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.

13426–13450 of 29188

SevereFDA (Drugs)·D-0099-2019·2018-10-31
Teva Recalls Metformin Hydrochloride Extended Release Tablets Due to Defective Delivery System
Teva Pharmaceuticals USA is recalling 3,397 bottles of Metformin Hydrochloride Extended Release Tablets, 500 mg, because some tablets may be missing laser drilling, which could affect drug release.
Product
Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 00591-2411-01
Category
Drug
Distribution
0 states
SevereFDA (Devices)·Z-0202-2019·2018-10-31
Boston Scientific Recalls Maestro 4000 Cardiac Ablation Systems Due to RF Energy Issue
Boston Scientific is recalling Maestro 4000 Cardiac Ablation Systems because radiofrequency energy may continue to deliver after the foot switch is released.
Product
Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,
Category
Medical Device
Distribution
46 states
SevereFDA (Drugs)·D-0098-2019·2018-10-31
Teva Recalls Fortamet Extended-Release Tablets Due to Defective Delivery System
Teva Pharmaceuticals USA is recalling specific lots of Fortamet (metformin HCl) extended-release tablets because some may lack laser drilling, potentially affecting drug release.
Product
Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham Park, NJ 07932, NDC 59630-575-60
Category
Drug
Distribution
0 states
SevereNHTSA·18V770000·2018-10-31
Forest River Recalls 2018-2019 Buses and RVs for Brake Bolt Issue
Forest River is recalling 2018-2019 Berkshire RVs and StarTrans/Glaval buses because brake caliper mounting bolts may be insufficiently tightened, increasing crash risk.
Product
STARTRANS — STARTRANS, FOREST RIVER, GLAVAL BUS PS2, BERKSHIRE, LEGACY
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0236-2019·2018-10-31
GE Medical Systems Recalls Signa Architect MRI Scanners Due to Burn Risk
GE Medical Systems is recalling four Signa Architect MRI scanners because a small area on the bore surface can get warm enough to cause a serious burn if proper padding is not used.
Product
SIGNA Architect system Product Usage: The Signa Architect system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0093-2019·2018-10-31
RemedyRepack Recalls Amlodipine/Valsartan HCTZ Tablets Due to NDMA Contamination
RemedyRepack Inc. is recalling Amlodipine/Valsartan HCTZ tablets due to trace amounts of NDMA detected in the active ingredient.
Product
Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0094-2019·2018-10-31
Heritage Pharmaceuticals Recalls Cidofovir Dihydrate Injection Due to Sterility Concerns
Heritage Pharmaceuticals is recalling Cidofovir Dihydrate Injection due to complaints of dried powder on the outside of the bottle, which raises concerns about the product's sterility.
Product
CIDOFOVIR DIHYDRATE — CIDOFOVIR DIHYDRATE (CIDOFOVIR DIHYDRATE)
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0090-2019·2018-10-31
Westlab Pharmacy Recalls ADAA Cataract Drops Due to Process Control Issues
Westlab Pharmacy is recalling 222 syringes of ADAA Cataract Drops nationwide due to a lack of process controls.
Product
ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide 0.0735%, Moxiflox 0.0294%, Ketorolac 0.0147%) 1x 1cc syringe, Westlab Pharmacy, Inc., Gainesville, FL 32607 --- NDC 10002-2579-05
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0237-2019·2018-10-31
McCain Foods Recalls Fire Roasted Diced Tomatoes Due to Listeria and Salmonella
McCain Foods USA is recalling Fire Roasted 1/2" Diced Tomatoes because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.
Product
Fire Roasted 1/2" Diced Tomatoes; Sold in 25 lb. containers. Brand Name: Jon-Lin¿
Category
Food
Distribution
0 states
SevereUSDA FSIS·107-2018·2018-10-31
Procesadora La Hacienda Recalls Corned Beef Due to Foreign Matter
Procesadora La Hacienda, Inc. is recalling ready-to-eat corned beef products that may contain soft plastic or metal. The products were distributed to institutions in Puerto Rico.
Product
Procesadora La Hacienda, Inc. — Procesadora La Hacienda, Inc., Recalls Beef Products due to Possible Foreign Matter Contamination
Category
Food
Distribution
1 state
SevereFDA (Food)·F-0233-2019·2018-10-31
McCain Foods Recalls Fire-Roasted Diced Onions Due to Listeria and Salmonella
McCain Foods USA is recalling Fire-Roasted 1/2" Diced Onions because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella.
Product
Fire-Roasted 1/2" Diced Onions; Sold in 25 lb. containers. Brand Name:Jon-Lin¿
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0068-2019·2018-10-31
Cedar's Chickpea Salad Recalled for Undeclared Soy Allergen
Cedar's Mediterranean Foods is recalling 8oz containers of Chickpea Salad because the product may contain undeclared edamame (soy).
Product
Cedar's Chickpea Salad, packaged in an 8oz plastic container, UPC: 044115337767. Product is refrigerated.
Category
Food
Distribution
30 states
SevereFDA (Devices)·Z-0198-2019·2018-10-31
Bovie J-Plasma Precise 360 Handpiece Recalled for Tip Separation Risk
Bovie Medical Corporation is recalling J-Plasma Precise 360 handpieces because the PEEK tip may separate and remain in patient tissue.
