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.

23226–23250 of 50435

  • HighNHTSA·20V269000·2020-05-13

    2020–2021 Forest River Vibe Trailers Recalled for Missing Refrigerator Roof Vent

    Forest River is recalling certain 2020–2021 Vibe trailers because the roof vent for the refrigerator may be missing. Without proper ventilation, the refrigerator could overheat and create a fire risk, or carbon monoxide could accumulate inside the trailer.

    Product
    FOREST RIVER — FOREST RIVER VIBE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1870-2020·2020-05-13

    Maquet Hemashield Platinum Vascular Grafts Recalled for Seam Line Defects

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

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft- 1 Branch, Product Code: M00202175824P0 - 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-1926-2020·2020-05-13

    Stryker Recalls Spy-Phi Drapes Packaged in Unsealed Pouches

    Stryker is recalling 21,078 units of Spy-Phi Drapes because they were packaged in unsealed pouches, compromising sterility.

    Product
    Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI: HH2020/20858701006326
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1890-2020·2020-05-13

    Intuitive Surgical Recalls daVinci XI Sureform Stapler Reloads Due to Deployment Defect

    Intuitive Surgical is recalling 22,752 daVinci XI Sureform 60 reloads worldwide because a manufacturing variation may prevent adjacent staples from deploying, potentially causing an incomplete staple line.

    Product
    daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx Only, Sterile EO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·010-2020·2020-05-13

    Evans Food Group Recalls Pork Skin Products Due to Undeclared Soy

    Evans Food Group is recalling ready-to-eat pork skin products because the variety pack label fails to declare soy, a known allergen.

    Product
    Evans Food Group — Evans Food Group Recalls Ready-To-Eat Pork Skin Products due to Misbranding
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1764-2020·2020-05-13

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

    Siemens is recalling 314 AXIOM Aristos FX 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 - Product Usage: 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. The MPRS allows radiographic exposures of the whole body including skull, spinal…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1879-2020·2020-05-13

    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: M00202175924P0 - 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-1882-2020·2020-05-13

    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 may cause intra-operative bleeding.

    Product
    HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175930P0 - 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-1899-2020·2020-05-13

    Varian Multileaf Collimator Recall Due to Software-Related Leaf Movement Failure

    Varian Medical Systems is recalling 151 Multileaf Collimators because a software upgrade caused leaves to fail to move during specific arc treatments.

    Product
    Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 120 leaf]; High Definition 120 Multileaf Collimator Model Number(s): product code: H54 and H56; MLC software version 8.5 - Product Usage: is intended to assist the clinician in the delivery of external…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1841-2020·2020-05-13

    Philips Recalls Transesophageal Ultrasound Transducers Due to Temperature Measurement Failure

    Philips Ultrasound Inc is recalling S7-3t transesophageal transducers because a manufacturing programming error prevents the system from correctly measuring tip temperature, which may stop auto-cooling and cause patient injury.

    Product
    Transducer S7-3t UDI (01)00884838061439 REF 989605406772 Can be used with: CX50, EPIQ 7, Affiniti 50 and Affiniti 70 Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1838-2020·2020-05-13

    Ivoclar Vivadent recalls dental ceramic blocks due to cracking during sintering

    Ivoclar Vivadent AG is recalling 332 units of IPS e.max ZirCAD ceramic blocks because they crack during the sintering process. The recall covers lots Y47472 and Z000V0 distributed nationwide.

    Product
    Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 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: 686194
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1888-2020·2020-05-13

    Inpeco Centrifuge Module Recall for Potential Unbalanced Load Damage

    Inpeco S.A. is recalling 23 Abbott Accelerator a3600 Centrifuge Modules because a loading algorithm defect may cause unbalanced loads that could damage the equipment.

    Product
    Abbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2-5-0.elf and CM_1-7-1.H86 or xCMd_2-5-1-849fad9.elf
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-1864-2020·2020-05-13

    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 Graft-Angled 4 Branch, Product Code: M00202175728AP0 - 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-1918-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling 25 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: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, Remv 3 Gang 1o2 Manifold w/3 Clave, Baseplate, Rotating Luer w/Filter Cap, 1 Ext, Sterile R, UDI: (01)00887709028241
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1919-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling 275 units of IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medications.

