The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

36976–37000 of 50506

  • HighFDA (Devices)·Z-0429-2016·2015-12-23

    bioMerieux Recalls MYLA Software Due to Patient Data Linking Error

    bioMerieux is recalling MYLA software because it may link test results to the wrong patient record when connected to specific laboratory systems.

    Product
    MYLA MASTER DVD V4.1 CLI Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0438-2016·2015-12-23

    Medtronic MiniMed 640G Insulin Pumps Recalled for Motor Malfunction

    Medtronic MiniMed is recalling 1,052 MiniMed 640G insulin pumps due to a potential drive motor malfunction that could stop insulin delivery.

    Product
    MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring…
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·15V876000·2015-12-23

    GM Recalls 2015 Chevrolet Cruze for Loose Seat Belt Bolts

    General Motors is recalling 2015 Chevrolet Cruze vehicles because a driver-side seat belt bolt may be loose. This defect could prevent the seat belt from holding in a crash.

    Product
    CHEVROLET — CHEVROLET CRUZE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0447-2016·2015-12-23

    Elekta Recalls MOSAIQ Oncology System Due to Drug Interaction Check Failure

    Elekta is recalling MOSAIQ Oncology Information System versions prior to 2.60 because a third-party database update prevents the software from checking for drug-drug, drug-allergy, and duplicate therapy interactions.

    Product
    MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0406-2016·2015-12-23

    Philips Ingenuity Core CT Scanner Software Recall

    Philips is recalling 105 Ingenuity Core CT scanners because software may set the scan length differently than planned during specific protocols.

    Product
    Philips Healthcare Ingenuity Core Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0444-2016·2015-12-23

    Myco Medical Supplies Recalls Unolok Blunt Fill Needles Due to Particulates

    Myco Medical Supplies Inc is recalling Unolok Blunt Fill Needles because complaints were received regarding rubber coring from injection vial closures.

    Product
    Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0404-2016·2015-12-23

    Kerry Foods Recalls Sprinkle King Gold Sanding Sugar Due to Metal Contamination

    Kerry Foods is voluntarily recalling Sprinkle King Gold Sanding Sugar because it may contain metal. The recall covers 32 lb bags distributed in 18 states.

    Product
    Sprinkle King, Gold Sanding Sugar, QGOL413.L32, UPC:10766818310904/ 00766818310907, NET WT: 32 lb (14.51 kg).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-0395-2016·2015-12-23

    Conte's Gluten Free Cheese Ravioli Recalled for Salmonella Risk

    Conte's Pasta Company is recalling 1,020 cases of Gluten Free Wheat Free Cheese Ravioli due to possible Salmonella contamination found in a raw product.

    Product
    Conte's Gluten Free Wheat Free Cheese Ravioli Net Wt. 12 Ounces Conte's Pasta Co. Inc. 310 Wheat Road, Vineland, NJ 08360 800.211.6607 www.contespasta.com UPC 734158940092
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0426-2016·2015-12-23

    bioMerieux MYLA Software Recall for Potential Patient Record Mismatch

    bioMerieux is recalling MYLA software due to a potential risk of linking test results to incorrect patient records.

    Product
    MYLA MASTER DVD 3.2 CLI DL380 Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0412-2016·2015-12-23

    Bestmed Digital Temple Thermometers Recalled for Inaccurate Temperature Readings

    Bestmed is recalling 305,548 digital temple thermometers sold under multiple retail brands because they display inaccurate, frequently lower temperatures than actual body temperature.

    Product
    Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medline, Meijer, Premier Value, Safeway, Life Brand, Target, Top Care, Best Choice, Western Family. Device is packaged in plastic blister with cardboard insert, 2 AAA batteries…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0408-2016·2015-12-23

    Philips Ingenuity CT Scanner Software Error Recalled by FDA

    The FDA is recalling 105 Philips Ingenuity CT scanners because software errors can cause the scan length to differ from the user's plan.

