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.

25626–25650 of 32194

SevereFDA (Devices)·Z-1482-2014·2014-05-07
Hospira Recalls Acclaim Infusion Pumps Due to Broken Door Assemblies
Hospira is recalling 13,218 Abbott Acclaim Infusion Pumps because broken door assemblies may prevent the door from closing, potentially causing unrestricted flow or therapy delays.
Product
Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·14V235000·2014-05-07
Fiat 500e Recall: Coolant Leak May Cause Loss of Propulsion
Chrysler is recalling 2013-2014 Fiat 500e vehicles because a coolant leak in the power inverter module may cause a short circuit, leading to loss of propulsion and increased crash risk.
Product
FIAT — FIAT 500E
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1483-2014·2014-05-07
Hospira Acclaim Encore Infusion Pump Recall for Broken Door Assemblies
Hospira is recalling 13,218 Acclaim Encore infusion pumps because broken door assemblies may prevent proper closure, causing unrestricted flow or therapy delays.
Product
Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1270-2014·2014-05-07
B. Braun Recalls Sodium Chloride Injection Due to Particulate Matter
B. Braun Medical Inc. is recalling 0.9% Sodium Chloride Injection USP due to visible particulate matter found in reserve samples.
Product
0.9 % Sodium Chloride Injection USP, 1000 mL, Catalog No. S4000-SS, Rx Only, Sterile, Single Dose Container, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-4000-55
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1512-2014·2014-05-07
Hospira Recalls GemStar Docking Stations Due to Power and Voltage Issues
Hospira is recalling GemStar Docking Stations because they may cause infusion pumps to fail to power up or stop infusions due to voltage errors.
Product
GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX.
Category
Medical Device
Distribution
53 states
SevereNHTSA·14V234000·2014-05-07
Chrysler Recalls 2010-2014 Minivans for Vent Window Switch Fire Risk
Chrysler is recalling 2010-2014 Town and Country and Grand Caravan minivans because the vent window switch may overheat and cause a vehicle fire.
Product
DODGE — DODGE, CHRYSLER GRAND CARAVAN, TOWN AND COUNTRY
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1275-2014·2014-05-07
B. Braun Recalls Hyperlyte CR Injectable Due to Particulate Matter
B. Braun Medical Inc. is recalling Hyperlyte CR injectable products because visible particulate matter was found in reserve sample units.
Product
Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx Only, Sterile, B Braun Medical Inc., Irvine CA 92614-5895, In Canada Dist by: B Braun Medical Inc., Scarborough, Ontario M1H 2W4, NDC 0264-1943-20, Canada DIN 01924311
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1268-2014·2014-05-07
B. Braun Recalls Cefazolin Sodium Injectable Due to Particulate Matter
B. Braun Medical Inc. is recalling specific lots of Cefazolin Sodium injectable products because visible particulate matter was found in reserve sample units.
Product
CEFAZOLIN SODIUM — CEFAZOLIN SODIUM (CEFAZOLIN SODIUM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1272-2014·2014-05-07
B. Braun Recalls 15% Amino Acids Injection Due to Particulate Matter
B. Braun Medical Inc. is recalling 15% Amino Acids Injection products due to visible particulate matter found in reserve sample units.
Product
15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No. S3200-SS, Pharmacy Bulk Package, Not For Direct Infusion, For Intravenous Use, Sterile, Single Dose Container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-3200-55
Category
Drug
Distribution
Distributed nationwide
SevereUSDA FSIS·027-2014·2014-05-03
Schnucks Kitchen Recalls Curry Chicken Salad for Possible Listeria Contamination
Schnucks Kitchen is recalling approximately 130 pounds of Curry White Meat Chicken Salad due to possible Listeria monocytogenes contamination. The product was sold in five states.
Product
Missouri Firm Recalls Curry Chicken Salad for Possible Listeria Contamination
Category
Food
Distribution
5 states
SevereNHTSA·14V231000·2014-05-02
Federal Coach Recalls 2010 Spirit and Premier Buses for Fire Risk
Federal Coach is recalling 2010 Spirit and Premier buses because voltage spikes may damage door actuator circuit boards, increasing the risk of fire.
Product
FEDERAL COACH — FEDERAL COACH SPIRIT, PREMIER
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·14V229000·2014-05-02
Nissan Recalls 2014 Pathfinder, Rogue, and Infiniti QX60 for Loose Lug Nuts
Nissan is recalling 2014 Pathfinder, Rogue, and Infiniti QX60 vehicles because a right-side lug nut may not be properly tightened, posing a wheel separation risk.
Product
NISSAN — NISSAN, INFINITI PATHFINDER, QX60, ROGUE
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·14V228000·2014-05-01
Coach and Equipment Recalls 2013 Metro Lite and Phoenix Buses
Coach and Equipment is recalling 2013 Metro Lite and Phoenix buses because a wheelchair lift cable may cause a short circuit and fire.
