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.

36951–36975 of 50506

  • HighFDA (Devices)·Z-0416-2016·2015-12-23

    Cook Medical Recalls VentriClear II Catheters Due to Sterilization Error

    Cook Medical is recalling specific lots of VentriClear II Ventricular Drainage Catheter Sets because double sterilization may reduce the antibiotic coating below labeled levels.

    Product
    VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-0407-2016·2015-12-23

    Kerry Foods Recalls Sprinkle King Red Sugar Due to Metal Contamination

    Kerry Foods is voluntarily recalling specific lots of Sprinkle King Red Sanding Sugar and Red Sugar because they may contain metal.

    Product
    Sprinkle King, Red Sanding Sugar,QRED413.L32, UPC:inner 766818312604; outer 10766818312601 , NET WT: 32 lb (14.51 kg). Sprinkle King, Red Sanding Sugar, QRED433.440, UPC: 10766818322655, NET WT: 40 lb (18.14 kg). Sprinkle King, Red Sugar,QRED443.00N…
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-0415-2016·2015-12-23

    MOOG Medical Devices Recalls EnteraLite Infinity Enteral Pump Delivery Sets

    MOOG Medical Devices Group is recalling EnteraLite Infinity Enteral Pump Delivery Sets because the purple ENFit connector may crack or break, causing leaks.

    Product
    Catalog No. INF0020-A  EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spiked set); Catalog No. INF0500-A - 500ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0401-2016·2015-12-23

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

    Kerry Foods is voluntarily recalling Sprinkle King Green Sanding Sugar in various sizes due to potential metal contamination. The recall covers 176,596 lbs distributed across 18 U.S. states.

    Product
    Sprinkle King, Green Sanding Sugar, Q35111.G32,, UPC: 10766818350023, NET WT: 320 lb (144.3 kg). Sprinkle King, Green Sanding Sugar, QGRN413.L32, UPC: 10766818311109/ 00766818311102, , NET WT: 32 lb (14.51kg). Sprinkle King, Green Sanding Sugar, QGRN433.440…
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-0399-2016·2015-12-23

    Kerry Foods Recalls Lime Green Sanding Sugar Due to Metal Contamination

    Kerry Foods is voluntarily recalling Sprinkle King Lime Green Sanding Sugar because it may contain metal. The product was distributed to 18 states.

    Product
    Sprinkle King, Lime Green Sanding Sugar, 30611201.00N, UPC #30763089281012, NET WT: 150 lb (68.182 kg)
    Category
    Food
    Distribution
    19 states
  • HighNHTSA·15V873000·2015-12-23

    H&H Trailers Recall 2015-2016 Utility and Bike Trailers for Hinge Defect

    H&H Trailers is recalling 1,847 model year 2015-2016 trailers because aluminum gate hinges may bend or break, potentially causing the gate to open unexpectedly.

    Product
    H&H — H&H RSA RAIL SIDE TANDEM AXLE, SSA SOLID SIDE TANDEM, AMS BIKE TRAILER, SSA SOLID SIDE SINGLE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0417-2016·2015-12-23

    Stryker Guidewire Introducer Needles Recalled for Expiration Date Issues

    Stryker is recalling 120 units of Guidewire Introducer Needles shipped after expiration or with minimal time remaining due to infection risk.

    Product
    Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer Needles are designed for the percutaneous puncture of the anterior/posterior wall of a blood vessel. This provides an entry for a guidewire, vessel dilator…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0394-2016·2015-12-23

    Metro Brand Gluten Free Cheese Ravioli Recalled for Salmonella Risk

    Contes Pasta Company is recalling Metro Brand Gluten Free Cheese Ravioli due to possible Salmonella contamination found in a raw product.

    Product
    Metro Brand Irresistibles Gluten Free Cheese Ravioli with Marinara Sauce Microwave Meal 340 g Use By 020317; Imported for Metro Brands, Montreal Quebec, H1C 1V6, Toronto (Ontario) M9B 1B9 UPC 059749935609
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0396-2016·2015-12-23

    Conte's Gluten Free Cheese Ravioli Recalled for Salmonella Risk

    Conte's Pasta Company is recalling gluten-free cheese ravioli with marinara sauce due to possible Salmonella contamination found in a raw product.

    Product
    Conte's Gluten Free Wheat Free Cheese Ravioli With Marinara Sauce Net Wt. 12 Ounces Conte's Pasta Co. Inc. 310 Wheat Road, Vineland, NJ 08360 800.211.6607 www.contespasta.com UPC 734158944458
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0419-2016·2015-12-23

    Teleflex Medical Recalls Hudson RCI Adult Universal Ventilator Circuits

    Teleflex Medical is recalling 2,600 Hudson RCI Adult Universal Ventilator Circuits because the inspiratory and expiratory tubes are transposed.

    Product
    Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-0420-2016·2015-12-23

    Verathon GlideScope Video Laryngoscope Blades Recalled for Potential Separation

    Verathon is recalling GlideScope Video Laryngoscope blades because silicone adhesive may fail, causing the blade halves to separate during use.

    Product
    GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001; GVL 5- 0574-0030. The system consists of a video laryngoscope and portable video monitor. The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0425-2016·2015-12-23

    bioMerieux MYLA Clinic Patch 3.2.0 CD Recall for Patient Data Linking Error

    bioMerieux, Inc. is recalling MYLA Clinic Patch 3.2.0 CD software because it may link test results to incorrect patient records when connected to specific laboratory systems.

