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.

8676–8700 of 29123

  • SevereNHTSA·21V031000·2021-01-29

    2021 BMW X5, X6, X7 Steering Column Defect Recall

    BMW is recalling certain 2021 X5, X6, and X7 models due to a defect in the steering column shaft universal joint that may not be tightened to specifications, potentially affecting vehicle handling and control.

    Product
    BMW — BMW X6, X5, X7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V034000·2021-01-29

    2021 Mercedes-Benz ISOFIX Bracket May Be Missing From Child Restraint Anchor

    Mercedes-Benz is recalling certain 2021 A220, A35 AMG, and CLA250 vehicles because the ISOFIX child seat anchoring bracket on the right-rear seat may be missing the right-side anchoring bar, preventing proper restraint of child car seats.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ A 220, CLA 250, AMG A35
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V033000·2021-01-29

    Mercedes-Benz Recalls 2019 GLA 250 for Transmission Control Defect

    Mercedes-Benz is recalling 2019 GLA 250 vehicles because the transmission control unit power supply may interrupt, causing the vehicle to shift into neutral while driving.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLA 250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V028000·2021-01-28

    Jeep Gladiator Manual Transmission Clutch Assembly Overheat and Fire Risk

    Chrysler is recalling certain 2021 Jeep Gladiator vehicles with manual transmissions. The clutch pressure plate may overheat and fracture, increasing the risk of fire and potential loss of drive.

    Product
    JEEP — JEEP GLADIATOR, WRANGLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0208-2021·2021-01-27

    JR Simplot Recalls Frozen Potatoes Due to Undeclared Wheat

    JR Simplot is recalling 400 cases of Spud-Queen Lattice Cut frozen potatoes distributed in Alabama and Mississippi because the product contains undeclared wheat.

    Product
    SPUD-QUEEN LATTICE CUT - SKIN ON FROZEN POTATOES, master case SKU 10071179 041290. Distributed by Mid America Potato Company P.O. BOX 9386 BOISE, ID. Each case contains 6/4.5 lbs. packages (net wt. 27 lbs.). Product is a foodservice item and product is packaged in a clear ba
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0238-2021·2021-01-27

    Edge Pharma Recalls Ceftazidime Sterile Ophthalmic Solution Due to Sterility Concerns

    Edge Pharma, LLC is recalling 48 syringes of Ceftazidime Sterile Ophthalmic Solution because the media used for sterility testing was expired, compromising the assurance of sterility.

    Product
    Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml (22.5mg/ml) 0.5ml per syringe. KEEP FROZEN UNTIL USE AND PROTECT FROM LIGHT SINGLE USE SYRINGE FOR INTRAOCULAR INJECTION Edge Pharma, LLC is an FDA-registered 503B outsourcing facility. This
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0876-2021·2021-01-27

    Steris Reliance Vision Washer/Disinfector Recalled for Fire Risk

    Steris is recalling Reliance Vision Single-Chamber Washer/Disinfector units because a faulty electrical contactor may cause the drying chamber to overheat, potentially leading to smoke or fire.

    Product
    Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments, s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0232-2021·2021-01-27

    American Health Packaging Recalls Nitrofurantoin Capsules for Dissolution Failure

    American Health Packaging is recalling 1,948 cartons of Nitrofurantoin Capsules USP 100 mg because they failed dissolution specifications. The recall is nationwide.

    Product
    Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton: 68084-446-01; NDC Blister Card: 68084- 446-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V026000·2021-01-27

    Volkswagen Atlas and Cross Sport steering knuckle fracture recall

    Front steering knuckles in certain Volkswagen Atlas and Atlas Cross Sport vehicles may fracture, causing loss of vehicle control and increasing crash risk. Volkswagen will inspect and replace affected knuckles free of charge.

    Product
    VOLKSWAGEN — VOLKSWAGEN ATLAS CROSS SPORT, ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V027000·2021-01-27

    Audi Recalls One 2019 Q3 for Steering Rack Defect

    Audi is recalling one 2019 Q3 vehicle because a production deviation may prevent a steering component from engaging properly, increasing the risk of a crash.