    Product
    Philips Healthcare Ingenuity CT Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0428-2016·2015-12-23

    bioMerieux MYLA Software Recalled for Potential Patient Record Mismatch

    bioMerieux is recalling MYLA software due to a potential risk of linking test results to incorrect patient records when connected to specific laboratory systems.

    Product
    MYLA MASTER DVD V4.0 CLI Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15V877000·2015-12-23

    Entegra Motorhomes Recalled for Unstable Electric Entry Steps

    Entegra is recalling specific 2008-2011 motorhomes because a bolt on the electric steps may fracture, causing the steps to become unstable and increasing the risk of injury.

    Product
    ENTEGRA — ENTEGRA INSIGNIA, ASPIRE, CORNERSTONE, EMBLEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0403-2016·2015-12-23

    Kerry Foods Recalls Blue Sanding Sugar Due to Metal Contamination

    Kerry Foods is recalling Sprinkle King Blue Sanding Sugar because it may contain metal. The voluntary recall affects 176,596 units distributed across 18 states.

    Product
    Sprinkle King, Blue Sanding Sugar, QBLU413.L32, , UPC:Inner: 00766818310303 ; Outer: 10766818310300, NET WT: 32 lb (14.51 kg).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-0407-2016·2015-12-23

    Philips CT Scanner Software Error May Alter Scan Length

    Philips is recalling 105 Ingenuity Core 128 CT scanners because software may unexpectedly change the scan length during specific protocols.

    Product
    Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0431-2016·2015-12-23

    bioMerieux MYLA CLI Software Recalled for Patient Data Linking Errors

    bioMerieux is recalling MYLA CLI software versions 3.x to 4.1 because it may link test results to incorrect patient records.

    Product
    MYLA CLI V3.X TO V4.1 ML350 SERVER Product Usage: MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0421-2016·2015-12-23

    Verathon GlideScope AVL Video Laryngoscope Blades Recalled for Separation Risk

    Verathon is recalling GlideScope AVL video laryngoscope blades because silicone adhesive bonding may be inadequate, creating a risk of blade separation during use.

    Product
    GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-0117. AVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor. This system has a digital…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15V866000·2015-12-22

    Winnebago and Itasca Motorhomes Recalled for Step Deployment Defect

    Winnebago is recalling 2015-2016 Sightseer, Vista, Adventurer, Sunova, Sunstar, and Suncruiser motorhomes because electric steps may extend while driving, increasing crash risk.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA VISTA, SUNOVA, SIGHTSEER, ADVENTURER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16717·2015-12-22

    John Deere Recalls Zero-Turn Lawn Mowers Due to Fire Risk

    John Deere is recalling about 150 zero-turn lawn mowers because a fuel hose could have been cut during manufacturing, posing a fire hazard.

    Product
    John Deere zero-turn lawn mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V858000·2015-12-22

    Ford Recalls 2016 F-650 and F-750 Trucks for Rear Brake Hose Chafing

    Ford is recalling 302 model year 2016 F-650 and F-750 trucks because rear brake hoses may chafe on the axle, potentially causing air leaks and reduced braking ability.

    Product
    FORD — FORD F-650 SD, F-750 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V856000·2015-12-21

    Starcraft RV Recalls 2015-2016 Trailers for Missing Sewer Valve Label

    Starcraft RV is recalling 2015-2016 Autumn Ridge and Solstice fifth wheel trailers because a missing caution label may allow sewer gas to enter the vehicle.

    Product
    STARCRAFT RV TT — STARCRAFT RV TT, STARCRAFT RV FW AUTUMN RIDGE, SOLSTICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V851000·2015-12-18

    Suzuki Recalls DL1000 Motorcycles for Wiring Harness Short Circuit Risk

    Suzuki is recalling certain 2014-2016 DL1000 motorcycles because a wiring harness may rub against the fuel tank, causing a short circuit that could stall the engine and increase crash risk.

    Product
    SUZUKI — SUZUKI DL1000
    Category
    Vehicle
    Distribution
    Distributed nationwide