Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. 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.

19251–19275 of 32115

SevereFDA (Food)·F-2217-2016·2016-09-21
General Mills Recalls Flour Products Linked to E. coli Outbreak
General Mills is recalling flour products due to a multistate E. coli O121 outbreak. The company states the bacteria has not been found in its products or facilities.
Product
5 lb Safeway Signature Kitchens Unbleached Flour All Purpose Enriched Note: Case uses BB (Best By) format, but consumer unit uses BIUB (Better/Best If Used By). Case UPC 100-21130-53022 Package UPC 000-21130-53022 Recalled BIUB MAY 27 17 Expanded Recall #2 7-25-16…
Category
Food
Distribution
6 states
SevereFDA (Food)·F-2258-2016·2016-09-21
SunOpta Recalls Sunflower Kernels for Listeria Contamination Risk
SunOpta is recalling various roasted and salted sunflower kernel products due to potential Listeria monocytogenes contamination. The recall covers multiple brands and package sizes distributed across the US and internationally.
Product
1. Roasted & Salted Sunflower Kernel, 0.7 oz plastic bag, Distributed by Newport Ingredients, Los Angeles, CA 90036; 2. Planters Sunflower Kernels, Net Wt 3 oz. (85g) plastic bag; 3. Dakota's Best! Biggy'z Roasted & Salted Kernels, Net Wt 16 oz (454g) plastic bag; 4.…
Category
Food
Distribution
31 states
SevereFDA (Food)·F-2215-2016·2016-09-21
General Mills Recalls Gold Medal Flour Due to E. coli O121 Outbreak Link
General Mills is recalling specific Gold Medal flour products due to a potential link to a multistate E. coli O121 outbreak, although the bacteria has not been found in the products.
Product
5 lb Gold Medal Unbleached Flour Case UPC 000-16000-12690 Package UPC 000-16000-19610 Recalled Better If Used By Dates 25MAY2017KC, 27MAY2017KC, 03JUN2017KC, 04JUN2017KC Expanded Recall: 19MAY2017KC through 24MAY2017KC, 11JUN2017KC, 12JUN2017KC Expanded Recall #2…
Category
Food
Distribution
6 states
SevereFDA (Food)·F-2208-2016·2016-09-21
Newly Weds Foods Recalls Flour Breader Due to E. Coli O121 Contamination
Newly Weds Foods is recalling bulk flour breader contaminated with E. Coli O121 from General Mills flour. The recall began on July 7, 2016.
Product
Bulk packaged flour based "breader" packaged in 25, 35, and 50 lb. bags.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-2289-2016·2016-09-21
General Mills Recalls Betty Crocker Cake Mix Due to E. coli O121 Risk
General Mills is recalling three flavors of Betty Crocker cake mix due to possible E. coli O121 contamination linked to a flour recall.
Product
Betty Crocker Super Moist Rainbow Bit Cake Mix,432 g, Package UPC, 1 00 65633 46589 0, Carton UPC 000-65633-46589.
Category
Food
Distribution
6 states
SevereFDA (Drugs)·D-1500-2016·2016-09-21
Hospira Recalls Dobutamine Injection Vials Due to Discoloration and Particulates
Hospira Inc. is recalling 24,000 vials of Dobutamine Injection due to reports of product discoloration and particulates. The affected lot was distributed nationwide and to Puerto Rico and the Bahamas.
Product
DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2025-20
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·16V678000·2016-09-20
New Flyer Recalls 2016 XN60 and XN40 Buses for CNG Defect
New Flyer is recalling 38 model year 2016 XN60 and XN40 transit buses because a pressure relief device may fracture, releasing high-pressure gas and increasing fire risk.
Product
NEW FLYER — NEW FLYER XN60, XN40
Category
Vehicle
Distribution
Distributed nationwide
SevereUSDA FSIS·084-2016·2016-09-20
Speedy Foods Recalls Chicken Spring Rolls Due To Undeclared Egg Allergen
Speedy Foods is recalling approximately 920 pounds of chicken spring rolls because they contain eggs, a known allergen not declared on the label.
Product
Speedy Foods LLC — Speedy Foods Recalls Chicken Spring Rolls Due To Misbranding And Undeclared Allergens
Category
Food
Distribution
2 states
SevereNHTSA·16V679000·2016-09-20
Ducati Recalls XDiavel Motorcycles for Loose Final Drive Pulley Nut
Ducati is recalling 2016-2017 XDiavel motorcycles because a loose final drive pulley nut may cause loss of power to the rear wheel, increasing crash risk.
Product
DUCATI — DUCATI XDIAVEL
Category
Vehicle
Distribution
Distributed nationwide
SevereUSDA FSIS·083-2016·2016-09-17
Gallo Meats Recalls Sausage, Beef, and Lamb Products Lacking Federal Inspection
Gallo Meats LLC is recalling approximately 82 pounds of sausage, beef, and lamb products produced without federal inspection. The hot Italian sausage may also contain undeclared allergens.
Product
Gallo Meats LLC. Recalls Sausage, Beef and Lamb Products Produced Without Benefit of Inspection
Category
Food
Distribution
Distributed nationwide
SevereUSDA FSIS·082-2016·2016-09-16
Bunge's Meats Recalls Pork Sausage Products Due to Water Contamination
Bunge's Meats is recalling pork sausage products made with water that failed EPA drinking water standards due to Coliform bacteria.
