2024.
Product
(1) GINGER CHICKEN BROCCOLI SALAD FS (UPC 27110800000) (2) READY MEALS GINGER CHICKEN BROCOLLI SALAD SS (UPC 29105700000) (3) GINGER BROCOLLI SALAD FS (UPC 29233600000) (4) CHICKEN CAESAR SALAD FS (UPC 29130700000) (5) CAESAR CHICKEN BOWL (UPC 29125500000) (6) READY MEALS CHICKEN
Category
Food
Distribution
21 states
CriticalFDA (Food)·F-0216-2025·2024-12-04
Atwater's Spider Web Tarts Recalled for Undeclared Almonds
One Roof LLC recalls Atwater's Spider Web Tarts for undeclared almonds. Consumers with tree nut allergies should not consume this product.
Product
Atwater's Spider Web Tarts, 26 tarts packaged individually, 5.73 in x 5.95 in x 3 in clear plastic clamshell container, Julienne date 292
Category
Food
Distribution
3 states
CriticalFDA (Food)·F-0143-2025·2024-11-27
Chicken Alfredo Kit Recalled Due to Listeria Contamination
Joseph Seviroli, LLC is recalling Chicken Alfredo Kit due to potential Listeria monocytogenes contamination in the chicken. The product was distributed across multiple states.
Product
Chicken Alfredo Kit
Category
Food
Distribution
15 states
CriticalFDA (Food)·F-0217-2025·2024-11-27
Frozen U-BAKE Apple Pie recalled for undeclared egg allergen
Grand Central Bakery FRE Co Inc is recalling 150 packages of U-BAKE Apple Pie due to undeclared egg. The product label declares wheat and milk but not egg, posing a serious risk to consumers with egg allergies.
Product
U-BAKE Apple Pie, frozen product and packaged in LDPE bag, net wt. 2lbs. 9oz. Made by Grand Central Baking Company. Label declares Wheat and Milk.
Category
Food
Distribution
2 states
CriticalFDA (Devices)·Z-0382-2025·2024-11-27
Baxter Peritoneal Dialysis Transfer Sets Recalled for Chemical Exposure
Baxter Healthcare Corporation is recalling 1,240 units of MiniCap Extended Life PD Transfer Sets (Part Number T5C4484) due to potential exposure to polychlorinated biphenyls and related compounds when used in peritoneal dialysis treatments.
Product
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal Dialysis
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0304-2025·2024-11-20
Draeger Atlan A350 Anesthesia Workstation Piston Ventilator Failure
Draeger Medical is recalling the Atlan A350 anesthesia workstation due to failures of the piston ventilator that either occurred before use or during patient anesthesia. Approximately 1,492 units are affected.
Product
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0135-2025·2024-11-20
Raw yellow onions recalled for potential E. coli O157:H7 contamination
Taylor Farms Colorado is recalling 42 cases of raw yellow onions in 5-lb bags distributed to food service facilities across six states due to potential E. coli O157:H7 contamination.
Product
raw, yellow onions (whole unpeeled), intended for food service, repacked into in 5-lb plastic bags
Category
Food
Distribution
6 states
CriticalFDA (Devices)·Z-0303-2025·2024-11-20
Boston Scientific POLARx Cryoablation Catheters Instructions Updated for Atrio-esophageal Fistula Risk
Boston Scientific issued a Class I recall of POLARx and POLARx FIT Cryoablation Balloon Catheters. Instructions for use are being updated due to risk of atrio-esophageal fistula, a serious complication.
Product
Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CRBS400Z0
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-0310-2025·2024-11-20
Monoject Insulin Syringes Recalled for Incompatibility with Needleless IV Connectors
Cardinal Health recalled approximately 371,326 Monoject U-100 insulin syringes due to incompatibility with needleless IV connectors. Affected units should not be used for IV push insulin administration via these connectors.
Product
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
Category
Medical Device
Distribution
Distributed nationwide
CriticalCPSC·25046·2024-11-14
Medical King adult bed rails recalled for entrapment and asphyxia hazard
Medical King bed rails (about 222,000 units) are being recalled because they can trap users between the rail and mattress, posing asphyxiation risk. One death has been reported.
Product
Medical King Bed Assist Rail adult bed rails
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-0104-2025·2024-11-13
Aunt Millie's Bakehouse Hot Dog Buns Recalled for Undeclared Sesame Allergen
Perfection Bakeries LLC is recalling Aunt Millie's Bakehouse Whole Grain White Hot Dog Buns for containing undeclared sesame. Approximately 10,987 cases distributed across multiple states.
Product
Aunt Millie s Bakehouse Whole Grain White Hot Dog Buns 6" Sliced 2 OUNCE. 12 unlabeled 12CT PKGS per sale unit case, product code 7502. Net. Wt. 18lbs.
Category
Food
Distribution
0 states
CriticalFDA (Food)·F-0077-2025·2024-11-06
Los Andes Foods Sweet Corn Pancakes Recalled for Undeclared Wheat Allergen
Los Andes Foods Sweet Corn Pancakes are being recalled because they contain undeclared wheat allergen. Consumers with wheat allergies should not consume the product and should discard it.
