The Recall Desk

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.

4451–4475 of 29102

  • SevereFDA (Devices)·Z-2372-2023·2023-08-23

    FDA Recalls MAHURKAR Dialysis Catheters Over Obstruction Defect Risk

    Covidien's MAHURKAR dialysis catheters are recalled due to excessive lubricant on the catheter tip causing partial or complete obstruction. This risks delaying treatment and may cause blood clots, hemolysis, or embolism.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 8888102004HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2377-2023·2023-08-23

    Acute Dialysis Catheters Recalled for Catheter Tip Occlusion

    Covidien recalls 519 MAHURKAR acute dialysis catheters (Lot 2200400292) due to excessive silicone lubricant coating the catheter tip that may cause partial or full occlusion and treatment delays.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, PASS Tray REF: 8888104004HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2411-2023·2023-08-23

    Alcon Custom Pak Intraocular Lens Packages Recalled for Plastic Debris Risk

    Alcon Custom Pak intraocular lens packages are recalled due to reports of patient injury during surgical procedures caused by plastic debris from over-tightening with the included plastic wrench.

    Product
    Alcon Custom Pak
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2374-2023·2023-08-23

    Dialysis Catheter Recall: Center Lumen Occlusion Due to Excessive Lubricant

    Covidien LP is recalling MAHURKAR 12 Fr dialysis catheters due to center lumen occlusion from excessive lubricant. The defect may cause treatment delays and serious complications including embolism and thrombosis.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, PASS Tray REF: 8888103002HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2408-2023·2023-08-23

    Infinity FMS Pak surgical device recalled for plastic debris hazard

    Alcon is recalling the Infinity FMS Pak surgical device after reports of patient injuries during procedures caused by plastic debris from over-tightening the included wrench. The recall affects 51,054 units distributed worldwide.

    Product
    Infinity FMS Pak
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2386-2023·2023-08-23

    MAHURKAR dialysis catheters recalled for center lumen occlusion risk

    Covidien LP recalls MAHURKAR dialysis catheters due to excessive silicone lubricant on the catheter tip, which can obstruct the center lumen. This may delay treatment and cause serious blood complications including embolism and thrombosis.

    Product
    MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF: 8888345611
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2367-2023·2023-08-23

    Covidien MAHURKAR Dialysis Catheter Recalled for Lumen Occlusion Risk

    Covidien is recalling dialysis catheters with excessive lubricant in the center lumen, which may cause occlusion, obstruct blood flow, and delay treatment.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2381-2023·2023-08-23

    MAHURKAR Dialysis Catheter Recalled for Excessive Lubricant Causing Occlusion

    The MAHURKAR dialysis catheter is recalled because excessive silicone lubricant can obstruct the center lumen, potentially delaying critical dialysis treatment.

    Product
    MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit REF: 8888340637HP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V591000·2023-08-22

    Harley-Davidson Softail Motorcycles Recalled for Faulty Shock Absorber Fastener

    Harley-Davidson is recalling certain 2018–2023 Softail motorcycles where a fastener securing the rear shock absorber may break, causing tire damage and loss of tire pressure. This can lead to loss of vehicle control and increased crash risk.

    Product
    HARLEY-DAVIDSON — HARLEY-DAVIDSON FXLRS, FXLRST, FXRST, FLHC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V588000·2023-08-17

    2023 Honda Accord and CR-V Hybrid transmission defect can cause power loss

    Honda is recalling certain 2023 Accord Hybrid and CR-V Hybrid vehicles because the electronic continuously variable transmission (e-CVT) may have been improperly manufactured, potentially resulting in loss of drive power and increased crash risk.

    Product
    HONDA — HONDA ACCORD HYBRID, CR-V HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23783·2023-08-17

    Ubio Labs power banks recalled due to fire hazard

    Costco is recalling approximately 350,000 Ubio Labs power banks (model PWB1071) that can overheat and ignite. The company has received three fire reports, including one on a commercial flight with four smoke inhalation reports and one minor burn injury.

    Product
    Ubio Labs power banks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1380-2023·2023-08-16

    Member's Mark Breaded Mozzarella Sticks Recalled for Undeclared Egg and Soy

    Member's Mark Breaded Mozzarella Sticks are being recalled because they contain undeclared egg and soy allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    Member's Mark brand BREADED MOZZARELLA STICKS; 72 STICKS; 2 RESEALABLE BAGS INCLUDED; NET WT 5 LB (2.26 kg); UPC 078742226880
    Category
    Food
    Distribution
    5 states
  • SevereCPSC·23262·2023-08-16

    Gree Recalls 1.56 Million Dehumidifiers Due to Fire and Burn Hazards

    Gree is recalling approximately 1.56 million dehumidifiers sold under brand names including GE, Kenmore, SoleusAir, Seabreeze, and Norpole because they can overheat, smoke, and catch fire, creating fire and burn hazards.

