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.

3201–3225 of 4878

SevereFDA (Food)·F-0080-2023·2022-10-26
Fenugreek dietary supplement recalled for potential Salmonella contamination
Best Nutritionals LLC is recalling Best Naturals Fenugreek 610mg capsules due to potential Salmonella contamination. The product was distributed online via internet sellers and FBA.
Product
White plastic bottle with green, gold, and blue labeling containing 360, 610mg hard gelatin capsules of Fenugreek seed powder, labeled in part, "Best Naturals Fenugreek Premium Herbal 610mg 3rd Party Lab Tested 360 CAPSULES DIETARY SUPPLEMENT", best by 10/24, lot 102120
Category
Food
Distribution
0 states
SevereFDA (Devices)·Z-0073-2023·2022-10-26
Iso-Gard Filter S Medical Gas Filter Recall Due to Splitting or Detachment
TELEFLEX LLC is recalling Iso-Gard Filter S microbial medical gas filters due to incidents where the device may split or detach during use. The FDA classified this as a Class I recall.
Product
Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0077-2023·2022-10-26
Teleflex Catheter Mount and Filter May Split or Detach During Use
Catheter mounts with filters (REF 191667-000100) used to connect endotracheal tubes or masks to breathing circuits may split or detach during patient use. Teleflex is recalling affected units distributed nationwide.
Product
Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0076-2023·2022-10-26
Medical gas filter recalled due to splitting and detachment risk
TELEFLEX LLC is recalling Iso-Gard Filter S medical gas filters due to incidents of device splitting or detaching during use. The affected filters may compromise patient safety.
Product
Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-use
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-0034-2023·2022-10-19
Albertsons Ready Meals Shrimp Recalled for Undeclared Fish Allergen
Albertsons Companies LLC is recalling Ready Meals Shrimp Cooked with Cocktail Sauce due to undeclared fish (anchovy) allergen. The product was distributed to Oregon and Washington stores.
Product
Ready Meals Shrimp Cooked with Cocktail Sauce SCE NET WT 12 OZ CAL 330 NET WT. 0lb 12oz (340g) ready2eat Ingredients: Shrimp (Litopenaues Viannamei), Lemon, Salt, Tomato Paste, Sodium Tripolyphosphate (to retain moisture), water, high fructose corn syrup, contains 2% or less Beet
Category
Food
Distribution
2 states
SevereFDA (Devices)·Z-0001-2023·2022-10-19
Jiangsu Well Biotech COVID-19 test kits distributed without FDA authorization
Approximately 620,000 COVID-19 rapid test devices were distributed in the U.S. without FDA Emergency Use Authorization or approval. Consumers should not use these unauthorized test kits.
Product
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Category
Medical Device
Distribution
1 state
SevereCPSC·23007·2022-10-13
Ancheer E-Bikes Recalled Due to Fire, Explosion and Burn Hazards
About 22,000 Ancheer e-bikes with lithium-ion batteries are being recalled because the batteries can ignite, explode, or spark, causing fire and burn injuries. Consumers should stop using the recalled bikes immediately and contact Ancheer for a free replacement battery and mount.
Product
Ancheer E-bikes
Category
Consumer Product
Distribution
Distributed nationwide
SevereCPSC·23702·2022-10-13
Ski-Doo 2022 Snowmobiles Recalled Due to Fire Hazard
BRP is recalling certain 2022 Ski-Doo snowmobiles with 850 E-TEC engines due to a loose fuel injector hose retainer screw that can cause fuel leaks and fires. The company has received five fuel-leak reports, resulting in two fires.
Product
Ski-Doo snowmobiles
Category
Vehicle
Distribution
Distributed nationwide
SevereCPSC·23006·2022-10-13
U-Line Outdoor Freezers Recalled Due to Fire Hazard
U-Line is recalling about 90 Outdoor Series 24-inch built-in convertible freezers that can overheat and pose a fire hazard. U-Line has received three reports of freezer fires with no injuries reported.