Product
Los Andes Foods Sweet Corn Pancakes, Cachapas de Maiz, NET WT. 24 Oz., 5 units, KEEP REFRIGERATED
Category
Food
Distribution
0 states
CriticalFDA (Devices)·Z-0005-2025·2024-10-16
Z-800 Infusion System Recalled for Air-in-Line Software Algorithm Defect
Zyno Medical LLC is recalling the Z-800 Infusion System due to a defect in the air-in-line software algorithm. Approximately 34,994 units distributed nationwide are affected by this Class I FDA recall.
Product
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Category
Medical Device
Distribution
Distributed nationwide
CriticalCPSC·25009·2024-10-10
Fisher-Price Recalls 2.1 Million Snuga Infant Swings for Suffocation Risk
Fisher-Price is recalling approximately 2.1 million Snuga Infant Swings due to suffocation hazard when the product is used for sleep or bedding is added. Five deaths have been reported between 2012 and 2022.
Product
All Models of Fisher-Price Snuga Swings
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1838-2024·2024-10-09
Kandy brand whole cantaloupes recalled for possible Salmonella contamination
Eagle Produce LLC is recalling Kandy brand whole cantaloupes due to possible Salmonella contamination. The recalled product (224 cases of 9-count boxes) was distributed to Michigan, Missouri, Ohio, Texas, and Virginia.
Product
Whole cantaloupe, brand name Kandy, packed in a corrugated box, 9 count
Category
Food
Distribution
5 states
CriticalFDA (Devices)·Z-3084-2024·2024-09-25
Baxter pharmaceutical compounding inlets recalled for particulate matter contamination
Baxter is recalling EXACTAMIX compounding device inlets due to particulate matter observed in sterile fluid pathways before use. Approximately 5.8 million units affected worldwide.
Product
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
Category
Medical Device
Distribution
0 states
CriticalCPSC·24359·2024-09-12
About 866,000 AirJet and HydroJet Spa Pumps Recalled for Fire Hazard
AirJet and HydroJet spa pumps can overheat and ignite, posing a fire hazard. One death has been reported, and consumers should stop using the pumps immediately.
Product
AirJet and HydroJet Spa Pumps
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1762-2024·2024-09-11
JFE Pico de Gallo Classic Products Recalled for Listeria Contamination
JFE FRANCHISING INC is recalling Pico de Gallo Classic products in Kentucky, Michigan, Ohio, and West Virginia due to potential Listeria monocytogenes contamination. Consumers should not consume affected products and should return them to the place of purchase or discard them.
Product
Pico de Gallo Classic Hot - 14 oz 639123880116 Pico de Gallo Classic Medium - 14 oz 639123880093 Pico de Gallo Classic Mild - 14 oz 639123880109 Plastic Clam-Shell Container
Category
Food
Distribution
4 states
CriticalFDA (Devices)·Z-2943-2024·2024-09-11
Trilogy Evo Ventilator Software Update for Identified Safety Issues
Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for the Trilogy Evo Universal Ventilator to address safety issues identified in earlier recalls. Affected units should implement the update.
Product
Trilogy Evo Universal Ventilator, Model No. DS2000X11B
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2606-2024·2024-09-04
Smiths Medical Bivona Neonatal Tracheostomy Tubes Recalled for Flange Tear
Smiths Medical recalls PORTEX Bivona Neonatal Tracheostomy Tubes due to manufacturing defect that may cause securement flange to tear, compromising tube stability.
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025; b) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N030; c) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N035
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2592-2024·2024-09-04
PORTEX Bivona Tracheostomy Tubes Recalled for Flange Tearing Defect
Smiths Medical is recalling PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect, risking loss of airway securement.
Product
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP30; c) NEONATAL TRACHEOSTOMY TUBE
Category
Medical Device
Distribution
0 states
CriticalCPSC·24350·2024-08-29
HALO 1000 Portable Power Stations Recalled for Fire and Burn Hazards
About 5,740 HALO 1000 Portable Power Stations are recalled because their lithium-ion batteries can overheat and catch fire. One death from smoke inhalation and four fire incidents have been reported.
Product
HALO 1000 Portable Power Stations
Category
Consumer Product
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2636-2024·2024-08-28
McGrath Mac Video Laryngoscope battery depletion may cause thermal event and explosion
McGrath Mac Video Laryngoscope devices may experience battery management system failures causing batteries to deplete below design thresholds, potentially resulting in thermal events and explosions.
Product
McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Food)·F-1709-2024·2024-08-21
Green peppers recalled due to potential Listeria contamination
RS Hanline and Company Inc is recalling Freshire Farms green peppers due to potential Listeria monocytogenes contamination. The recall affects 850 cases distributed across nine states.
Product
Freshire Farms - Green Peppers packaged in plastic bags containing 3 peppers, 16 bags per case
Category
Food
Distribution
0 states
CriticalFDA (Food)·F-1707-2024·2024-08-21
Freshire Farms jalapenos recalled for potential Listeria monocytogenes contamination
Freshire Farms jalapenos packaged in 8-ounce bags are being recalled due to potential contamination with Listeria monocytogenes. The recall affects 2,298 cases distributed across nine states.
Product
Freshire Farms - Jalapenos packaged in plastic bags at 8oz, 18 bags per case
Category
Food
Distribution
0 states