The Recall Desk

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.

28851–28875 of 32253

  • SevereNHTSA·13E001000·2013-01-14

    Ricon Recalls Wheelchair Lifts Due to Fire Risk from Cable

    Ricon is recalling S and K Series wheelchair lifts equipped with an optional armored pendant cable that may cause a short circuit and fire.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V011000·2013-01-11

    Blue Bird Recalls 2007-2009 L4RE Buses for Steering Gear Defect

    North American Bus Industries is recalling 53 Blue Bird L4RE transit buses from 2007-2009 due to a defective steering gear attachment that could cause loss of steering control.

    Product
    BLUE BIRD — BLUE BIRD L4RE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-121-2013·2013-01-09

    New England Compounding Center Recalls Lidocaine Vials Due to Sterility Concerns

    New England Compounding Center is recalling Lidocaine vials because the FDA determined there is a lack of assurance of sterility.

    Product
    Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-119-2013·2013-01-09

    New England Compounding Center Recalls Isovue Vials Due to Sterility Concerns

    New England Compounding Center is recalling Isovue 200 mg/mL and 300 mg/mL vials nationwide due to a lack of assurance of sterility.

    Product
    Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-117-2013·2013-01-09

    New England Compounding Center Recalls Glycerin 100% Vials for Sterility Concerns

    New England Compounding Center is recalling 165 vials of Glycerin 100% PF due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0620-2013·2013-01-09

    SynCardia Recalls Companion External Batteries Due to Thermal Event Risk

    SynCardia Systems is recalling Companion External Batteries used with the Companion 2 Driver System because they may be at risk of thermal events or physical damage.

    Product
    Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-112-2013·2013-01-09

    New England Compounding Center Recalls Betamethasone Repository Injections

    New England Compounding Center is recalling Betamethasone Repository injections due to a lack of assurance of sterility. The recall covers all lot codes distributed nationwide.

    Product
    Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-118-2013·2013-01-09

    New England Compounding Center Recalls Hyaluronidase Vials Due to Sterility Concerns

    New England Compounding Center is recalling Hyaluronidase 150 u/ml PF vials nationwide because the FDA determined there is a lack of assurance of sterility.

    Product
    Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-114-2013·2013-01-09

    New England Compounding Center Recalls Bupivacaine Products Due to Sterility Concerns

    New England Compounding Center is recalling Bupivacaine 0.25%, 0.5%, and 0.75% PF products because the agency cannot assure the sterility of the medication.

    Product
    Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V006000·2013-01-09

    Autocar Recalls 2012 Xpert Vehicles Due to Seat Belt Anchorage Defect

    Autocar is recalling 80 model year 2012 Xpert vehicles because seat belt anchorages may fail to meet federal safety standards, increasing injury risk in crashes.

    Product
    AUTOCAR — AUTOCAR XPERT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0622-2013·2013-01-09

    Hill-Rom Recalls Liko Standard Slingbar 450 Due to Injury Reports

    Hill-Rom is recalling 261 Liko Standard Slingbar 450 units after receiving reports of serious injuries. The device is used with ceiling and mobile patient lifts.

    Product
    Liko Standard Slingbar 450. The Standard Slingbar 450 is a versatile sling bar which can be used for most lifting situations. It can be used with different Liko ceiling and mobile lifts.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0628-2013·2013-01-09

    Stryker Medical Surgical Beds Recalled for Brake Ring Defect

    Stryker is recalling 9 Model 3002SEX and 3005S3EX medical surgical beds because brake rings may not meet specifications, negatively impacting holding force.

    Product
    Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg Bed, is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital facilities. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-106-2013·2013-01-09

    Hospira Recalls Epinephrine Injection Due to Potential Glass Particulates

    Hospira is recalling specific lots of Epinephrine Injection USP because they may contain glass particles.

    Product
    Epinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM, Hospira, Inc., Lake Forest, IL --- NDC 0409-7241-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-113-2013·2013-01-09

    Betamethasone Sodium Phosphate Injection Recalled for Sterility Concerns

    New England Compounding Center is recalling Betamethasone Sodium Phosphate injections due to a lack of assurance of sterility.

    Product
    Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection, Betamethasone Sodium Phosphate 8 mg/mL PF Injection, Betamethasone Sodium Phosphate 12 mg/mL PF Injection, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0855-2013·2013-01-09

    Sanh Yuan Preserved Plum Candy Recalled for Lead Contamination

    Cho Fuku Group is recalling Sanh Yuan Preserved Plum Candy due to unacceptable levels of lead. The product was distributed in California and Washington.

    Product
    Sanh Yuan Preserved Plum Candy (Sweet and Sour Prune), 5 oz (142g)
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0624-2013·2013-01-09

    Hospira Recalls Plum A+ Infusion Pumps Due to Door Roller Defect

    Hospira is recalling 297,833 Plum A+ infusion pumps because a door roller assembly may break, causing unrestricted flow or over-delivery of IV fluids.

    Product
    Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971; b) list 11973 - software version 10.3; c) list 12391 - software version 11.3; d) list 20679 - Hospira MedNet Software e) list 20792…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-116-2013·2013-01-09

    New England Compounding Center Recalls Dexamethasone Sodium Phosphate Vials

    New England Compounding Center is recalling Dexamethasone Sodium Phosphate vials due to a lack of assurance of sterility.

    Product
    Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0621-2013·2013-01-09

    Fisher & Paykel Healthcare Recalls Reusable Breathing Circuits Due to Hole Damage

    Fisher & Paykel Healthcare is recalling specific lots of reusable breathing circuits because tube hole damage could cause gas leaks and loss of pressure during oxygen therapy.

    Product
    Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Drugs)·D-115-2013·2013-01-09

    New England Compounding Center Recalls Clonidine Vials Due to Sterility Concerns

    New England Compounding Center is recalling Clonidine 100 mcg/mL vials nationwide due to a lack of assurance of sterility.

    Product
    Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V005000·2013-01-07

    Forest River Recalls 2010-2012 Berkshire and Charleston Motorhomes

    Forest River is recalling 2010-2012 Berkshire and Charleston diesel motorhomes because loose diode jumpers may prevent brake lights from working or cruise control from disengaging.

    Product
    FOREST RIVER — FOREST RIVER CHARLESTON, BERKSHIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V003000·2013-01-04

    Polaris Recalls GEM Electric Vehicles Due to Parking Brake Defect

    Polaris is recalling 2010-2013 GEM electric vehicles because the parking brake may fail to engage, increasing the risk of the vehicle rolling away.

    Product
    GEM — GEM E2 XLD, E6S, E4S, E2S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0525-2013·2013-01-02

    Praxair Vantage Grab n Go Gas Cylinder Pressure Regulator Recall

    Praxair Inc. is recalling Vantage Grab n Go gas cylinder pressure regulators due to isolated incidents of ignition inside cylinders subjected to significant physical impact.

    Product
    Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG Usage: Regulator reduces pressure in oxygen-containing cylinder.
    Category
    Medical Device
    Distribution
    Distributed nationwide