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.

28026–28050 of 32242

SevereFDA (Food)·F-1576-2013·2013-07-03
See's Candies Recalls Dark and Milk Chocolate Covered Raisins for Allergen Risk
See's Candies is recalling 4,700 pounds of dark and milk chocolate covered raisins due to potential nut and egg residue.
Product
See's Dark Raisins: Ingredients: Raisins, Sugar,chocolate, cocoa butter, butter (milk), vanilla, soy lecithin, Dextrin, Confectionery glaze. May contain traces of eggs, tree nuts and peanuts. Sold in Net Wt. 8 oz (227 g) clear plastic packages or purchased by customer…
Category
Food
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-611-2013·2013-07-03
Hospira Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns
Hospira is voluntarily recalling 0.9% Sodium Chloride Injection in flexible containers due to possible leaking bags that may compromise sterility.
Product
0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC 0409-7983-30), b) 1000 mL (NDC 0409-7983-48), c) 250 mL (NDC 0409-7983-02), d) 150 mL (NDC 0409-7983-61), Rx Only, by Hospira, Inc., Lake Forest, IL 60045
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-616-2013·2013-07-03
Hospira Recalls 20% Dextrose Injection Due to Possible Leaking Bags
Hospira is voluntarily recalling 20% Dextrose Injection, USP, due to possible leaking bags that may compromise sterility.
Product
20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30), c) 1000 mL VisIV Container, (NDC 0409-7953-48), Rx Only, Hospira, Inc., Lake Forest, IL 60045
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-617-2013·2013-07-03
Hospira Recalls 0.9% Sodium Chloride Irrigation Due to Sterility Concerns
Hospira is voluntarily recalling 0.9% Sodium Chloride Irrigation bags due to possible leaking that compromises sterility.
Product
0.9% Sodium Chloride Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·13V293000·2013-07-03
Dutchmen Recalls 2013-2014 Travel Trailers Due to Propane Hose Fire Risk
Dutchmen is recalling 2013-2014 Aspen, Coleman, and Dutchmen travel trailers because heat from the range burner may melt the propane supply hose, increasing the risk of a fire.
Product
ASPEN TRAIL — ASPEN TRAIL, COLEMAN, DUTCHMEN TRAVEL TRAILER
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1576-2013·2013-07-03
Medtronic Recalls Sutureless Connector Intrathecal Catheters Due to Occlusion Risk
Medtronic is recalling 115,722 Sutureless Connector Intrathecal Catheters worldwide because the previous design has a greater potential for misalignment and occlusion.
Product
Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segment with length markings and guide wire, 66-cm pump segment, 15 T-gauge introducer needle, Transparent Strain-relief sleeves, Opaque Strain-relief sleeves, and V-wing anchors. Contents of inner package…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1559-2013·2013-07-03
BIMBO Bakeries Recalls Great Value Hamburger Buns Due to Metal Fragments
BIMBO Bakeries USA is recalling Great Value 8 Jumbo Hamburger Buns due to possible metal fragments from a faulty manufacturing part.
Product
Great Value 8 Jumbo Hamburger Buns Distributed By: Wal-Mart Stores, inc., Bentonville, AR 72716
Category
Food
Distribution
4 states
SevereFDA (Food)·F-1568-2013·2013-07-03
BIMBO Bakeries Recalls Whole Wheat Hamburger Buns Due to Metal Fragments
BIMBO Bakeries USA is recalling 12-count packs of Foodservice 100% Whole Wheat Hamburger Buns due to the possible presence of metal fragments caused by a faulty manufacturing part.
Product
Foodservice 100% Whole Wheat Hamburger Buns - 12 Ct Earthgrains Baking companies, Inc. Horsham, PA 19044
Category
Food
Distribution
4 states
SevereFDA (Devices)·Z-1571-2013·2013-07-03
Medtronic SynchroMed EL Pumps Recalled for Unintended Drug Delivery
Medtronic is recalling SynchroMed EL implantable pumps due to a risk of unintended drug delivery during the priming bolus function, which may cause overdose or underdose.
Product
Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion system that stores and delivers a…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-618-2013·2013-07-03
Hospira Recalls 1.5% Glycine Irrigation Due to Sterility Concerns
Hospira is voluntarily recalling 1.5% Glycine Irrigation, USP, 3000 mL, due to possible leaking bags that may compromise sterility.
Product
1.5% Glycine Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7974-08
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1560-2013·2013-07-03
BIMBO Bakeries USA Recalls Kerns Beef Buns Due to Metal Fragments
BIMBO Bakeries USA is recalling 812 cases of Kerns Beef Buns due to possible metal fragments from a faulty manufacturing part.
Product
Kerns Beef Buns - 12 count Distributed By: K-VA-T Food Stores, Inc., Arbingdon, VA 24210
Category
Food
Distribution
4 states
SevereNHTSA·13V292000·2013-07-03
Toyota Recalls 2012 Yaris Vehicles for Power Steering Defect
Toyota is recalling 2012 Yaris vehicles because a relay in the power steering system could short-circuit, disabling steering assistance and increasing crash risk.
Product
TOYOTA — TOYOTA YARIS
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1579-2013·2013-07-03
Medtronic SynchroMed II Pumps Recalled for Electrical Shorting Risk
Medtronic is recalling SynchroMed II pumps due to potential electrical shorting that may cause therapy loss or reduction.
