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.

28426–28450 of 32252

SevereFDA (Devices)·Z-1189-2013·2013-05-08
Philips HeartStart MRx Monitor/Defibrillator Recalled for Therapy Failure Risk
Philips is recalling HeartStart MRx Monitor/Defibrillators because they may fail to deliver defibrillation therapy in Manual Defib or AED mode.
Product
HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1373-2013·2013-05-08
Buffalo Trace Bourbon Fudge Sauce Recalled for Missing Allergen Labeling
Buffalo Trace Distillery is recalling 1,686 jars of Bourbon Fudge Sauce because the label failed to list milk and soy allergens.
Product
BUFFALO TRACE BOURBON FUDGE SAUCE 8 oz glass jars Net Wt. 8 fl. oz./227 g, PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail…
Category
Food
Distribution
27 states
SevereFDA (Food)·F-1375-2013·2013-05-08
Buffalo Trace Barbecue Sauce Recalled for Missing Soy and Anchovy Allergens
Buffalo Trace Distillery is recalling 16 fl. oz. jars of Original Flavor Barbecue Sauce because the label failed to list soy and anchovy allergens.
Product
BUFFALO TRACE ORIGINAL FLAVOR BARBEQUE SAUCE Net Wt. 16 fl. oz./532 ml PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: [email protected]…
Category
Food
Distribution
27 states
SevereNHTSA·13V182000·2013-05-08
Spartan Motorhome Chassis Recall for Steering Bracket Cracking
Spartan Motors is recalling 2006-2011 K2, K3, and MM motorhome chassis because steering brackets may crack and detach, causing loss of steering.
Product
SPARTAN — SPARTAN K3, MM, K2
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1191-2013·2013-05-08
Medtronic Recalls DBS Therapy Kits Due to Potential Lead Damage
Medtronic is recalling DBS Therapy for Dystonia Kits because the provided lead cap may damage the lead connector, potentially compromising the device.
Product
Medtronic DBS Therapy for Dystonia Kit, models 3317, 3319, 3337 and 3339. Sterile and Non-Pyrogenic. Product Usage: Dystonia Therapy Kit is indicated for unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) to aid in…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1169-2013·2013-05-08
Hospira GemStar Infusion Pumps Recalled for Unintended Shutdowns
Hospira Inc. is recalling GemStar infusion pumps because they may shut off during use without warning. The recall affects pumps distributed worldwide.
Product
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-308-2013·2013-05-08
Hospira Recalls Morphine Sulfate Injection Due to Sterility Concerns
Hospira Inc. is recalling 26,100 vials of Morphine Sulfate Injection because a loose crimp on the vial cap may compromise sterility.
Product
MORPHINE SULFATE — MORPHINE SULFATE (MORPHINE SULFATE)
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·13V185000·2013-05-08
Temsa Recalls TS35C Coach Buses Due to Fuel Tank Leak Risk
Temsa is recalling 172 model year 2011-2013 TS35C coach buses because a production error may cause the fuel tank to leak, posing a fire risk.
Product
TEMSA — TEMSA TS35C
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1159-2013·2013-05-08
Hospira Recalls GemStar Infusion Pumps Due to Battery Data Loss
Hospira Inc. is recalling GemStar infusion pumps because low battery levels can corrupt history logs and cause an error that prevents the device from being used.
Product
GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1368-2013·2013-05-08
Rich Products Recalls Farm Rich Pizza Dough Stuffed with Mozzarella
Rich Products Corp is recalling Farm Rich Stuffed Crust Pizza Dippers potentially contaminated with E. coli O121. The recall covers nationwide distribution.
Product
Farm Rich Stuffed Crust Pizza Dippers-Pizza Dough Stuffed with Mozzarella Cheese, Net Wt. 27-LBS (10 X 2.7-LB), UPC Code 10041322652659, Product Code 65265; Net Wt. 25-LB (1 X 25-LB) UPC Code 10041322652680, Product Code 65268.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1177-2013·2013-05-08
Maquet SERVO-i Ventilator Battery Modules Recalled for Shorter Run Time
Maquet is recalling SERVO-i ventilator battery modules because some units have shorter battery run times than expected.
Product
Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1190-2013·2013-05-08
Medtronic Recalls Deep Brain Stimulation Lead Kits Due to Damage Risk
Medtronic is recalling 30,000 Deep Brain Stimulation lead kits worldwide because the provided lead cap may damage the lead connector during use.
Product
Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system delivers electrical stimulation to selected targets in the brain. DBS Leads are indicated for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1367-2013·2013-05-08
Rich Products Recalls Mozzarella Bites for E. coli O121 Contamination
Rich Products Corp is recalling Mozzarella Bites potentially contaminated with E. coli O121. The recall covers 820,577 cases distributed nationwide.
Product
Mozzarella Bites distributed under the following labels: Farm Rich Cheese In a Pizzeria Style Crust, Product Code 36450 Net Wt. 22-oz bag-UPC Code 0 41322 37443 1; Product Code 37443 Net Wt. 22-oz bag-UPC Code 0 41322 37443 1; Product Code 37433 Net Wt. 22-oz bag-UPC Code 0…
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-1376-2013·2013-05-08
Buffalo Trace Hot Barbeque Sauce Recalled for Missing Allergen Labels
Buffalo Trace Distillery is recalling 16 fl. oz. jars of Hot Barbeque Sauce because the labels failed to list soy and anchovy allergens.