Product
COACH AND EQUIPMENT — COACH AND EQUIPMENT METRO LITE, PHOENIX
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·14V227000·2014-05-01
Polaris Recalls Victory Motorcycles Due to Engine Seizure Risk
Polaris is recalling specific 2014-2015 Victory motorcycles because an engine defect may cause the engine to seize, increasing the risk of a crash.
Product
VICTORY — VICTORY GUNNER, VISION, VEGAS EIGHT BALL, BOARDWALK
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·14V224000·2014-04-30
GM Recalls 1.1 Million Vehicles for Transmission Shift Cable Fracture Risk
General Motors is recalling 1,131,113 vehicles due to a transmission shift cable that may fracture, causing unintended movement or rollaway.
Product
CHEVROLET — CHEVROLET, PONTIAC, SATURN MALIBU MAXX, MALIBU, G6, AURA
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·14E021000·2014-04-30
UCI-FRAM Recalls Ignition Switches for GM Vehicles Due to Stalling Risk
UCI-FRAM is recalling specific ignition switches used in GM vehicles because they may shift out of the run position, causing the engine to stall and disabling air bags.
Product
PONTIAC — PONTIAC, SATURN, CHEVROLET PURSUIT, ION, COBALT, SOLSTICE
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1481-2014·2014-04-30
RaySearch Ray Station Software Recalled for Dose Miscalculations
RaySearch Laboratories is recalling Ray Station software versions 2.0 through 4.0 due to dose miscalculations for support structures on CT images.
Product
RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1492-2014·2014-04-30
Ion Beam Applications Recalls Proteus 235 Proton Therapy System Software
Ion Beam Applications is recalling Proteus 235 Proton Therapy System Legacy Software due to incorrect dose rate calculations for non-zero beam line options.
Product
Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy
Category
Medical Device
Distribution
4 states
SevereFDA (Food)·F-1882-2014·2014-04-30
Natural Grocers Organic Black Peppercorns Recalled for Salmonella Risk
Natural Grocers by Vitamin Cottage is recalling Organic Black Peppercorns due to potential Salmonella contamination.
Product
Natural Grocers by Vitamin Cottage, Pepper Black Whole Organic, about 0.30 lb, UPC 201046804762, packaged in plastic bags.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1480-2014·2014-04-30
GE Healthcare Recalls MR Scanners Due to Gradient Coil Overheating Risk
GE Healthcare is recalling 1,546 MRI scanners worldwide because gradient coil connections may loosen, causing overheating, smoke, and potential fire.
Product
GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1883-2014·2014-04-30
Jolly Time Microwave Popcorn Recalled for Metal Fragment Contamination
American Pop Corn Co is recalling Jolly Time Microwave Popcorn due to potential contamination with stainless steel metal fragments.
Product
Jolly Time Microwave popcorn, Butter, 3/3-oz bags/carton. The cartons are packaged 12-cartons/case. Individual carton UPC 028190007876, on the 12-ct case - UPC 10028190007804 and 48-ct case UPC 128190487873 American Pop Corn Company, Sioux City, IA.
Category
Food
Distribution
22 states
SevereFDA (Devices)·Z-1484-2014·2014-04-30
Baxter Recalls Sigma Spectrum Volumetric Infusion Pumps Due to System Errors
Baxter Healthcare is recalling Sigma Spectrum Volumetric Infusion Pumps due to repeated System Error 322 occurrences.
Product
SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1252-2014·2014-04-30
Glycopyrrolate Injectable Recalled for Bacillus thuringiensis Contamination
Brookfield Prescription Center Inc. is recalling one lot of Glycopyrrolate solution for injection due to Bacillus thuringiensis contamination.
Product
Glycopyrrolate (MDV) 0.2 MG/ML Injectable, 5 mL Vials, Sterile Serum Vials/Sterile Syringes, for use by a licensed professional only, not for resale, MD Custom Rx, 19035 W Capitol Dr Ste 105, Brookfield, WI 53045.
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-1261-2014·2014-04-30
Hospira Recalls Potassium Chloride Vials Due to Particulate Matter
Hospira is recalling 255,900 vials of Potassium Chloride for Injection due to the presence of red and black particulate matter identified as iron oxide.
Product
Potassium Chloride for Inj. Concentrate, USP, 40 mEq (2 mEq/mL), 20 mL Single-dose Fliptop Vial, For IV use, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA
Category
Drug
Distribution
Distributed nationwide
SevereCPSC·14166·2014-04-30
White-Rodgers Recalls Home Heating and Cooling Thermostats Due to Fire Hazard
White-Rodgers is recalling about 740,000 digital thermostats in the U.S. and 403,000 in Canada because leaking batteries can cause a fire. Consumers should check for a battery icon on the screen to see if their unit is affected.
Product
Home Heating and Cooling Thermostats
Category
Consumer Product
Distribution
Distributed nationwide