Product
Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the…
Category
Medical Device
Distribution
0 states
SevereFDA (Food)·F-1569-2013·2013-07-03
BIMBO Bakeries Recalls Earthgrains Hamburger Buns Due to Metal Fragments
BIMBO Bakeries USA is recalling Earthgrains Food Service Hamburger Buns Wheat with Oat due to possible metal fragments from a faulty manufacturing part.
Product
Food Service Hamburger Buns Wheat with Oat 12 CT Earthgrains Baking companies, Inc. Horsham, PA 19044
Category
Food
Distribution
4 states
SevereFDA (Food)·F-1575-2013·2013-07-03
See's Candies Recalls Milk Raisins for Potential Nut and Egg Residue
See's Candies is recalling 5,814 pounds of Milk Raisins because they may contain undeclared nut or egg residues. The product was sold in 240 stores and 10 licensees nationwide.
Product
See's Milk Raisins: Ingredients: Raisins, Sugar, Cocoa butter, milk chocolate, soy lecithin, Vanillin, Dextrin, Confectionery glaze.May contain traces of eggs, tree nuts and peanuts Sold in Net Wt. 8 oz (227 g) clear plastic packages or purchased by customer at counter in…
Category
Food
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1574-2013·2013-07-03
Medtronic Recalls Intrathecal Catheter Pump Segment Revision Kits
Medtronic is recalling unused Model 8596SC Pump Segment Revision Kits due to a design flaw that increases the risk of catheter occlusion.
Product
Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 60-cm pump segment with attached sutureless pump connector, Spinal Segment Strain-relief sleeves, Pump segment strain-relief sleeves, Connector pin. Contents of inner package are STERILE. The…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-615-2013·2013-07-03
Hospira Recalls 5% Dextrose and 0.45% Sodium Chloride Injection Due to Sterility Concerns
Hospira Inc. is voluntarily recalling 74,256 units of 5% Dextrose and 0.45% Sodium Chloride Injection due to possible leaking bags that may compromise sterility.
Product
5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-48
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1558-2013·2013-07-03
BIMBO Bakeries Recalls Colonial Seeded Buns Due to Metal Fragments
BIMBO Bakeries USA is recalling Colonial 12 Seeded Enriched Buns due to possible metal fragments from a faulty manufacturing part.
Product
Colonial 12 Seeded Enriched Buns Sara Lee, Downers, Grove, IL 60515
Category
Food
Distribution
4 states
SevereFDA (Drugs)·D-612-2013·2013-07-03
Hospira Recalls 70% Dextrose Injection Due to Possible Leaking Bags
Hospira is voluntarily recalling 14,706 units of 70% Dextrose Injection USP due to possible leaking bags that may compromise sterility.
Product
70% Dextrose Injection USP, 2000 mL, Rx Only, by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7120-07
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-1572-2013·2013-07-03
Bimbo Bakeries Recalls Hamburger Buns Due to Possible Metal Fragments
Bimbo Bakeries USA is recalling food service hamburger buns due to the possible presence of metal fragments caused by a faulty manufacturing part.
Product
Hamburger Buns Bimbo Bakeries USA 255 Business Center Dr. Horsham, PA 19044 Food Service Hamburger Buns, Seeded and Unseeded, all counts:
Category
Food
Distribution
4 states
SevereFDA (Devices)·Z-1586-2013·2013-07-03
Medrad Recalls DC Power Cables for Veris MR Vital Signs Monitor
Medrad Inc is recalling 1,066 DC power cables for the Veris MR Vital Signs Monitor due to a design issue that could cause shorting and heating.
Product
DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-1554-2013·2013-07-03
Bimbo Bakeries Recalls Earthgrains Hot Dog Buns Due to Metal Fragments
Bimbo Bakeries USA is recalling 8,572 units of Earthgrains Hot Dog Buns due to possible metal fragments caused by a faulty manufacturing part.
Product
Hot Dog Buns 8 Count Earthgrains Baking companies, Inc. Horsham, PA 19044
Category
Food
Distribution
4 states
SevereFDA (Devices)·Z-1573-2013·2013-07-03
Medtronic Sutureless Pump Connector Revision Kit Recalled for Occlusion Risk
Medtronic is recalling Sutureless Pump Connector Revision Kits due to a design flaw that increases the risk of catheter occlusion.
Product
Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with attached sutureless pump connector, catheter, connector pin, and strain-relief sleeve to be used with Medtronic SynchroMed implantable drug infusion pumps. Contents of inner…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-614-2013·2013-07-03
Hospira Recalls 5% Dextrose Injection Due to Sterility Concerns
Hospira is voluntarily recalling 5% Dextrose Injection USP bags due to possible leaking that compromises sterility assurance.
Product
5% Dextrose Injection USP, a) 250 mL (NDC 0409-7922-02), b) 500 mL (NDC 0409-7922-30), by Hospira, Inc., Lake Forest, IL 60045
Category
Drug
Distribution
Distributed nationwide
SevereNHTSA·13V288000·2013-07-02
Chrysler Recalls 2013 RAM Trucks Due to Track Bar Bolt Defect
Chrysler is recalling 2013 RAM 4500 and 5500 trucks because an incorrect bolt may break, causing the vehicle to pull to one side and increasing crash risk.
Product
RAM — RAM 4500, 5500
Category
Vehicle
Distribution
Distributed nationwide