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.

25976–26000 of 32215

  • SevereFDA (Devices)·Z-0963-2014·2014-03-05

    Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1050-2014·2014-03-05

    Medline Recalls Surgical Kits With Flaking Guidewire Coating

    Medline Industries is recalling 304 surgical kits containing guidewires with a potential for coating to flake off.

    Product
    CATH TRAY; REF: DYNJ41101; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1046-2014·2014-03-05

    Medline Recalls Angiography Packs Due to Guidewire Coating Flaking Risk

    Medline Industries is recalling 1,194 angiography packs because a guidewire component may have flaking coating. The recall covers distribution in seven US states.

    Product
    ANGIOGRAPHY PACK; REF: DYNJ26855D; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1554-2014·2014-03-05

    Kinnikinnick Pancake and Waffle Mix Recalled for Undeclared Milk

    Bozzutos Inc. is recalling Kinnikinnick Pancake & Waffle Mix due to undeclared milk, a major food allergen.

    Product
    Kinnikinnick Pancake & Waffle Mix -Weight: 454g/16 oz Cardboard Box UPC 62013310512 2
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Devices)·Z-1069-2014·2014-03-05

    Terumo Recalls VirtuoSaph Plus Endoscopic Vessel Harvesting System

    Terumo is recalling 26 units of the VirtuoSaph Plus Endoscopic Vessel Harvesting System due to potential sterility compromise.

    Product
    VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph  Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1089-2014·2014-03-05

    Caraco Recalls Metformin HCl ER Tablets Due to Foreign Tablet Presence

    Caraco Pharmaceutical is recalling 2,528 bottles of Metformin HCl ER 500 mg tablets because a customer reported finding Gabapentin tablets in the bottle.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1109-2014·2014-03-05

    Philips HeartStart XL Defibrillators Recalled for Power Board Failure

    Philips is recalling 5,234 HeartStart XL Defibrillators/Monitors because a power board failure may prevent the device from defibrillating.

    Product
    Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A HeartStart XL Defibrillator/Monitor is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0962-2014·2014-03-05

    Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during use, potentially compromising the patient's airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0960-2014·2014-03-05

    Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during use, potentially compromising the patient's airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1091-2014·2014-03-05

    Instrumentarium Dental FOCUS 3.0 Intraoral X-ray Units Recalled for Mounting Flaw

    Instrumentarium Dental is recalling FOCUS 3.0 intraoral x-ray units due to incomplete welding in the wall mount hardware, which could cause the unit to drift or fall.

    Product
    The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOCUS is connected to the Sigma USB terminal which is connected to a PC, which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1552-2014·2014-03-05

    UNFI Recalls Kinnikinnick Panko Bread Crumbs for Undeclared Milk

    UNFI is recalling Kinnikinnick Panko Style Bread Crumbs nationwide due to undeclared milk, a major allergen.

    Product
    Kinnikinnick Panko Style Bread Crumbs-Weight: 350g/12.5oz Cardboard Box UPC 62013360015 3
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereCPSC·14120·2014-03-05

    Twin-Star Recalls Duraflame Electric Space Heaters Due to Fire and Burn Hazards

    Twin-Star is recalling about 31,000 Duraflame electric space heaters because they can overheat, melt, and catch fire. Consumers should unplug the units and contact the company for a refund.

    Product
    Duraflame electric space heaters
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1048-2014·2014-03-05

    Medline Recalls Heart Catheter Kits Due to Coating Defect

    Medline Industries is recalling 160 Heart Cath Custom Packs because a guidewire component may have a flaking coating.

    Product
    HEART CATH CUSTOM PACK; REF: DYNJ39747A; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1074-2014·2014-03-05

    Philips BrightView Gamma Cameras Recalled for Patient Contact Risk

    Philips is recalling 1,143 BrightView gamma cameras because a positioning error can cause detectors to contact patients during imaging.

    Product
    Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1555-2014·2014-03-05

    Kinnikinnick Panko Bread Crumbs Recalled for Undeclared Milk Allergen

    Bozzutos' Inc. is recalling Kinnikinnick Panko Style Bread Crumbs due to undeclared milk. The product was distributed in several northeastern states.

    Product
    Kinnikinnick Panko Style Bread Crumbs-Weight: 350g/12.5oz Cardboard Box UPC 62013360015 3
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Devices)·Z-1054-2014·2014-03-05

    Medline Recalls Surgical Kits with Flaking Guidewire Coating

    Medline Industries is recalling five surgical kits containing a guidewire with a potential coating flake-off defect.

    Product
    STERILE SAMPLE BUILD; REF: SAMP0147; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1102-2014·2014-03-05

    Fresenius Optiflux F200NRe Dialyzers Recalled for Dialysate Port Leak

    Fresenius Medical Care is recalling Optiflux F200NRe dialyzers because the dialysate port may leak during priming, posing a risk to patients.

    Product
    Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chronic hemanalysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1051-2014·2014-03-05

    Medline Recalls Angiography Surgical Kits Due to Guidewire Coating Defect

    Medline Industries is recalling 120 surgical kits containing guidewires with a potential coating flaking defect.

    Product
    CATH PACK; REF: DYNJ41103; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1589-2014·2014-03-05

    Natural Grocers Recalls Dark Chocolate Almonds for Undeclared Peanuts

    Natural Grocers by Vitamin Cottage is recalling Dark Chocolate Almonds because some bags may contain undeclared peanuts.

    Product
    Natural Grocers brand Dark Chocolate Almonds; six-ounce bags bearing UPC code 0-0008265007-0
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0958-2014·2014-03-05

    Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1049-2014·2014-03-05

    Medline Recalls Cath Lab Custom Packs Due to Guidewire Coating Defect

    Medline Industries is recalling 120 Cath Lab Custom Packs because the guidewire coating may flake off. The kits were distributed nationwide to specific states.

    Product
    CATH LAB CUSTOM PACK; REF: DYNJ40926; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1550-2014·2014-03-05

    UNFI Recalls Kinnikinnick Bread Mix for Undeclared Milk Allergen

    UNFI is recalling Kinnikinnick Kinni-Kwik Bread & Bun Mix nationwide due to undeclared milk. Consumers with milk allergies should not consume the product.

    Product
    Kinnikinnick Kinni-Kwik Bread & Bun Mix-Weight 350g/16oz Cardboard Box UPC 62013310550 4
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0955-2014·2014-03-05

    Teleflex Recalls ISIS HVT Tracheal Tubes Due to Kinking Risk

    Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.

    Product
    ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1053-2014·2014-03-05

    Medline Recalls Sterile Sample Cath Lab Packs Due to Coating Defect

    Medline Industries is recalling 10 units of Sterile Sample Cath Lab Packs because a guidewire component has a potential for its coating to flake off.

    Product
    STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1542-2014·2014-03-05

    The Cultured Kitchen Recalls Herb Cashew Cheese Due to Salmonella Risk

    The Cultured Kitchen is recalling six varieties of Herb Cashew Cheese due to potential Salmonella contamination. Affected products have expiry dates up to and including April 19, 2014.

    Product
    The Cultured Kitchen Herb Cashew Cheese; Processed raw at low temperatures to preserve minerals, enzymes and nutrients. Wheat, dairy, soy and gluten free. This product contains live active cultures Keep Refrigerated 8 oz., (226.8 grams) Plastic container UPC 794504922714…
    Category
    Food
    Distribution
    1 state