Product
J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparascopic surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0091-2019·2018-10-31
Westlab Pharmacy Recalls Cyclosporine Eye Drops Due to Process Control Issues
Westlab Pharmacy is recalling Cyclosporine 1% Human Eye Drops due to a lack of process controls. The recall covers nationwide distribution.
Product
Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-2776-92
Category
Drug
Distribution
Distributed nationwide
SevereUSDA FSIS·108-2018·2018-10-31
O Sole Mio Recalls Chicken Tortellini Produced Without Inspection
Les Aliments O Sole Mio, Inc. is recalling approximately 3,880 pounds of chicken tortellini produced without the benefit of inspection by the Canadian Food Inspection Agency.
Product
Les Aliments O Sole Mio, Inc., Recalls Poultry Products Produced without Benefit of Inspection
Category
Food
Distribution
5 states
SevereFDA (Food)·F-0256-2019·2018-10-31
McCain Recalls Fire Roasted Diced Button Mushrooms Due to Listeria and Salmonella
McCain Foods USA is recalling Fire Roasted 1/2" Diced Button Mushrooms because finished product was released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.
Product
Fire Roasted 1/2" Diced Button Mushrooms: Sold in 25 lb. containers. Brand Name: Jon-Lin¿
Category
Food
Distribution
0 states
SevereNHTSA·18V769000·2018-10-31
Suzuki Recalls 2010-2013 Kizashi Vehicles for Fuel Tank Fire Risk
Suzuki is recalling 2010-2013 Kizashi vehicles because dust in the vent line may crack the fuel tank, increasing the risk of a fuel leak and fire.
Product
SUZUKI — SUZUKI KIZASHI
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Food)·F-0065-2019·2018-10-31
Ladyfingers Ham Rolls Recalled for Possible Listeria Contamination
Ladyfingers Catering is recalling 50,627 packages of Shaved Country Ham Rolls due to potential Listeria monocytogenes contamination.
Product
LADYFINGERS GOURMET TO GO SIGNATURE SHAVED COUNTRY HAM ROLLS; ONE DOZEN PER PACKAGE (15oz - 425 grams); ALLERGEN INFORMATION: CONTAINS WHEAT, PRODUCED IN FACILITY THAT PROCESSES PEANUTS AND TREE NUTS. www.ladyfingersofraleigh.com; 919-828-2270; 627 East Whitaker Mill Rd Raleigh…
Category
Food
Distribution
8 states
SevereFDA (Drugs)·D-0097-2019·2018-10-31
Teva Recalls Paliperidone Extended Release Tablets Due to Missing Laser Drilling
Teva Pharmaceuticals USA is recalling 3,785 bottles of Paliperidone Extended Release Tablets 9 mg because some tablets may be missing laser drilling, which could affect drug release.
Product
Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0591-3695-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054
Category
Drug
Distribution
0 states
SevereFDA (Food)·F-0207-2019·2018-10-31
McCain Corn and Black Bean Blend Recalled for Listeria and Salmonella
McCain Foods USA is recalling Corn and Black Bean Blend sold in 2 lb. and 25 lb. packages due to potential Listeria monocytogenes and Salmonella contamination.
Product
Corn and Black Bean Blend: Sold in 2 lb. and 25 lb. packages. Brand Name: Jon-Lin¿ NatureSmart¿; Jon-Lin¿, Chef Sensations¿
Category
Food
Distribution
0 states
SevereFDA (Food)·F-0219-2019·2018-10-31
McCain Recalls Fire Roasted Diced Yellow Peppers Due to Listeria and Salmonella
McCain Foods USA is recalling Fire Roasted 1/2" Diced Yellow Peppers because products were released after presumptive positive tests for Listeria monocytogenes and Salmonella without confirmation.
Product
Fire Roasted 1/2" Diced Yellow Peppers: Sold in 25 lb. Brand Name: Jon-Lin¿
Category
Food
Distribution
0 states
SevereFDA (Drugs)·D-0095-2019·2018-10-31
Pfizer Recalls Meropenem Injection Due to Loss of Sterility Assurance
Pfizer is recalling 71,075 vials of Meropenem for Injection because the containers may have lost integrity, compromising sterility.
Product
Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL 60045, USA. NDC carton: 0409-3506-01; NDC vial: 0409-3506-11
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Food)·F-0053-2019·2018-10-31
Sprout Creek Farm Recalls Margie Cheese Due to Improper Pasteurization
Sprout Creek Farm is recalling Margie Cheese because it was not properly pasteurized. The product was distributed in New York.
Product
Margie Cheese, Pasteurized Cow's Milk Cheese, Sprout Creek Farm Poughkeepsie, NY 12603 Plant # 36-8436
Category
Food
Distribution
1 state
SevereFDA (Devices)·Z-0185-2019·2018-10-31
Alcon Recalls CyPass Micro-Stent Due to Endothelial Cell Loss
Alcon Research is recalling CyPass Micro-Stent devices because long-term study data showed statistically significant endothelial cell loss in patients.
Product
CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·18V762000·2018-10-30
Altec Recalls 2009 Aerial Devices Due to Riser Assembly Cracking Risk
Altec Industries is recalling 2009 LSS 60 and LSS 70 Elevator Aerial devices because the elevator riser assembly may crack and fail, increasing the risk of injury or death.
Product
ALTEC — ALTEC AERIAL DEVICE
Category
Vehicle
Distribution
Distributed nationwide