    Product
    REF: Z3239, 126" 10 Drop Primary Set w/3 MicroClave, 2 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile R, UDI: (01)00887709030473
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1923-2020·2020-05-13

    Philips Brilliance IQon Spectral CT Recall for Cooling Unit Bolt Issue

    Philips is recalling two Brilliance IQon Spectral CT systems because a bolt on the cooling unit was not tightened to specification.

    Product
    Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1905-2020·2020-05-13

    Medtronic Recalls Visualase Cooled Laser Applicator System Tubing Sets

    Medtronic is recalling Visualase Cooled Laser Applicator System tubing sets due to assembly defects that may disrupt saline flow.

    Product
    Visualase Cooled Laser Applicator System Tubing Set kits Product numbers: VCLAS 9735559, 3mm tip/1.65mm catheter VCLAS 9735560, 10mm tip/1.65mm catheter VCLAS 9735561, 15mm tip/1.85mm catheter
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1903-2020·2020-05-13

    Ortho Development Recalls Tibial Tray Due to Manufacturing Defect

    Ortho Development Corporation is recalling 27 units of Tibial Tray Nonporous A Size 2 due to a manufacturing defect in the locking mechanism that may cause assembly resistance.

    Product
    Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1906-2020·2020-05-13

    Intuitive Surgical Recalls da Vinci SP Instrument Arm Drapes

    Intuitive Surgical is recalling da Vinci SP Instrument Arm Drapes because they may tear, compromising the sterile barrier.

    Product
    da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 Pouch
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Food)·F-0936-2020·2020-05-13

    La Sonorense Recalls Whole Wheat Flour Tortillas for Undeclared Wheat

    La Sonorense, Inc. is recalling whole wheat flour tortillas because the packaging does not properly display the ingredient list and contains undeclared wheat.

    Product
    14", 10" Hand Stretched Whole Wheat Flour Tortillas, packaged in quantities of 1-2 dozen per package. Each package is twist-tied and placed in a box. Box is then sealed for delivery.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0934-2020·2020-05-13

    La Sonorense Pressed Wheat Flour Tortillas Recalled for Undeclared Wheat

    La Sonorense, Inc. is recalling pressed wheat flour tortillas because the product does not properly display the list of ingredients and contains undeclared wheat.

    Product
    12", 10" Pressed Wheat Flour Tortillas, packaged in quantities of 1-2 dozen per package. Each package is twist-tied and placed in a box. Box is then sealed for delivery.
    Category
    Food
    Distribution
    1 state
  • HighUSDA FSIS·PHA-05122020-01·2020-05-12

    P&S Raw Beef Ravioli Alerted for Possible E. Coli O157:H7 Contamination

    USDA FSIS issued a public health alert for P&S raw beef ravioli due to possible E. coli O157:H7 contamination. Consumers should discard or return the product.

    Product
    P&S Ravioli — FSIS Issues Public Health Alert for Raw Beef Ravioli Products Due to Possible E. Coli O157:H7 Contamination
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·20V266000·2020-05-12

    Blue Bird Recalls School Buses Due to Air Conditioner Fire Risk

    Blue Bird is recalling 2020-2021 Vision and All American school buses because an incorrectly installed air conditioning circuit breaker may increase the risk of a fire.

    Product
    BLUE BIRD — BLUE BIRD VISION SCHOOL BUS, ALL AMERICAN SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·20V267000·2020-05-12

    Blue Bird Recalls 2020-2021 Transit Buses for A/C Fire Risk

    Blue Bird is recalling 2020-2021 Vision and All American buses because an incorrectly installed air conditioning circuit breaker may increase the risk of a fire.

    Product
    BLUE BIRD — BLUE BIRD VISION TRANSIT BUS, ALL AMERICAN TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide