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.

11026–11050 of 29159

SevereFDA (Food)·F-0024-2020·2019-10-16
Lion Foods Recalls Crispy Fried Onions Due to Potential Metal Contamination
Lion Foods is recalling specific lots of Greenland and Chirag brand crispy fried onions due to potential metal contamination. The products were distributed in the US, Europe, and Canada.
Product
Greenland All Natural Gourmet Crispy Fried Onions NET WT 400g UPC 5415685068 packaged in foil bag then carton; Chirag Gourmet Crispy Fried Onion Net Weight 400 Grams/14 oz. UPC 6421832035 packaged in foil bag then carton
Category
Food
Distribution
2 states
SevereFDA (Food)·F-0037-2020·2019-10-16
Consider Bardwell Farm Goat Cheese Recalled for Listeria Risk
Consider Bardwell Farm is recalling Slyboro Handmade Goat Cheese because it may be contaminated with Listeria monocytogenes.
Product
Consider Bardwell Farm brand Slyboro Handmade Goat Cheese - Ingredients Raw Goat Milk, Cultures, Salt, Microbial Rennet - 2 lb Wheel - Consider Bardwell Farm, LLC 133 RTE. 153 W.Pawlet, Vermont 05775
Category
Food
Distribution
6 states
SevereNHTSA·19V735000·2019-10-16
Porsche Recalls Cayenne and Panamera for Brake Warning Defect
Porsche is recalling 2017-2020 Cayenne and Panamera vehicles because the instrument cluster may fail to warn drivers when brake pads are worn out.
Product
PORSCHE — PORSCHE CAYENNE, PANAMERA
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Food)·F-0042-2020·2019-10-16
Lipari Foods Recalls Premo Bologna & Cheese Wedges Due to Listeria
Lipari Foods is recalling Premo brand Bologna & Cheese Wedges because FDA environmental testing detected Listeria monocytogenes.
Product
Premo brand Bologna & Cheese Wedge, refrigerated 5 oz. wedge cut sandwich, UPC 612510093306.
Category
Food
Distribution
11 states
SevereFDA (Drugs)·D-0128-2020·2019-10-16
Sandoz Recalls Ranitidine Capsules Due to NDMA Impurity Detection
Sandoz is recalling 13,130 bottles of Ranitidine Hydrochloride Capsules 150mg because a trace amount of the impurity NDMA was detected.
Product
Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2855-05
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0127-2020·2019-10-16
Sandoz Recalls Ranitidine Capsules Due to NDMA Impurity
Sandoz is recalling specific lots of Ranitidine Hydrochloride Capsules 150mg because a trace amount of the impurity NDMA was detected.
Product
Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0038-2020·2019-10-16
Consider Bardwell Farm Dorset Handmade Cow Cheese Recalled for Listeria Risk
Consider Bardwell Farm is recalling Dorset Handmade Cow Cheese because the product may be contaminated with Listeria monocytogenes.
Product
Consider Bardwell Farm brand Dorset Handmade Cow Cheese - Ingredients Raw Cow Milk, Cultures, Salt, Microbial Rennet - 2.5 lb Wheel - Consider Bardwell Farm, LLC 133 RTE. 153 W.Pawlet, Vermont 05775
Category
Food
Distribution
6 states
SevereFDA (Devices)·Z-0118-2020·2019-10-16
TriMed Dorsal Wrist Hook Plate Recalled for Structural Integrity Issues
TriMed Inc. is recalling 5 Dorsal Wrist Hook Plates due to unqualified design modifications that may compromise structural integrity.
Product
TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonsterile, Single Use Only, Rx. The firm name on the label is TriMed, Santa Clarita, CA.
Category
Medical Device
Distribution
5 states
SevereFDA (Drugs)·D-0130-2020·2019-10-16
Morton Grove Recalls Prednisolone Sodium Phosphate Oral Solution Due to Impurity Failure
Morton Grove Pharmaceuticals is recalling Prednisolone Sodium Phosphate Oral Solution because it failed impurity specifications for Prednisolone Impurity 14.
Product
Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053. NDC 60432-212-08
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0049-2020·2019-10-16
Becton Dickinson Recalls CareFusion MaxPlus Clear Needleless Connectors
Becton Dickinson is recalling 115,200 CareFusion MaxPlus Clear Needleless Connectors because the valve may fail to close, posing risks of blood loss and air embolism.
Product
CareFusion MaxPlus Clear Needleless Connector. Intended for Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy Cat. No. MP1000-C
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·19V734000·2019-10-16
Airstream Atlas Motorhomes Recalled for Electrical Wiring Fire Risk
Airstream is recalling 2019-2020 Atlas motorhomes because incorrect wiring may cause overheating and fire. Dealers will correct the wiring free of charge.
Product
AIRSTREAM — AIRSTREAM ATLAS
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·19V732000·2019-10-15
BMW Recalls 2019-2020 330i and Z4 Models for Engine Bearing Defect
BMW is recalling 2019-2020 330i and 2019 Z4 vehicles because improperly installed counterbalance shaft bearings may loosen, causing severe engine damage and increasing crash risk.