Product
U-Line Outdoor Series 24-inch Built-In Convertible Freezers
Category
Consumer Product
Distribution
Distributed nationwide
SevereFDA (Food)·F-1811-2022·2022-10-12
Organic Tahini Recalled Due to Potential Salmonella Contamination
Kenover Marketing Corp. is recalling Mighty Sesame Organic Tahini over potential Salmonella contamination. Approximately 13,766 units were distributed to stores across 20 states.
Product
"Mighty Sesame 10.9oz Organic Tahini" in a 10.9oz plastic squeeze bottle, 8 Units per Cases .
Category
Food
Distribution
20 states
SevereFDA (Food)·F-0010-2023·2022-10-12
Fiesta Corn Recalled Due to Listeria Monocytogenes Contamination
Renaissance Food Group is recalling Fiesta Corn (10 oz) after positive test results confirmed Listeria monocytogenes in the finished product. All products made with the same components are affected.
Product
Fiesta Corn, NET WT, 10 OZ (283g), Dist. By: Renaissance Food Group LLC 4322 Moreland Ave. Conley, GA 30288, UPC, 8 26766 18462 ?
Category
Food
Distribution
0 states
SevereFDA (Devices)·Z-1782-2022·2022-10-12
DreamWisp CPAP mask recalled for missing implant safety warnings
Philips Respironics is recalling 930,813 DreamWisp Nasal Masks worldwide due to missing warnings about magnetic components that could interfere with implantable medical devices or cause metallic splinters.
Product
DreamWisp Nasal Mask with Over the Nose Cushion
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-0011-2023·2022-10-12
Renaissance Food Group Hamburger Fixin's Recalled for Listeria Contamination
Renaissance Food Group is recalling Hamburger Fixin's (10 oz units) distributed in Alabama, Georgia, and South Carolina due to positive test results for Listeria monocytogenes in the finished product.
Product
Hamburger Fixin's, NET WT, 10 OZ (283g), Dist. By: Renaissance Food Group LLC 4322 Moreland Ave. Conley, GA 30288, UPC, 8 26766 19028 7
Category
Food
Distribution
0 states
SevereFDA (Devices)·Z-1783-2022·2022-10-12
Wisp and Wisp Youth nasal masks recalled for missing implanted device warnings
Philips Respironics is recalling Wisp and Wisp Youth nasal masks because they lack warnings about magnetic components that could interfere with implanted medical devices or cause eye injuries from metallic splinters.
Product
Wisp and Wisp Youth Nasal Mask
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-0012-2023·2022-10-12
Hatch Chile Guacamole Blender Recalled for Listeria Risk
Renaissance Food Group is recalling Hatch Chile Guacamole Blender due to positive test results for Listeria monocytogenes. Products were distributed to Alabama, Georgia, and South Carolina.
Product
Hatch Chile Guacamole Blender, NET WT, 9 OZ (255g), Dist. By: Renaissance Food Group LLC 4322 Moreland Ave. Conley, GA 30288, UPC, 8 26766 14454 5
Category
Food
Distribution
0 states
SevereFDA (Devices)·Z-1780-2022·2022-10-12
CPAP Full-Face Mask Recalled for Missing Implantable Device Warnings
Philips Respironics Amara View Full-Face Mask lacks critical safety warnings about magnetic components for patients with implantable medical devices. The Class I recall affects 5.6 million units worldwide.
Product
Philips Respironics Amara View Minimal Contact Full-Face Mask
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-0025-2023·2022-10-12
Spicy Guacamole Blender Recalled Due to Listeria Contamination
Renaissance Food Group is recalling Spicy Guacamole Blender products because positive test results confirmed Listeria monocytogenes contamination in the finished product.
Product
Spicy Guacamole Blender, NET WT, 9 OZ (255g), Dist. By: Renaissance Food Group LLC 4322 Moreland Ave. Conley, GA 30288, UPC, 8 26766 14436 5
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0007-2023·2022-10-12
Diced Bell Pepper and White Onion Recalled for Listeria Contamination
Renaissance Food Group is recalling diced bell pepper and white onion products due to positive test results for L. monocytogenes. The recalled products were distributed in Alabama, Georgia, and South Carolina.
Product
Diced Bell Pepper & White Onion, NET WT, 7 OZ (198g), Dist. By: Renaissance Food Group LLC 4322 Moreland Ave. Conley, GA 30288, UPC, 8 26766 19004
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0021-2023·2022-10-12
Seasoned Squash Onion & Dill Recalled Due to Listeria Contamination
Renaissance Food Group is recalling 106 units of Seasoned Squash Onion & Dill due to detection of Listeria monocytogenes. Products were distributed to Alabama, Georgia, and South Carolina.
Product
Seasoned Squash Onion & Dill, NET WT, 10.5 OZ (297g), Dist. By: Renaissance Food Group LLC 4322 Moreland Ave. Conley, GA 30288, UPC 8 26766 19036 2
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0026-2023·2022-10-12
Steak Topper seasoning recalled for listeria monocytogenes contamination
Renaissance Food Group is recalling Steak Topper seasoning (7.5 oz units) due to positive test results for Listeria monocytogenes. The affected product was distributed in Alabama, Georgia, and South Carolina.
Product
Steak Topper, NET WT, 7.5 OZ (212g), Dist. By: Renaissance Food Group LLC 4322 Moreland Ave. Conley, GA 30288, UPC, 8 26766 19026 3
Category
Food
Distribution
0 states
SevereNHTSA·21V917000·2022-10-11
2022 Nissan Frontier Missing Tow Hitch Affects Fuel Tank Integrity
2022 Nissan Frontier Crew Cab Long Bed trucks lack an installed tow hitch, compromising fuel tank structural integrity. In a rear crash, the leaf spring could contact the fuel tank, risking fire or injury.
Product
NISSAN — 2022 NISSAN FRONTIER
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·21V830000·2022-10-10
2021-2022 Forest River XLR Toy Hauler Recalled for Missing Furnace Protective Panel
Forest River is recalling certain 2021-2022 XLR Toy Hauler recreational vehicles with a missing protective panel between the furnace and cargo area. The missing panel could allow cargo to contact furnace wiring, creating a fire hazard.
Product
FOREST RIVER — 2022 FOREST RIVER XLR TOYHAULER
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Food)·F-1791-2022·2022-10-05
Chocolate to Die For Premium Ice Cream recalled for undeclared peanuts
Belfonte Ice Cream's Chocolate to Die For Premium Ice Cream may contain undeclared peanuts. Affected products were sold at Hy-Vee, Cash Saver, Harps, Price Mart, and Heartland in Kansas City, Tulsa, Columbia, and Springfield areas.
Product
1.5 quarts (1.41 L) Chocolate to Die For Premium Ice Cream UPC: 83057 17049 Plant Code 29-050
Category
Food
Distribution
3 states
SevereFDA (Devices)·Z-1763-2022·2022-10-05
TANDEM LIFE controller software failures affecting cardiopulmonary bypass equipment nationwide
FDA recalls TANDEM LIFE LivaNova LIFESPARC Controllers due to critical software failures that cause the device to freeze, crash, or stop displaying data. The controllers are used in cardiopulmonary bypass procedures.
Product
TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-0045-2023·2022-10-05
Mother's Touch Complete Nutrition infant formula fails FDA conformance standards
Mother's Touch Complete Nutrition for New Babies infant formula is being recalled because it does not conform to FDA safety standards for infant formula sold in the United States.
Product
Mother's Touch Complete Nutrition for New Babies Net WT. 13.8 OZ (391.6g) packaged in a white plastic circular container, 6 units per case
Category
Food
Distribution
4 states