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.

15926–15950 of 29205

SevereFDA (Devices)·Z-2301-2017·2017-06-14
Arrow QuickFlash Radial Artery Catheterization Kit Recalled for Needlestick Risk
Arrow International is recalling QuickFlash Radial Artery Catheterization Kits because the packaged BD Eclipse Needle may disengage, posing a needlestick injury risk.
Product
QuickFlash(R) Radial Artery/Arterial Line Catheterization Kit The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-2271-2017·2017-06-14
High Liner Foods Recalls Lightly Breaded Cod Tail Portions for Undeclared Milk
ISF "USA", LLC is recalling High Liner Foods Lightly Breaded Cod Tail Portions due to undeclared milk. The recall affects 2,244 cases distributed within the United States.
Product
High Liner Foods, Lightly Breaded Cod Tail Portions 4 oz. and 5 oz
Category
Food
Distribution
0 states
SevereFDA (Devices)·Z-2270-2017·2017-06-14
Arrow International Recalls CVC Kits Due to Needlestick Injury Risk
Arrow International is recalling ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kits because packaged BD Eclipse Needles may disengage, posing a needlestick injury risk.
Product
ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit. The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It ma be inserted into the jugular, subclavian or femoral veins
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2276-2017·2017-06-14
Arrow Catheter Kits Recalled for Needlestick Injury Risk
Arrow International is recalling catheterization kits because the packaged BD Eclipse Needle has a safety cover that can disengage, causing needlestick injuries.
Product
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter, Sharps Safety Features, and Maximal Barrier Precautions The ARROWg+ard Blue Plus" antimicrobial catheter is indicated in the short-term ( < 30 days)…
Category
Medical Device
Distribution
Distributed nationwide
SevereUSDA FSIS·071-2017·2017-06-13
Joseph Seviroli Inc. Recalls Beef Ravioli Due to Undeclared Milk Allergen
Joseph Seviroli Inc. is recalling approximately 114,409 pounds of beef ravioli products because they contain undeclared milk, a known allergen.
Product
Seviroli Foods, LLC — Joseph Seviroli Inc. Recalls Beef Products Due to Misbranding and Undeclared Allergens
Category
Food
Distribution
4 states
SevereUSDA FSIS·070-2017·2017-06-13
OFD Foods Recalls Beef Hash Due to Possible Rubber Contamination
OFD Foods is recalling Mountain House freeze-dried beef hash due to possible rubber contamination. No illnesses have been reported.
Product
OFD Foods LLC — OFD Food, LLC. Recalls Beef Products Due to Possible Foreign Matter Contamination
Category
Food
Distribution
Distributed nationwide
SevereUSDA FSIS·069-2017·2017-06-10
Packer Avenue Foods Recalls Chicken Salad for Undeclared Milk Allergen
Packer Avenue Foods is recalling ready-to-eat chicken salad because it may contain undeclared milk, a known allergen. The products were distributed to five states.
Product
Packer Avenue Foods, Inc — Packer Avenue Foods, Inc. Recalls Ready-To-Eat Chicken Salad Due to Misbranding and Undeclared Allergens
Category
Food
Distribution
5 states
SevereUSDA FSIS·060-2017·2017-06-09
Advance Pierre Foods Recalls Chicken Tenders for Undeclared Milk Allergen
Advance Pierre Foods is recalling approximately 54,699 pounds of chicken tenders and breaded dark meat chicken products due to misbranding and undeclared milk allergens.
Product
AdvancePierre Foods, Inc. — Advance Pierre Foods, Inc. Recalls Chicken Tenders and Breaded Dark Meat Chicken Products Due to Misbranding and Undeclared Allergens
Category
Food
Distribution
6 states
SevereUSDA FSIS·067-2017·2017-06-09
Tyson Recalls Breaded Chicken Products Due to Undeclared Milk Allergen
Tyson Foods is recalling approximately 2.5 million pounds of ready-to-eat breaded chicken products because they may contain undeclared milk, a known allergen.
