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.

15726–15750 of 29205

SevereFDA (Devices)·Z-2751-2017·2017-07-26
BD 3ml Syringes Recalled for Insufficient Sterilization Irradiation
Becton Dickinson is recalling 648,000 units of BD 3ml Syringes because several lots did not receive the specified dose of irradiation required to meet the Sterility Assurance Level.
Product
BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-2589-2017·2017-07-26
YouBar Chocolate Peanut Butter Bars Recalled for Listeria Risk
YouBar is recalling Chocolate Peanut Butter Whole Food Bars because cashew butter used in the product may contain Listeria monocytogenes.
Product
YouBar Whole Food Bar, Chocolate Peanut Butter; 1.58 oz. (45g); Gluten Free, Non GMO, Vegan; 12 bars per box Manufactured by YouBar Inc. Monterey Park, CA.
Category
Food
Distribution
0 states
SevereFDA (Drugs)·D-0995-2017·2017-07-26
PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns
PharMEDium Services is recalling specific lots of Potassium Phosphate in 5% Dextrose Injection due to a media fill failure that compromised sterility assurance.
Product
Potassium PHOSphate in 5% Dextrose Injection, 9 mMol in 50 mL in 50 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5310 NDC# 61553-310-41
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-2590-2017·2017-07-26
YouBar High Protein Bar Recalled for Potential Listeria Contamination
YouBar is recalling High Protein Bars, Vanilla Chocolate Chip, because the cashew butter used in the product is under recall for potential Listeria monocytogenes.
Product
YouBar High Protein Bar, Vanilla Chocolate Chip; 1.51 oz. (43 g) 2G sugar, Non GMO, Vegan, Superfood; Manufactured by YouBar Inc. Monterey Park, CA.
Category
Food
Distribution
0 states
SevereFDA (Food)·F-2594-2017·2017-07-26
YouBar Chocolate Almond Protein Bars Recalled for Listeria Risk
YouBar is recalling High Protein Bar Chocolate Almond bars because cashew butter used in the product is under recall for potential Listeria monocytogenes.
Product
YouBar High Protein Bar Chocolate Almond Bar. 12 bars per box 2 Grams Sugar, Non GMO, Vegan, Superfood 1.55 oz. (45g); 12 bars per box Manufactured by YouBar Inc. Monterey Park, CA.
Category
Food
Distribution
0 states
SevereFDA (Food)·F-2604-2017·2017-07-26
YouBar Wicked Maple Energy Bars Recalled for Listeria Risk
YouBar is recalling Wicked Maple Energy Bars because the cashew butter ingredient is under recall for potential Listeria monocytogenes contamination.
Product
All in Nutrition Wicked Maple Energy Bars 18 g protein, 9 g net carbs, Gluten Free, GMO Free, 100% natural 1.94 oz. (55g); YouBar Inc. Monterey Park, CA.
Category
Food
Distribution
0 states
SevereFDA (Drugs)·D-0997-2017·2017-07-26
PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns
PharMEDium Services is recalling specific lots of Potassium Phosphate in 5% Dextrose Injection because a media fill failure at the manufacturer raised concerns about sterility.
Product
Potassium PHOSphate in 5% Dextrose Injection, 15 mMol in 250 mL in 250 mL Intravia Bag Service, Rx Only. PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5300 NDC# 61553-300-11
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0986-2017·2017-07-26
PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns
PharMEDium Services is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride Injection due to a media fill failure that compromised sterility assurance.
Product
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL in 150 mL Intravia Bag (NDC 61553-288-48) Service Code: 2K5288, and b) 250 mL in 250 mL Intravia Bag (NDC 61553-281-11) Service Code: 2K5281, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-2596-2017·2017-07-26
YouBar Coconut Protein Bars Recalled for Listeria Risk
YouBar is recalling High Protein Coco-Coconut Protein Bars because the cashew butter ingredient is under recall for potential Listeria monocytogenes contamination.
Product
YouBar High Protein Coco-Coconut Protein Bar; Gluten Free, High Fiber, No Sugar added Bar. 12 bars per box 1.58 oz. (45g); 12 bars per box Manufactured by YouBar Inc. Monterey Park, CA.
Category
Food
Distribution
0 states
SevereFDA (Food)·F-2592-2017·2017-07-26
YouBar Protein Bars Recalled for Potential Listeria Contamination
YouBar is recalling High Protein Cherry Cashew Chia bars because the cashew butter ingredient is under recall for potential Listeria monocytogenes.
Product
YouBar, High Protein Cherry Cashew Chia; 3 G Sugar, Non GMO, Vegan, Superfood 1.44 oz. (41 g); 12 bars per box Manufactured by YouBar Inc. Monterey Park, CA.
Category
Food
Distribution
0 states
SevereFDA (Food)·F-2607-2017·2017-07-26
YouBar Cranberry Cashew Protein Bars Recalled for Listeria Risk
YouBar is recalling OutClass Nutrition Cranberry Cashew Protein Bars because the cashew butter ingredient is under recall for potential Listeria monocytogenes.
Product
OutClass Nutrition Cranberry Cashew Protein Bar; No Artifical Colors or flavors 2.15 oz. (65 g) YouBar Inc. Monterey Park, CA.
Category
Food
Distribution
0 states
SevereFDA (Food)·F-2599-2017·2017-07-26
YouBar Nancy's Nutrition Bar Recalled for Listeria Risk
YouBar is recalling Nancy's Nutrition Bars because the cashew butter ingredient may be contaminated with Listeria monocytogenes.
Product
Nancy Adler Nutrition Nancy's Nutrition Bar 1.58 oz. (45g); Please keep refrigerated Handmade by YouBar Inc. Monterey Park, CA.
