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.

22476–22500 of 32171

  • SevereFDA (Devices)·Z-2137-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Detachment Risk

    DePuy Orthopaedics is recalling ATTUNE FB PS Articulation Surface instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.

    Product
    ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation…
    Category
    Medical Device
    Distribution
    51 states
  • SevereFDA (Devices)·Z-2198-2015·2015-07-29

    Philips Recalls GEMINI TF Base CT/PET Systems Due to Software Defects

    Philips is recalling two GEMINI TF Base CT/PET systems because four software defects in the Tumor LOC application may cause incorrect tissue irradiation.

    Product
    GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2111-2015·2015-07-29

    FDA Recalls Sterile Surgical Kits with Compromised Gloves

    The FDA is recalling 4,136 sterile surgical kits because the Devon Light Gloves inside contain splits or holes that compromise sterility.

    Product
    ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Decription: 573328 7437-NRF SURGICAL ASC KIT 50000511 7516-UNI Universal ASC Kit 50000512 7557-UNI Universal ASC Kit 50000515 7667-BRT Breast ASC Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2156-2015·2015-07-29

    FDA Recalls Sureflex 150 Lithotripsy Fibers Due to Sterilization Validation Issues

    American Medical Systems is recalling Sureflex 150 Lithotripsy Fibers because cleaning and sterilization validation data do not meet FDA guidance for reusable medical devices.

    Product
    Sureflex 150 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2110-2015·2015-07-29

    Surgical Set Up Kits Recalled Due to Sterility Compromise in Gloves

    FDA is recalling 33,256 surgical set up kits containing Devon Light Gloves that have splits or holes compromising sterility.

    Product
    Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31144895 7614-T4 Single Basin Set Up Kit 31144960 7693-T4 Single Basin Set Up Kit 31144978 7766 Double Basin Set Up Kit 31145215 7896 Double Basin Set Up Kit 31145231 7897…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2197-2015·2015-07-29

    Philips GEMINI TF Ready CT/PET System Software Defect Recall

    Philips is recalling GEMINI TF Ready CT/PET systems due to software defects that may cause incorrect radiation treatment.

    Product
    GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·15200·2015-07-29

    Jenn-Air Wall Ovens Recalled for Burn Risk from Roller Rack

    Whirlpool is recalling Jenn-Air wall ovens because the extendable roller rack can unexpectedly disengage, posing a burn risk. Consumers should stop using the rack and contact Whirlpool for a free repair.

    Product
    Jenn-Air Single, Double Wall Ovens and Combination Microwave/Wall Ovens
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2859-2015·2015-07-29

    Golden Plains Recalls Roseli Sundried Tomato Pesto Sauce for Salmonella

    Golden Plains Frozen Foods is recalling Roseli Sundried Tomato Pesto sauce because it tested positive for Salmonella. The product was contained and not distributed to consumers.

    Product
    Roseli Sundried Tomato Pesto sauce. #408744 (Dot Item) , # 627328 (Roseli item),3- 2 lbs tubs (poly) packed in corrugated shipper. Keep Frozen - Thaw under refrigeration.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2175-2015·2015-07-29

    FDA Recalls Fiber Stripper Tools Due to Sterilization Validation Issues

    American Medical Systems is recalling Fiber Stripper tools because cleaning and sterilization validation data do not meet FDA guidance for reusable products.

    Product
    Tool, Stripper W/BLD, 12S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2865-2015·2015-07-29

    GloryBee Recalls Turkish Organic Diced Apricots Containing Rocks and Metal

    GloryBee Inc is recalling 107 boxes of Turkish Organic Diced Apricots with Rice Flour due to the presence of rocks and metal.

    Product
    Turkish Organic Diced Apricots with Rice Flour (5-7 mm), FOODIMPEX brand, Item# 17496, product is packged in a white cardboard box. Net wt. 28 lbs.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-2857-2015·2015-07-29

    Marine Harvest Recalls Kirkland Signature Fresh Farmed Atlantic Salmon Fillets

    Marine Harvest is recalling Kirkland Signature fresh farmed Atlantic salmon fillets due to potential Listeria monocytogenes contamination.

    Product
    Kirkland Signature Fresh Farmed Atlantic Salmon Fillet Product of Chile Processed in USA approx 2lbs. Packaged in a styrofoam tray and wrapped in plastic.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2138-2015·2015-07-29

    DePuy ATTUNE Knee Trial Instrument Recall for Balseal Disassociation Risk

    DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil may detach and be left in patients during surgery.