Product
BUFFALO TRACE HOT BARBEQUE SAUCE Net Wt. 16 fl. oz./532 ml PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: [email protected] website…
Category
Food
Distribution
27 states
SevereFDA (Food)·F-1374-2013·2013-05-08
Buffalo Trace Meat Marinade Recalled for Missing Wheat and Anchovy Allergens
Buffalo Trace Distillery is recalling 12 fl. oz. meat marinade bottles because the label failed to list wheat and anchovy allergens.
Product
BUFFALO TRACE MARINADE FOR MEAT Net Wt. 12 fl. oz. PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail: [email protected] website…
Category
Food
Distribution
27 states
SevereFDA (Food)·F-1370-2013·2013-05-08
Farm Rich Pizza Dippers Recalled for Potential E. coli O121 Contamination
Rich Products Corp is recalling Farm Rich Better For You Pizza Dippers nationwide due to potential E. coli O121 contamination.
Product
Farm Rich Better For You Pizza Dippers-Pizza Dough Stuffed with Reduced Fat Mozzarella Cheese, Net Wt 25-LBS (5 X 5-LB), UPC Code 10041322652338, Product Code 65233.
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1185-2013·2013-05-08
Medi-Trace Pediatric Defibrillation Electrodes Recalled for Arcing Risk
FDA is recalling Medi-Trace Cadence Pediatric Defibrillation Electrodes because arcing or sparking may damage the leadwire, preventing the device from delivering appropriate energy to patients.
Product
Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1160-2013·2013-05-08
Hospira Recalls GemStar Infusion Pumps Due to Battery Data Loss
Hospira is recalling GemStar infusion pumps because low battery levels can corrupt data and cause an error that prevents the device from being used.
Product
GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1372-2013·2013-05-08
Buffalo Trace Bourbon Flavored Caramel Sauce Recalled for Missing Milk Allergen Label
Buffalo Trace Distillery is recalling 1,504 jars of Bourbon Flavored Caramel Sauce because the label failed to list milk as an allergen.
Product
BUFFALO TRACE BOURBON FLAVORED CARAMEL SAUCE 8 oz glass jars Net Wt. 8 fl. oz./227 g, PRODUCED BY: APPLECREEK ORCHARDS LLC P.O. Box 8383 Lexington, KY 40533 BUFFALO TRACE DISTILLERY 113 Great Buffalo Trace Franklin County Frankfort, KY 40601 800-654-8471 e-mail…
Category
Food
Distribution
27 states
SevereFDA (Drugs)·D-309-2013·2013-05-08
Hospira Recalls Diazepam Injection Vials Due to Sterility Concerns
Hospira Inc. is recalling 172,350 vials of Diazepam Injection due to a loose crimp on the fliptop vial that compromises sterility assurance.
Product
DIAZEPAM — DIAZEPAM (DIAZEPAM)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1366-2013·2013-05-08
Wegmans Recalls Roasted Red Pepper Dip Due to Missing Allergen Labeling
Wegmans is recalling Roasted Red Pepper Dip because some containers have incorrect labels that fail to list milk and eggs.
Product
Wegmans Food You Feel Good About Roasted Red Pepper Dip, Net Wt 8 oz. (227g) Product is packaged in plastic containers, 12 containers per case. UPC: 77890 23286 with a best-by date of 5/17/2013. Commodity Code: 23286, Item #: DIPWG23286
Category
Food
Distribution
6 states
SevereFDA (Drugs)·D-311-2013·2013-05-08
Axara Recalls Well at Walgreens Antacid Liquid Due to E. Coli Contamination
Tarmac Products, Inc. is recalling specific lots of Well at Walgreens Regular Strength Antacid Liquid due to elevated microbial counts and E. Coli contamination.
Product
"Well at Wallgreens" Regular Strength Antacid Liquid (Alumina/Magnesia/Simethicone/Antacid & Anti Gas); Mint, a)12 oz bottle (NDC 0363-0073-02), b) 26 oz. bottle (NDC 0363-0073-26), Distributed by Walgreens CO., 200 Wilmot Rd, Deerfield, IL 60015.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1171-2013·2013-05-08
Newport Medical Instruments Recalls HT70 Ventilator Power Pac Batteries
Newport Medical Instruments is voluntarily recalling HT70 and HT70 Plus ventilator Power Pac batteries because they may cause the ventilator to alarm and switch to backup power sooner than expected.
Product
Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70 Plus. The HT70 and HT70 Plus ventilator systems are intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of…
Category
Medical Device
Distribution
39 states
SevereNHTSA·13V184000·2013-05-08
Autocar Recalls 2005-2013 Trucks Due to Missing Air Brake Drain Valves
Autocar is recalling 82 model year 2005-2013 ACX, WX, and WXLL trucks because their air brake systems lack required drain valves, potentially reducing brake performance.
Product
AUTOCAR — AUTOCAR WXLL, WX, ACX
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·13V179000·2013-05-07
Lion Bus Recalls One 2014 Model 360 Bus for Brake Line Chafing
Lion Bus is recalling one 2014 model year 360 bus because the air compressor and hydraulic brake lines may chafe, causing a hole in the brake line and increasing crash risk.
Product
LION — LION 360
Category
Vehicle
Distribution
Distributed nationwide