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.

23176–23200 of 50435

  • HighCPSC·20743·2020-05-14

    Jade Bloom Essential Oils Recalled for Non-Child-Resistant Packaging

    W8 Distributing is recalling Jade Bloom Wintergreen and Birch Sweet Essential Oils because the packaging is not child-resistant, posing a poisoning risk to young children.

    Product
    Jade Bloom Wintergreen and Birch Sweet Essential Oils
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·20V275000·2020-05-14

    Heartland Recalls 2020 Trailers Due to Spare Tire Carrier Defect

    Heartland is recalling 2020 Trail Runner, Wilderness, Mallard, and Prowler trailers because a U-bolt on the spare tire carrier may break, causing the tire to detach.

    Product
    HEARTLAND — HEARTLAND WILDERNESS, TRAIL RUNNER, MALLARD, PROWLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·20745·2020-05-14

    Organic Pure Oil Recalls Wintergreen Essential Oil for Packaging Defect

    Organic Pure Oil is recalling Wintergreen Essential Oil because the packaging is not child-resistant, posing a risk of poisoning to young children.

    Product
    Organic Pure Oil Wintergreen Essential Oil
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·20123·2020-05-14

    Sterno Home Recalls Path Light Kits Due to Electric Shock Hazard

    Sterno Home is recalling Hampton Bay, Patriot, and Paradise path light kits because a defective power supply poses an electric shock risk.

    Product
    Hampton Bay, Patriot Lighting and Paradise light kits with Sterno Home LED power supplies
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1765-2020·2020-05-13

    Siemens AXIOM Aristos FX Plus X-Ray System Recalled for Unintended Radiation

    Siemens is recalling 399 AXIOM Aristos FX Plus x-ray systems worldwide because they may perform exposures without the button being pressed, resulting in low-dose unintended radiation.

    Product
    System AXIOM Aristos FX Plus - A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems; and allows radiographic exposures of the whole body including skull, spinal column, chest…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1896-2020·2020-05-13

    Intuitive Surgical Recalls da Vinci Xi Universal Surgical Manipulators

    Intuitive Surgical is recalling 270 Universal Surgical Manipulator units from da Vinci Xi systems due to high friction causing arm movement issues.

    Product
    da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the IS4000 system and its…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1837-2020·2020-05-13

    Ivoclar Vivadent recalls dental ceramic blocks due to cracking during sintering

    Ivoclar Vivadent AG is recalling 9 units of IPS e.max ZirCAD CER/inLab LT A1 C17/5 ceramic blocks because they crack during the sintering process.

    Product
    Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/CAM technology Product Number: 686193
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1880-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175926P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1855-2020·2020-05-13

    Nobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screws

    Nobel Biocare is recalling 215 Snappy Abutment 5.5 CC RP 3 mm units because they may contain incorrect screws that could loosen.

    Product
    Snappy Abutment 5.5 CC RP 3 mm; pre-manufactured prosthetic components directly connected to the endosseous implant, catalog no. 36683 - - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-1 Branch, Product Code: M00202175832P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1897-2020·2020-05-13

    Intuitive Surgical Recalls da Vinci X Universal Surgical Manipulators

    Intuitive Surgical is recalling 270 Universal Surgical Manipulators for da Vinci X systems due to high friction causing arm movement issues.

    Product
    da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the IS4000 system and its…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1916-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling 650 units of IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.

    Product
    REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp, UDI: (01)(01)00887709026889
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Food)·F-0932-2020·2020-05-13

    Aldi Recalls Organic Red Split Lentils for Undeclared Wheat

    Aldi is recalling Simply Nature Organic Red Split Lentils because the product may contain undeclared wheat. This poses a risk to individuals with wheat allergies or celiac disease.

    Product
    Simply Nature Organic Red Split Lentils, 16 oz bag, UPC 041498299507
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1921-2020·2020-05-13

    Philips Brilliance iCT Computed Tomography Systems Recalled for Bolt Defect

    Philips North America, LLC is recalling 19 Brilliance iCT Computed Tomography X-Ray Systems because a bolt affixing the cooling unit to the rotor was not tightened to specification.

    Product
    Philips Brilliance iCT Computed Tomography X-Ray System; Model # 728306; UDI #s (01)00884838059474(21)100783, (01)00884838059474(21)100848
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1875-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0951-2020·2020-05-13

    Benefiber Prebiotic Fiber Supplement Recalled for Potential Plastic Contamination

    Glaxosmithkline is recalling specific lots of Benefiber Prebiotic Fiber Supplement because the product may contain small plastic pieces.

    Product
    Benefiber Prebiotic Fiber Supplement, packaged in the following ways 1) Net Wt. 500 g (17.6 oz) bottle. UPC 886790218302 and 2) Net Wt. 760 g bottle UPC 8886790211907
    Category
    Food
    Distribution
    25 states
  • HighFDA (Devices)·Z-1866-2020·2020-05-13

    Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Line Bleeding Risk

    Maquet Cardiovascular is recalling Hemashield Platinum Woven Double Velour Vascular Grafts due to potential small holes at seam lines that may cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175732P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1901-2020·2020-05-13

    Delfi VariFit Contour Cuffs Recalled for Inadequate Weld

    Delfi Medical Innovations is recalling 59 units of VariFit Contour Cuffs due to a manufacturing defect that may cause the cuff to leak.

    Product
    Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1885-2020·2020-05-13

    Northgate Technologies Recalls ACMI 9FR Probes Due to Biocompatibility Failure

    Northgate Technologies is recalling ACMI 9FR probes used for stone fragmentation because a lot failed biocompatibility testing.

    Product
    ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1881-2020·2020-05-13

    Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Defects

    Maquet is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 4 Branch, Product Code: M00202175928P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1884-2020·2020-05-13

    Northgate Technologies Recalls Autolith Uro-Tch 9FR Probes for Biocompatibility Failure

    Northgate Technologies is recalling Autolith Uro-Tch 9FR probes because a lot failed biocompatibility testing. The recall covers 198 boxes distributed nationwide.

    Product
    AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1877-2020·2020-05-13

    Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes

    Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at the seam lines that could cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175914P0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
    Category
    Medical Device
    Distribution
    Distributed nationwide