    Product
    MYLA CLINIC PATCH 3.2.0 CD 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-0427-2016·2015-12-23

    bioMerieux MYLA Clinic Patch 3.3.0 Recalled for Patient Data Linking Error

    bioMerieux is recalling MYLA Clinic Patch 3.3.0 software because it may link test results to incorrect patient records when connected to specific laboratory systems.

    Product
    MYLA CLINIC PATCH 3.3.0 CD 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 (Food)·F-0408-2016·2015-12-23

    Kerry Foods Recalls White Sanding Sugar Due to Metal Contamination

    Kerry Foods is voluntarily recalling specific lots of Bake Sense and Sprinkle King white sanding sugar because they may contain metal.

    Product
    Bake Sense, White Sanding Sugar,m QWHI413.01, 52273, 92273 ( net wt 8 lb), UPC: inner 92273; outer 10018609922736, , NET WT: 32 lb (14.51 kg). Sprinkle King, White Sanding Sugar,QWHI413.L32, UPC:inner 766818313106, outer 10766818313103, NET WT: 32 lb (14.51 kg).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-0430-2016·2015-12-23

    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 DL380 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-0434-2016·2015-12-23

    Beckman Coulter Recalls DxH Slidemaker Stainer Software Due to ID Errors

    Beckman Coulter is recalling specific software versions for the DxH 600 and 800 Slidemaker Stainer systems because they allow the creation of multiple orders with the same specimen ID but different patient IDs.

    Product
    UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No. B23858 The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0393-2016·2015-12-23

    Metro Gluten Free Cheese Ravioli Recalled for Possible Salmonella Contamination

    Contes Pasta Company is recalling Metro Irresistibles Gluten Free Cheese Ravioli due to possible Salmonella contamination found in a raw product.

    Product
    Metro Irresistibles Gluten Free Cheese Ravioli 6- 9 ounce bags Use By 020317; Imported for Metro Brands, Montreal Quebec, H1C 1V6, Toronto (Ontario) M9B 1B9 UPC 059749935609
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0413-2016·2015-12-23

    GE Healthcare Recalls Optima CL323i and IGS 320 X-ray Systems

    GE Healthcare is recalling 108 Optima CL323i and Optima IGS 320 angiographic X-ray systems due to a potential loss of displayed imaging.

    Product
    GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0409-2016·2015-12-23

    Kerry Foods Recalls Yellow Sanding Sugar Due to Metal Contamination

    Kerry Foods is voluntarily recalling Sprinkle King Yellow Sanding Sugar because it may contain metal. The recall covers 32 lb bags distributed to 19 states.

    Product
    Sprinkle King, Yellow Sanding Sugar,QYEL413.L32, UPC:Inner: 766818313403; Outer: 10766818313400, NET WT: 32 lb (14.51 kg).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-0405-2016·2015-12-23

    Kerry Foods Recalls Sprinkle King Orange Sanding Sugar Due to Metal

    Kerry Foods is recalling Sprinkle King Orange Sanding Sugar because it may contain metal. The product was distributed in 18 states.

    Product
    Sprinkle King, Orange Sanding Sugar, QORG413.L32, UPC:766818311706/ 10766818311703, NET WT: 32 lb (14.51 kg). Sprinkle King, Orange Sanding Sugar,QORG413DDA.L32, UPC:766818311706/ 10766818311703, NET WT: 32 lb (14.51 kg). Sprinkle King, Orange Sanding…
    Category
    Food
    Distribution
    19 states
  • HighNHTSA·15V875000·2015-12-23

    Forest River Recalls 2016 Prime Time Trailers with Incorrect Tire Placards

    Forest River is recalling 2016 Prime Time recreational trailers because the Federal placard lists the wrong tire load range, which may lead to overinflation and tire failure.

    Product
    PRIME TIME — PRIME TIME SPARTAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0397-2016·2015-12-23

    Conte's Gluten Free Cheese Ravioli Recalled for Salmonella Risk

    Conte's Pasta Company is recalling gluten-free cheese ravioli with marinara sauce due to possible Salmonella contamination found in a raw product.

    Product
    Conte's Gluten Free Wheat Free Cheese Ravioli With Marinara Sauce (French Labeling - Raviolis Au Fromage avec sauce Marinara) Net Wt. 340 g (12 Ounces) Conte's Pasta Co. Inc. 310 Wheat Road, Vineland, NJ 08360 800.211.6607 www.contespasta.com UPC 734153944458
    Category
    Food
    Distribution
    11 states
  • HighNHTSA·15V872000·2015-12-23

    Holiday Rambler and Monaco Motorhomes Recalled for Unstable Entry Steps

    Allied Recreation Group is recalling specific Holiday Rambler and Monaco motorhomes because a bolt on the electric entry steps may fracture, causing instability and injury risk.

    Product
    HOLIDAY RAMBLER — HOLIDAY RAMBLER, MONACO, MONACO RV AMBASSADOR, ENDEAVOR, KNIGHT, NEPTUNE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0400-2016·2015-12-23

    Kerry Foods Recalls Coarse White Sugar Due to Metal Contamination

    Kerry Foods is voluntarily recalling specific lots of Sprinkle King and Bake Sense coarse white sugar due to potential metal contamination. The recall covers 176,596 lbs distributed across 19 states.

    Product
    Sprinkle King, White Coarse Sugar, 30621693.L32, UPC: Outer: 30763089281623 / Inner: 763089280601, ,NET WT: 32 lb (14.51 kg). DDA, WHITE CON AA DDA (Coarse White Sugar) , Q31320.L32, 01064873, 01064823 (net wt 8 lb), UPC: Outer: 29519151867 / Inner: 29519151850, NET WT…
    Category
    Food
    Distribution
    19 states