Category
Food
Distribution
0 states
SevereFDA (Devices)·Z-2752-2017·2017-07-26
BD 10mL Syringes Recalled for Insufficient Sterilization Irradiation
Becton Dickinson is recalling 547,600 units of BD 10mL Syringes because several lots did not receive the specified dose of irradiation required to meet Sterility Assurance Level standards.
Product
BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0989-2017·2017-07-26
PharMedium Recalls Potassium Phosphate Injection Due to Sterility Concerns
PharMedium Services is recalling specific lots of Potassium Phosphate in 5% Dextrose Injection due to a media fill failure that compromised sterility assurance.
Product
Potassium PHOSphate in 5% Dextrose Injection, 30 mMol 500 mL in 500 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5283 NDC# 61553-283-03
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0994-2017·2017-07-26
PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns
PharMEDium Services is recalling specific lots of Potassium Phosphate Injection due to a media fill failure that compromised sterility assurance.
Product
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 9 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5286 NDC# 61553-286-48
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0992-2017·2017-07-26
PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns
PharMEDium Services is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride Injection because of a media fill failure that compromised sterility assurance.
Product
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7.5 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5298 NDC# 61553-298-48NDC# 61553-298-48
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-2601-2017·2017-07-26
YouBar Double Chocolate Protein Bars Recalled for Listeria Risk
YouBar is recalling Double Chocolate Protein Bars because the cashew butter ingredient is under recall for potential Listeria monocytogenes contamination.
Product
Rassel-Daigneault Family Chiropractic; Double Chocolate Protein Bar Paleo Friendly, 20 g or protein, Gluten Free JD-RDDC-WP-F-V1 2.56 oz. (70g); YouBar Inc. Monterey Park, CA.
Category
Food
Distribution
0 states
SevereFDA (Drugs)·D-0996-2017·2017-07-26
PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns
PharMEDium Services is recalling specific lots of Potassium Phosphate in 0.9% Sodium Chloride Injection due to a media fill failure at the manufacturer that raises concerns about sterility.
Product
Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL in 250 mL Intravia Bag Service Code 2K5290 NDC# 61553-290-11, b) 500 mL in 500 mL Intravia Bag Service Code 2K5285 NDC# 61553-285-03, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar…
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-2818-2017·2017-07-26
Evoke Organic Muesli Recalled Due to Listeria Contamination Risk
New England Natural Bakers is recalling Evoke Organic Muesli Athlete Fuel pouches due to potential Listeria monocytogenes contamination.
Product
Evoke Organic Muesli Athlete Fuel -12 oz .pouch UPC: 853305003029
Category
Food
Distribution
Distributed nationwide
SevereFDA (Food)·F-2605-2017·2017-07-26
YouBar Cherry Cashew Nutrition Bar Recalled for Listeria Risk
YouBar is recalling Cherry Cashew Nutrition Bars because the cashew butter ingredient may be contaminated with Listeria monocytogenes.
Product
The Only Bar Cherry Cashew, Nutrition Bar Gluten Free, Vegan, 9 grams of pant program, 100% Natural 1.55 oz. (44g); YouBar Inc. Monterey Park, CA.
Category
Food
Distribution
0 states
SevereFDA (Food)·F-2620-2017·2017-07-26
YouBar Recalls Zesty Lemon Cashew Protein Bars Due to Listeria Risk
YouBar is recalling Zesty Lemon Cashew protein bars because the cashew butter ingredient is under recall for potential Listeria monocytogenes contamination.
Product
Koona Positive Nutrition - Zesty Lemon Cashew; Plant Based protein Snack 2.11oz. (60 g) YouBar Inc. Monterey Park, CA.
Category
Food
Distribution
0 states
SevereFDA (Food)·F-2598-2017·2017-07-26
YouBar Nancy's Cookie Bars Recalled for Potential Listeria Contamination
YouBar is recalling Nancy's Cookie Bars because the cashew butter ingredient is under recall for potential Listeria monocytogenes contamination.
Product
Nancy Adler Nutrition Nancy's Cookie Bar 1.58 oz. (45g); Please keep refrigerated Handmade by YouBar Inc. Monterey Park, CA.
Category
Food
Distribution
0 states
SevereFDA (Drugs)·D-0985-2017·2017-07-26
PharMedium Recalls Succinylcholine Chloride Injection Due to Sterility Concerns
PharMedium Services is recalling specific lots of Succinylcholine Chloride Injection due to a media fill failure that compromised sterility assurance.
Product
Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL, 10 mL Total Volume in BD Syringe, For IV Use, PharMedium Services, LLC, Cleveland, MS --- NDC 61553-364-65
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-2615-2017·2017-07-26
YouBar Nutrifuel Protein Bars Recalled for Listeria Risk
YouBar is recalling Nutrifuel Chocolicious Nutrition Bars because cashew butter used in the product is under recall for potential Listeria monocytogenes.
Product
Nutrifuel - Chocolicious Nutrition Bar Gluten Free, All Natural, 10 g protein 1.58 oz. (45 g) YouBar Inc. Monterey Park, CA.
Category
Food
Distribution
0 states
SevereFDA (Drugs)·D-0988-2017·2017-07-26
PharMEDium Recalls Potassium Phosphate Injection Due to Sterility Concerns
PharMEDium Services is recalling specific lots of Potassium Phosphate Injection due to a media fill failure that raises concerns about sterility.
Product
Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 mMol in 100 mL in 150 mL Intravia Bag, Rx Only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 800-523-7749 Service Code 2K5287 NDC# 61553-287-48
Category
Drug
Distribution
Distributed nationwide