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.

33251–33275 of 50502

  • HighFDA (Devices)·Z-1127-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled Due to Sterility Compromise

    Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers 155 units distributed worldwide.

    Product
    Intact Disposable Wands (part of the Intact System) 900-112: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·17V075000·2017-02-08

    Volkswagen Recalls 2017 Passat Vehicles Due to Brake Fluid Leak Risk

    Volkswagen is recalling 2017 Passat vehicles because brake fluid may leak from line connections, potentially increasing stopping distance and crash risk.

    Product
    VOLKSWAGEN — VOLKSWAGEN PASSAT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1124-2017·2017-02-08

    Synthes Radial Head Prosthesis Recalled for Potential Stem Loosening

    Synthes (USA) Products LLC is recalling 50,311 units of the Radial Head Prosthesis System because the radial stem may loosen post-operatively at the stem bone interface.

    Product
    Synthes Radial Head Prosthesis System, Surgical instrument motors and accessories Product Usage: Intended for primary and revision joint replacement of the radial head.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1430-2017·2017-02-08

    West Coast Laboratories Recalls Xambo and Devagrass Due to DMAA Presence

    West Coast Laboratories is recalling Xambo and Devagrass capsules because they may contain 1,3-dimethylamylamine (DMAA). The recall involves 964,240 capsules distributed in Colombia.

    Product
    Xambo, 80 boxes of bulk capsules. Each containing 12,053 capsules in each box.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1135-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling Intact Disposable Wands because the sterile barrier was breached, compromising product sterility.

    Product
    Intact Disposable Wands (part of the Intact System) 777-120BT: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1111-2017·2017-02-08

    Organ Preservation Solution Recalled for Potential Bacterial Contamination

    Organ Recovery Systems is recalling SPS-1 Static Preservation Solution bags due to potential bacterial contamination.

    Product
    SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0450-2017·2017-02-08

    Dr. Reddy's Recalls Flucanazole Tablets for Dissolution Failures

    Dr. Reddy's is recalling Flucanazole tablets that failed dissolution and stability specifications. Patients should stop using the affected lots and consult their healthcare provider.

    Product
    FLUCONAZOLE — FLUCONAZOLE (FLUCONAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1121-2017·2017-02-08

    Medtronic Strata II Valves Recalled for Pressure Discrepancies

    Medtronic is recalling Strata II and Strata NSC valves used for hydrocephalus management due to reported discrepancies between the set pressure level and x-ray readings.

    Product
    Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type valves are used in the management of hydrocephalus. The Strata II/Strata NSC valve is a shunt component designed to allow for continuous flow of cerebrospinal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·17083·2017-02-08

    La-Z-Boy Recalls Lift Chair Power Supplies Due to Shock Hazard

    La-Z-Boy is recalling specific power supplies sold with lift chairs because the covers can crack and detach, exposing electrical components and posing a shock hazard.

    Product
    Power supplies sold with lift chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1120-2017·2017-02-08

    Siemens IMMULITE PSA Kit Recall Due to Negative Bias Results

    Siemens is recalling two lots of IMMULITE PSA kits because they produce negative bias results, potentially affecting prostate cancer screening accuracy.

    Product
    IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1363-2017·2017-02-08

    Rich Products Recalls Ice Cream Layer Cakes Due to Undeclared Walnuts

    Rich Products Corp is recalling Jon Donaire Ice Cream Layer Cakes because they may contain undeclared walnuts from a supplier.

    Product
    Jon Donaire Ice Cream Layer Cake, Deliciously moist white cake with rich, creamy strawberries & cream ice cream, NET WT 4 LB 8 OZ, KEEP FROZEN, UPC 0 49800 04776 1 (retail), Product Code 04776 --- Rich Products Corp., Buffalo, NY 14213
    Category
    Food
    Distribution
    35 states
  • HighFDA (Devices)·Z-1125-2017·2017-02-08

    Covidien Nellcor SpO2 Forehead Sensor Recalled for Latex Labeling Error

    FDA is recalling 7,453 units of the Covidien Nellcor SpO2 Forehead Sensor because the label incorrectly states the product is latex-free, while the headband contains latex.