Product
Tyson Foods, Inc. — Tyson Foods Inc. Recalls Ready-To-Eat Breaded Chicken Products Due to Misbranding and Undeclared Allergens
Category
Food
Distribution
Distributed nationwide
SevereUSDA FSIS·068-2017·2017-06-09
Gourmet Boutique Recalls Breaded Chicken Products Due to Undeclared Milk Allergen
Gourmet Boutique LLC is recalling approximately 294,744 pounds of ready-to-eat breaded chicken products because they may contain undeclared milk, a known allergen.
Product
Gourmet Boutique, LLC — Gourmet Boutique LLC Recalls Ready-To-Eat Breaded Chicken Products Due to Misbranding and Undeclared Allergens
Category
Food
Distribution
Distributed nationwide
SevereUSDA FSIS·064-2017·2017-06-09
Pork King Sausage Recalls Raw Sausage Links for Undeclared Milk Allergen
Pork King Sausage, Inc. is recalling approximately 44,035 pounds of raw sausage link products because they may contain undeclared milk, a known allergen.
Product
Pork King Sausage, Inc. — Pork King Sausage, Inc. Recalls Raw Sausage Link Products Due to Misbranding and Undeclared Allergen
Category
Food
Distribution
13 states
SevereUSDA FSIS·063-2017·2017-06-08
Water Lilies Recalls Breaded Chicken for Undeclared Milk Allergen
Water Lilies Food Inc. is recalling approximately 4,335 pounds of ready-to-eat breaded chicken products because they may contain undeclared milk, a known allergen.
Product
Water Lilies Food, LLC — Water Lilies Food Inc., Recalls Ready-To-Eat Breaded Chicken Products Due to Misbranding and Undeclared Allergens
Category
Food
Distribution
10 states
SevereUSDA FSIS·061-2017·2017-06-08
Maid-Rite Recalls Beef Products Due to Undeclared Milk Allergen
Maid-Rite Specialty Foods is recalling approximately 174,000 pounds of beef products because they contain undeclared milk, a known allergen.
Product
Maid-Rite Specialty Foods, Inc — Maid-Rite Specialty Foods, LLC. Recalls Beef Products Due to Misbranding and Undeclared Allergens
Category
Food
Distribution
Distributed nationwide
SevereNHTSA·17V368000·2017-06-07
Porsche Recalls Panamera and Cayenne Models for Engine Stall Risk
Porsche is recalling specific 2010-2012 Panamera and 2011 Cayenne vehicles because loose camshaft controllers may cause the engine to stall, increasing crash risk.
Product
PORSCHE — PORSCHE PANAMERA S, PANAMERA 4S, PANAMERA TURBO, PANAMERA
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0877-2017·2017-06-07
SCA Pharmaceuticals Recalls Cefazolin Sodium Bags Due to Leaking
SCA Pharmaceuticals is recalling 70 bags of cefazolin sodium due to leaks at the seam, which compromises the product's sterility.
Product
ceFAZolin sodium added to 100 mL 0.9% Sodium Chloride injectable, 3g, Total Approximate Volume 115 mL, Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0524-32
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0879-2017·2017-06-07
SCA Pharmaceuticals Recalls Phenylephrine Injectable Bags Due to Leaking
SCA Pharmaceuticals is recalling 30 bags of Phenylephrine HCL injectable solution because the bags are leaking at the seam, compromising sterility.
Product
PHENYLephrine HCL in 0.9% Sodium Chloride injectable, 10 mg (Final Concentration = 0.1 mg per mL) Total Volume 100 mL, Single Dose Container bag, Preservative Free (Contains Sulfites), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0810-32
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-2253-2017·2017-06-07
Green Chile Foods Recalls Bean and Cheese Burritos for Listeria Risk
Green Chile Foods is voluntarily recalling specific bean and cheese burritos because they may be contaminated with Listeria monocytogenes.
Product
Bean & Cheese Burrito with Monterey Jack, Salsa, Green Chile, Rice, & Serrano Peppers!, Item # 484, Case UPC 8 33425 00086 3, Item UPC 8 83350 02411 3. Unit Size 8oz. Packaged in Paper Wrap sealed with Item Label, 12 units per case. Frozen or refrigerated.