Product
Bunge's Meats Recalls Pork Products Formulated With Water That Did Not Meet EPA Drinking Water Standards
Category
Food
Distribution
1 state
SevereUSDA FSIS·081-2016·2016-09-16
Tucson Tamale Wholesale Recalls Beef Tamales Lacking Federal Inspection
Tucson Tamale Wholesale Company is recalling 915 pounds of beef tamales because the meat was produced without federal inspection. No illnesses have been reported.
Product
Tucson Tamale Wholesale Company LLC — Tucson Tamale Wholesale Company, LLC Recalls Beef Tamale Products Containing Meat Produced Without Benefit of Federal Inspection
Category
Food
Distribution
Distributed nationwide
SevereCPSC·16264·2016-09-15
Polaris Recalls Ranger 900 Vehicles Due to Fire and Burn Hazards
Polaris is recalling about 42,500 model year 2014 Ranger 900 vehicles because a heat shield can fall off, creating fire and burn risks.
Product
Polaris Ranger 900 recreational off-highway vehicles (ROVs)
Category
Vehicle
Distribution
Distributed nationwide
SevereCPSC·16265·2016-09-15
GE Profile Top-Loading Clothes Washers Recalled for Fire Hazard
GE Appliances is recalling about 222,000 Profile top-loading clothes washers because an electrical component can overheat and cause a fire.
Product
GE Profile™ top-loading clothes washers
Category
Consumer Product
Distribution
Distributed nationwide
SevereCPSC·16266·2016-09-15
Samsung Recalls Galaxy Note7 Smartphones Due to Fire and Burn Hazards
Samsung is recalling Galaxy Note7 smartphones sold before September 15, 2016, because the lithium-ion battery can overheat and catch fire, posing a burn hazard.
Product
Samsung Galaxy Note7 smartphones sold prior to September 15, 2016
Category
Consumer Product
Distribution
Distributed nationwide
SevereNHTSA·16V668000·2016-09-15
Chrysler Recalls Vehicles Due to Potential Airbag and Seat Belt Failure
Chrysler is recalling specific 2010-2014 models because a module may short circuit, preventing airbags and seat belt pretensioners from deploying in a crash.
Product
JEEP — JEEP, DODGE, CHRYSLER COMPASS, CALIBER, PATRIOT, SEBRING
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1487-2016·2016-09-14
Amerisource Health Services Recalls Mispackaged Amphetamine Extended-Release Capsules
Amerisource Health Services is recalling 126 cartons of amphetamine extended-release capsules due to unit dose mispackaging where blister cavities may contain multiple capsules.
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 15 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2701-2016·2016-09-14
MicroPort Advance II Modular Tibial Base Recalled for Component Loosening
MicroPort Orthopedics is recalling Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.
Product
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA50, SIZE 5 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 5 FEMUR & SIZE 5 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total…
Category
Medical Device
Distribution
0 states
SevereFDA (Drugs)·D-1498-2016·2016-09-14
Allergy Laboratories Recalls Ephedrine Sulfate Injection Due to Sterility Concerns
Allergy Laboratories is recalling Ephedrine Sulfate Injection vials because an FDA inspection raised concerns about product sterility.
Product
Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01); and b) 25 x 2 mL Vials (NDC 69053-008-02), Rx only, Manufactured for: Andersen Pharmaceutical, White Plains, NY 10605.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1489-2016·2016-09-14
Amerisource Health Services Recalls Mispackaged Amphetamine Extended-Release Capsules
Amerisource Health Services is recalling 115 cartons of 25 mg amphetamine extended-release capsules due to unit dose mispackaging where blister cavities may contain more than one capsule.
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules CII 25 mg 20 UD Capsules (5 x 4), Rx, Packaged and Distributed by: American Health…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2700-2016·2016-09-14
MicroPort Recalls Advance II Modular Tibial Bases Due to Component Loosening
MicroPort Orthopedics is recalling 77 Advance II Modular Tibial Bases because they are experiencing higher than expected revision rates due to component loosening.
Product
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA41, SIZE 4+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FEMUR & SIZE 4 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2696-2016·2016-09-14
MicroPort Advance II Modular Tibial Base Recalled for Component Loosening
MicroPort Orthopedics is recalling Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.
Product
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA21, SIZE 2+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2698-2016·2016-09-14
MicroPort Advance II Modular Tibial Base Recalled for Component Loosening
MicroPort Orthopedics is recalling Advance II Modular Tibial Bases due to a higher than expected revision rate caused by component loosening.
Product
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA31, SIZE 3+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 3 FEMUR & SIZE 3 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY,MicroPort Knee Systems Total Knee Systems MicroPort Total Knee…
Category
Medical Device
Distribution
0 states
SevereFDA (Drugs)·D-1482-2016·2016-09-14
Amerisource Recalls Mispackaged Amphetamine Tablets Due to Unit Dose Errors
Amerisource Health Services is recalling 2,276 cartons of 10 mg amphetamine tablets because blister cavities may contain more than one tablet.
Product
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 10 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2717-2016·2016-09-14
Aribex Recalls NOMAD Pro2 X-Ray Systems Due to Battery Fire Risk
Aribex Inc is recalling 16,871 NOMAD Pro2 X-Ray systems because internal lithium-ion batteries may short-circuit, causing overheating, smoke, or ignition.
Product
NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X-Ray System Black, Part Number 08500022; NOMAD Pro2 Vet Packaged X-Ray System, Part Number 08500023; NOMAD Pro2 Vet Packaged X-Ray System Black, Part Number 08500024; NOMAD Pro2 Packaged X-Ray System…
Category
Medical Device
Distribution
52 states