    Product
    Covidien Nellcor SpO2 Forehead Sensor Item Code: RS10; The Covidien Nellcor¿ Forehead SpO2Sensor, model RS10, is indicated for use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing more than 40 kg.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1129-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling 252 Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The devices are used for breast tissue removal.

    Product
    Intact Disposable Wands (part of the Intact System) 777-112BT: 5 Pack 12mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1036-2017·2017-02-08

    Olympus Vanta XRF Analyzers Recalled for LED Warning Light Failure

    Olympus is recalling Vanta VCR and VMR XRF analyzers because the LED warning lights may fail to illuminate during X-ray emission.

    Product
    Olympus Scientific Solutions Americas Corporation (OSSA) VANTA¿ XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems
    Category
    Medical Device
    Distribution
    22 states
  • HighFDA (Drugs)·D-0465-2017·2017-02-08

    VistaPharm Recalls Methadone Hydrochloride Due to Potential Bacterial Contamination

    VistaPharm is recalling Methadone Hydrochloride Oral Concentrate because purified water used in manufacturing may have been contaminated with Burkholderia cepacia.

    Product
    METHADONE HYDROCHLORIDE — METHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1426-2017·2017-02-08

    Raley's Canned Cut Green Beans Recalled Due to Rat Presence

    Raley's is recalling 14,000 cans of 14.5oz Cut Green Beans after a partial black rat was found in the product.

    Product
    Raley'ss Canned Cut Green Beans 14.5oz ; UPC: 4656700204
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1376-2017·2017-02-08

    Arro Corporation Recalls Hot Cocoa Pouches Due to Salmonella Risk

    Arro Corporation is recalling 46 cases of Hot Cocoa due to possible Salmonella contamination from powdered milk and buttermilk ingredients.

    Product
    Hot Cocoa, NOT FOR RETAIL SALE, Prod: 28OCT2016, BB: 28JUN2017, Net Weight: 907 g (2.0 lb), Best Before: 28JUN2017
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1134-2017·2017-02-08

    Medtronic Intact Disposable Wands Recalled for Sterility Compromise

    Medtronic is recalling 326 Intact Disposable Wands because the sterile barrier was breached, compromising sterility. The recall covers units distributed in the US and several international countries.

    Product
    Intact Disposable Wands (part of the Intact System) 777-120: 5 Pack 20mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1366-2017·2017-02-08

    Rich's White Cake with Vanilla Ice Cream Recalled for Undeclared Walnuts

    Rich Products Corp is recalling specific lots of Rich's 1/4 Sheet White Cake with Vanilla Ice Cream because the product may contain undeclared walnuts.

    Product
    RICH'S 1/4 Sheet White Cake with Vanilla Ice Cream Cake, KEEP FROZEN, UNIT NET WT: 60 OZ (3 LB 12 OZ), COUNT: 4 x 1/4 SHEET CAKES, NET CASE WT: 15 LB, UPC 049800 290013 (retail), Product Code 29001 --- RICH PRODUCTS CORP BUFFALO, NY 14213
    Category
    Food
    Distribution
    35 states
  • HighFDA (Devices)·Z-1119-2017·2017-02-08

    Siemens Recalls IMMULITE PSA Kits Due to Negative Bias

    Siemens Healthcare Diagnostics is recalling IMMULITE PSA kits worldwide because patient samples show an average negative bias of approximately -22%.

    Product
    IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Kit Catalog) Product Usage: For in vitro diagnostic use with the IMMULITE¿ and IMMULITE 1000 Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1365-2017·2017-02-08

    Rich Products Vanilla Ice Cream Cake Recalled for Undeclared Walnuts

    Rich Products Corp is recalling Signature SELECT Vanilla Ice Cream & White Cake ICE CREAM CAKE because it may contain undeclared walnuts.

    Product
    Signature SELECT Vanilla Ice Cream & White Cake ICE CREAM CAKE , NET WT 4 LB 13 OZ, KEEP FROZEN, UPC 021130 114641, Product Code 06620 ---
    Category
    Food
    Distribution
    35 states