    Product
    ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation…
    Category
    Medical Device
    Distribution
    51 states
  • SevereFDA (Devices)·Z-2136-2015·2015-07-29

    Volcano Intravascular Ultrasound Systems Recalled for Inaccurate FFR/iFR Values

    Volcano Corporation is recalling s5/s5i/CORE Intravascular Ultrasound Systems due to a software issue that may calculate inaccurate FFR/iFR values.

    Product
    Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2856-2015·2015-07-29

    Marine Harvest Recalls Raw Chilean Salmon Due to Listeria Risk

    Marine Harvest is recalling raw, fresh, farmed Chilean Atlantic salmon fillets due to potential Listeria monocytogenes contamination. The affected product was distributed in California, Arizona, and Nevada.

    Product
    Raw, Fresh, Farmed Chilean Atlantic Salmon -Atl Fs Sal Chilean Fill Tr D 3-4 lbs 40lbs -Atl Fs Sal Chilean Fill Deep Skinned Tr E 3-4 lbs 10LBS -Atl Fs Sal Chilean Fill Tr E 3-4 lbs 40lbs -Chilean Fresh Atl Trim D 1-6 Factory 40lbs -Chilean Fresh Atl Factory 1-6 SK off…
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2116-2015·2015-07-29

    FDA Recalls Sterile Augmentation Kits with Compromised Devon Light Gloves

    The FDA is recalling 144 sterile Augmentation Kits containing Devon Light Gloves due to splits or holes that compromise sterility. The affected kits were distributed worldwide.

    Product
    Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2107-2015·2015-07-29

    FDA Recalls Sterile Delivery Kits Containing Defective Devon Light Gloves

    The FDA is recalling sterile delivery and C-section kits containing Devon Light Gloves with splits or holes that compromise sterility.

    Product
    Delivery/C-Section, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 56479 7335-SMC C-Section Kit 31404851 7382-OTO2 Delivery Kit 52000076E 7339-ES C-SECTION DELUXE PACK 52000082E 7335-HUV DELIVERY KIT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V473000·2015-07-28

    Altec Recalls 2006-2015 Aerial Devices Due to Outrigger Interlock Defect

    Altec Industries is recalling 2,514 aerial devices from 2006-2015 because the outrigger interlock system may fail to detect proper deployment, risking boom instability and injury.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V477000·2015-07-28

    Newmar Recalls Toy Haulers Due to Unprotected Fuel System Fire Risk

    Newmar is recalling specific All Star and Canyon Star toy haulers because unprotected plastic wrap around the fuel system could burn if exposed to an ignition source.

    Product
    NEWMAR — NEWMAR ALL STAR, CANYON STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V470000·2015-07-28

    Chrysler Recalls 2015 Chrysler 200 Vehicles for Electrical Connector Defect

    Chrysler is recalling 77,971 model year 2015 Chrysler 200 vehicles because a defective electrical connector may cause intermittent power failures, potentially leading to the vehicle stalling without warning.

    Product
    CHRYSLER — CHRYSLER 200
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V468000·2015-07-27

    Chrysler Recalls 2015 Ram 4500 and 5500 Trucks for Suspension Defect

    Chrysler is recalling 199 model year 2015 Ram 4500 and 5500 pickup trucks due to a front suspension weld defect that may reduce vehicle stability and increase crash risk.

    Product
    RAM — RAM 5500, 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V462000·2015-07-24

    Forest River Recalls 2007-2015 Glaval Bus Titan II for Electrical Fire Risk

    Forest River is recalling 2007-2015 Glaval Bus Titan II vehicles due to a misrouted electrical cable that may cause a loose connection or arching, increasing the risk of a vehicle fire.

    Product
    GLAVAL BUS — GLAVAL BUS TITAN II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·104-2015·2015-07-23

    Brown Packing Recalls Veal Trimmings Due To Possible E. Coli Contamination

    Brown Packing Company is recalling raw veal trimmings that may be contaminated with E. coli O157:H7 and non-O157 STEC. No illnesses have been reported.

    Product
    Brown Packing Recalls Veal Products Due To Possible E. Coli Contamination
    Category
    Food
    Distribution
    8 states