Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. 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.

4501–4525 of 4878

SevereFDA (Food)·F-0022-2022·2021-10-27
Kalona Supernatural Organic Whole Chocolate Milk Recall for Improper Pasteurization
Kalona Supernatural Organic Whole Chocolate Milk was distributed without proper pasteurization. The product was sold in 16 FL OZ, 32 FL OZ, and 64 FL OZ bottles across seven states.
Product
Kalona Supernatural Organic Whole Chocolate Milk, Manufactured in Iowa for Kalona Organics, LLC. Kalona IA in 16 FL OZ (UPC 8-81245-10516-9, 8 bottles per case) 32 FL OZ (UPC 8-81245-10532-9, 6 bottles per case) and 64 FL OZ (UPC8-81245-10564-0, 6 bottles per case)
Category
Food
Distribution
7 states
SevereCPSC·22009·2021-10-27
myCharge Powerbanks Recalled Due to Fire and Burn Hazards
myCharge is recalling approximately 67,000 powerbanks sold from August 2018 through December 2019 because the lithium-ion battery can overheat and ignite, posing fire and burn hazards. The company has received 30 overheating reports resulting in seven injuries and property damage.
Product
myCharge powerbanks
Category
Consumer Product
Distribution
Distributed nationwide
SevereFDA (Food)·F-0021-2022·2021-10-27
Kalona Supernatural Organic Half & Half Recalled for Improper Pasteurization
Farmers' All Natural Creamery LLC is recalling Kalona Supernatural Organic Half & Half in 16 FL OZ and 32 FL OZ bottles because the product was shipped without being properly pasteurized, creating a food safety risk.
Product
Kalona Supernatural Organic Half & Half, Manufactured in Iowa for Kalona Organics, LLC. Kalona IA in 16 FL OZ (UPC 8-81245-12516-7, 8 bottles per case) and 32 FL OZ (UPC 8-81245-12532-7, 6 bottles per case)
Category
Food
Distribution
7 states
SevereFDA (Food)·F-0056-2022·2021-10-27
Roasted Salted Cashew Halves and Pieces Recalled for Glass Contamination
Suntree Snack Foods, LLC is recalling 32 oz. jars of Roasted Salted Cashew Halves and Pieces because the product may contain glass pieces. Consumers who have purchased the affected product should stop consuming it.
Product
Roasted Salted Cashew Halves and Pieces, 32 oz. , UPC 072036734907. 6 jars/case.
Category
Food
Distribution
11 states
SevereFDA (Devices)·Z-0107-2022·2021-10-27
Infusion Pump Air Detector Malfunction May Prevent Alarm to Clinician
Smiths Medical CADD-Solis VIP ambulatory infusion pumps may fail to detect air in the infusion line and alert clinicians due to intermittent air-detector malfunction.
Product
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-01
Category
Medical Device
Distribution
1 state
SevereFDA (Drugs)·D-0014-2022·2021-10-27
Coppertone SPORT Sunscreen Spray recalled for benzene contamination
Beiersdorf Inc. is recalling Coppertone SPORT Sunscreen Spray 50 (1.6 oz cans) nationwide due to the presence of benzene, a known carcinogen. Affected lot TN00BU3 expires 05/31/2024.
Product
Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, NET WT 1.6 OZ (45 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 41100 00506 9
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0013-2022·2021-10-27
Coppertone SPORT MINERAL 50 Sunscreen Spray Recalled for Benzene Contamination
Beiersdorf Inc. is recalling Coppertone SPORT MINERAL 50 Sunscreen Spray due to the presence of benzene, a chemical contaminant. The recall affects 142,236 cans distributed nationwide.
Product
Coppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02870 1
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0063-2022·2021-10-27
Mountain Trail Mix Recalled for Potential Glass Contamination
Suntree Snack Foods is recalling Mountain Trail Mix (28 oz., UPC 814314024146, Lot 86960) because a customer reported finding glass pieces in the product. The affected cases were distributed to multiple states.
Product
Mountain Trail Mix, 28 oz. , UPC 814314024146. 6 bags/case.
Category
Food
Distribution
11 states
SevereFDA (Food)·F-0023-2022·2021-10-27
SunGarden Mung Bean Sprouts Recall for Listeria monocytogenes
SunGarden Mung Bean Sprouts (5lb and 10lb packages) are being recalled because the product tested positive for Listeria monocytogenes. The affected lots were distributed to a customer in Florida.
Product
SunGarden Mung Bean Sprouts 5lb & 10lb packaged in clear plastic bag in white cardboard box
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0064-2022·2021-10-27
Lightly Salted Cashew Halves & Pieces recalled for glass contamination
Suntree Snack Foods is recalling Lightly Salted Cashew Halves & Pieces (16 oz., UPC 842379195341) due to the presence of glass pieces in the product. The recall affects approximately 4,200 bags distributed across 11 states and Washington, D.C.
Product
Lightly Salted Cashew Halves & Pieces, 16 oz., UPC 842379195341. 6 bags/case.
Category
Food
Distribution
11 states
SevereFDA (Drugs)·D-0012-2022·2021-10-27
Coppertone Pure & Simple Baby Sunscreen Spray Recalled for Benzene Contamination
Beiersdorf Inc. is recalling Coppertone Pure & Simple Baby 50 Sunscreen Spray nationwide due to the presence of benzene, a chemical contaminant. Consumers should stop using affected products immediately.
Product
Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0023-2022·2021-10-27
AirDuo Digihaler 55/14 Inhalation Powder Recalled for Subpotent Dose
Teva Pharmaceuticals is recalling AirDuo Digihaler 55/14 inhalation powder due to subpotent emitted dose of salmeterol. Approximately 1,978 inhalers distributed nationwide may deliver less medication than labeled.