Category
Food
Distribution
0 states
SevereFDA (Food)·F-2289-2017·2017-06-07
Mikawaya Recalls Mochi Ice Cream Due to Potential Peanut Allergen
Mikawaya is recalling Mochi Ice Cream Chocolate Chocolate because it may contain Chocolate Peanut Butter Ice Cream, posing a risk to individuals with peanut allergies.
Product
Mikawaya Mochi Ice Cream Chocolate Chocolate, 6-1.5oz (43g) pieces, Net Wt. 9.1oz (258g), UPC 070934990609, 24 boxes/case
Category
Food
Distribution
0 states
SevereFDA (Food)·F-2252-2017·2017-06-07
Green Chile Burritos Recalled for Potential Listeria Contamination
Green Chile Foods is recalling specific burritos due to potential Listeria monocytogenes contamination. Consumers should check their freezers and refrigerators for the affected product.
Product
Bean & Cheddar with Salsa, FIRE ROASTED Corn & Red Bell Pepper Burrito. MILD, Net WT 7oz, Item # 886, Case UPC 833425001464, Item UPC 8 33425 00336 9. Packaged in Paper Wrap sealed with Item Label, 12 units per case. Frozen or refrigerated.
Category
Food
Distribution
0 states
SevereFDA (Food)·F-2288-2017·2017-06-07
Northern Fisheries Recalls Tuna Steaks Due to High Histamine Levels
Northern Fisheries Ltd. is recalling frozen Tuna King Tuna Steaks because histamine levels were found above 50ppm. The product was distributed in Maryland, Ohio, and Rhode Island.
Product
Tuna King Tuna Steaks 10 oz.. ,10 lb Box. Frozen UPC Codes: 8158380206764
Category
Food
Distribution
3 states
SevereFDA (Food)·F-2260-2017·2017-06-07
FDA Recalls Smoked Trout Fillets Due to Listeria Contamination Risk
The Smokehouse of New York is recalling refrigerated smoked trout fillets because FDA testing found Listeria monocytogenes in the facility.
Product
Refrigerated, ready-to-eat, sliced, hot SMOKED TROUT fillets in 8 oz. vacuum packages -- KEEP REFRIGERATED-- 38 DEGREES F or Below --- THE SMOKEHOUSE OF NY, MAMARONECK, NY 10543
Category
Food
Distribution
7 states
SevereFDA (Drugs)·D-0871-2017·2017-06-07
SCA Pharmaceuticals Recalls Morphine Sulfate Injectable Bags Due to Leaking
SCA Pharmaceuticals is recalling 56 bags of morphine sulfate in 0.9% Sodium Chloride injectable because the bags are leaking at the seam, compromising sterility.
Product
morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100 mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-55
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0870-2017·2017-06-07
SCA Pharmaceuticals Recalls Morphine Sulfate Injectable Bags Due to Leaking
SCA Pharmaceuticals is recalling 80 bags of morphine sulfate injectable solution because the bags are leaking at the seam, compromising sterility.
Product
morphine sulfate in 0.9% Sodium Chloride injectable, 1 mg per mL, Total Volume 100 mL, Single Dose Container bag, (Total morphine Dose 100 mg/ 100mL), Preservative Free (Contains Sulfites), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, NDC 70004-0100-32.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-2290-2017·2017-06-07
La Nica Honduran Cheese Recalled for Listeria Contamination
La Nica Products is recalling 6,000 lbs of Queso Hondureno cheese due to Listeria monocytogenes contamination. The product was distributed in California.
Product
Queso Hondureno, Queso Duro Blando - Honduran Cheese, Dry Hard Cheese; 1 lb 454 g
Category
Food
Distribution
1 state
SevereFDA (Drugs)·D-0874-2017·2017-06-07
SCA Pharmaceuticals Recalls Fentanyl Injectable Bags Due to Sterility Concerns
SCA Pharmaceuticals is recalling fentanyl citrate injectable bags because they are leaking at the seam, which compromises sterility.
Product
fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL, Single Dose Container bag, (Total fentanyl Dose 2,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-203-32
Category
Drug
Distribution
Distributed nationwide