    Product
    Dehumidifiers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1382-2023·2023-08-16

    Vans Gluten-Free Original Waffles Recalled for Undeclared Wheat

    Vans gluten-free original waffles are being recalled because they contain undeclared wheat. Consumers with wheat allergies should not consume this product.

    Product
    Vans gluten free ORIGINAL WAFFLES, NET WT. 9 OZ (255G), INGREDIENTS: GLUTEN FREE BLEND (BROWN RICE FLOUR, POTATO STARCH, RICE FLOUR, SOYFLOUR), WATER, EXPELLER PRESSED CANOLA OIL***CONTAINS SOY***DISTRIBUTED BY: VAN'S INTERNATIONAL FOODS OAKBROOK TERRACE, IL 60181 USA***UPC# 0
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-1401-2023·2023-08-16

    Cava Spicy Hummus recalled nationwide for undeclared sesame

    Cava Spicy Hummus (8oz, UPC 89832800227) is being recalled because it contains undeclared sesame. The product was distributed nationwide; consumers with sesame allergies may be at risk.

    Product
    Cava Spicy Hummus UPC 89832800227 Net Wt. 8oz./226.8 g Packaged in clear plastic container. 12 units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1366-2023·2023-08-16

    Energy balls recalled for undeclared sesame allergen

    Betty Lou's Paleo Java Nuts About Energy Balls are being recalled due to undeclared sesame in the product. The recall affects packages distributed nationwide.

    Product
    Betty Lou's Paleo Java Nuts About Energy Balls with Cacao, Coffee & Pumpkin Seeds, shelf-stable, 12-month shelf life, 1.5 oz (42g) package and 12/1.5 oz. packages per display box. Packages are sold individually (UPC 0 1607352146 5) or packaged into 12-ct display box (UPC 0 16073
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1421-2023·2023-08-16

    Food Recall: ONO Vegan Blueberry Protein Overnight Oats for Undeclared Milk

    ONO LLC is recalling ONO Vegan Blueberry Muffin Protein Overnight Oats because they contain undeclared milk, a common allergen. The product was distributed nationwide and poses a risk to consumers with milk allergies.

    Product
    ONO Vegan Blueberry Muffin Protein Overnight Oats, 2.75oz. UPC 01-95893-47024-2
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1383-2023·2023-08-16

    Corsican Sheep's Milk Cheese Recalled for Potential Listeria Contamination

    A Corsican sheep's milk cheese has been recalled due to possible Listeria monocytogenes contamination. The product was distributed to a customer in Oregon.

    Product
    FABRIQUE' EN CORSE TOMME CORSE AU LAIT DE BREBIS***ANTOINE OTTAVI FROMAGER***aFFINAGE 3 A' 5 MOIS SARL Fromagerie Ottavi 20240 Ghisonaccia Corsica
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·037-2023·2023-08-15

    Bellboy Import Recalls Frozen Raw Pork Belly for Import Violation

    Bellboy Import Corporation is recalling approximately 551 pounds of frozen, raw pork belly because the products were not presented for import reinspection into the United States.

    Product
    Bellboy Import Corporation Recalls Frozen, Raw Pork Products Produced Without Benefit of Import Reinspection
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·23V572000·2023-08-10

    Moto Guzzi Recalls 2023 V100 Mandello Models for Rear Shock Absorber Defect

    Piaggio Group Americas is recalling 260 2023 Moto Guzzi V100 Mandello and Mandello Aviazione motorcycles because a missing bushing may cause the rear shock absorber to break.

    Product
    MOTO GUZZI — MOTO GUZZI V100 MANDELLO AVIAZIONE, V100 MANDELLO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V570000·2023-08-10

    Maserati Recalls 2023 MC20 Cielo for Windshield Frame Sealant Defect

    Maserati is recalling 59 2023 MC20 Cielo vehicles because missing windshield frame sealant may reduce roof strength and body structure performance in a crash.

    Product
    MASERATI — MASERATI MC20 CIELO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V571000·2023-08-10

    Autocar Recalls 2023 Xpeditor and Legend Vehicles for Driveline Bearing Defect

    Autocar is recalling 2023 Xpeditor and Legend vehicles because the powertrain driveline center support bearing hardware may not be properly secured, which could cause the driveline to detach.

    Product
    AUTOCAR — AUTOCAR XPEDITOR, LEGEND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23256·2023-08-10

    Sensio Electric and Stovetop Pressure Cookers Recalled for Burn Hazard

    Sensio Inc. is recalling approximately 860,000 electric and stovetop pressure cookers because the lid can unlock and be removed during use, causing hot contents to splash out and burn consumers. The company has received 63 incident reports, including 61 burn injuries with some involving second and third degree burns.

    Product
    Electric and stovetop pressure cookers
    Category
    Consumer Product
    Distribution
    Distributed nationwide