Product
BMW — BMW Z4, 330I
Category
Vehicle
Distribution
Distributed nationwide
SevereUSDA FSIS·097-2019·2019-10-14
Kenosha Beef International Recalls Seasoned Beef Products Due to Metal Contamination
Kenosha Beef International is recalling seasoned beef products that may contain metal shavings. The recall affects restaurant distribution nationwide.
Product
Kenosha Beef International, Ltd. — Kenosha Beef International Recalls Seasoned Beef Products due to Possible Foreign Matter Contamination
Category
Food
Distribution
Distributed nationwide
SevereNHTSA·19V728000·2019-10-11
Arcimoto Recalls 2019 FUV Motorcycles Due to Tie Rod Separation Risk
Arcimoto is recalling 2019 FUV motorcycles because insufficient thread engagement in the tie rods could cause separation, leading to loss of steering and increased crash risk.
Product
ARCIMOTO — ARCIMOTO FUV
Category
Vehicle
Distribution
Distributed nationwide
SevereCPSC·20009·2019-10-10
Carrier Recalls Ductless Heat Pumps Due to Fire Hazard
Carrier is recalling specific ductless heat pumps because a fan motor failure can cause overheating and fire. No injuries have been reported.
Product
Carrier- and Bryant-branded 1.5-ton multi-zone, 4-ton multi zone and 4-ton single-zone ductless heat pumps
Category
Consumer Product
Distribution
Distributed nationwide
SevereNHTSA·19E068000·2019-10-10
Dorman Recalls Accelerator Pedal Assemblies for Acura and Honda Vehicles
Dorman is recalling specific accelerator pedal assemblies for Acura and Honda vehicles because the rotating portion may bind, increasing crash risk.
Product
ACURA — ACURA, HONDA MDX, ACCORD, RIDGELINE, CR-V
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·19V722000·2019-10-10
Western Star 4900 and 5700 Recall for Door Hinge Adhesive Failure
Daimler Trucks North America is recalling 2017-2020 Western Star 4900 and 5700 trucks because the adhesive bond on side doors may fail, allowing doors to separate from the vehicle.
Product
WESTERN STAR — WESTERN STAR 4900, 5700
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2593-2019·2019-10-09
Medtronic Recalls SHERPA NX Active Guiding Catheters Due to Material Loss
Medtronic Vascular is recalling 5 units of SHERPA NX Active Guiding Catheters because a defect may expose underlying stainless-steel braid wires.
Product
SHERPA NX ACTIVE GUIDING CATHETER, 6F, JR4.0, 90CM, 070", REF SA6JR40D. for cardiovascular use
Category
Medical Device
Distribution
0 states
SevereFDA (Drugs)·D-0049-2020·2019-10-09
FDA Recalls Fentanyl IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling 492 bags of fentanyl IV solution nationwide due to a lack of assurance of sterility.
Product
fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216282300
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0111-2020·2019-10-09
KRS Global Biotechnology Recalls Vitamin D Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 508 vials of Vitamin 10 D Lyophilized due to a lack of assurance of sterility. The product is distributed nationwide.
Product
Vitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678341
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0105-2020·2019-10-09
FDA Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns
KRS Global Biotechnology is recalling 3,820 syringes of Succinylcholine Chloride because the company cannot guarantee the product is sterile.
Product
SUCCinylcholine Chloride (PF), 200 mg/10 mL (20 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678416
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0091-2020·2019-10-09
KRS Global Biotechnology Recalls Quadmix #13A Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 91 vials of Quadmix #13A because the company cannot ensure the product is sterile.
Product
Quadmix #13A (Prostaglandin E1-0.3 mg / Papaverine HCl-200 mg / Phentolamine Mesylate-30 mg / Atropine Sulfate Monohydrate-0.375 mg / Vial) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678398
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0112-2020·2019-10-09
KRS Global Biotechnology Recalls Vitamin 5 B Vials Due to Sterility Concerns
KRS Global Biotechnology is recalling 616 vials of Vitamin 5 B for IM use because the company cannot ensure the product is sterile.
Product
Vitamin 5 B, 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674253
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0103-2020·2019-10-09
KRS Global Biotechnology Recalls Succinylcholine Chloride Syringes for Sterility Concerns
KRS Global Biotechnology is recalling 7,905 syringes of Succinylcholine Chloride (PF) due to a lack of assurance of sterility. The recall covers all lots remaining within expiry and is distributed nationwide.
Product
SUCCinylcholine Chloride (PF), 100 mg / 5 mL (20 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, For IV Use-Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678418
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0081-2020·2019-10-09
KRS Global Biotechnology Recalls Repinephrine IV Bags Due to Sterility Concerns
KRS Global Biotechnology is recalling 1,464 bags of Repinephrine in 0.9% Sodium Chloride due to a lack of assurance of sterility.
Product
NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678406
Category
Drug
Distribution
Distributed nationwide