    Product
    AUDI — AUDI Q3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0872-2021·2021-01-27

    Medtronic Recalls Neonatal Delta Valve Shunt Assemblies Due to Catheter Defect

    Medtronic is recalling Neonatal Delta Valve Shunt Assemblies because a manufacturing defect may cause the ventricular catheter to disconnect from the valve, leading to shunt malfunction.

    Product
    REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0234-2021·2021-01-27

    Complete Pharmacy Recalls Human Chorionic Gonadotropin Due to Potency Testing Deviations

    Complete Pharmacy and Medical Solutions is recalling 1,182 vials of Human Chorionic Gonadotropin because the product lacked required potency testing.

    Product
    HUMAN CHORIONIC GONADOTROPIN 11,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0868-2021·2021-01-27

    Laerdal Compact Suction Unit Recalled for Potential Suction Loss

    Laerdal Medical is recalling 5,035 Compact Suction Units (LCSU 4) because component failures may cause the device to lose suction, potentially delaying treatment or causing suffocation.

    Product
    Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0236-2021·2021-01-27

    Complete Pharmacy Recalls Human Chorionic Gonadotropin Due to Lack of Potency Testing

    Complete Pharmacy and Medical Solutions is recalling 1,144 vials of Human Chorionic Gonadotropin 5,000 IU because the product lacked required potency testing.

    Product
    HUMAN CHORIONIC GONADOTROPIN 5,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0873-2021·2021-01-27

    Medtronic Recalls Neonatal Delta Valve Shunt Assemblies Due to Catheter Defect

    Medtronic is recalling specific Neonatal Delta Valve Shunt Assemblies because a manufacturing defect may cause the ventricular catheter to disconnect, leading to shunt malfunction.

    Product
    REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0871-2021·2021-01-27

    Medtronic Recalls Neonatal Delta Valve Shunt Assemblies Due to Catheter Defect

    Medtronic is recalling 95 Neonatal Delta Valve Shunt Assemblies because a manufacturing defect may cause the ventricular catheter to disconnect from the valve, leading to shunt malfunction.

    Product
    REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E005000·2021-01-25

    Brembo Brake Pads Recalled for Potential Friction Material Detachment

    Brembo is recalling specific brake pads that may corrode and detach, potentially increasing stopping distance and crash risk.

    Product
    SERVICE BRAKES, HYDRAULIC:FOUNDATION COMPONENTS:DISC:PADS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0226-2021·2021-01-20

    Edge Pharma Recalls Methotrexate Syringes Due to Sterility Testing Concerns

    Edge Pharma, LLC is recalling 71 syringes of Methotrexate USP Sterile Solution for Injection because the media used for post-compounding sterility testing was expired.

    Product
    Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRINGE FOR IM INJECTION, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178, Barcode 0544650505
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0829-2021·2021-01-20

    Fresenius Citrasate Liquid Acid concentrate drums recalled for low sodium levels

    Fresenius Medical Care is recalling 176 drums of Citrasate Liquid Acid concentrate because sodium and/or calcium levels were below manufacturing specifications.

    Product
    Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0729-2021·2021-01-20

    Boston Scientific Recalls Lotus Edge Valve Systems Due to Deployment Defect

    Boston Scientific is recalling 319 Lotus Edge Valve Systems because a visual inspection failure may prevent the delivery system from releasing during deployment.

    Product
    Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVSUS250, GTIN 08714729960911, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
    Category
    Medical Device
    Distribution
    38 states
  • SevereNHTSA·21V016000·2021-01-20

    RAM 4500 and 5500 Recalled for Rear Brake Line Wear Risk

    Custom Truck And Body Works is recalling 2020 RAM 4500 and 5500 vehicles because a rear brake line may wear, causing brake failure.

    Product
    RAM — RAM 4500, 5500
    Category
    Vehicle
    Distribution
    Distributed nationwide