Product
AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC Frazer, PA 19355, Manufactured in Ireland, NDC 59310-111-06
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0020-2022·2021-10-27
Kalona Supernatural Organic Whipping Cream Recalled for Improper Pasteurization
Kalona Supernatural Organic Whipping Cream was shipped without proper pasteurization, creating a potential food safety risk. The recall affects 16 FL OZ and 32 FL OZ bottles distributed to retailers in multiple states.
Product
Kalona Supernatural Organic Whipping Cream, Manufactured in Iowa for Kalona Organics, LLC. Kalona IA in 16 FL OZ (UPC 8-81245-12016-2, 8 bottles per case) and 32 FL OZ (UPC 8-81245-12032-2, 6 bottles per case)
Category
Food
Distribution
7 states
SevereFDA (Food)·F-0057-2022·2021-10-27
Tropical Trail Mix recalled for glass contamination
Suntree Snack Foods is recalling Tropical Trail Mix (15 oz bags, UPC 072036735003) because the product may contain glass pieces. Affected lots were distributed across multiple southeastern and mid-Atlantic states.
Product
Tropical Trail Mix, 15 oz. , UPC 072036735003. 8 bags/case.
Category
Food
Distribution
11 states
SevereFDA (Devices)·Z-0091-2022·2021-10-27
Cardiosave Li-Ion battery pack recalled for insufficient runtime specification
Datascope Corp. is recalling Cardiosave Li-Ion battery packs that failed to meet minimum runtime requirements. These nonconforming batteries were inadvertently released to customers worldwide.
Product
Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numbers. 1. Cardiosave Hybrid. Model Numbers: 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-36, 099
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0007-2022·2021-10-20
Potassium Chloride Injection Recall Due to Sterility Assurance Lack
SSM Health Care St. Louis is recalling 385 bags of Potassium Chloride 40 mEq in 0.9% Sodium Chloride injection due to lack of assurance of sterility. The affected lot was distributed in Missouri.
Product
Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx Only, SSM Health Care Corporation, 1015 Bowles, Fenton, MO. NDC 60652-6429-1
Category
Drug
Distribution
1 state
SevereFDA (Devices)·Z-0067-2022·2021-10-20
FDA Recalls Ultrasound Gels and Lotions for Potential Bacterial Contamination
Ultrasound gels and lotions from National Distribution & Contracting Inc are being recalled due to potential bacterial contamination. About 25,103 units distributed nationwide and in Canada are affected.
Product
ECO 85CB Lotion Ultrasound 8.5 oz 24/cs ECO 40JBC Gel Ultrasound Transmission Clr 8.5 oz BTL 24/cs ECO 40JMC Gel Ultrasound Transmission Clr 5L 4/cs NDC P301008 ProAdvantage Gel Ultrasound Transmission 8.5 oz 12/cs NDC P301105 ProAdvantage Gel Ultrasound Transmission 5 Liter
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0005-2022·2021-10-20
Abbott Alinity m Resp-4-Plex Respiratory Diagnostic Kit Recalled for False Positive Results
Abbott is recalling the Alinity m Resp-4-Plex AMP Kit, an in vitro diagnostic used for respiratory pathogen testing, due to potential for false positive results affecting approximately 8,469 units distributed worldwide.
Product
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0068-2022·2021-10-20
Ultrasound gel products recalled for potential bacterial contamination
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. Products distributed nationwide in the U.S., Canada, and other locations have been recalled.
Product
ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0009-2022·2021-10-20
Glucagon Emergency Kit Recall: Subpotent Drug in Vials
Eli Lilly is recalling Glucagon Emergency Kits (Lot #D239382D, expiration April 2022) because some vials contain liquid instead of powder and do not deliver the full expected drug effect when administered.
Product
Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe. Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285; Glucagon, NDC: 0002-8031-01
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0089-2022·2021-10-20
FDA recalls Eco-Med ultrasound gels due to bacterial contamination risk
FDA recalls ultrasound gels manufactured by Eco-Med Pharmaceutical due to possible bacterial contamination. Healthcare providers and facilities should stop use immediately.
Product
EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0004-2022·2021-10-20
Abbott SARS-CoV-2 Diagnostic Kit Recalled for Risk of False Positive Results
Abbott Molecular is recalling 60,563 units of the Alinity m SARS-CoV-2 Amp Kit due to potential false positive test results. The affected kits were distributed worldwide from September 2021 through January 2023.
Product
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0006-2022·2021-10-20
Abbott Alinity m SARS-CoV-2 Amp Kit Recalled for Potential False Positive Results
Abbott Molecular has recalled 71,314 units of the Alinity m SARS-CoV-2 Amp Kit due to potential false positive results. The kit was distributed worldwide.
Product
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0088-2022·2021-10-20
Eco-Med Ultrasound Gel Recalled for Bacterial Contamination Risk
Eco-Med Pharmaceutical's ultrasound gel products are recalled due to potential bacterial contamination. The FDA advises healthcare providers to stop using the affected product.
Product
EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Food)·F-0015-2022·2021-10-20
Frozen vegan crabcakes recalled for undeclared egg allergen
Cuisine Innovations Unlimited, LLC is recalling Vemondo Vegan Crabless Mini Crabcakes sold at Lidl due to undeclared egg. The product may pose a risk to consumers with egg allergies.
Product
Vemondo Vegan Crabless Mini Crabcakes by Lidl 8.5 OUNCES (240g) coated paper box ten (10) packages per case. Frozen.
Category
Food
Distribution
3 states